cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Fibula Free-flap MR With or Without PVP in Patients With OOPC

This is a national multicenter, randomized, stratified, open label study, aiming to compare mandibular reconstruction (MR) with or without preoperative virtual planning (PVP), in patients with oral/oropharyngeal cancer (OOPC).

PVP-assisted MR includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory: Materialise laboratory).

PVP-assisted MR includes the production of :

* surgical cutting guides required for mandibular resection and fibula free-flap conformation
* preformed plates for flap osteosynthesis

Patients will be selected after the multidisciplinary decision of oncological surgery including segmental mandibulectomy and immediate MR. Patients will be randomized in 2 groups (ratio 1:1, stratified on center and tumor N status \[0-1 vs 2-3\]).

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over
2. Primary or recurrent OOPC, histologically proven, requiring segmental mandibulectomy
3. Planned immediate fibula free flap MR to be performed at the same time as the tumor ablation by segmental mandibulectomy
4. MR requiring at least one osteotomy for contouring the flap (i.e. at least 2 bone fragments)
5. East Cooperative Oncology Group (ECOG) performance status 0 or 1
6. American Society of Anesthesiologists Physical Status (ASA) score 1, 2, or 3
7. Patients considered fit for surgery as decided by the multidisciplinary team
8. Patients must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures
9. Patients must be affiliated to a Social Security System (or equivalent)
10. Patients must have signed a written informed consent form prior to any trial specific procedures. If the patients are physically unable to give their written consent, a trusted person of their choice, not related to the investigator or the sponsor, can confirm in writing the patient's consent

Exclusion Criteria:

1. Non resectable tumors (T4b primary tumor, non resectable metastatic lymph nodes)
2. Comorbidities factors that would contraindicate surgery (such as severe peripheral artery disease)
3. MR requiring no osteotomy for contouring the flap (i.e. one bone fragment)
4. Patients with distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or positron emission tomography (PET)-CT
5. Other uncontrolled malignancy
6. Serious, non-healing or dehiscing wound, active ulcer or ongoing bone fracture at the free-flap donor site
7. Patients unwilling or unable to comply with the medical follow-up required by the trial because of psychosocial, familial, social, or geographical reasons
8. Participation in another clinical study with an investigational medicinal product during the last 30 days prior to inclusion
9. Patients deprived of their liberty or under protective custody or guardianship
Remote Brain Microhaemorrhages May Predict Haematoma in Glioma Patients Treated With Radiation Therapy

the study aim to evaluate the prevalence of cerebral remote microhaemorrhages (RMH) and remote haematomas (RH) using magnetic resonance susceptibility-weighted imaging (SWI) among patients treated for gliomas during follow-up.


Eligibility Criteria:
Inclusion Criteria:

* glioma

Exclusion Criteria:

-
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.

The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.


Eligibility Criteria:
Inclusion Criteria:

* Age 24-75 years old at time of screening.
* Diagnosed with Type 1 diabetes ≥10 years prior to screening.
* On pump therapy for ≥ 6 months prior to screening.
* Not on Real Time continuous glucose monitoring for ≥ 3 months prior to screening.
* HbA1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening.
* A documented Severe Hypoglycemia event ≤ 12 months prior to screening, OR Clarke score ≥4 assessed at time of screening, OR
* Gold score ≥4 assessed at time of screening.
* Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.

Exclusion Criteria:

* Untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
* Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
* Renal failure defined by creatinine clearance \<30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab.
* Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
* Current pregnancy or intention to conceive.
* Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
* Alcohol or drug abuse, other than nicotine, per investigator judgment.
* Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
* Legally incompetent, illiterate or vulnerable person.

Randomization Criteria:

* If subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study:

  * Subject has worn two weeks the sensor with transmitter during the run-in period.
  * Subject has shown acceptable tolerance of sensor wear, per investigator judgment.
  * Subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by CareLink™ Clinical data upload as the mean number of SMBG/day over the past 14 days (SMBG number / day ≥ 3.5 rounds up to 4).
  * Subject showed ability to comprehend the pump training and study procedures, per investigator judgment.
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19

The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.

This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 positive test result (including presumptive positive).
* Hospitalization
* Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
* Age ≥18 years old.
* Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
* Able to read/write/speak English or Spanish fluently.
* Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.

provide informed consent, and provide authorization of use and disclosure of personal health information.

* Negative pregnancy test for women of childbearing potential.

Exclusion Criteria:

* Severe allergy to any IVIG product formulation
* History of DVT, PE, thromboembolic stroke or other thrombotic events
* Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
* Uncontrolled hypertension (SBP\>180 mm Hg or DBP\>120mmHg)
* Active participant in another research treatment study
* Mechanically ventilated patient
* Code status is Do Not Resuscitate or Do Not Intubate
Impact of Sedation With HFNOT on tcPCO2, mitoPO2 and mitoVO2.

Deep procedural sedation has seen an increased use indication over the last couple of years aided by the introduction of high flow nasal oxygen therapy (HFNOT) during these procedures. However, this level of deep sedation does come with the increased risk of examining whether a patient is adequately ventilated during this procedure.

The definition of deep sedation is: 'a drug-induced depression of consciousness during which patients cannot be easily aroused but respond purposefully following repeated or painful stimulation. The ability to independently maintain ventilatory function may be impaired. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained.' As the definition showed there may be an insufficient ventilation during deep sedation. Therefore, HFNOT is used to ensures that the peripheral oxygen saturation is sufficient. However, there are two potential disadvantages. HFNOT can mask the presence of an insufficient respiratory minute volume and an insufficient gas exchange, which can lead to high arterial CO2 (paCO2) levels. Another risk associated with HFNOT is the fact that high oxygen levels are toxic, and prolonged exposure to high partial oxygen pressures, can cause oxidative damage to cell membranes, collapse of the alveoli in the lungs, retinal detachment, and seizures. Most of this damage can be explained by hyperoxia that increases the 'leak' of electrons from the mitochondrial electron transport chain and the resulting increased generation of reactive oxygen species (ROS). Low paCO2 levels and hyperoxia cannot be examined using standard monitoring techniques therefore, this study will use the transcutaneous carbon dioxide (tcPCO2) a proven technique which correlates well to the arterial CO2 (paCO2) to evaluate whether there is an adequate level of ventilation during deep procedural anesthesia with HFNOT. Moreover, the cutaneous mitochondrial oxygenation (mitoPO2) will be monitored to determine the effects that deep procedural sedation with HFNOT has on the cellular oxygenation.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Acceptable proficiency of the Dutch language
* Scheduled for a procedure requiring deep procedural sedation with HFNOT.

Exclusion Criteria:

* Porphyria
* Known intolerance to components of the ALA plaster
* Presence of mitochondrial disease
* Pregnancy/lactation
* Patients with skin lesions on the measurement location which impede measurements
* Incapability to provide inform consent, due to a mental condition interfering with the ability to understand the provided information
Effect of Empagliflozin on Ventricular Repolarization.

The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, the investigators will verify if empagliflozin is associated with a reduction in electrical instability.

Cardiovascular diseases are the leading cause of morbidity and mortality in diabetic patients.

New hypoglycemic drugs are required to undergo cardiovascular safety studies for their release. In 2015, EMPA-REG OUTCOME, which was done for empagliflozin´s approval was the first study to provide evidence that an antidiabetic agent could decrease cardiovascular events. The results demonstrated a reduction in the primary outcome (death by cardiovascular causes, nonfatal infarction, and nonfatal stroke), cardiovascular mortality and hospitalization for heart failure in patients with type 2 diabetes at high cardiovascular risk who received empagliflozin in combination with standard treatment. It is noteworthy that the study population was under-optimized clinical treatment with antihypertensives, statin and aspirin and especially it is noteworthy that the difference in the primary outcome over placebo became evident only three months after treatment´s start.

The potential mechanisms underlying the surprising cardiovascular benefits of empagliflozin are not fully understood.

The present project aims to investigate if the empagliflozin has an antiarrhythmic action. Analyzing the T-wave heterogeneity index, a new electrocardiographic risk marker associated with the prediction of cardiovascular risk, in diabetic patients and coronary artery disease, we will verify if empagliflozin is associated with a reduction in electrical instability.

Eligibility Criteria:
Inclusion Criteria:

* • Age ≥ 18 years;

  * Fasting glycemia\> 100 mg/dl or previous diagnosis of type 2 diabetes mellitus;
  * Coronary artery disease, defined by one of the following criteria: the antecedent of myocardial infarction; the evidence of significant coronary stenosis in previous coronary angiography; the noninvasive positive test for ischemia (stress electrocardiogram, stress echocardiogram, stress scintigraphy)
  * TWH ≥ 80 microvolts

Exclusion Criteria:

* Chronic renal insufficiency with glomerular filtration rate ≤ 45 ml / min / 1.73m2;
* Hepatic insufficiency (determined by Child-Pugh, B or C classification);
* Age ≥ 85 years;
* 12-lead resting electrocardiogram with the following changes: intraventricular conduction disorders (bundle branch block), pacemaker rhythm, atrial fibrillation or flutter, artifact stroke distortion or baseline fluctuation
Physical Training Introduction in Lifestyle of Facioscapulohumeral Dystrophy Patients

It is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. In patients suffering from facioscapulohumeral dystrophy (FSHD), aerobic training has been reported to be associated to physiological and functional positive effects without alteration in quality of life. The review papers from Van der Kooi et al. (2005), Cup et al. (2007) and Féasson et al. (2010) suggest that the combination of endurance and strength training is even more relevant. Only a few controlled and randomized studies have been conducted on this topic. The impact of such training programs on the skeletal muscle regenerative capacities has not been yet addressed. Moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not regular exercise practice can be maintained in patient's daily life. Also, only a few experiments have reported an integrative view of the potential benefits of such programs on functional, biological and quality of life.

Our research project aims at establishing a program of physical training that will fulfill the two following conditions: (i) being compatible with the daily professional, social and family activity of the patients so it can be integrated in their life habits and (ii) being intensive enough to induce functional benefits. This experimental work will be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires. This work will be based on a collaboration between the Universities of Saint Etienne (L. Féasson), Grenoble (B Wuyam) and Örebro (F Kadi) within the Rhône-Alpes Reference Centre for Rare Neuromuscular Diseases (JC Antoine).

It is accepted that exercise therapy can be recommended for patients with myopathies but long-term training load still has to be determined for each pathology. In the specific context of facioscapulohumeral dystrophy, we aim at associating the scientific evaluation of physical activity benefits and a therapeutic education of patients in order to contribute to recommendations for physicians and physiotherapists. The purpose of this study is to combine an integrated approach with a better understanding of biological process implicated in this physiological treatment strategy.

Eligibility Criteria:
Inclusion Criteria:

* facioscapulohumeral dystrophy
* Being capable of supporting an exercise on ergocycle
* Social Security regimen affiliated
* Consent form signed

Exclusion Criteria:

* Severe cardiac or respiratory insufficiency
* Cardiac pacemaker
* Morbid obesity (BMI upper to 35)
* Anti platelet therapy
Observational Study of the Quality of Life for the Chronic Pain Patients Included in a Therapeutic Education Program Focused on Relaxation Techniques

The benefit of learning psychocorporal techniques in Therapeutic Education on the quality of life of patients with chronic pain will be studied.

The purpose of this nursing research protocol is to highlight the improvement of the quality of life of chronic pain patients through psycho-physical techniques performed during group therapeutic education workshops.

The study will be performed at Centre for the Study and Treatment of Pain. The patients with chronic pain will participate to a group programm of therapeutic education.

The programm consists of 9 workshops about psycho-corporal techniques performed in group.

The patients will complete questionnaries before beginning the program, at the end of the programm, 6 months after the end of the program, and 12 months after the end of program.

The questionnaries will be SF36, HADS, CPAQ, and digital pain scale.

Eligibility Criteria:
Inclusion Criteria:

* chronic pain since more the 3months
* Patients for whom a group "relaxation techniques" program is planned and accepted by the patient

Exclusion Criteria:

* Patient with progressive cancer pain
* severe psychiatric pathology (example: psychosis, deep melancholy)
* Patient not compliant or refusing to participate in research
* Person who does not understand French, or illiterate
* Person physically unable to complete questionnaires (visually impaired or blind)
* Person protected by sections L1121-5 to L1121-8.1 of the French Public Health Code
Influenza Vaccine in Children With Asthma

The occurence of influenza can be a factor of imbalance of asthma. Asthma patients are recommended for annual influenza vaccination . However there is insufficient vaccination coverage of asthmatic patients despite this recommendation. The aim of this study is to evaluate the rate of influenza vaccination coverage of children with asthma aged from 6 month to 17 years of age followed in pediatric pneumology consultation at the university hospital of Nancy.

Using a questionnaire, the investigator will estimate the percentage of the asthmatic patients vaccinated against influenza. He will then compare the 2 groups of vaccinated and unvaccinated patients : comparison of patients characteristics, comparison of asthma characteristics (severity, asthma control...). He will also analyze the causes of vaccination or non-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* asthmatic patients followed in pediatric pneumology consultation at university hospital of Nancy aged from 6 months to 17 years

Exclusion Criteria:

* asthmatic children who have been followed for less than 1 year
Appropriateness of Colonoscopy Indication: an Evaluation of the Clinical and Economic Impact.

The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.

Colonoscopy is the most frequently conducted endoscopic examination in industrialized countries, occupying a considerable number of personnel and resources. However, colonoscopy is often over-prescribed, resulting in great waste of resources and increased risk to the patient with no discernible benefit. Colonoscopy has many indications and needs precise prescribing criteria to avoid inappropriate use of resources, especially in an open-access health care system such as the Italian one, criteria recently systematized by EPAGE (European Panel for Appropriateness in Gastrointestinal Endoscopy) and ASGE (American Society for Gastrointestinal Endoscopy) based on a set of observational studies. In these studies, it has been shown that colonoscopies with an appropriate indication frequently find significant lesions compared with colonoscopies prescribed according to inappropriate criteria, which are often negative. The aim of the study is to evaluate the appropriateness of colonoscopy prescription and the impact of colonoscopies in diagnostic performance in order to develop and validate a predictive model for selecting patients most likely to present with significant lesions and thus lower costs and waiting lists.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Patients undergoing outpatient and inpatient colonoscopy for any pathology, as part of the normal care process
* Obtaining informed consent.

Exclusion Criteria:

* Investigations performed in an emergency/emergency setting
Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

Pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. Over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. Although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma.

In this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes will be technical feasibility and device safety. The secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* undergoing transsphenoidal surgery
* diagnosis of pituitary adenoma on pre-operative MRI
* able to provide consent

Exclusion Criteria:

* patients less than 18 years of age
* patients undergoing transcranial surgery
* diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma
* unable to provide consent e.g., mental illness or later withdrawing consent.