cyrilzakka/clinical-trials huggingface dataset:
Glial Tumors Electromagnetic Signature Study by MagnetoEncephaloGraphy (MEG) "CONDUCTOME"

The purpose of this study is to determine the correlation between functional MEG analysis of the tumor and its periphery and the tumor stage and treatment response.

A better tumor grade definition would provide an optimized surgical care, prognosis and therapeutical response evaluation.

Eligibility Criteria:
Inclusion Criteria:

* more or equal than 18 years old
* patient affiliated to social security or similarly regime
* informed consent form signed
* supra-tentorial primitive cerebral tumor

Exclusion Criteria:

* Pregnant women and lactating mothers
* Ward of court or under guardianship
* Adult unable to express their consent
* Person deprived of freedom by judicial or administrative decision
* Person hospitalized without their consent
* Person under legal protection
* Magnetic Resonance Imaging (MRI) contraindication (implanted material non MRI-compatible, ferro-magnetic foreign body, claustrophobia)
* Patients needed emergency medical care for other pathology
* severely altered general health (Performance Status 3 or 4)
Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy

About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis.

Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late.

The management of these patients is therefore complex and the literature is poor on the subject.

In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy.

The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.'

The aim is also to describe the consequences of the surgery and analyse the end of the pregancy

Eligibility Criteria:
Inclusion Criteria:

* Women going through pregnancy

Exclusion Criteria:

-
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis.
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in the protocol
* Must be willing and able to provide informed consent and to participate in all study procedures
* Positive skin test to a prevalent Texas Mountain Cedar allergen

Exclusion Criteria:

* On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
* Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
* Nasal surgery or sinus surgery within the previous year.
* Chronic sinusitis - more than 3 episodes per year
* Planned travel outside of the study area during the study period
* The use of any investigational drug within 30 days prior to Screening. No investigational products are permitted for use during the conduct of this study
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
* Respiratory Tract Infections within 14 days prior to screening
* Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
* Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
* Significant pulmonary disease including COPD
* Clinically significant arrhythmia or symptomatic cardiac conditions
* A known history of alcohol or drug abuse within the last 2 years
* Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
* Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

The aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR, see also below). Changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional MRI. In due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery

Exclusion Criteria:

* low global performance state
* pregnancy
* lactation period
* presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips
Lung Recruitment Assessment With Lung Ultrasound In Pediatric Patient Scheduled For Laparoscopic Surgery

Anesthesia-induced atelectasis is a well-known entity observed in approximately 68-100% of pediatric patients undergoing general anesthesia. The collapse of dependent lung zones starts with anesthesia induction but can persist for hours or even days after surgery. Such anesthesia-related atelectasis has a number of negative clinical consequences such as the impairment of arterial blood oxygenation and lung mechanics as well as the predisposition for ventilator-associated lung injury. The adjustment of ventilator settings for preventing the occurrence of atelectasis and for reducing pulmonary complications remains controversial.

Lung sonography (LUS) plays an important role in diagnosing pulmonary diseases in children, including atelectasis of different origins. LUS has demonstrated its high sensitivity and specificity for diagnosing anesthesia-induced atelectasis in children.

Compare lung aeration between two different mechanical ventilation strategies (protective mechanical ventilation and recruitment maneuvers) in pediatric patients scheduled for abdominal laparoscopic surgery using ultrasound imaging and a four-point-aeration score to assess the lung aeration.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent by parents.
* Patients aged 6 months to 7 years old
* Scheduled for abdominal laparoscopic surgery
* American Society of Anesthesiologists classification: physical status I-II

Exclusion Criteria:

* Acute airway infection
* Cardiovascular and or pulmonary disease
* Previous thoracic procedure
Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis

To clarify the following matters:

* Unknown adverse reactions (especially clinically significant adverse reactions)
* Incidence and conditions of occurrence of adverse reactions in the clinical setting
* Factors that may affect the safety and effectiveness of Humira


Eligibility Criteria:
Inclusion Criteria:

* All patients prescribed and treated with Humira are included in this survey.

Exclusion Criteria:

* Contraindications according to the Package Insert:

  * Patients who have serious infections,
  * Patients who have tuberculosis,
  * Patients with a history of hypersensitivity to any ingredient of Humira,
  * Patients who have demyelinating disease or with a history of demyelinating disease,
  * Patients who have cardiac failure congestive.
Clinical Study of Pegylated Somatropin to Treat Children Growth Hormone Deficiency

To evaluate the safety and efficacy of PEG Somatropin Injection (Jintrolong®) in the treatment of short stature due to endogenous growth hormone deficiency (GHD) in the broad of population of children.


Eligibility Criteria:
Inclusion Criteria:

* Before starting treatment, the child is diagnosed as GHD according to medical history,clinical symptoms and signs, GH provocation tests and imaging examinators and other examinators.
* According to the height statistical data of Chinese children's physical development in nine cities in 2015, the height of the child is lower than the third percentile of normal children's growth curve in the same age and same gender.
* Height velocity (HV) ≤5.0 cm/yr.
* GH provocation tests with two different mechanisms showed that GH peak concentration of the child is \< 10.0ng/ml.
* Bone age (BA) ≤9 years in girls or ≤ 10 years in boys, and the BA is 1 year less than the CA.
* Prepuberty status (Tanner I stage), age ≥3 years old, girls and boys are acceptable.
* The child did not receive the treatment of growth hormone within 6 months.
* Subjects are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, and they sign informed consent.

Exclusion Criteria:

* The child is dysfunction of liver and kidney (ALT) 2 times of the upper limit of normal value, Cr\> the upper limit of normal value).
* The child has positive hepatitis B core antibody (HBc), hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg).
* The child is known as hypersensitivity to PEG Somatropin.
* The child has severe cardiopulmonary, hematological diseases, malignant tumors, general infection or immunodeficiency diseases.
* The child has potential tumor (family history).
* The child has diabetics.
* The child has abnormal growth and development, such as Turner's syndrome, constitutional delay of growth and puberty, Laron syndrome, growth hormone receptor deficiency, short stature girls with potential chromosomal abnormalities.
* The child took part in other clinical trials within 3 months.
* Other conditions are excluded when the investigator preclude the enrollment into the study.
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years

The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs) against 3 N. meningitidis serogroup B reference strains (H44/76, 5/99, and NZ98/254) and as measured by ELISA geometric mean concentrations (GMCs) against vaccine antigen 287-953, approximately 30 days after a primary vaccination course of two doses administered one month apart.

Novartis will consider this study a success if, at one month following the second vaccination, the two-sided 95% CI of the ratio of the hSBA GMTs for each of 3 serogroup B reference strains (H44/76, 5/99, and NZ98/254) and the two-sided 95% CI of the ratio of the ELISA GMCs against vaccine antigen 287-953 are contained within the interval (0.5, 2.0).

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects (11-17 years of age inclusive) who have given their written assent and whose parents or legal guardians have given written informed consent at the time of enrollment
* who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period)
* in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

* History of any serogroup B meningococcal vaccination
* Current or previous, confirmed or suspected disease caused by N. meningitidis
* Exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment
* Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38.0 °C) within the previous day
* Antibiotic use within 3 days (72 hours) prior to enrollment
* Pregnancy or nursing (breastfeeding) mothers
* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the 2 months duration of the study. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry
* Any serious chronic or progressive disease, Known or suspected impairment/alteration of the immune system
* Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
* History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
Study of NMS-1116354 in Advanced/Metastatic Solid Tumors

The purpose of this study is to evaluate the safety profile of NMS-1116354, a CDC7 kinase inhibitor, in adult patients with advanced/metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced/metastatic solid tumors, for which no alternative effective standard therapy is available
2. Maximum of 4 regimens of prior cancer therapy allowed
3. Prior radiotherapy allowed if no more than 25% of BM reserve irradiated
4. Resolution of all acute toxic effects (excluding alopecia) of any prior anticancer therapy
5. ECOG performance status (PS) 0 or 1
6. Adult (age \>/= 18 and \</= 80 years) patients
7. Adequate renal, liver and BM reserve
8. Capability to swallow capsules intact

Exclusion Criteria:

1. Current enrollment in another therapeutic clinical trial
2. Known brain metastases
3. Currently active second malignancy
4. Major surgery within 4 weeks prior to treatment
5. Any of the following in the past 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis
6. Pregnancy or breast-feeding women
7. Known active infections
8. Gastrointestinal disease or other malabsorption syndromes that would impact on drug absorption
9. Adrenal insufficiency
10. Other severe acute or chronic medical or psychiatric condition that could compromise protocol objectives
A Randomized Controlled Trial on the Effect of Exercise on Physical, Cognitive and Affective Function in Dementia Subjects

Studies have shown conflicting results of the effect of exercise on dementia patients.

The aim of this study is to examine the role of physical activity on the risk of cognitive impairment and dementia in older persons.

To promote the benefits of aerobic exercise on dementia patients and encourage exercise prescription in the management of dementia subjects.


Eligibility Criteria:
Inclusion Criteria:

* MMSE\<26
* Age \>60
* Community dwelling and ambulatory
* Have a caregiver that is willing to participate and escort patient to hospital for training and assessment

Exclusion Criteria:

* MMSE\<10
* live in old age home
* poor mobility, unable to attend exercise training
* no carer to bring patient to attend hospital training
Specified Drug Use Survey on AJOVY Subcutaneous Injection for Long-term Use

To evaluate the long-term safety of AJOVY in patients under actual use conditions and to specifically evaluate cardiovascular events. In addition, information on efficacy will be collected.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to components of AJOVY
Comparison of Intubating Conditions in 25° Head-up Position and Strict Supine

Tracheal intubation, particularly before surgery, is traditionally done in supine position. It was shown in the general population and in obese patients in particular, that the pre-oxygenation in a 25° head-up position provided a better efficiency of the pre-oxygenation and an apnea time longer. This position would also allow for better intubation conditions in direct laryngoscopy.

The investigators intend to assess two different patient's intubation position : supine position and 25° head-up position

Randomization assigned in random block, stratification by operator (20 patients per operator, 10 in each group).

Interim analysis every 100 patients.

Eligibility Criteria:
Inclusion Criteria:

* - patients scheduled for various surgeries requiring general anesthesia with curare, with intubation of the trachea, eligible for intubation by direct laryngoscopy.
* \> 18 years
* patients with social security

Exclusion Criteria:

* Emergency surgery.
* Patient who requiring rapid sequence induction.
* Intubation without curare.
* Expected difficult intubation with planned modification of the intubation protocol (i. e. intubation under fibroscopy, airtrach or videolaryngoscopy)
* Patient with a history of epilepsy, pulmonary or cardiovascular disease (including ischemic heart disease, symptomatic asthma or obstructive pulmonary disease).
* Patient with mask phobia.
* BMI\> 30kg / m2
* Patient who are refusing to take part.
* Patient protected major, minor, pregnant women, patients deemed incapable of giving informed consent.
Effect of an Low Carbon High Fat Diet on Pain- and Quality of Life in Patients With Lipedema

Lipedema is a chronic disease with unproportional, symmetrical fat accumulation in the lower extremities. Patients experience pain in affected areas, and reduced quality of life. Today's treatment is physiotherapy and surgery (liposuction). Recent research shows that ketogenic-diet with low carbohydrate, high fat (LCHF) conant can lead to reduced pain, increased quality of life and change in body composition. Goals: Investigate the effect of LCHF diet on pain, quality of life and body composition.


Eligibility Criteria:
Inclusion Criteria:

* weight stable over the last three months (+ 2-3 kg)
* not currently dieting to loose weight.
* willing to meet for weekly follow-ups during the intervention and the reintroduction of a regular diet.
* sign an informed consent before entering the study.

Exclusion Criteria:

* pregnant or breast feeding
* history of infectious diseases
* medication known to affect obesity
* enrolment in any other obesity treatment
* have had a bariatric surgery
* history of psychological disorders
* mentally disabled
* not mastering a Scandinavian language
* having a malign disease or any disease that leads to dietary advice that is not consistent with intervention advices in the study
Treatment of CIK for Patients With Refractory Non-Hodgkin Lymphoma

The purpose of this study is to study the safety and efficacy of chemotherapy usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.

Autologous cytokine-induced killer (CIK) cells transfusion(\>2\*10\^9 cells count) within 2 weeks after regular chemotherapy every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as non-Hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy

Exclusion Criteria:

* patients refuse the therapy or have no tolerance for the therapy
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation

Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart.

The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.


Eligibility Criteria:
Inclusion Criteria:

* A clinical indication for a transvenous pacemaker or defibrillator implantation,
* Must have a documented PFO determined from Transthoracic Echocardiogram (TTE) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure.
* The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a guidewire is used).
* All subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening.

Exclusion Criteria:

* Subjects with a survival expectancy of less than one year.
* Subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes.
* Absence of a clinical indication for a transvenous CIED system.
* Subjects with any clinical indication mandating anticoagulation.
* Subjects with previously placed CIED devices will be excluded.
* Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix).
* With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins.
* With active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
* With known intracardiac thrombi.
* Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD) implant