cyrilzakka/clinical-trials huggingface dataset:
Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients

This is an open-label, phase 4 study to examine the safety and efficacy of vigabatrin (Sabril) in Tuberous Sclerosis patients, a subset of the larger refractory complex partial epilepsy population for which the drug is approved. While enrolled on this trial, subjects will continue to take all of their normally prescribed medications, including their other antiepileptic drugs (AEDs).

Alternatively, there is a prospective observational arm that subjects who are about to take Sabril as treatment for seizures associated with Tuberous Sclerosis may join. Subjects who join this arm will not have any study visits and will not be asked to do anything specifically for the study. The study team will collect all study data from subjects' medical records only.


Eligibility Criteria:
Inclusion Criteria:

* The patient or patient's legally authorized representative must sign and date the Institutional Review Board approved Informed Consent and HIPPA Authorization Form.
* Male and female patients 18+ years of age with a clinical diagnosis of Tuberous Sclerosis who experience an average of at least three partial seizures every two months, of which one must be a complex partial seizure
* Patient must be on at least one and a maximum of four AEDs. Patient must be on a stable AED dose regimen for at least 30 days prior to screening. Neither a Vagal Nerve Stimulator (VNS) nor the ketogenic diet will count as an AED
* In the investigator's opinion, the patient or caregiver must be able to keep a seizure diary
* An MRI in the last 5 years, or willingness to undergo an MRI as part of the screening process

Exclusion Criteria:

* Cause of patient's seizures is a neurologic disease that is not Tuberous Sclerosis
* Current, clinical diagnosis of a major depressive episode or suicidal ideation
* Patient is taking more than four concurrent AEDs. Note: VNS or ketogenic diet is allowed and will not be counted in the four allowed AEDs
* Patient has a progressive CNS lesion confirmed by magnetic resonance imaging (MRI) or computed tomography (CT) scan
* Patient is currently abusing drugs or alcohol
Role of Omalizumab in Reducing the Incidence of Oxaliplatin-induced Hypersensitivity Reaction

Pilot study to evaluate the activity of omalizumab in the prevention of recurrent oxaliplatin hypersensitivity reaction (HSR) in oxaliplatin-sensitive patients. The study will also evaluate the safety of omalizumab (Xolair) when administered in this setting.

This is an open label single arm pilot study studying the effects of omalizumab in the treatment of oxaliplatin hypersensitivity reaction (HSR) for patients with stage IV GI cancer.

Eligibility Criteria:
Inclusion Criteria:

* Clinically evident HSR to oxaliplatin, with symptoms of flushing, urticaria, pruritus, rash, and/or dyspnea without bronchospasm that emerge during or shortly after of oxaliplatin infusion
* Responding (complete or partial) or stable disease according to RECIST criteria while undergoing treatment with oxaliplatin containing regimen or need to resume an oxaliplatin based regimen in the setting of well-documented recent oxaliplatin hypersensitivity reaction
* Histologically confirmed stage IV GI cancer (AJCC 7th edition) currently sensitive to oxaliplatin containing chemotherapy regimen
* Age 18 years or older
* ECOG performance status 0-2
* Adequate bone marrow, liver, and kidney function. (WBC \> 1500 cells/uL, platelets \> 50,000/uL, ALT/AST \< 5xULN (unless due to liver metastasis), Creatinine \< 2.0 mg/ld)
* Willing to give written informed consent, adhere to the visit schedules and meet study requirements

Exclusion Criteria:

* Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
* History of hypersensitivity reaction to Xolair or any ingredient of Xolair
* Concurrent therapy with investigational agents
* Use of any other investigational agent in the last 15 days and all toxicity of prior therapy resolved
* Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule
* Women of childbearing potential not using the contraception method(s), as well as women who are breastfeeding
* Patients with severe medical conditions that in the view of the investigator prohibits participation in the study
Health and Nutrition Survey on Shenzhen Children

1. Master and analyze the nutritional health, growth and development status of primary and secondary school students in Shenzhen, and discover the main nutritional health, growth and development problems and influencing factors.
2. Provide basic data and evidence-based basis for the municipal government and related departments to formulate child health policies and measures.


Eligibility Criteria:
Inclusion Criteria:

With signed consent to be a study subject.

Exclusion Criteria:

None.
Consequences of a Maternal-fetal Chikungunya Virus Infection

Chikungunya is an infectious disease caused by an alphavirus transmitted by the Aedes mosquitoes which has known a worldwide expansion since its re-emergence in 2004. Regarding to an unprecedented epidemic, Reunionese pediatricians described in 2005-2006 a vertical maternal-fetal transmission of this virus, at the time of childbirth. Since then, this mode of transmission has been widely confirmed, with an absolute risk estimated between 15.5% and 48.3%. The main consequences for the child are neuromotor, neurosensory or neurocognitive. They were studied around the age of 2 in 33 children in the CHIMERE cohort, as well as at the age of 5 in a small fraction of these children followed at the C.A.M.S.P (Center for Early Medico-Social Action). The results suggested an overall delay in psychomotor acquisitions secondary to neonatal infection, affecting the functions of the prefrontal region (in particular coordination and language). Performance was correlated with the severity of the clinical presentation (more severe in case of encephalitis or encephalopathy) while remaining suboptimal in children with uncomplicated infection. During neurodevelopmental monitoring, other disturbing traits complemented the spectrum of problems presented by these children, such as microcephaly, cerebral palsy, epilepsy, interaction disorder or attention deficit disorder. At around age 10, the investigators reassessed 21 of these children using the Childhood Cognitive Function and Learning (EDA) screening test. The investigators would now like to confirm and characterize their impairments using a battery of confirmatory tests around the age of 13.


Eligibility Criteria:
Inclusion Criteria:

* Child born between March 2005 and July 2006
* Of which the mother identified in the CHIMERE cohort or the perinatal register of maternities
* Exposed: child infected with the chikungunya virus at the time of childbirth
* Not exposed: child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified in chapter 5.2
* Affiliated to a social insurance

Exclusion Criteria:

* Prematurity \<33 weeks
* Prenatal alcoholization authenticated by fetal alcohol syndrome
* Intellectual disability or secondary epilepsy of origin other than CHIKV infection (caused by ACSOS or any other cause of brain damage of inflammatory, metabolic or infectious origin)
Vasopressor Support, Mean Arterial Pressure and Capillary Refill Time in Critically Ill Patients

The goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (CRT) value in crtically ill patients. The main questions it aims to answer are:

* How do vasopressor drugs determine CRT value
* How does mean arterial pressure (MAP) determine CRT value
* How often CRT value is normal (\< 3 sec) despite hypotensive MAP (\<65 mmHg)

Participants will have the CRT measured over the course of the ICU hospitalization. At the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence CRT value.

The goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (CRT) value in critically ill patients. The main questions it aims to answer are:

* How does norepinephrine dose influence CRT value
* How does epinephrine dose influence CRT value
* How does argipressin dose influence CRT value
* How does dobutamine dose influence CRT value
* How does mean arterial pressure (MAP) determine CRT value
* How often CRT value is normal (\< 3 sec) despite hypotensive MAP (\<65 mmHg)

Participants will have the CRT measured over the course of the ICU hospitalization. At the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence CRT value. CRT will be a dependent variable. Independent variables will be as follows: age, MAP, norepinephrine dose, epinephrine dose, argipressin dose, dobutamine dose.

CRT measurements will be performed in a standarized rigor (light, chronometer, pressure and ambient temperature will be the same in all patients)

Eligibility Criteria:
Inclusion Criteria:

* critical illness requiring vasopressor support
* invasive blood pressure monitoring

Exclusion Criteria:

* finger distal phalanx not available
* patient in a room of suboptimal ambient temperature
Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus

Tinnitus, i.e., the perception of sounds or noise in the absence of auditory stimuli, is a frequent and often severely disabling symptom of different disorders of the auditory system. There are currently no causal treatments. Using repetitive transcranial magnetic stimulation (rTMS), we have previously demonstrated that the temporoparietal cortex is critically involved in tinnitus perception and that tinnitus can be reduced by rTMS applied to these cortical regions. Therefore, it is reasonable to test rTMS as a potential new treatment strategy against tinnitus. At this stage, small pilot studies indicate some effect on tinnitus impairment but the reduction is predominantly reported to be transient, with high interindividual variability, and questionable clinical relevance. Moreover, the optimal stimulation area is unclear.

Here, we use theta burst stimulation (TBS), a new rTMS paradigm for the prolonged modulation of cortical activity. The aim of this study is to test safety and effectivity of 4 weeks of daily bilateral TBS to two cortical areas on chronic tinnitus compared to sham-stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Subjective tinnitus \> 6 mo , \< 5 ys

Exclusion Criteria:

* Objective tinnitus
* Seizures
* Brain trauma
* Brain surgery
* Pacemaker
* intake of: benzodiazepines, antiepileptics, neuroleptics
* Suicidality
Neuropathy in Patients Monitored for Wild-type TTR Cardiac Amyloidosis (Non-mutated)

Transthyretin (TTR) amyloidosis is a rare disabling disorder that can be hereditary or sporadic. Depending on the form, various tissues are affected. While in hereditary cases, neuropathy is predominant, cardiac impairment is the main manifestation in the sporadic form.

The main objective of this project is to evaluate the proportion of patients with neuropathy in a population of patients with a non-mutated TTR amyloid cardiopathy condition.

Transthyretin (TTR) amyloidosis belongs to a group of severe and multi-systemic diseases caused by an extracellular accumulation of fibrillar proteins arranged in beta-pleated sheets. This pathology can be hereditary (mutations in the TTR gene) or sporadic. Depending on the form, various tissues are affected: peripheral nervous system (leading to neuropathy, especially vegetative), heart, kidney... While in forms linked to TTR mutations neuropathy is the main manifestation, in the sporadic form (also called wild-type), the cardiac impairment is predominant. Other organ damages are rarely reported in this second form. In the THAOS registry (Coelho T. et al, 2013), a clinical peripheral neuropathy is reported in 28.4% out of 67 patients with the sporadic form of the disease, although the authors do not provide a precise description of the neuropathy type. We propose to prospectively study patients with a wild-type amyloid cardiopathy condition to identify and describe the associated neuropathy. A pilot study conducted at the Bordeaux University Hospital demonstrated the feasibility and interest of this research: it showed the presence of an undetermined aetiology polyneuropathy in 35.7% out of 14 patients followed for senile cardiac amyloidosis.

Tafamidis is used on familial amyloid neuropathy and a recent study shows an effect on senile amyloid cardiopathy (Maurer MS et al., 2018) which strengthens the need to determine the frequency of neuropathies associated with wild-type amyloid cardiopathy and to type them more accurately.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both gender, over 18 years old, with transthyretin amyloid cardiopathy according to one of the two American Heart Association definitions of 2016
* No mutation in the TTR gene
* Patients giving their free and informed consent to participate after information about the research
* Patients affiliated to or benefiting from a social security scheme

Exclusion Criteria:

* Patients with chronic neuropathy related to a known aetiology
* Patients under guardianship or curatorship
Pre-operative Magnetic Resonance Imaging (MRI) in Young Breast Cancer Patients

Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients \<= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.

Inclusion Criteria:

* female aged ≤ 50
* histologically proven invasive breast cancer

Exclusion Criteria:

* Is not considered a surgical candidate
* Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
* Has a contraindication to undergoing breast MRI
* Has inflammatory breast cancer according to the standard clinical definition
* Has locally advanced breast cancer according to the standard clinical definition
* Patient is pregnant
* Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol

Eligibility Criteria:
Inclusion Criteria:

* Female aged \<= 50 years
* Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
* Premenopausal

Exclusion Criteria:

* Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
* Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
* Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
* Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
* Patient has locally advanced breast cancer according to the standard clinical definition.
* Patient is pregnant
* Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19

A Trial of GC4419 in Patients with Critical Illness due to COVID-19


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects at least 18 years of age.
2. Ability to understand and the willingness to sign a written informed consent.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by a positive PCR test documented prior to randomization
4. Requirement for intensive inpatient hospital care
5. Acute hypoxemic respiratory failure typifying ARDS
6. Adequate liver function
7. Use of effective contraception

Exclusion Criteria:

1. Expected survival for less than 48 hours after randomization
2. Child-Pugh stage C hepatic impairment and/or portal hypertension secondary to cirrhosis
3. Stage IV chronic kidney disease or end-stage kidney disease on maintenance hemodialysis
4. Requirement for extra-corporeal membrane oxygenation (ECMO)
5. Acute Myocardial Infarction (AMI)
6. Active bleeding requiring transfusion
7. Concurrent participation in another clinical trial of experimental treatment for SARSCoV-2
8. Female patients who are pregnant or breastfeeding
9. Requirement for concurrent treatment with nitrates
Analysis of Chemical Pattern Exhaled by Different Neoplasms Through Chemoresistive Nanostructured Sensors

The aim of the study is to identify a pattern of chemoresistive sensors able to recognise the presence of a tumoral pathology from a health state through the analysis of Volatile Organic Compounds inside the specimen.

The chemoresistive nanostructured sensors are into an innovative patented device SCENT B1 which can analyse different specimens: blood samples, tissue biopsies, cell cultures.

In this study SCENT B1 wil be used to compare the measures of:

* tumoral and health tissues taken from different neoplasms after their surgical resection
* blood samples from healthy and tumor affected people
* pre and post- operative blood samples of tumor affected people

SCENT B1 is a patented device constituted by four chemoresistive nanostructured sensors able to vary their conductance depending on chemical substances present in the environment. These sensors are extremely sensitive as they can identify substances at a concentration of tens parts per billion such as volatile organic compounds derived from tumor cells metabolism.

Every sensor answers differently from the others and the aim of the study is to find the best array of sensors able to discriminate among tumoral and healthy specimens.

Different specimens are tested: tissue biopsies and blood samples. Blood samples are collected from patients undergoing surgical resection of the neoplasm. A first blood sample is collected before the surgery and it is compared to a control sample taken from an healthy volunteer. The second blood sample is taken from the patient during a follow-up visit after the finish of any post-operative therapy. Blood samples are conserved at ambient temperature and analyzed by SCENT B1 on the same day of the collection.

Health and tumoral tissue biopsies are collected from surgical resection specimens, kept in breeding ground, cleaned from bacteria, adipose tissue and other contaminants and finally processed in SCENT B1 on the day after the collection.

The four sensors' outputs are combined in statistical analysis in order to define the threshold between health and tumor affected specimens.

Eligibility Criteria:
Inclusion Criteria:

* patients who undergo to open or laparoscopic surgery for colorectal cancer in election regimen
* patients who underwent to open or laparoscopic surgery for colorectal cancer and who have finished chemotherapy or radiotherapy yet

Exclusion Criteria:

* patients operated in emergency regimen
* pregnant women
Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.


Eligibility Criteria:
Inclusion Criteria:

* therapeutic need according to the approved specific products characteristics (SPC)

Exclusion Criteria:

* contraindication according to the SPC
SCS for the Treatment Of Chronic Pain of the Upper Extremities

This is a prospective, multi-center post-market study of the Senza System in subjects with chronic, intractable pain of the upper extremities. Data at follow-up visits will be compared to Baseline data collected at the beginning of the study.


Eligibility Criteria:
Key Inclusion Criteria:

1. Have been diagnosed with chronic, intractable pain of an upper extremity of neuropathic origin, which has been refractory to conservative therapy for a minimum of 3 months.
2. Have an average pain intensity (over a period of 7 days) of an upper extremity of ≥ 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.
3. Be on stable pain medications for at least 28 days and be willing to stay on those medications with no dose adjustments until activation of the permanently implanted SCS device.
4. Be 18 years of age or older at the time of enrollment.
5. Be an appropriate candidate for the surgical procedures required in this study.
6. Be capable of subjective evaluation, able to read and understand English-written questionnaires, and are able to read, understand and sign the written inform consent in English.
7. Have stable neurological status measured by motor, sensory and reflex function.

Key Exclusion Criteria:

1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures.
2. Have a current diagnosis of a progressive neurological disease.
3. Have a current diagnosis or condition such as a coagulation disorder, bleeding diathesis, platelet dysfunction, progressive peripheral vascular disease or uncontrolled diabetes mellitus that presents excess risk for performing the procedure.
4. Have mechanical spine instability as determined.
5. Have significant stenosis, based on MRI.
6. Have an existing drug pump and/or another active implantable device (switched on or off) such as a pacemaker or other SCS devices.
7. Have a condition currently requiring or likely to require the use of whole body MRI or diathermy.
8. Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal).
9. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications, alcohol or illicit drugs.
10. Be involved in an injury claim under current litigation.
11. Have a pending or approved worker's compensation claim.
12. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome, as determined by a psychologist.
Real-time Assessment of Frameless Intrafraction Motion

The purpose of this study is to assess the ability of a modified thermoplastic mask system in keeping an individual head stationary for a predefined amount of time. The investigators hope to know if the modified mask is study enough, and also if the modification on the mask will allow the investigator see and track the individual's movement underneath the mask by means of a camera that can detect light reflected from the individual. Participants will lay down on their backs and their heads will be held in place with the mask system for approximately 1 hour.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individual
* Age \> 18 years.
* Males and females of all races and ethnic groups

Exclusion Criteria:

* Severe claustrophobia