cyrilzakka/clinical-trials huggingface dataset:
Infrared Camera for Brain Mapping During Surgery

It is extremely important to identify and distinguish healthy brain tissue from diseased brain tissue during neurosurgery. If normal tissue is damaged during neurosurgery it can result in long term neurological problems for the patient.

The brain tissue as it appears prior to the operation on CT scan and MRI is occasionally very different from how it appears during the actual operation. Therefore, it is necessary to develop diagnostic procedures that can be used during the operation

Presently, the techniques used for intraoperative mapping of the brain are not reliable in all cases in which they are used. Researchers in this study have developed a new approach that may allow diseased brain tissue to be located during an operation with little risk. This new approach uses nfrared technology to locate the diseased tissue and identify healthy brain tissue.

The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to locate diseased tissue and distinguish it from normal functioning tissue during the operation.

It is important during neurosurgical procedures to identify and preserve eloquent functional cortex adjacent to a resectable lesion. Resection of a lesion infiltrating vital cerebral cortex can be associated with postoperative neurological deficits if the surgeon cannot clearly distinguish between the infiltrating borders of a lesion and surrounding functionally eloquent tissue. Spatial relationships between a lesion and surrounding normal brain can change significantly from those determined by preoperative methods such as CT and MRI scans. Necessary intraoperative interventions such as cerebrospinal fluid drainage, osmotic diuresis and lesion debulking cause quantitatively unpredictable brain shift in three dimensions. Therefore functional localization in real time that can be performed in the operating room is desirable. However, intraoperative real-time functional mapping techniques now available cannot be used in many surgical situations and are not sufficiently reliable in all cases in which they are used.

We have developed an intraoperative approach that may permit reliable lesion localization and brain functional mapping in real time with minimal risk. This approach makes use of infrared technology to identify functionally active eloquent cortex and may differentiate abnormal tissue from normal cortex.

The goal of this study is to investigate the clinical use of intraoperative infrared (IR) neuroimaging to differentiate intracranial lesions from surrounding normal functionally important tissue in real time. Reliable real-time intraoperative functional mapping of eloquent cortex adjacent to lesions by this technique would improve the safety and effectiveness of many neurosurgical procedures.

Eligibility Criteria:
Adult patients who will be undergoing craniotomy for lesions such as tumor, epileptic focus, vascular malformation or infection.

Adult patients who are able to provide informed consent.
Isoelectric Focusing of Tears in Children With Radiologically Isolated or Clinically Isolated Syndrome

The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.

Multiple Sclerosis (MS) is a disease that affects the white matter of the central nervous system. In France, approximately 100,000 patients are affected. It is one of the most common neurological condition in young adults.

The presence of supernumerary oligoclonal bands (OCBs) in the cerebrospinal fluid (CSF) in comparison to the serum was established in 2017 as a criterion for temporal dissemination in MS patients. This is a predictive factor of conversion to MS in the clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS), either in children or adults.

However, the main inconvenient of OCB analysis in CSF is the requirement of a lumbar puncture, which is a traumatising technique that may raise ethical concerns especially when it has to be performed in children.

Searching for OCBs in tears, which are more accessible, may represent an attractive alternative. Some published articles studying adult populations go in this direction, but there are no data in the literature regarding children.

The main gold of this study is to lead a multicentric, prospective study, to evaluate the diagnostic quality of tears in children with clinically isolated syndrome (CIS) and radiologically isolated syndrome (RIS) during a longitudinal follow-up.

Eligibility Criteria:
Inclusion Criteria:

* age \< 18 years old
* informed consent from the child and the parents (at least one of the two legal guardians)
* child covered by social security

For the RIS population:

* asymptomatic child
* fortuitous discovery of lesions strongly suggesting sclerosis multiple on a Magnetic resonance imaging (MRI) scan

For the CIS population:

- child presenting a CIS in the past three months

Exclusion Criteria:

* patient with remitting MS
* patient with progressive MS
* patient with eye infection
* patient under immunosuppressive therapy on the day of inclusion due to the treatment of another disease than MS
Risk Factors for Thrombosis in Children With Central Venous Lines

This project addresses the role of lab markers around the time of central line placement in predicting risk of thrombosis in pediatric patients with central venous lines being placed. The project proposes an innovative way to predict higher risk of thrombosis in the pediatric population to give clinicians a valid tool to guide clinical practice for these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 5 kg and less than 18 years of age.
* Patients having a central venous catheter or cardiac catheterization performed

Exclusion Criteria:

* prior history of thrombosis
* patients with hemophilia A or B
Limited Access Protocol for the Use of Oral Cisapride

Due to the lack of other drugs to treat gastroparesis Janssen and FDA approved the compassionate use of cisapride to treat patients who had no other effective therapy. For this observational study, 3 patients who had already been prescribed cisapride by outside physicians, were followed to determine the effectiveness of cisapride on their gastric emtpying.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastroparesis.

Exclusion Criteria:

* No diagnosis of gastroparesis.
Videocapillaroscopy Assessment During Systemic Agent Therapy in Psoriasis

The aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assess psoriasis severity and to document improvement during treatment by measuring changes in vascular features.

This is a single-center, prospective, observational study that will recruit subjects from Northwestern University to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. Thirty patients with a confirmed diagnosis of "active" psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumab and 15 patients receiving methotrexate.

Eight visits will be completed for each subject: visit 0 (baseline) and visits 1-8 (week 2, 4, 6, 8, 12, 16 and 24). At the baseline visit, after informed consent is obtained, a capillaroscopic examination will be performed to assess for evidence of characteristic vascular alterations. If such changes are present, the remainder of the baseline visit will be completed. This includes gathering personal information (age, race, gender etc.), clinical history (time of first diagnosis, presentation site, treatment used, biopsy results if previously performed, etc.) and past medical history (including current and previous medications). At each of the subsequent visits (visit 1-8), any changes to medical history and/or medications will be obtained and recorded. At each of the eight visits, a dermatologic physical examination, including PASI and PGA scores will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a clinical diagnosis of chronic active plaque psoriasis
* Subjects eligible for systemic monotherapy (oral or biologic agents).
* Subjects with evidence of characteristic vascular alterations on capillaroscopic examination.
* Subjects who are able to complete the study visits and procedures, including completion of the DLQI questionnaire.
* Subjects who are willing to have standardized digital photographs taken of 2 different target plaque lesions on the extremities.
* Subjects who are willing to have videocapillaroscopic photographs taken of 2 different target plaque lesions as well as of 2 areas of uninvolved skin on the extremities.
* Subjects who have had a "4 week" washout period if they have recently changed systemic psoriatic therapy.

Exclusion Criteria:

* Those who do not fit the inclusion criteria.
* Subjects who are unable to understand the protocol or give informed consent.
A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery

A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery.

This will direct future research and treatment.

We will recruit 60 subjects for this study. Volunteers will provide pre-operative semen and blood samples prior to undergoing weight-reduction surgery.

Those with normal pre-operative sperm samples will be invited to continue participating in the study by providing subsequent post-operative semen samples and hormonal testing over a two year time period.

It is estimated to take approximately one year to enroll the desired 60 subjects. The study will conclude two years from the last enrollment.

The main analysis will be a comparison of sperm concentrations over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult male subjects between the ages of 18-65 undergoing bariatric surgery

Exclusion Criteria:

* Subjects with abnormal sperm analysis
A Study of Hypoxia Imaging in Advanced Pancreatic Cancer Patients Being Treated With Gemcitabine and TH-302 or TH-302 Placebo

Researchers are looking for better ways of diagnosing and treating pancreatic cancer. It is believed that looking for low levels of oxygen (hypoxia) in tumours may give a better understanding of how certain tumours grow or respond to certain treatments. This study will look at hypoxia in pancreatic tumours while participants are receiving treatment with the combination of gemcitabine and TH-302/placebo in the EMR 200592-001 clinical research study.

This study will use positron emission tomography (PET) scans to look at hypoxia in tumours. PET is an imaging test that can be used to measure hypoxia in tumours. For this study, a radioactive tracer called Fluoroazomycin Arabinoside (FAZA) will be used to "label" areas of hypoxia in tumours. Determining the levels of hypoxia in tumour tissue using FAZA-PET scans and comparing these levels with the patient's response to treatment with gemcitabine and TH-302/placebo for pancreatic cancer may help the researchers to determine the relationship between hypoxia and response to this treatment.

The main purpose of this study is to see how useful looking at hypoxia in tumours are when they are done at different centres.


Eligibility Criteria:
Inclusion Criteria:

* Have consented to participating on the first-line Gemcitabine + TH-302/placebo (study number EMR200592-001) study
* Age 18 years or older
* Cytologic/histologic diagnosis of pancreatic adenocarcinoma
* Advanced stage pancreatic cancer: locally advanced or metastatic.
* No prior chemotherapy for advanced/metastatic disease. Adjuvant chemotherapy allowed if completed \> 6mths from study entry. Prior radio-sensitizing doses of 5-FU or gemcitabine also allowed.
* ECOG performance status 1 or less
* Adequate end organ and marrow function
* Measureable or non-measureable disease by RECIST 1.1
* Female patients of child-bearing potential must have a negative serum pregnancy test (BhCG) and must agree to abstinence or use adequate contraception for the duration of the study
* Disease-free period of more than 5 years from prior malignancies other than pancreas (except curatively treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix and ductal carcinoma in situ (DCIS) breast disease).
* Ability to provide written informed consent
* Must be able to lie flat comfortably for 30 to 60 min to complete imaging study

Exclusion Criteria:

* Inability to lie supine for 30 to 60 minutes
* Concurrent second primary
* Life expectancy of less than 12 weeks
* On treatment with disulfiram (antabuse) due to \[18F\]FAZA injection containing up to 10% (v/v) ethanol in PBS (phosphate-buffered saline)
Repetitive Bihemispheric Transcranial Direct Current Stimulation After Stroke

Non-invasive repetitive bi-hemispheric transcranial direct current stimulation (tDCS) may restore post-stroke bi-hemispheric balance by increase peri-lesional cortex activity and suppress abnormal inhibition from non-lesional hemisphere, and therefore enhance after-effects of rehabilitation. In this double-blind, randomized controlled trial, investigators aim to investigate whether multi-session, bihemispheric tDCS to the primary motor cortex (M1) in combination with upper extremity rehabilitation therapy affected motor functional outcome, ipsilesional motor circuit excitability using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG) measures.

Investigators will consecutively enroll subacute (2-6 weeks after stroke onset) patients with first-time, unilateral, ischemic subcortical stroke in the middle cerebral artery territory with mild to moderate hand weakness. All subjects will be randomly allocated to receive daily bihemispheric tDCS (anodal tDCS to ipsilesional M1 and cathodal tDCS to contralesional M1 with 2 mA stimulation for 20 min) or daily sham tDCS (same but stimulation for only 30 seconds) with simultaneous physical/occupational therapy, for total 10 sessions. Changes in upper extremity motor function score (Fugl-Meyer test and Action Research Arm test), corticospinal excitability from the transcranial magnetic stimulation(TMS), and sensorimotor oscillations from the magnetoencephalography (MEG) will be assessed before and after intervention, as well as 3 months after stroke. All stroke patients will receive tDCS and standard medical, rehabilitation treatments in rehabilitation ward.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-80 years old
* Patients with first-time, unilateral, ischemic stroke with contralateral mild to moderate hand weakness
* Brain MRI confirmed subcortical stroke in the middle cerebral artery territory
* Post-stroke 2-6 weeks with stable clinical condition

Exclusion Criteria:

* Stroke with cortical lesions
* Containing metal implants (such as implanted electrodes, pacemakers)
* Sensitive or fear of electromagnetic waves
* Pregnant women
* History of alcohol or drug abuse
* History of seizures or epilepsy
* Claustrophobia
* Other significant disease or neuropsychiatric disorders
Real-life Use of Cefazolin for the Treatment of Meticillin-susceptible Staphylococcal Infective Endocarditis: Comparison to a Treatment Cohort With Penicillin M

Retrospective, regional, multicenter study (including the Annecy-Genevois Hospital Center, the Chambéry Métropole Savoie Hospital Center, and the Grenoble University Hospital Center), comparing a cohort of patients treated with Cefazolin with a cohort of patients treated with Penicillin M

The use of Cefazolin for the treatment of infective endocarditis caused by Staphylococcus meti - S has become commonplace in France following the stockout of injectable Penicillin M, the reference treatment, which occurred during 2016.

There is currently no clinical data to prejudge the efficacy of Cefazolin in the context of high inoculum, such as in the treatment of infective endocarditis.

On the other hand, recent data have described a better tolerance profile for Cefazolin than for Penicillin M.

The objective of this study is to compare the efficacy and safety of Cefazolin with that of Penicillin M in the management of methicillin-susceptible staphylococcal endocarditis, through the analysis of two retrospective cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Definite infective endocarditis according to Duke criteria
* Documented SAMS or meticillin-sensitive SCN
* Treated with Cefazolin or Penicillin M for at least 10 consecutive days
* Treatment initiated between 01/01/2014 and 12/31/2018

Exclusion Criteria:

* Patients under 18 years old
* Patients under 18 years old.
Neoadjuvant Chemotherapy With a Combination of Pegylated Liposomal Doxorubicin (Caelyx®) and Paclitaxel in Breast Cancer

In this study, PLD, an anthracycline encapsulated in stealth liposomes, which are believed to efficiently deliver the doxorubicin within the tumour mass with less toxicity compared with standard doxorubicin formulation was used. The study aimed to determine whether the combination of PLD-docetaxel would increase tumour response in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed breast cancer;
2. Age \>18 years;
3. Eastern Cooperative Group (ECOG) performance status 0-2;
4. measurable disease (as per radiological imaging); life
5. expectancy \>12 months;
6. adequate haematologic blood profile;
7. normal liver and kidney function;
8. adequate cardiac function;
9. no metastatic disease;
10. negative pregnancy test (premenopausal women);
11. signed informed consent.

Exclusion Criteria:

1. Level 2 cardiac toxic effects were deﬁned as asymptomatic systolic dysfunction (NYHA class I) or mildly symptomatic heart failure (NYHA class II) ;
2. Previous treatment for breast cancer, including surgery, radiation, cytotoxic and endocrine treatments (except surgical diagnostic procedures);
3. Active infection or other serious underlying medical or psychiatric condition which would impair the ability of the patient to receive protocol treatment;
Efficacy and Safety of Patupilone in Patients With Advanced Solid Tumors in Japan

The study will evaluate the safety and efficacy of Patupilone in adult patients with advanced solid tumors.


Eligibility Criteria:
Inclusion criteria:

* Patients with a histologically/cytologically confirmed diagnosis of advanced solid tumors refractory to or unsuitable for standard therapy, or for whom no standard therapy exists
* Patients with WHO Performance Status of 0-1 ( Karnofsky Performance Status of 80-100)
* At least one measurable lesion

Exclusion criteria:

* Patients with any peripheral neuropathy
* Patients with unresolved diarrhea
* Patients with severe and/or uncontrolled medical conditions or infections that require systemic therapy

Other protocol-defined inclusion/exclusion criteria may apply
Proliferation of Endometrial Stromal Cells in Adenomyosis

Adenomyosis refers to the presence of endometrial glands and stroma that is haphazardly deep within the myometrium. However, the etiology and pathologic mechanism responsible for adenomyosis are not yet very well known. Our previous results revealed that the expression of killer inhibitory receptors on natural killer cells was decreased in eutopic endometrium in women with adenomyosis. It implies that the formation of adenomyosis might be due to abnormal endometrial tissues, but not the aberrant local immunological dysfunction in myometrium. Our further investigation revealed that in vitro coculture of macrophages and endometrial stromal cells (ESCs) increase the expression of IL-6 mRNA in ESC, which might further enhance the proliferation of ESC and subsequently result in the formation of ectopic endometrial implants in adenomyosis.

Abnormal cell proliferation has been generally found in the tumorigenesis, including the formation of endometriosis. Adenomyosis is considered to have a similar pathophysiology with endometriosis, and it must be interesting to examine whether there is abnormal cell proliferation in the eutopic endometrium of adenomyosis. Lipopolysaccharide (LPS) was found to promote proliferation of ESCs via induction of TNF-a and IL-8 expression, whereas IFN-g significantly inhibited ESCs proliferation. Therefore, whether abnormal cell proliferation occurs under the effects of LPS and IFN-g in the eutopic endometrium of adenomyosis needs further clarification.

Adenomyosis preferentially affects women between the ages of 35 and 50 years, and the symptoms subside gradually after menopause. It is well known that there is a close conjunction between estrogen and adenomyosis. Estradiol (E2) was demonstrated to induce endometrial cell proliferation, whereas medroxyprogesterone (MPA) inhibited endometrial cell proliferation via antagonizing estrogenic effects. Experiments to investigate these steroid effects on ESC proliferation in vitro in the eutopic endometrium of adenomyosis are of clinical relevance.

In this study, we try to collect endometrial tissues from women with and without adenomyosis, and then purify ESCs from endometrium. ESCs are cultured for 2 days with the supplement of LPS, IFN-gamma, Estradiol, MPA and Estradiol+MPA. Quantification of cell proliferation was done with Cell Proliferation Assay Kit and immunocytochemical detection of Ki-67, in an attempt to examine the cell proliferation of ESCs in women with adenomyosis.

Eutopic endometrium was obtained and separated into single endometrial stromal cell (ESC) in women with adenomyosis (study group) and without adenomyosis (control group).

ESCs are cultured for 2 days with the supplement of LPS, IFN-gamma, Estradiol, MPA and Estradiol+MPA.

Quantification of cell proliferation was done with Cell Proliferation Assay Kit and immunocytochemical detection of Ki-67.

Eligibility Criteria:
Inclusion Criteria:

* women with adenomyosis
* at early- to mid-secretory phases

Exclusion Criteria:

* postmenopausal
* malignancy
Radiochemotherapy in Elderly Patients With Oesophagus Cancer

Phase II study of radiochemotherapy for elderly patients with oesophagus cancer.

Phase II study of radiochemotherapy for elderly patients with oesophagus cancer with Radiotherapy = 50 Gy, 2Gy/f ans chemotherapy with 2 arms arm Cisplatin = Cisplatin 75mg/m2 J1J22 or arm Oxaliplatine = oxaliplatine 85mg/m2 every 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* patients aged 75 or more with oesophagus cancer (squamous or adenocarcinoma), fit to treat

Exclusion Criteria:

* previous radiotherapy
* no fit to treat