cyrilzakka/clinical-trials huggingface dataset:
Reorganization of the Healthcare System During COVID-19 Pandemic: Impact on Management of Patients With Exocrine Pancreatic Cancer

Pancreatic adenocarcinoma will be the 2nd cause of death by cancer in Europe in 2030. Pancreatic adenocarcinoma has poor prognosis with an all-stages combined 5-year survival rate below 8%.

Since December 2019, a new coronavirus (Severe Acute Respiratory Syndrome Corona Virus 2, SARS-CoV-2) is responsible of COVID-19 infection with potentially severe respiratory syndrome or even multi-organ failure. An increased risk of severe COVID-19 infection in cancer patients is suggested in several Chinese series. Cancer care structures quickly reorganized to limit high-risk situations (diagnostic procedure, major surgery, cytotoxic poly-chemotherapy) and use alternatives such as on-hold chemotherapy. These reorganizations could be associated with a loss of chance for pancreatic adenocarcinoma.

The aim of this study is to study impact of reorganization of the healthcare system during COVID-19 pandemic on pancreatic adenocarcinoma patients management

Eligibility Criteria:
Inclusion criteria :

1. aged 18 or over,
2. with pancreatic adenocarcinoma diagnosed by anatomopathological specimen or without biopsy but with suspicion of pancreatic adenocarcinoma in presence of imaging techniques or Ca19.9 level without evidence for neuroendocrine tumor,
3. assessed during multidisciplinary meeting in one participating center between 01/09/2019 and 31/10/2020,
4. accepting to participate to the study,
5. with or without SARS-CoV-2 infection.

Exclusion criteria :

1. with neuroendocrine neoplasia
2. for whom histology showed non pancreatic
3. with cystadenoma or IPMN without invasive adenocarcinoma
the Anatomical Reduction and Functional Recovery Effects of Two Transvaginal Apical Slings on Pelvic Organ Prolapse

The study is a prospective study at a single institution. Investigators create strict inclusion and exclusion criteria, selecting 124 patients with POP(≥II degree and have symptoms that need operation) . 62 patients in the intervention group accept extraperitoneal high uterosacral ligament suspension. The other 62 patients in the other group accept sacrospinous ligament suspension.

Investigators evaluate all women's operation method, operation time, bleed volume, overactive bladder questionnaire, PFDI-20，ICIQ-SF, I-QoL, PISQ-12, PFIQ-7, UDI-6, pre- and post-operation (at 1 month, 3 months, 6months and 1 year).

Eligibility Criteria:
Inclusion Criteria:

Age ≥30 years old;

pelvic organ prolapse, with or without abnormal urination or defecation or sexual disturbance, which affects the quality of life

Pelvic organ prolapse quantitation (POP-Q) is greater than or equal to Those who are in stage II and have symptoms and require surgery

The patient agrees to conduct the study and can be followed up on time.

Exclusion Criteria:

Those who cannot tolerate surgery and anesthesia

Those who need to remove the uterus

Those who have removed the uterus

Those who cannot be followed up on time.
Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects

This study will evaluate the effect of CYP3A weak inducer rufinamide on the pharmacokinetics (PK) of Quizartinib in healthy subjects

This is a clinical pharmacology study with 2 treatment groups (Test treatment group receiving both rufinamide weak CYP3A inducer and quizartinib and Reference treatment group receiving quizartinib only) investigating the effect of rufinamide on the PK of quizartinib in healthy subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* Male and female subjects 18 to 55 years of age (inclusive), with a BMI of 18 kg/m2 to 32 kg/m2 (inclusive) at Screening.
* Has vital signs (measured after subject has been supine for at least 5 minutes) at Screening within the following ranges: heart rate: 50-100 beats per minute (bpm); systolic blood pressure (BP): 90-145 mmHg; diastolic BP: 50-95 mmHg. Out-of-range vital signs may be repeated once.
* Liver function test results (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], and total bilirubin \[TBbil\]) must be equal to or below the upper limit of normal (ULN). Hemoglobin levels must be ≥11.5 g/dL for female subjects and ≥12.5 g/dL for male subjects.
* In females, documented surgical sterilization (i.e., documented hysterectomy, bilateral tubal ligation, or bilateral salpingo-oophorectomy, Essure® with hysterosalpingogram \[documentation to confirm tubal occlusion 12 weeks after procedure\]), postmenopausal status for at least 1 year (follicle stimulating hormone \[FSH\] \> 40 mIU/mL serum and estradiol \<40 pg/mL \[\<147 pmol/L\] at Screening), or agreement to have sterile male partner, or agreement to use 1 of the protocol-approved means of contraception from Screening until 7 months after the dose of quizartinib.
* In males, documented surgical sterilization, or sexual abstinence, or agreement to use 1 of the protocol-approved means of contraception from Screening until 4 months after the dose of quizartini

Key Exclusion Criteria:

* Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality) that could interfere with subject's safety, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
* History of a clinically significant illness, in the opinion of the Investigator, within 4 weeks prior to administration of quizartinib.
* History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula (QTcF) \>450 milliseconds (ms) at Screening.
* Females who are pregnant or breastfeeding
* Laboratory results (serum chemistry, hematology, and urinalysis) outside the normal range, if considered clinically significant by the investigator. Estimated creatinine clearance (CrCl)\<90 mL/min (calculated by using the Cockcroft-Gault Equation) at Screening.
Fluorescence and Glioma Heterogeneity

The investigators aim to study the heterogeneity of fluorescence within malignant gliomas by sampling tissues from these variable areas within the same tumor. These tissue samples will then be subjected to pathological and biological analysis to assess proteins related to ALA metabolism and correlated with the fluorescence emitted as well as levels of protoporphyrin IX in the tissues.

Malignant gliomas are the commonest malignant brain tumors but are extremely challenging to treat. Neuro-oncology has seen little progress in its treatment despite extensive research. Extent of resection remains a very important prognostic factor in these tumors. Better the resection, better the outcomes. However resecting these tumors is not very easy primarily due to their infiltrative nature and difficulty in discerning tumor boundaries intraoperatively. Fluorescence guided resection (FGR) has recently been shown to be a very important and useful adjunct in maximizing this goal. FGR involves administration of aminolevulinic acid (ALA) to the patient prior to surgery. The ALA is converted to protoporphyrin IX (PPIX) in glioma cells. The PPIX is a fluorophore and can be visualized intraoperatively using a suitably modified microscope. Neurosurgeons can then resect the tumor radically guided by this fluorescence which is superior to the conventional microscopic resection. Selective PPIX accumulation in glioma cells is the key to the accuracy of this technique. The biological basis of selectivity of PPIX accumulation within glioma cells is however poorly understood. Various mechanisms could be involved starting from variable transport (related to blood-brain barrier properties), differential uptake (governed by active transport mechanisms) and differential metabolism within the cell. Understanding these mechanisms can lead to refinements in this strategy, overcoming its present limitations and development of methods to extend its scope.

Eligibility Criteria:
Inclusion Criteria:

Per-primum glioma

* Adults (18-65 years)
* Radiologically suspected malignant gliomas
* Variable contrast enhancement on MRI (patchy and/or non-uniform)
* Eligible for surgical therapy (craniotomy NOT stereotactic biopsy )
* No contraindication for surgery

Exclusion Criteria:

* Poor general condition (KPS \< 70)
* Prior treatment (except biopsy)
* Compromised renal/hepatic function
* Immunocompromised status
* Known photosensitivity / allergy to 5-ALA
SPEARHEAD-3 Pediatric Study

This is a pediatric basket study to investigate the safety and efficacy of afamitresgene autoleucel in HLA-A\*02 eligible and MAGE-A4 positive subjects aged 2-21 years of age with advanced cancers


Eligibility Criteria:
Inclusion Criteria:

* Age 2-21 years
* Body weight ≥ 10 kg
* Subject has histologically confirmed diagnosis of any one of the following cancers: (A) Synovial Sarcoma, (B) MPNST, (C) Neuroblastoma, or (D) Osteosarcoma
* Must have previously received a systemic chemotherapy
* Measurable disease according to RECIST v1.1 (or INCR, 2017 Neuroblastoma only).
* HLA-A\*02 positive
* Tumor shows MAGE-A4 expression confirmed by central laboratory.
* Performance Status: ECOG 0-1 or Lansky Score ≥ 80

Exclusion Criteria:

* HLA-A\*02:05 in either allele; or any A\*02 having same protein sequence as HLA-A\*02:05
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide.
* History of autoimmune or immune mediated disease
* Known central nervous system (CNS) metastases.
* Other prior malignancy that is not considered by the Investigator to be in complete remission
* Clinically significant cardiovascular disease
* Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
* Pregnant or breastfeeding
Feasibility of a Newborn Screening for Spinal Muscular Atrophy (SMA) in France: DEPISMA Prefigurator Project in Grand-Est and Nouvelle-Aquitaine

Spinal muscular atrophy (SMA) is a genetic disease of the nervous system that affects about 1 in 7,0001.2 births and results in very high mortality for patients with the disease. There are about 120 new cases in France each year and an estimated total of 2500 patients. It is the leading cause of genetic mortality in children in France. Until 2017, no etiological treatment was available. Currently, three treatments have been approved and have authorizations in France. The current clinical developments in SMA show the importance of an early treatment for patients. 3. The identification of pre-symptomatic patients is therefore essential to improve the effectiveness of treatments on an individual level and to avoid any loss of chance, as well as to reduce the societal cost of disability for patients treated in post-symptomatic. Several countries in Europe and around the world have implemented regional pilot screening programs for the disease. The screening test is based on a molecular genetic analysis that has been performed for many years, and which is highly reliable; there is currently no biochemical marker that can be used.

The objective of our project is to demonstrate the feasibility of neonatal screening for spinal amyotrophy in two French regions before being able to propose to extend it to the whole of France. The management of all screened patients will be decided outside the pilot study, by the existing national multidisciplinary consultation meeting, according to the best available standards of care and will be based on the national network of neuromuscular disease reference centers The objective of the project is not the evaluation of the efficacy of treatments or neonatal screening: these objectives are being studied by existing or otherwise ongoing studies around the world.

This project has been set up to be in line with the existing structures in France that are responsible for neonatal screening (via the regional neonatal screening centers (CRDN) and the regional perinatal networks) and for the management of rare diseases (via the neuromuscular disease reference centers and their FILNEMUS network). This project is performed in collaboration with AFM Telethon, Directorate of Health Care Supply, Regional Health Agency (ARS), FILNEMUS network, Novartis Gene Therapies, Roche Pharma AG,Biogen.

Investigator wish, as far as possible, to bring this study closer to real life and to be able to generate as much information as possible that can be used directly to prefigure the potential generalization of this screening strategy to the entire national territory.


Eligibility Criteria:
Inclusion Criteria:

* - Newborns born in the Grand-Est or Nouvelle Aquitaine regions during the study period
* Parent(s) or legal guardian(s) who do not object to "conventional" newborn screening
* Parent(s) or legal guardian(s) who give consent for newborn screening for SMA
* Child with health coverage

Exclusion Criteria:

* Parent(s) under curators or guardianship
The Effect of Palonosetron on the QTc Interval During Perioperative Period

The purpose of this study is to assess the effects of palonosetron on corrected QT interval duration during and after general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Elective abdominal surgery under general anesthesia

Exclusion Criteria:

* Cardiac valvular disease
* Clinically significant arrhythmias including atrial fibrillation
* Anti-emetics within 24 hours before surgery
* Steroids within 1 week before surgery
* Cancer chemotherapy or radiotherapy within 4 weeks before surgery
* Diabetes mellitus
* Pregnancy
* Patients receives a QT-prolonging drug
Circulating microRNAs and Adverse Cardiovascular Outcomes in Patients With Coronary Artery Disease

Coronary artery disease (CAD) resulting from atherosclerotic obstruction of epicardial coronary arteries accounts for more than one-third of deaths in subjects over the age of 35 worldwide. The global incidence of CAD is on the rise owing to the international epidemic of obesity, type 2 diabetes and aging, all of which are potent risk factors for coronary atherosclerosis. Participants with CAD are at high risk for subsequent adverse cardiovascular (CV) events and death; it has been estimated that one out of every five CAD patients will experience at least one adverse CV event during a 5-year follow up period. There is, however, no reliable diagnostic tool to predict the risk of adverse CV events or death in participanrs with CAD. Increasing evidence suggests that miRNAs are stably present in serum, plasma, urine, saliva and other body fluids and are considered a novel class of non-invasive biomarkers for various diseases including cancer, neurodegenerative and cardiovascular diseases

Objective：To identify the novel circulating miRNA expression profiles that may serve as a sensitive and reliable biomarker to predict future adverse CV outcomes and death in patients with established CAD.

Methods：The investigators propose to utilize next-generation sequencing (RNASeq) to identify the novel plasma miRNA expression signature linked to adverse CV outcomes in participanrs with CAD. The identified miRNA candidates that are predictive of adverse CV events will be validated in a larger independent cohort of CAD patients. In addition, miRNAs that are linked to adverse CV outcomes in CAD patients will be investigated mechanistically in human aortic endothelial cells to understand their functional contribution to the occurrence of adverse CV events.

What is New or Innovative in this Study? This study could be one of the few studies to investigate circulating miRNAs as novel biomarkers for risk stratification and the clinical outcome prediction in patients with established CAD. This report will also demonstrate that some dysregulated circulating miRNAs might contribute to endothelial dysfunction and adverse CV events in CAD patients.

Scientific or Clinical Implication of the Expected Results：The results from this study will provide a new prognostic tool to predict CV outcomes in CAD patients using plasma miRNA expression signature. It will also provide important scientific insights into the complex non-coding RNA regulatory network involved in the pathogenesis of atherosclerosis. The insights from this study may provide a unique opportunity to improve the risk assessment of adverse CV events in CAD patients by targeting theses miRNAs.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female older than 20 years old.
2. Have a history of cardiovascular disease (including coronary heart disease, or peripheral vascular disease)

Exclusion Criteria:

Significant valvular or congenital heart disease, cancer, immunosuppressive therapy, or other conditions or treatment your physician thinks you have
Predictors of Acute Toxicity and Flap Failure After Adjuvant Treatment for Locally Advanced Head and Neck Cancer

Head and Neck cancer treatment may have significant functional consequences. Decisions about treatment are usually hard to make, as they must strike a balance between efficacy of the treatment and likelihood of survival. Reconstructive surgery with flaps plays a key role in the head and neck cancer resection in order to achieve local control, but often leaves a large, disfiguring composite defect that not only compromises the patient's functional and aesthetic outcome, but also significantly affects quality of life.

Adjuvant treatment, including post operative Radiation Therapy (poRT) and chemotherapy, is crucial in improving locoregional control and survival in locally-advanced cases and the flaps are usually included in radiotherapy fields.

Fourthysix patients undergoing to reconstructive surgery followed by radiation or chemioradiation between Decembre 2017 to December 2022 at San Raffaele Hospital will be enrolled in this study. The first aim of the study is to understand potential predictors of the occurrence of overall acute toxicity following adjuvant treatment in locally-advanced head and neck cancers submitted to upfront surgery with flap reconstruction. By analyzing patient data and treatment variables, the study aims at identifying factors that may influence the incidence and severity of acute treatment-related toxicities, such as mucositis, dysphagia, xerostomia and dermatitis.

The second aim of the study is to evaluate whether the same variables may influence the viability and integrity of the flap at the end of the adjuvant treatment.


Eligibility Criteria:
Inclusion Criteria:

* locally advanced head and neck cancer squamocellular carcinoma
* treated with post operative radiotherapy +/- chemotherapy
* surgical resected with flap reconstruction

Exclusion Criteria:

* salvage surgery after primary relapse
* previously irradiated
* recurrent/metastatic
An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.


Eligibility Criteria:
Inclusion Criteria:

* Patients having histologically-proven solid tumors, who are either refractory to standard chemotherapy
* Patients whom chemotherapy with an investigaional agent in combination with docetaxel, or paclitaxel + carboplatin is appropriate
* Creatinine clearance according to Cockcroft-Gault formula : Normal \> 80 mL/min, Mild 50-80 mL/min, Moderate 30-\<50 mL/min
* A minimum of 4 weeks must have elapsed since the last treatment with other cancer therapies
* Potassium, calcium, magnesium and phosphorus values within the normal range
* Body Mass Index (BMI) must be within the range of 18 and 30

Exclusion Criteria:

* Patients having CNS metastases, must have a CT or MRI of the brain performed to rule out CNS metastases
* Patients with leptomeningeal disease metastases
* Radiotherapy \</- weeks prior to starting study drug
* Major surgery \</ 4 weeks prior to the start of study
* Administration of CYP1A2 and CYP3A4/5 enzyme inducing or inhibiting drugs within 14 days prior to starting study drug

Other protocol-defined inclusion/exclusion criteria may apply
A Natural History Study of Charcot-Marie-Tooth 4J (CMT4J)

Charcot-Marie-Tooth 4J (CMT4J) is a rare inherited peripheral neuropathy often characterized by rapidly progressive, asymmetrical upper and lower extremity weakness, muscle atrophy leading to loss of ambulation, respiratory compromise and premature death with no available treatment.

The purpose of this study is to investigate the clinical characteristics and natural clinical progression of symptoms in individuals with CMT4J. This natural history study is important to better understand disease course to be able to determine clinically meaningful outcome measures for use in future clinical trials.

Charcot-Marie-Tooth (CMT) diseases are the most common inherited motor and sensory neuropathies, composed of a group of pathologically and genetically distinct subtypes ranging from slowly to rapidly progressive disease.

CMT4J is a rare subtype of CMT caused by mutations in the FIG4 gene. Pediatric-onset disease can often be characterized by rapid progression of muscle weakness and atrophy, culminating in loss of ambulation and respiratory compromise and premature death. Adult-onset CMT4J can present with a more variable disease course.

No prospective natural history study for CMT4J has been reported. This study aims to prospectively investigate the natural history of CMT4J, and concurrently to identify potential outcome measures that could be used in future clinical trials. No investigational product will be provided in the study.

Eligibility Criteria:
Subjects must have a prior confirmed molecular (genetic) diagnosis of CMT4J by clinical presentation and genetic testing.
Medical Clowning and Patient Experiences in a Children's Hospital

A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children aged 4-17 years coming for a minor operative procedure including pre-operative cannula insertion will be included. Part of the patients will be exposed to medical clowning intervention and the reference group will be treated preoperatively as routinely without clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will be monitored during the day. A survey on the emotions and expectations of the parents will be done.

This study aims to measure experiences of children and their parents during day-surgery in hospital setting.

A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children aged 4-17 years coming for a minor operative procedure including pre-operative cannula insertion will be included. Part of the patients will be exposed to medical clowning intervention and the reference group will be treated preoperatively as routinely without clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will be monitored during the day. A survey on the emotions and expectations of the parents will be done.

A novel digital survey tool will be used to measure patient experiences before and after the insertion of a venous cannula needed for anaesthesia.

The research questions are as follows:

How does engagement with a medical clown during pre-operative cannulation impact on children and their parents' patient experience? How feasible is a novel data collection tool for measuring patient experience and the impact of an intervention on the patient experience of families?

Eligibility Criteria:
Inclusion Criteria:

* a patient coming for a day surgery (any) procedure in Helsinki Children's Hospital
* understands the Finnish language,
* between 4 and 17 years of age and
* the procedure includes the insertion of a venous cannula.

Exclusion Criteria:

* does not understand the Finnish language
* the child is under 4 years old or 18 years or older
* the procedure does not include the insertion of a cannula but for example mask anaesthesia