cyrilzakka/clinical-trials huggingface dataset:
Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age

Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.

The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.

Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room).


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 1 month and 16 years who report to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication (defined as contact with a substance that is toxic per se or in such quantities as to cause a harmful effect on the body or administered by a route not intended for that substance)

Exclusion Criteria:

* not acquired informed consent
Phone or Email Reminder in Increasing Vaginal Dilator Use in Patients With Gynecologic Cancers Undergoing Brachytherapy

This randomized, pilot phase I trial studies whether phone or email reminders increases vaginal dilator use in patients with endometrial, cervical, or vaginal cancers after they undergo brachytherapy. Brachytherapy is a type of internal radiation which uses radioactive material placed directly into or near a tumor to kill tumor cells. A reminder program may help increase use of vaginal dilators and decrease long-term side effects following brachytherapy.

PRIMARY OBJECTIVES:

I. Evaluate whether vaginal dilator adherence is improved with additional reminder phone calls and/or email reminder survey.

SECONDARY OBJECTIVES:

I. Evaluate whether there are differences in the length of vaginal canal between the non-intervention and intervention groups. Evaluate rates of gynecologic, urinary, and gastrointestinal toxicity.

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM I: Patients receive no additional reminders.

ARM II: Patients receive a reminder email survey every 2 weeks for 1 year after completing radiation.

ARM III: Patients receive a reminder email survey as in Arm I and 4 additional phone calls at 4-8 weeks, 3-5 months, 7-8 months, and 10-11 months during their first year of follow-up.

After completion of study, patients are followed up at 10-14 weeks, 5-7 months, 8-10 months, 11-13 months, 15-17 months, 19-21 months, and 23-25 months post treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with gynecologic cancer who are undergoing vaginal brachytherapy as part of their treatment
* Patients cannot have previously received pelvic external beam radiation or brachytherapy. Patients may be enrolled while undergoing vaginal brachytherapy radiation treatment.
* Patients should have a life expectancy of at least 1 year
* No Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status requirements
* No organ and marrow function requirements
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients who have received prior pelvic external beam radiation or brachytherapy will be excluded
* No restrictions regarding use of other investigational agents
* No exclusion requirements due to co-morbid disease or intercurrent illness
* No investigational agent, so no exclusion requirements regarding history of allergic reactions attributed to compounds of similar chemical or biologic composition to investigational agent or device
* No exclusion criteria relating to concomitant medications
* No exclusion criteria for pregnant or nursing patients from participating in this study (Of note, pregnant patients will not be treated with vaginal brachytherapy, a requirement for enrolling on this study)
Long-term Outcomes of Tunnel Technique

Few studies evaluate the outcomes beyond 1 year follow up for gingival recessions treatments using the tunnel technique in combination with connective tissue graft. The aim of this randomized controlled trial (RCT) was to compare the 4-year outcomes of the CAF versus the pouch/tunnel (TUN) technique both associated with CTG.


Eligibility Criteria:
Inclusion Criteria:

* Miller's class I recessions;
* Recession of 2 mm to 5 mm;
* Maxillary incisors, canines or premolars;
* Identifiable cementoenamel junction (CEJ);
* Patients minimum 18 years old;
* No/controlled periodontal disease;
* ASA1 or ASA2 (American Society of Anesthesiologists) general health status;
* Providing a signed informed consent form.

Exclusion criteria were:

* Smokers;
* Presence of cervical carious lesion;
* Pocket depth greater than 4 mm;
* Sites where previous muco-gingival therapy was performed;
* Pregnancy.
* In presence of non-carious cervical lesions, the anatomical CEJ was reconstructed by the use of a composite before the procedure.
Capture of Prostatic Trans-rectal Ultrasound Scans for Research

Through this study the investigators seek to build up a repository of prostate ultrasonography videos and prostate MRI scans to enable research into novel anatomical registration techniques. These data will facilitate the development of improved technology that enables targeting of tumours seen on MRI using free-hand biopsy techniques, without the need for a gantry or overlaid perineal grid.

The purpose of this study is to explore whether mathematical and computational modelling techniques can be used to enable anatomical based real-time image registration for guiding prostate biopsies. This would lead to the ability to perform free-hand trans-perineal biopsy without the need for supporting gantries or a biopsy grid placed over the perineum. This will significantly decrease costs of trans-perineal biopsy, reduce the number of puncture sites through the perineal skin - reducing pain and bleeding - and reduce the procedure time. Alongside locally developed local-anaesthetic transperineal biopsy techniques it will allow targeted biopsy to be taken in the outpatient setting, improving patient convenience, and helping health services to meet growing demands on targeted biopsies.

The investigators aim to create a new method of mapping the prostate using free-hand ultrasound, without any additional physical equipment. This may require collaborations with approved International groups with particular skills in relevant mathematical or engineering techniques.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing trans-perineal prostate biopsy under general anaesthesia who have had an MRI of their prostate within the preceding 12 months.
* Male.
* Age 18-100.

Exclusion Criteria:

* Those unable to provide informed consent.
* Any medical condition, vital sign or laboratory value that, in the opinion of the investigator or responsible anaesthetist makes any prolongation of general anaesthesia unsafe to the participant.
* Patients unable to have an MRI
Central Post-Stroke Pain - a Prospective Study

Part 1: The purpose of the first part of the study is to investigate the prevalence of pain at stroke onset and 3 and 6 months after stroke in a consecutive cohort of stroke patients admitted to a stroke unit.

Part 2: The purpose of the second part of the study is to identify patients who develop central post-stroke pain within the first 6 months following stroke and to try to identify early prognostic factors for the development of pain.

Part 1:

* Within 3 days of admission: medical history, pain history, sensory examination
* Telephone follow-up at 3 and 6 months post-stroke: pain history

Part 2:

* Medical history, Pain history, Sensory examination

Eligibility Criteria:
Inclusion Criteria:

* Recent cerebrovascular stroke

Exclusion Criteria:

* Severe dementia, aphasia or psychosis
* Patients who cannot cooperate at time of inclusion
* Patients who do not understand Danish
An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease

Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female age greater than 18
* Patients suffering from Crohn's disease
* Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug
* Able and willing to sign an informed consent
* Patient will be available for follow up.

Exclusion Criteria:

* Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
* Known immunodeficiency.
* Exclusion Criteria for injecting biologic adhesive:

  * Known allergy to fibrin glue or one of its components.
  * An undrained perianal abscess, diagnosed by a physical examination or imaging methods.
* Known Alcohol or drug abuse
Effects of Physical Exercise on Response to Treatement in Breast Cancer

The goal of this clinical trial is to learn how regular physical exercise affects breast cancer patients' response to standard neoadjuvant chemotherapy (NAC) and to gain an insight into the molecular mechanisms underlying the effects of exercise on cancer biology. of exercise-induced alterations in cancer gene expression and the immune tumor microenvironment. The main questions it aims to answer are:

* Does a high-intensity interval training (HIIT) program during treatment improve patients' response to NAC and quality of life as compared to low level of physical activity during the treatment?
* What are the differences in the residual tumor gene expression and tumor infiltrating immune cell profile between patients taking HIIT during the NAC and patients with low level of physical activity?
* What are the roles of extracellular vesicles (EVs) in mediating the effects of exercise on cancer progression?

Patients in HIIT group will undergo a personalized HIIT program consisting of 3 training sessions per week for the whole duration of NAC, whereas patients from the control group (Ctrl) will be advised to maintain their usual level of physical activity during NAC. After the breast surgery, response to NAC will be assessed by Miller-Payne grading. Tumor and normal breast tissue specimens will be collected for RNA sequencing analysis. Blood samples will be collected before and immediately after the training for the analysis of RNA and protein cargo of circulating EVs.


Eligibility Criteria:
Inclusion criteria:

* Primary breast cancer; stage IIA-B, IIIA-C (TNM: T1-4, N0-3, M0) at diagnosis
* Diagnosis established by core needle biopsy
* Age 30-65 years
* Prescribed doxorubicin/cyclophosphamide-based NAC
* Oral and written consent

Exclusion criteria:

* Cardiac pathologies
* Pregnancy
* Blood transfusion in the last six months
* Another oncological disease
* Previous chemotherapy, hormonal or X-ray treatment
* Participation in another clinical trial
* Currently performing more than 180 min of moderate to high intensity aerobic training per week
Study on Neutropenia Induced by Adjuvant Paclitaxel/Carboplatin Chemotherapy in Patients With Epithelial Ovarian Cancer

To develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.


Eligibility Criteria:
Inclusion Criteria:

* Patients with FIGO stage I-IV epithelial ovarian cancer after staging or debulking surgery
* Patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin
* Patients who have signed approved informed consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease
* Previous pelvic radiation therapy
* Previous chemotherapy (prospective cohort)
* Patients with disease which can cause neutropenia
* Patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort).
* Pregnant or lactating woman
Monocentric Study on the Use of Teriparatide in Children With hypoparathyroïdism

Pediatric hypoparathyroidism is an orphan disease. Conventional management combines native and active vitamin D, calcium supplementation and sometimes phosphate binders, with the risk of long term hypercalciuria, nephrocalcinosis and further renal impairment. The use of teriparatide has been reported in adults (daily or bi-daily subcutaneous infusions) and in children (rather continuous subcutaneous infusion) as second-line therapy.

The objective of this study is to obtain efficacy and safety data on the use of teriparatide in children with hypoparathyroidism to improve our knowledge of their management.


Eligibility Criteria:
Inclusion Criteria:

* Patients with hypoparathyroidism
* Patients treated with teriparatide
* Patients followed in the reference center for calcium and phosphate metabolism diseases of Lyon.
* For children under 18: patient and parent (s) / parent having been informed of the study and having expressed their non-opposition

Exclusion Criteria:

* No social security support
A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, 18 - 60 years of age
* Female subjects must be surgically sterile or post-menopausal
* Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
* Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)

Exclusion Criteria:

* History or evidence of any clinically significant disease or disorder
* Pregnant or lactating women
* Male partners of women who are lactating or trying to become pregnant
* Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
* Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
* Positive for hepatitis B, hepatitis C or HIV infection
* Participation in an investigational drug, biologic, or device study within three months before first study drug administration
Safety and Efficacy of Topically Applied CTA018 in Plaque Psoriasis

Vitamin D and its analogs are currently widely used for the treatment of psoriasis. The study drug (CTA018) is a novel analog of vitamin D, and this Phase 2 study will investigate the efficacy and safety of CTA018 in the treatment of psoriasis. Patients with chronic plaque psoriasis will receive one of three doses of CTA018 cream or vehicle (no study drug) daily for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic plaque psoriasis for 6 months to a max 15% body surface area excluding face, scalp, groin, axillae, palms, soles of feet
* at least two evaluable plaques with CPSS \>/= 6
* baseline PSGA \>/= 2
* women of childbearing potential msut agree to use an effective form of contraception

Exclusion Criteria:

* cannot have guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
* cannot have concomitant serious illness/condition that may interfere with participation in the study
* cannot have used topical therapy within 2 weeks prior to baseline visit
* cannot have used photo-therapy or systemic psoriasis therapy within 4 weeks prior to baseline visit
* cannot have had prolonged exposure to natural or artificial UV radiation within 4 weeks of baseline visit or intend to have exposure during the study
* cannot have used systemic immunomodulatory therapy within 12 weeks prior to baseline visit
* cannot have a history of hypercalcemia or kidney stones
* cannot be unable or unwilling to discontinue calcium and/or vitamin D supplementation during the study
* cannot be pregnant or a nursing mother
* cannot be participating in or have participated in an interventional study within 30 days of study start
Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma

The non-interventional study SEATTLE aims to answer open scientific questions regarding QoL and tolerability/safety and AE management of selinexor as well as effectiveness and dosing in clinical routine. Thus, SEATTLE will provide real-world evidence complementary to pivotal studies.

Multiple myeloma (MM) accounts for approximately 10% of hematological malignancies. Since MM patients are elderly and often comorbid patients, risk-adapted treatment strategies to further improve outcome in is crucial.Selinexor, a potent, oral, SINE (selective inhibitors of nuclear exports) binds reversibly to XPO. This leads to nuclear localization and functional activation of tumor suppressor proteins, which further leads to suppression of nuclear factor κB activity, and reduction in oncoprotein mRNA translation. All this induces apoptosis of tumor cells. Since treatment options for MM are various and the most important factor is to keep or improve quality of life (QoL) of the patients, there is an urge for real-world clinical data of MM patients treated with selinexor in clinical routine. The objective of this non-interventional study is to evaluate QoL and tolerability/safety and AE management as well as effectiveness and dosing in adult patients with relapsed or refractory MM, which receive selinexor in combination with bortezomib and dexamethasone in the 2nd or later therapy line in a real-world setting.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory multiple myeloma
* Indication and decision for ≥2nd-line treatment with selinexor in combination with bortezomib and dexamethasone according to current selinexor SmPC as assessed by the treating physician
* Treatment decision before inclusion into this non-interventional study
* Willingness and ability to participate in the electronic patient-reported outcome (ePRO) module and answering of questionnaires
* Age ≥18 years
* Signed and dated informed consent form
* Inclusion before start of treatment (prospective inclusion)

Exclusion Criteria:

* Contraindications according to selinexor SmPC for patients with MM
* Participation in an interventional clinical trial
Creation of a Clinical Database of Lumbar Spine MRI

The creation of a clinical database including patients who suffer from low back pain and underwent a lumbar spine MRI Exam.

This database will allow us to :

* Collect patients symptoms, medical history, and MRI exams
* Launch the annotation of the MRI exams by expert radiologists
* Link and relate information between the exams and the diagnostic done by the experts
* Train and develop a diagnostic platform for th spinal pathologies based on artificial intelligence.

Low back pain is classically characterized by pain in the lower back, which may be accompanied by varying degrees of restricted mobility and pain radiating down to the feet. The management of low back pain is a global public health issue, since it represents one of the major causes of disability worldwide.

Degenerative disc disease (DDD) is the most common underlying pathology. These include herniated discs, pinched discs and degenerative spondylolisthesis (slippage of one vertebra in relation to its neighbor). Worldwide, 266 million patients suffer from DDD every year. The socio-economic impact of these pathologies is considerable.

DDD results from a variety of pathologies that may interact with each other. The diversity of these pathologies and the complexity of their interactions often lead to failure of a clear diagnosis, and consequently to inappropriate treatment.

In clinical practice, MRI is the reference test for the diagnosis of these pathologies, but inter-observer reliability remains moderate between 2 practitioners (sensitivity 56% and Cohen's κ ⊂ \[0.41-0.6\]) or even low (κ ⊂ \[0.21-0.4\]) between 2 practitioners of different specialties. So there is still a major gap to be bridged in order to make radiologists' diagnoses more reliable and standardized.

In this context, the creation of a clinical database including patient symtoms and exams is of hogh interest.Thsi database will allow us to :

1. Annotate the MRI exams by experts radiologists in order to train and develop AI algorithms
2. Create a tool to support radiologists in their diagnoses would therefore be a considerable step forward. Such a tool, combined with non-invasive data, would make it possible to establish a specific diagnosis early on,

The database will also allow us to develop or participate in multicentric clinical studies, at the national or international level, as well as to facilitate the identification of correlations between MRI findings, the patients symptoms and the origin of the low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged ≥ 18, no age limit;
* Suffering of low back pain ;
* Patient exam performed at the Centre Hospiralier Universitaire de Montreal (CHUM), Canada

Exclusion Criteria:

* Patients with orthopedic material
* Patients with traumatic cases (ex : accidents)