cyrilzakka/clinical-trials huggingface dataset:
Role of BMP Pathway in MDS Progression

Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described.

The Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance.

Preliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML.

If appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with myelodysplastic syndrome or suspected myelodysplastic syndrome according to the criteria defined by the World Health Organization Or
* Adult patient with suspicion of de novo acute myeloid leukemia at initial treatment

Exclusion Criteria:

* Frontier MDS/myeloproliferative syndromes including chronic myelomonocytic leukemia
* MDS and AML having already benefited from cytotoxic treatment including hydroxycarbamide, azacytidine, intensive chemotherapy
* Patients objecting to their inclusion in the study
* Pregnant or breastfeeding women
* Patients under legal protection measure
The Relationships Between Personal Identity, Autobiographical Memory and Future Thinking in People With Multiple Sclerosis

Personal identity is composed of multiple facets of the self that are constructed and nourished through memories of past experiences (i.e., autobiographical memory) and the imagination of events that may occur in the future (i.e., future thinking) .

While our previous work has shown that people with relapsing-remitting multiple sclerosis (pwRRMS) have autobiographical memory and future thought disorders, their impact on personal identity has not yet been explored. Based on a cognitive and clinical neuropsychology approach, this research project aims to better understand the cognitive mechanisms involved in the relationship between identity, autobiographical memory and future thinking in pwRRMS. We will examine the extent to which pwRRMS manage to maintain and reshape their identity through life experiences, with a particular interest in the potential integration of the disease as a facet of their identity. In addition, we will explore the positive and/or negative consequences of disease-related identity changes on emotional well-being and quality of life, as well as their links with the duration and severity of the disease. Overall, this research project will contribute to identify new therapeutic levers that can be used for the development of adapted and personalized care.


Eligibility Criteria:
For the clinical group:

Inclusion Criteria:

* Diagnosis of relapsing-remitting MS according to the McDonald's revised diagnostic criteria
* People aged between 18 and 55
* French native speaker
* Access to a computer or tablet, equipped with internet access, a camera and a microphone

Non-inclusion Criteria:

* MS relapse in the month prior to the inclusion
* Treatment with corticosteroids during the month preceding the inclusion
* Form of MS other than the relapsing-remitting form
* Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
* Other diagnosed chronic pathology(ies) (other than MS for patients)
* Severe cognitive impairment
* Persons mentioned in Articles L1121-6 to L1121-8 in the French law (minors, persons deprived of liberty, adults subject to protective measures)

For the control group:

Inclusion Criteria:

* People aged between 18 and 55
* Matched in age, gender and level in education
* French native speaker
* Access to a computer or tablet, equipped with internet access, a camera and a microphone

Non-inclusion Criteria:

* Neurological history (other than MS for patients), history or current presence of psychiatric disorders (e.g., depression, anxiety disorders, schizophrenia), substance abuse (e.g., alcohol, cannabis; past or present)
* Other diagnosed chronic pathology(ies) (other than MS for patients)
* Severe cognitive impairment
* Persons mentioned in Articles L1121-6 to L1121-8 in the French law (minors, persons deprived of liberty, adults subject to protective measures)
Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation

Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with \> 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.


Eligibility Criteria:
Inclusion Criteria:

* the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.
Transfusion and COVID-19

Alsace was particularly and early on affected by SARS-CoV-2 and quickly implemented a reduction in scheduled admissions and non-urgent surgical interventions, making it possible to reduce requests for labile blood products linked to non-urgent surgical procedures. as has been reported in the literature; the population containment measures also led to a major reduction in traffic - and consequently accidents on the public roads. At the same time, other demands for blood products related to activities such as onco-hematology were little affected. Finally, the blood banks have adapted their collection procedure.

To answer these questions, we propose to conduct a retrospective study over two parallel periods of 2019 and 2020 of the consumption of blood products on the one hand and the availability of stocks on the other hand.


Eligibility Criteria:
Inclusion criteria:

* Adults patient (≥18 years old)
* Patients admitted to Strasbourg University Hospitals for suspicion of Covid-19, between February 24 and May 31 of 2019 and 2020
* Labile blood products consumed between February 24 and May 31 of 2019 and 2020
* Subjects not having his opposition, after information, to the reuse of his data for the purposes of this research.

Non-inclusion criteria:

* Patients who expressed opposition to participating in the study
* Patients under legal protection
* Patients under guardianship or curatorship
A Phase III Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

The study consists of 3 parts. Part 1 is screening period, Part 2 is Placebo control period and part 3 is Long term treatment follow-up period. The research period is 61 weeks in total.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged ≥18 years old.
* Subjects with confirmed ankylosing spondylitis before screening.
* During screening and before randomization, BASDAI score ≥ 4, total back pain score≥ 4.
* Subjects received at least 2 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond, or with contraindications or intolerance to the use of NSAIDs.
* Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids(The daily dose should be ≤10mg prednisone or equivalent dose of glucocorticoid) as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization. If the drug has been discontinued, at least 2 weeks washout period is required before randomization.
* Subjects taking methotrexate (MTX) (≤25mg/week) or Sulfasalazine (≤3g/day) are allowed to continue their medication if started at least 12 weeks prior to baseline, with a stable dose for at least 4 weeks before randomization. If the drug has been discontinued, at least 4 weeks washout period is required before randomization.
* Subjects who are able to understand and voluntarily sign the ICF and complete the study procedure.

Exclusion Criteria:

* Subjects with symptom of pain that affected the evaluation of efficacy.
* Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS).
* Subjects who are using strong opioid analgesics.
* Received glucocorticoid intramuscular or intravenous injection within 2 weeks prior to randomization; Received intraarticular or paraspinal glucocorticoid therapy within 4 weeks before randomization.
* Received other antirheumatic drugs (except methotrexate, sulfasalazine), proprietary Chinese medicine or traditional Chinese medicine decoction, JAK inhibitor treatment for AS within 4 weeks before randomization.
* Received Natalizumab or other B cell or T cell modulator in the 12 months prior to randomization.
* Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.
* Received multiple tumor necrosis factor α (TNF-α) inhibitors; The eluting period of biologics received before randomization is shorter than the protocol.
* Participated in a clinical study of any other drug or medical device within 1 month (≤30 days) prior to randomization, or last received the investigational drug within 5 half-lives.
* The presence of any other systemic disease or laboratory abnormalities that the investigator has judged unsuitable for clinical trials.
Diet, Physical Activity and Body Composition Changes During R-CHOP

In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the course of R-CHOP treatment for non-Hodgkin lymphoma (NHL).

Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) is the "gold standard" first-line treatment for patients with non-Hodgkin lymphoma, yet it is estimated that R-CHOP is not curative for 30- 50% of patients. Preliminary studies suggests that modifiable lifestyle factors such as body composition, exposure to endocrine disrupting chemicals, and changes in the gut microbiome may contribute to variation in R-CHOP treatment response. If true, it could be possible to modify these factors in an effort to improve treatment outcomes, however more detailed information is needed to confirm these preliminary findings and test whether lifestyle modification can improve outcomes.

In this observational study, data will be collected on dietary intake, ability to be physically active, body composition, environmental exposure to endocrine disrupting chemicals and changes in the gut microbiome over the course of R-CHOP for NHL. The study will provide more detailed information on the usual trajectory of these lifestyle factors during R-CHOP treatment than has previously been collected, especially how these factors co-vary over time. The study findings are expected to inform future intervention studies aimed at improving R-CHOP treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of one of the non-Hodgkin lymphomas
* Scheduled to receive R-CHOP at the George Washington University Cancer Center

Exclusion Criteria:

* Diagnosis of cancer other than one of the non-Hodgkin lymphomas
* Patients who are scheduled to receive their R-CHOP somewhere other than the George Washington University Cancer Center
* Patients who are not competent to provide informed consent to participate
Phase I/II Clinical Trial of NP41 for Cranial Nerve Fluorescence Imaging

Preclinical evidence has shown that NP41 is a novel nerve-binding peptide with safe pharmacokinetics. Fluorescently labeled NP41 is effective for the intraoperative visualization of cranial nerves during neurosurgery. This Phase I/II clinical trial is aimed to investigate the safety and validity of FAM-NP41 for the fluorescence imaging of cranial nerves. In the Phase I trial, biological safety and adverse events will be evaluated, and pharmacokinetic parameters will be measured. In the Phase II trial, the sensitivity and specificity of FAM-NP41 for the fluorescence imaging of cranial nerves will be investigated, and the signal-to-background ratio will be calculated.


Eligibility Criteria:
Inclusion Criteria:

1. Enhanced brain MRI with or without cranial CT confirms a diagnosis of tumor in the anterior skull base, the middle cranial fossa, or the posterior cranial fossa. Structural images, DTI sequences and 3D-CISS sequences confirm that the tumor is adjacent to the cranial nerve or the cranial nerve will be exposed during the neurological surgery.
2. The body weight is within ±20% of standard body weight \[0.7×(height cm-80)\]kg;
3. The preoperative laboratory examination parameters of heart, lung, liver, kidney and blood are all in the normal range;
4. Be able to understand the potential risks and benefits of the clinical trial, and sign a written informed consent.

Exclusion Criteria:

1. Preoperative hepatorenal insufficiency: ALT or AST increased ≥ 2 times than the upper limit of normal range; serum creatinine \> 2.0 mg/ dL (177 μmol/L) or glomerular filtration rate \> 30 ml/min×1.73 m2;
2. Positive reaction in the allergy test, or allergic constitution (such as allergic to two or more foods/drugs, or known to be allergic to protein or to this polypeptide);
3. Preoperative imaging data (enhanced MRI) are incomplete;
4. Serious primary diseases involving important organs;
5. Mentally or physically disabled patients;
6. Alcohol abuse or long-term medication may affect the drug metabolism;
7. According to the judgment of the investigator, the potential intolerance to the drug (such as weak or severe malnutrition);
8. Primary or secondary cranial nerve dysfunction, such as facial paralysis, hearing loss caused by otitis media, etc.
9. Female patients undergoing neurosurgery during pregnancy or lactation.
Correlation Study of Vascular Parameters in Hypertensive Men With Erectile Dysfunction

The purpose of the study is to assess the correlation of FMD of brachial artery and carotid intima media thickness with ED severity and clinical response to vardenafil in hypertensive men.

To achieve this objective, a prospective study will be conducted, with hypertensive patients ranging from 50 to 70 years, presenting vasculogenic erectile dysfunction for over six months and sexually actives. All patients will be assessed for clinical and laboratorial data, endothelial dysfunction, endothelium independent vasodilation and carotid intima media thickness at the inclusion of the study. They will receive medical orientations from the same urologist and will return after four attempts with 20 mg of vardenafil.

Eligibility Criteria:
Inclusion Criteria:

* arterial hypertension and erectile dysfunction of vascular origin for at least 6 month

Exclusion Criteria:

* other condition that cause erectile dysfunction such as depression, hypogonadism, surgery, trauma, major cardiovascular event
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis

A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis

In this investigation, it will be investigated whether the effectiveness of surgical intervention with Coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. The main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. Therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* is 40 to 85 years old at time of surgery
* has INC, as noted by leg/buttock/groin pain with or without back pain. Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair
* has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications
* has a regular indication for surgical intervention of INC
* has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI
* is physically and mentally willing and able to comply with, or has a caregiver who is willing and able to comply with, the post-operative evaluations.

Exclusion Criteria:

* has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
* has Paget's disease, severe osteoporosis or metastasis to the vertebrae
* has significant scoliosis (Cobb angle \> 25 degrees)
* has a Body Mass Index (BMI) \> 40 kg/m2
* has had any surgery of the lumbar spine
* has degenerative spondylolisthesis \> grade 1 (on a scale 1 to 4) at the affected level
* has significant instability of the lumbar spine
* has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study
* has a fused segment at the indicated level.
* has a herniated disk on the level of interest
Study of the Impact of a Pediatric Nurse's Consultation on Parental Anxiety During a Febrile Convulsion in Children

Febrile seizures are considered a very common syndrome presented in the pediatric emergency room. Witnessing these seizures may can cause anxiety in parents and generate them psychological sequelae such as major depressive disorder in the short term, or sleep disorders in the long term.

An appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology and its care, and thus to reduce their anxiety and prevent potential inappropriate or even deleterious behavior and maneuvers towards the child.

Febrile seizures occupy a large place in pediatric practice in the emergency room, their prevalence varies between 3 and 8% in children under 7 years old, hence the notion of a very common syndrome.

When parents witness this event, they can experience it as terrifying, and which can alone cause anxiety and generate psychological sequelae. In the literature, it is described that a third of the parents present a major depressive disorder after the event and a third of the parents still describe sleep disorders after one year.

After the arrival at the pediatric emergency room following the febrile seizure, the priority is given to the care of the child and parents are given succinct medical information. Due to parental anxiety, which may still be significant at this time, this information may not be understood. All of this can make the parent's level of knowledge about this pathology and its management low, potentially leading to future behaviors and maneuvers (such as shaking) that are inappropriate or even harmful to the child.

A different course with appropriate care for parents must be put in place in the emergency department, with the objective of improving their knowledge of this pathology, its care and to reduce parent's anxiety. This is why the CONSULFE childcare consultation is proposed in this research.

Eligibility Criteria:
Inclusion Criteria:

* Participant being an adult parent who attended the febrile seizure of their child aged 1 to 5, episode lasting less than 15 minutes occurring within 24 hours
* Participant having signed the free and informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Parent who already has experience of febrile seizures in one of the siblings
* Parent of a child with a convulsive or neurological history
* Non-French speaking parents
* Parent with a diagnosed psychiatric illness
* Parent benefiting from a legal protection measure
* Parent participating in a study related to the management of anxiety
iCanCope With Post-Operative Pain (iCanCope PostOp)

There are few applications available in the community to help teenagers manage pain after surgery. The focus of this study is to better understand the pain experience of children after having surgery and to design a Smartphone app called "iCanCope with Post-Operative Pain" (iCanCope PostOp), to help children and parents to better manage pain at home after surgery. The app will help keep track of pain, provide information about the teenager's surgery and provides "in-the-moment" advice wherever and whenever the patient needs it.

More than 80,000 Canadian children undergo surgery each year. Despite evidence-based pain management and clinical standards, moderate to severe postoperative pain in children is common. Inadequate postoperative pain management contributes to poor health outcomes, increased opioid use, and the development of chronic postsurgical pain. Successful postoperative pain management requires regular monitoring and treatment of pain after hospital discharge. Smartphones are nearly ubiquitous, and growing evidence supports their use to overcome barriers to pain care. Computerized clinical decision support systems (CDSS) can improve pain self-management by tracking symptoms over time and offering tailored evidence-informed pain management advice based on standardized algorithms. A comprehensive and sustainable approach is needed to address poorly managed pediatric postoperative pain in the home setting. To address these gaps in care, we are developing "iCanCope with Post-Operative Pain" (or iCanCope PostOp), a smartphone-based CDSS app that provides remote, in-the-moment advice to improve pain and health-related quality of life (HRQL) for adolescents following surgery.

Eligibility Criteria:
Inclusion Criteria:

1. aged 12 to 18 years;
2. own a smartphone compatible with the iCanCope app (iOS or Android);
3. diagnosed with adolescent idiopathic scoliosis or pectus carinatum or pectus excavatum;
4. are able to speak and read English; and
5. scheduled to undergo scoliosis or minimally invasive pectus repair surgery.

Exclusion Criteria:

1. significant cognitive impairment or other co-existing medical condition that could limit the ability to use the iCanCope app, as identified by their health care provider;
2. participated in a previous study of iCanCope PostOp;
3. a diagnosed chronic pain condition not related to the surgical condition; or