louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06790745: Plasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache
Official title: Plasma Rich Fibrin Epidural Injection by Racz Catheter Versus Epidural Blood Patch in Postdural Puncture Headache
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plasma Rich Fibrin
Epidural
Racz Catheter
Epidural Blood Patch
Postdural Puncture Headache
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate plasma-rich fibrin epidural injection by Racz catheter and epidural blood patch in Post dural puncture headache.

Detailed description: Post-dural puncture headache (PDPH) is also known as post-lumbar puncture (LP). PDPH is a major complication of neuraxial anesthesia that can occur following spinal anesthesia and with inadvertent dural puncture during epidural anesthesia.

Traditional management strategies include conservative measures such as oral analgesia, bed rest, oral or intravenous hydration, oral or intravenous caffeine, and administration of epidural crystalloid before catheter removal, but in refractory cases, more invasive techniques may be necessary. An epidural blood patch (EBP) has been the most favorable treatment for PDPH after an accidental dural puncture.

One innovative approach is the use of plasma-rich fibrin (PRF) derived from autologous whole blood, which contains and releases several different growth factors and cytokines to stimulate the healing of bone and soft tissue via degranulation. This approach has recently gained popularity in pain management. Another is the Racz catheter, a thin and flexible catheter used for targeted delivery of therapeutic agents.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from post-dural puncture headache.

Exclusion Criteria:

* Uncooperative patients.
* Severe comorbid conditions.
* Pregnancy.
* Anticoagulant therapy.
* Known allergies to plasma-rich fibrin or epidural blood patch components.
* Body mass index (BMI) ≥35 kg/m2.

Primary outcomes:
measure: Success rate of the procedures
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 8 days postoperatively
measure: Length of bed rest
timeFrame: 8 days postoperatively
measure: Change in optic nerve sheath diameter (ONSD)
timeFrame: 6 hours the procedure
measure: Incidence of complications
timeFrame: 8 days postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT03244345: Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Official title: Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression and Epilepsy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.

Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.

In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.


Eligibility criteria: Inclusion Criteria:

* Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
* Known or unknown etiology (symptomatic or cryptogenic epilepsy)

Exclusion Criteria:

* Psychogenic non-epileptic seizures
* Psychotic disorders and bipolar disorders

Primary outcomes:
measure: Depression
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Urielle DESALBRES
role: STUDY_DIRECTOR
References:
Clinical trial NCT06980545: Total Neoadjuvant 6 Cycles of Chemotherapy Versus 3 Cycles in Partial Responder Patients Diagnosed With Epithelial Ovarian Cancer
Official title: Phase 3 Study to Evaluate the Role of Total Neoadjuvant Chemotherapy in Partial Responders of Locally Advanced Ovarian Cancer Cancers (NeoPAR Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Stage III and IV Ovarian Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: neoadjuvant chemotherapy in stage III and IV ovarian cancer is given in 3-4 cycles with patients who R0 surgical resection is less likely to occur, in this study will assess total neoadjuvant chemotherapy 6 cycles then interval debulking surgery (experimental arm) versus 4 cycles then interval debulking surgery (control arm) in patients who achieve partial response or stationary disease by imaging after 3- 4 cycles of neoadjuvant chemotherapy, investigators'' primary end points will be event free survival, safety and tolerability and time to relapse, our secondary end points will be overall survival and surgical morbidity and mortality


Eligibility criteria: Inclusion Criteria:

1. \> 18 years of age
2. Recently diagnosed with stage III and IV OC
3. Patients eligible for Platinum-based CTH
4. Patients have PR or SD after 3-4 cycles of NACT

Exclusion Criteria:

1. Relapsed ovarian cancer
2. patients ineligible for Platinum-based CTH
3. Patient not candidate for IDS
4. stage I, II OC
5. Patients progressed after 3 cycles

7-Patients do not tolerate CTH

Primary outcomes:
measure: event free survival
timeFrame: it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03449745: Immune Checkpoint Receptors in AML-Leukemic Initiating Cells
Official title: Analysis of Immune Checkpoint Receptors Expression in the LIC Fraction pf AML Cells - ICAML-LIC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Immune Checkpoint Ligand
Flow Cytometry
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Acute Myeloid Leukemia

Brief summary: This project aim at deciphering immune mechanisms that allow the immunoescape of AML initiating cells.

Detailed description: Leukemic Initiating Cells (LIC) were shown to play a key role in AML relapses, and are characterized by resistance to treatment and a high capacity to escape to immune system. Immune checkpoints (ICP) maintain self-tolerance and physiological amplitude of the immune response. We decided to focus our work on ICP receptors and ligand that could be expressed by AML LIC and lymphocytes subsets. The tumor cells are able to express these ligands to exploit the ICP to overcome the anti-cancer immune response. Few studies are published in AML in the field of ICP, some studied limited cohort and others analyzed the expression of these ligands in total leukemic population, with a limited interest since the LIC fraction represents a small subset but mainly contributes to relapse. These cells are rare and their profile of expression could be highly different but not detectable in these studies because of technical limits. We aim at analyzing ICP ligands and receptors expression at diagnosis and relapse, the phenotype of BM cells will be analyzed by flow cytometry according to different panels of monoclonal antibodies using standard immunostaining protocols.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* newly diagnosed AML

Exclusion Criteria:

* isolated extramedullary AML
* mixed phenotype acute leukemia

Primary outcomes:
measure: Immune checkpoints (ICP) ligand expression
timeFrame: At inclusion
Secondary outcomes:
measure: Levels of ICP ligand expression
timeFrame: At inclusion
measure: Levels of ICP ligand expression
timeFrame: At inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Edouard FORCADE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953845: Artificial Intelligence System in Medical Regulation
Official title: Artificial Intelligence System for the Medical Regulation of Emergencies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Emergency Medical Communication Centres
Call Management
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 500000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient which call the emergency medical communication centres

Brief summary: Population health needs are increasing. Information and communication technologies are changing. The digital shift offers new opportunities for the exploration and analysis of mass health data. It is possible to rely on these new technologies to modernize, optimize patient management at the level of emergency medical communication centres.

Our project aims to integrate the methods and tools of artificial intelligence for emergency medical communication centres. The system aims to help regulate emergency calls at CRRA 15 in France, or Centrale 144 in Switzerland, to assess the severity of calls, identify care pathways, and improve efficiency when committing resources.

The development of such a system is aimed at securing and optimising the information system and the means of telecommunication used in the emergency medical communication centres, and provide an individualized response to the patient management.


Eligibility criteria: Inclusion Criteria:

* all patient which call the emergency medical communication centres

Exclusion Criteria:

* patient opposed to the study

Primary outcomes:
measure: Performance (sensitivity and specificity) of the artificial intelligence system in Emergency medical Communication Centres, concerning time sensitive disease
timeFrame: through study completion, average 3 years
Secondary outcomes:
measure: Patient transport time
timeFrame: through study completion, average 3 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06837545: Uric Acid and Surgical Prognosis
Official title: Sex-specific Associations of Preoperative Serum Uric Acid Levels with Mortality and Morbidity in Non-cardiac Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uric Acid
Keywords: Uric Acid
Mortality
Surgical Prognosis
Acute Kidney Injury
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 309353
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes adult patients aged 18 years or older who underwent non-cardiac surgeries at a tertiary hospital. Patients with emergency surgeries, pregnancy, cadavers, and incomplete data with missing preoperative uric acid levels, or missing follow-up information were excluded from the analysis. The study focuses on evaluating the impact of preoperative uric acid on postoperative outcomes, including mortality and morbidities.

Brief summary: Preoperative serum uric acid significantly impacted mortality and morbidity in non-cardiac surgery.

Detailed description: Preoperative SUA levels demonstrate a nonlinear, sex-specific relationship with postoperative outcomes in non-cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Patients who underwent non-cardiac surgery

Exclusion Criteria:

* Emergency surgery
* Pregnancy
* Cadavers
* Patients with missing preoperative SUA values or no follow-up after surgery

Primary outcomes:
measure: 30-day postoperative mortality
timeFrame: 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa
Study officials:
References:
Clinical trial NCT02239445: Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Administration Related Reaction
Failed Moderate Sedation During Procedure
Chloral Hydrate Adverse Reaction
Lead sponsor: Guangzhou Women and Children's Medical Center
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 158
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine is as effective as second dose of oral chloral hydrate for rescue sedation in infant age between 1 and 6 months who were not adequately sedated following initial dose of chloral hydrate.


Eligibility criteria: Inclusion Criteria:

* 160 children of ASA physical status I or II, aged between 1 and 6 months, failed chloral hydrate sedation during MRI scanning

Exclusion Criteria:

* known allergy or hypersensitive reaction to dexmedetomidine or CH, organ dysfunction, pneumonia, acute upper respiratory airway inflammation, preterm, cardiac arrhythmia or and congenital heart disease.

Primary outcomes:
measure: successful rescue sedation rate
timeFrame: up to 1 hours after MRI scaning
Secondary outcomes:
measure: sedation induction time
timeFrame: up to 30 min after rescue drug administration
measure: Wake -up time
timeFrame: up to 4 hours after rescue drug administration
Other outcomes:
measure: non-invasive systolic blood pressure
timeFrame: baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
measure: heart rate
timeFrame: baseline, before and 15 , 30, 60, 75, 90 min after rescue drug administration
measure: Oxyhemoglobin desaturation
timeFrame: baseline and four hours after rescue medicine administration
Locations:
city: Guangzhou
country: China
facility: Department of Anesthesiology of Guangzhou Women and Children's Medical Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Women and Children's Medical Center
state: Guangdong
Study officials:
References:
citation: Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
citation: Zhang W, Wang Z, Song X, Fan Y, Tian H, Li B. Comparison of rescue techniques for failed chloral hydrate sedation for magnetic resonance imaging scans--additional chloral hydrate vs intranasal dexmedetomidine. Paediatr Anaesth. 2016 Mar;26(3):273-9. doi: 10.1111/pan.12824. Epub 2015 Dec 30.
citation: Miller J, Xue B, Hossain M, Zhang MZ, Loepke A, Kurth D. Comparison of dexmedetomidine and chloral hydrate sedation for transthoracic echocardiography in infants and toddlers: a randomized clinical trial. Paediatr Anaesth. 2016 Mar;26(3):266-72. doi: 10.1111/pan.12819. Epub 2015 Nov 30.
Clinical trial NCT02429245: Single Cutting Guides System for the Installation of a Total Knee Replacement
Official title: Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Keywords: Knee
Knee osteoarthritis
Knee replacement
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Brief summary: The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up to 30%) are disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be the poor positioning of implants. Individual cutting guides are produced after a CT scan response planning carried out according to the CT scan anatomy of each patient, and subsequently adapted to its real anatomy during surgery, thus theoretically better accuracy of the implementation over conventional techniques. It has been shown in the past that the navigation has been the gold standard in measuring the three-dimensional orientation of the implants during surgery, and this system is systematically used in the service for over 10 years.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis.

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Improvement in the quality of life of patients after Knee replacement
timeFrame: every 3 months over a period of one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Jean-Yves JENNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Gori M, Adamczewski B, Jenny JY. Value of the cumulative sum test for the assessment of a learning curve: Application to the introduction of patient-specific instrumentation for total knee arthroplasty in an academic department. Knee. 2017 Jun;24(3):615-621. doi: 10.1016/j.knee.2017.03.007. Epub 2017 Apr 7.
Clinical trial NCT04367545: Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Official title: Development of a Molecular Diagnostic Strategy for SARS-CoV2 Based on Saliva in the Context of the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID
RT-ddPCR Multiplex
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to develop and validate a molecular diagnostic strategy (RT-ddPCR multiplex) of COVID-19 based on a saliva sample and alternative to the RT-qPCR method, in order to :

1. to compensate for the risk of a shortage of diagnostic kits, reagents and materials necessary for molecular diagnosis;
2. to increase the molecular diagnostic capacity of COVID-19 at the Rouen University Hospital;
3. and to have a method compatible with screening extended to populations at risk.


Eligibility criteria: Inclusion Criteria:

* Person aged over 18 years presenting to the COVID-19 consultation of the Rouen University Hospital for screening
* Person affiliated to a social security scheme

Exclusion Criteria:

* Person objecting to participation in the research after reading information
* Person under the protection of justice,
* Person deprived of their liberty by administrative or judicial decision (guardianship, curatorship, etc.)
* Patient under guardianship or curatorship

Primary outcomes:
measure: Number of positive patient using saliva method compared to number of positive patient using standard method
timeFrame: One hour
measure: Number of negative patient using saliva method compared to number of negative patient using standard method
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Thierry FREBOURG, Pr
role: PRINCIPAL_INVESTIGATOR
References: