louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05022420: SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
Official title: SAfety and TOlerance of the Biopsies in Auto-immune Rare dIseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tolerance
Biopsy Site Itching
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients that underwent a biospy for his auto-immune rare disease

Brief summary: Biopsies are performed in several autoimmune diseases to diagnose or classify them Tolerance and information of the patients have been poorly evlauated our objective is to evaluate tolerance and information of the patients after the biopsies for salivary gland, temporal arteries and neuromuscular.

Detailed description: patinets that benefited of arterial temporal biospy or salivary gland biospy or muscuar biopsy or neuro muscular biospy for his auto -mmune disease will be included and fill standardized questionnaires concerning tolerance, information and side effect at inclusion , day 7 and day 30 after the biopsy data will be analysed to evaluate information, tolerance and risk factor af side effect

Eligibility criteria: Inclusion Criteria:

* biospy required for the diagnsis or follow up aged of more than 18 non opposition form

Exclusion Criteria:

* unable to consent demencia unable to fill the form and questionnaire patient Under juridical protection refusing to participate

Primary outcomes:
measure: tolerance of each type of biopsy
timeFrame: tolerance at day 7 after the biospy was performed
Secondary outcomes:
measure: tolerance of each type of biopsy 30 days after
timeFrame: tolerance at day 30 and at inclusion after the biospy was performed
measure: evaluation of the qualitiy of patient's information at inclusion
timeFrame: questionnaire at inclusion
measure: risk factor of sied effect of each biospy
timeFrame: standardized questionnaire at inclusion, day 7 and 30
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'ANGERS
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Brest
country: France
facility: CHRU de Brest
city: Lille
country: France
facility: CHU de LILLE
city: Marseille
country: France
facility: CHU de Marseille
city: Paris
country: France
facility: Hôpital de la Salpétrière
city: Quimper
country: France
facility: CH de Quimper
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
Clinical trial NCT04692220: Drug-Related Problems : Focus on Age and Diabetes
Official title: Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Events
Keywords: Drug-Related Problems
Clinical Pharmacist
Elderly
Diabetes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 27000
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: Study population was composed of patient admitted in emergency department or medical units of Montpellier University hospital.

Brief summary: Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs.

DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including

* medication reconciliation,
* an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients.

In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP.

Translated with www.DeepL.com/Translator (free version)


Eligibility criteria: Inclusion criteria:

- Patients aged above 18 years old, admitted to the emergency department or hospital

Exclusion criteria:

* Patients presenting acute psychological disturbance
* Patients that did not agree to participate

Primary outcomes:
measure: Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems
timeFrame: 1 day
Secondary outcomes:
measure: Number and type of Adverse Drug Events and Drug-Related Problems
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Cyril BREUKER, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01556620: Is NIRS Able to Detect Ischemia Following Brain Insult
Official title: The New 4 Wavelengths EQUANOX NIRS Sensor: Correlation and Detection of Ischemic Episodes. An Observational Comparative Study Versus PtiO2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Trauma
SAH
ICH
Keywords: PtiO2
NIRS
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brain injury (head trauma, SAH, ICH)

Brief summary: We hypothesize that newly developped NIRS sensor (EQUANOX Advance™, 8004CA, NONIN Medical, USA)is able to detect ischemic events recorded by brain tissue oxygen probe (Licox, Integra Neurosciences, USA) and that values are correlated.


Eligibility criteria: Inclusion Criteria:

* Necessity of monitoring by PtiO2 and ICP

Exclusion Criteria:

* Inability to apply NIRS sensor

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toulon
country: France
facility: Sainte Anne Military Teaching Hospital
Study officials:
affiliation: Direction Centrale du Service de Santé des Armées
name: Henry BORET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02434120: MRI Perfusion Curves Typology and Orbital Tumors (PERFORM)
Official title: Validation, for Orbital Tumors, of the MRI Perfusion Curves Typology Established for Salivary Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orbital Tumor
Keywords: MRI
Orbital neoplasm
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-05-05
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing a MRI because of an orbital mass

Brief summary: Orbital masses develop at the expense of the orbital structures lacrimal glands, oculomotor muscles, optic nerve, meningeal spaces, peripheral nerves, bone wall, orbital fat, lymphoid structures or vascular structures. These masses can be tumors, benign or malignant, or pseudotumor, mainly represented by specific or non-specific orbital inflammation.

Pathology is of considerable importance for the diagnosis and the treatment of those masses. However, biopsy or surgical resection of the orbital masses is sometimes difficult and dangerous outside expert centers.

The identification of a non-invasive technique for distinguishing tumors from pseudotumors, thus avoid in some cases a biopsy, would be a major contribution for the patients.

For salivary glands, MRI allows to identify 4 different types of MRI characteristics, one (type C) being related to malignant tumors.

In this study, the investigators will try to see if extrapolation of those data to orbiltal tumors is feasible.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or more
* with orbital mass for which a biopsy and/or a surgical removal is planned
* undergoing an MRI
* before surgery

Exclusion Criteria:

* contra-indication to MRI
* intolerance to constrast agent
* pregnancy
* breast feeding
* patient under a legal protection procedure
* patient denying to participate to the study
* lack of affiliation to a social security system

Primary outcomes:
measure: Concordance of the MRI type and the pathological findings as assessed by the kappa coefficient
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A De Rothschild
Study officials:
References:
citation: O'Shaughnessy E, Cossec CL, Mambour N, Lecoeuvre A, Savatovsky J, Zmuda M, Duron L, Lecler A. Diagnostic Performance of Dynamic Contrast-Enhanced 3T MR Imaging for Characterization of Orbital Lesions: Validation in a Large Prospective Study. AJNR Am J Neuroradiol. 2024 Mar 7;45(3):342-350. doi: 10.3174/ajnr.A8131.
citation: O'Shaughnessy E, Senicourt L, Mambour N, Savatovsky J, Duron L, Lecler A. Toward Precision Diagnosis: Machine Learning in Identifying Malignant Orbital Tumors With Multiparametric 3 T MRI. Invest Radiol. 2024 Oct 1;59(10):737-745. doi: 10.1097/RLI.0000000000001076. Epub 2024 Apr 11.
Clinical trial NCT03041220: Best Incision Site for Obese Patients - Low Versus High Transverse
Official title: Best Incision Site for Obese Patients - Low Versus High Transverse
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cesarean Section
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ages between 18 - 45 years, female, and no limitation on ethnic background.

Brief summary: Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.

Detailed description: Past studies have looked primarily at vertical vs low transverse skin incision. There is data that performing a high transverse skin incision on obese patients leads to better visualization and less wound infection but there are few studies comparing it directly to low transverse skin incision.

Retrospective chart review of obese patient's who have had a cesarean section at St Mary's hospital by either a low or high transverse skin incision between January 1, 2009 - July 31, 2014. We will review charts up to 6 week postpartum.

Pregnancies will be identified through identifing those who have cesarean sections. They will be narrowed down by those who have BMI of \> 30. Maternal prenatal records, postnatal records and delivery records will be reviewed.

Eligibility criteria: Inclusion Criteria:

* obese patients (BMI of 30 or greater) who have had a cesarean section

Exclusion Criteria:

* Vaginal delivery

Primary outcomes:
measure: Type of skin incision
timeFrame: Delivery to 6 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St. Louis University
name: Heather Said, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423820: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries
Official title: Preoperative Ondansetron Lozenge for Prevention of Postoperative Nausea and Vomiting in Pediatrics Undergoing Squint Surgeries: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ondansetron Lozenge
Postoperative Nausea and Vomiting
Pediatrics
Squint
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the role of ondansetron lozenge on prevention of postoperative nausea and vomiting (PONV) in pediatrics undergoing squint surgeries.

Detailed description: Post-operative nausea and vomiting (PONV) are two of the most common and distressing complications related to surgery and anesthesia.

In several studies PONV occurred in 13% to 42% of pediatric surgical patients, while severe cases are less common, occurring in 1-3% of patients. Volatile anesthetics are the main cause in the early post-operative period (0-2 h), with dose-response relationship. In the delayed post-operative period (2-24 h) the main predictors are childhood, PONV in the early period, and the use of postoperative opioids.

Ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. Ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, Ondansetron is an effective drug in the prevention and treatment of PONV by having low side effects.

Eligibility criteria: Inclusion Criteria:

* Age from 4 to 15 years.
* American Society of Anesthesiology (ASA) physical status I, II.
* Pediatric patients undergoing squint surgeries.

Exclusion Criteria:

* Patients who had received any medication with antiemetic properties within 24 h before surgery.
* Post-operative period (for reasons other than rescue antiemetic therapy).
* Patients with known liver or renal disease.
* Patients with a history of vomiting or retching within 24 h before surgery.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Severity of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: Number of emetic episodes
timeFrame: 24 hours postoperatively
measure: Time to onset of emesis
timeFrame: 24 hours postoperatively
measure: Incidence of oculo-cardiac reflex (OCR)
timeFrame: 24 hours postoperatively
measure: Parental satisfaction
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06195020: Examining the Effect of Metaverse-Based Epilepsy Education
Official title: Examining the Effect of Metaverse-Based Epilepsy Education on Parents' Epilepsy Knowledge Level: Randomized Controlled Experimental Research
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Examining the Effect of Metaverse-based Epilepsy Education on Parents' Knowledge Level
Keywords: Epilepsy
metaverse
parent
knowledge level
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The research is a randomized controlled experimental study and was planned to examine the effect of metaverse-based epilepsy education on the epilepsy knowledge level of parents.

Detailed description: Developments in the field of technology, patient density in polyclinic services, limited number of nurses specialized in the field and the desire to carry out effective workforce planning bring different education methods to the agenda in the field of nursing. Creating the metaverse universe, which has been used in many technological fields in recent years, is among the newest of these technological developments. When the content created in Metaverse-based training is presented to the user, the user has the opportunity to enter the universe, choose the avatar the participant wants, and navigate and gain information by entering the desired module among the training modules created for participant. At the same time, since it offers an interactive training module to the participant, there are no limitations such as time, place or subject as in other training models. When the literature was examined, no study was found in which metaverse-based education was used in the field of epilepsy. In this context, our research aimed to examine the usability of metaverse-based epilepsy education and its effect on parents' epilepsy knowledge level.

Eligibility criteria: Inclusion Criteria:

* Must be able to use a smartphone with internet access
* Having a child diagnosed with epilepsy

Exclusion Criteria:

* Having an additional chronic disease (diabetes, chronic kidney failure, cancer, etc.) other than epilepsy

Primary outcomes:
measure: Introductory Form Regarding Parents and the Child's Illness
timeFrame: 3 months
measure: Epilepsy Knowledge Test Developed for Parents
timeFrame: 3 months
Secondary outcomes:
measure: Application Content and Quality Evaluation by the Expert Group [DISCERN Measurement Tool (Quality of Criteria for Consumer Health Information)]
timeFrame: 3 months
measure: System Usability Scale (SUS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Mehmet Duray
Study officials:
References:
Clinical trial NCT05469620: Adaptive Nutrition Therapy in Hemodialysis
Official title: Open-label, Randomized Comparative Clinical Trial on the Clinical Effect of Adaptive Nutrition Therapy in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Keywords: nutrition
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Hallym University Kangnam Sacred Heart Hospital
name: KangWon National University Hospital
name: Korea University Guro Hospital
name: Korea University Ansan Hospital
name: Myongji Hospital
name: Korea Data Agency
name: Eatmapl
name: Daejeon Eulji Medical Center
name: Seoul National University
First posted: 2022-07-22
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 by 2 factorial design, consisting of nutrition education and meal kit prescription.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 8-week adaptive nutrition intervention for participants undergoing hemodialysis, consisting of nutrition education and meal kit.


Eligibility criteria: Inclusion Criteria:

* have been on hemodialysis for over 3 months

Exclusion Criteria:

* diagnosed with cancer within 5 years

Primary outcomes:
measure: Potassium
timeFrame: 4 weeks
measure: Phosphate
timeFrame: 4 weeks
measure: Malnutrition
timeFrame: 8 weeks
Secondary outcomes:
measure: Depression
timeFrame: 8 weeks
measure: Self-Efficacy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
Study officials:
References:
Clinical trial NCT05073120: Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib
Official title: Survey Among Healthcare Professionals Treating Patients With Metastatic Breast Cancer in Selected European Countries to Evaluate Their Knowledge on Management of Hyperglycemia When Using Alpelisib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: educational material
PASS
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material).

Brief summary: This was a multinational, non-interventional, cross-sectional survey conducted among HCPs based in the EU/EEA who prescribe Piqray. The survey assessed the knowledge of HCPs prescribing Piqray in relation to the management of hyperglycemia in patients treated with Piqray.


Eligibility criteria: Inclusion Criteria:

* Had prescribed Piqray to at least 1 locally advanced or MBC patient within 6 months prior to completing the survey.
* Provided permission to share their anonymized responses in aggregate with EMA or NCAs, if requested.

Exclusion Criteria:

HCPs who are direct employees of Novartis, the EMA (or any other regulatory bodies), or ICON.

Primary outcomes:
measure: assess HCPs' knowledge and understanding of the key information included in the Piqray Prescriber's/HCP Guide for hyperglycemia
timeFrame: Throughout study completion, an average of 1 year
Secondary outcomes:
measure: Assess HCPs' reported levels of receipt, and reading, of the Piqray Prescriber's/HCP Guide for hyperglycemia
timeFrame: Throughout study completion, an average of 1 year
measure: Assess HCPs' knowledge levels for each survey question regarding knowledge of, and management of, hyperglycemia
timeFrame: Throughout study completion, an average of 1 year
measure: Assess the primary source from which HCPs learned about the messages included in the Piqray Prescriber's/HCP Guide for hyperglycemia
timeFrame: Throughout study completion, an average of 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: