louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06815484: Preventing Burnout Among Caregivers Through Physical Activity
Official title: Single-centre, Randomised, Controlled Study Designed to Evaluate the Impact of a Nine-week Supervised Physical Activity Programme Physical Activity Programme on Reducing the Risk of Burnout in Burnout in Carers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Out
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2025-02-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, prospective, comparative, randomised (2 arms), controlled study
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the impact of an adaptive physical activity programme to prevent the risk of burnout at the end of the programme (10 weeks after the start of the intervention).

Detailed description: The PACA trial is a pilot, prospective, comparative, randomised (2 arms), controlled, single-centre study.

The study population consisted of adult healthcare professionals at the Clinique de la Sauvegarde with a low to moderate level of physical activity and no contraindications to physical activity.

Participants will be randomised into two arms (ratio 1:1):

* Arm A (intervention): Participants will benefit from an adaptive physical activity programme supervised by a physical activity professional over a 9-week period.
* Arm B (control): Participants will receive the recommendations of the world health organisation for physical activity.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years ;
* Non-physician health professionals at the Clinique de la Sauvegarde ;
* Low or moderate level of physical activity, as assessed by the questionnaire International Physical Activity Questionnaire. In fact, work-related physical activity is not associated with a reduction in burnout ;
* Absence of serious chronic pathology incompatible with the physical activity of the protocol ;
* Willing and available to commit to the project for the duration of the study ;
* Using a personal smartphone or tablet and with an Internet connection ;
* Able to read, write and understand French ;
* Membership of a social security scheme.

Exclusion Criteria:

* High level of physical activity (not including work-related physical activity) ;
* Contraindication to physical activity (uncontrolled hypertension, uncontrolled heart disease...) ;
* Concurrent participation in another physical activity study ;
* Pregnant or likely to be pregnant ;
* Unable to be monitored for medical, social, family, geographical or psychological reasons for the duration of the study ;
* Persons deprived of their liberty by judicial or adm inistrative decision, or adults protected by law.

Primary outcomes:
measure: Shirom - Melamed Burnout Measure
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT06477484: Blood Biomarkers for Screening of Alzheimer's Disease
Official title: Blood-based Biomarkers for Early Alzheimer's Disease Screening
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease
Blood Biomarkers
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 180
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alzheimer's disease, mild cognitive impairment due to AD, and cognitively normal individuals.

Brief summary: The goal of this observational study is to estimate the screen performance of blood biomarkers of interest (Aβ40 and Aβ42, P-Tau181, P-Tau217, GFAP and NfL) in patients with Alzheimer's disease (AD), mild cognitive impairment due to AD, and cognitively normal individuals. The main questions it aims to answer are:

* to identify core blood biomarker suitable for early screening of AD.
* to establish a comprehensive model for the early identification of AD.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years;
* AD (meets the 2011 NIA-AA AD diagnostic criteria), or MCI (meets the 2004 Peterson MCI diagnostic criteria), or cognitively normal subjects;
* Signed informed consent form.

Exclusion Criteria:

* The presence of other disorders that can cause cognitive impairment;
* Unable to cooperate with the completion of cognitive assessment;
* Refusal to draw blood.

Primary outcomes:
measure: Evaluate the diagnostic accuracy of blood biomarkers of Aβ42, Aβ40, Aβ42/Aβ40, P-Tau181, P-Tau217, GFAP and NfL.
timeFrame: 2 years
Secondary outcomes:
measure: Evaluate the diagnostic accuracy of a comprehensive model combined with core blood biomarkers and clinical information.
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06019884: A Tele-detection and Referral Pathways Model for Early Childhood Caries Control
Official title: A Tele-detection and Referral pAthways Model for Early Childhood cariEs Control- a Randomized Factorial Study: The TRACE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Early Childhood Caries
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 480
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to assess the effectiveness of ECC tele-detection methods combined with referral pathways, with and without user fee removal, in controlling ECC.


Eligibility criteria: Inclusion Criteria:

* Age \<6 years old with primary dentition only.
* Written consent from the legal guardian

Exclusion Criteria:

* Children above 6 years old.
* Children with mixed or permanent dentitions.
* Children with physical disabilities or psychiatric disorders.
* Children with intellectual disabilities.
* Children indicated for dental treatment under general anesthesia

Primary outcomes:
measure: The percentage of teeth receiving care
timeFrame: up to 12 months
Secondary outcomes:
measure: Oral health-related quality of life
timeFrame: up to 12 months
measure: Procedure time
timeFrame: throughout the procedure completion
measure: The child's behavior during dental photography
timeFrame: throughout the procedure completion
measure: The child's mood during dental photography
timeFrame: throughout the procedure completion
measure: Percentage of preventive visits completed per child
timeFrame: up to 12 months
measure: Rate of treatment completion
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Nourhan M Aly, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Mona K El Kashlan, PhD
role: STUDY_CHAIR
affiliation: University Hospital Center of Montpellier, France
name: Nicolas Giraudeau
role: STUDY_CHAIR
affiliation: Alexandria University
name: Maha El Tantawi, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06329284: Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia
Official title: Midkine Interplays With Oxidative Stress and Inflammatory Milieu to Induce Preeclampsia in Normotensive Pregnant Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 80
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Newly pregnant normotensive (NT) women with singleton fetus
Primary purpose: DIAGNOSTIC

Brief summary: Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.

Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils.


Eligibility criteria: Inclusion Criteria:

* Newly pregnant normotensive (NT) women with singleton fetus;
* Free of the Exclusion Criteria.

Exclusion Criteria:

* Women with history of complicated pregnancy;
* Had manifest essential hypertension, Diabetes Mellitus or chronic kidney diseases;
* Had multiple gestational sacs, morbid obesity with Body Mass Index at time of pregnancy diagnosis over 35 kg/m2;
* Had genetic disorders, coagulopathy, autoimmune diseases or maintained on immunosuppressive therapy.

Primary outcomes:
measure: Severity of Pre-Eclampsia (PE)
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Banha University
state: El- Qalyobia
Study officials:
References:
Clinical trial NCT05867784: Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
Official title: Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ustekinumab
Vitamin D Supplementation
Crohn's Disease
Clinical Efficacy
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese

Brief summary: It is uncertain whether vitD3 supplementation is beneficial for the remission of Crohn's disease (CD). The effects of vitD3 supplements on the efficacy of ustekinumab in Chinese CD patients were retrospectively analyzed. Methods: Patients with moderate to severe CD were recorded. These patients were initially treated with UST. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of UST and continued throughout the follow-up period. Disease activity was assessed using Harvey Bradshaw Index.


Eligibility criteria: Inclusion Criteria:

* moderate-to-severe CD
* Treated with Ustekinumab

Exclusion Criteria:

* had recent supplementation of vitD3
* pregnant
* had cognitive/developmental disorders that affected their ability to complete the study procedures
* had medical illness or therapies potentially affecting bone, nutrition or growth status
* unknown or untested baseline serum 25(OH)D level

Primary outcomes:
measure: Serum 25 (OH) D level
timeFrame: 24 weeks
measure: disease activity
timeFrame: 24weeks
Secondary outcomes:
measure: Serum 25 (OH) D level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: SAHWenzhouMU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Wenzhou Medical University
name: Yi Jiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03388684: Conjoined Twins: a Report of Four Cases.
Official title: Conjoined Twins: a Report of Four Cases.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Conjoined Twin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: conjoined twins whether symmetrical or asymmetrical.

Brief summary: The present study aims to report our experience in conjoined twin separation surgery in Assuit university and pediatric hospital, Assiut university, Assiut, Egypt over a period of 20 years.

Detailed description: A conjoined twin is a subset of monozygotic twin gestation. It's a rare phenomenon with an incidence of 1 in 50,000 to 1:100,000 births with the higher incidence in Africa and Southwest Asia. Based on the terminology proposed by Spencer and colleagues, conjoined twins are classified according to the most prominent site of conjunction into three major groups; First, twins with a ventral union; \[cephalopagus (head), thoracopagus (Thorax), omphalopagus (Abdomen) and ischiopagus (pelvis)\]. Second; twins with a dorsal union; \[pygopagus (sacrum), rachipagus (spine, back) and craniopagus (cranium)\] and lastly; twins with a lateral union that is referred to as parapagus (side). Depending on the aspect of the embryonic disc, the most common types are thoracopagus (19%).

Surgical separation of conjoined twins is extremely challenging taking in consideration the high perioperative risk. The low incidence of such surgeries and anatomical variations in each type of conjoined twins makes each separation surgery a unique experience.

Eligibility criteria: Inclusion Criteria:

* conjoined twins
* symmetrical or
* asymmetrical.

Exclusion Criteria:

* conjoined twins incompatible with life
* conjoined twins with decapitating medical illness.

Primary outcomes:
measure: Success of the conjoined twin separation surgery
timeFrame: For each case was the 1 week survival
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
name: Hala S Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Takrouney MH, Ibrahim IA, Abdel-Ghaffar HS, Abdel-Wahhab AI, Mostafa MM, Ali WN, Abd-Elaal MS. Conjoined twins: A report of four cases. Int J Surg Case Rep. 2020;73:289-293. doi: 10.1016/j.ijscr.2020.06.072. Epub 2020 Jun 20.
Clinical trial NCT00739284: A Prospective Comparison Between Ureteral Stent and Nephrostomy Tube for an Urgent Drainage of Obstructed Kidney
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Disease
Keywords: preferred
procedure
drainage
obstructed
kidney
stone
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2008-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kidney obstruction might be caused by a stone in the urinary tract. In case of accompanying fever or renal failure, an urgent drainage might be needed. This can be done either by placing an ureteral stent or a nephrotomy tube. Only limited number of studies examined the question which of the two is preferred. A debate exist regarding the effectiveness of each procedure to improve symptoms, renal function and treating an infection. Our goal is to resolve this debate and to state whether one way is preferred on the other.


Eligibility criteria: Inclusion Criteria: Patient suffering from obstructed kidney by a stone and at least one of these situations:

1. fever (above 38c)
2. A rise in creatine to above 1.5
3. Pain resistent to multiple analgetic treatments

Exclusion Criteria:

* Patients with medical condition that prevent the use of one of the procedures

Primary outcomes:
measure: quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin medical center
Study officials:
References:
Clinical trial NCT00657384: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy
Official title: Tranexamic Acid Versus Placebo to Reduce Perioperative Bleeding After Major Hepatectomy : a Prospective Randomized Double-blinding Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Blood Loss, Surgical
Keywords: Specify the primary condition or disease being studied Major Hepatectomy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Blood loss was reported as a prognostic risk factor of morbidity and overall survival after hepatic resection. The aim of this study prospective randomized was compare the efficacy of the administration of tranexamic acid versus placebo to reduce perioperative bleeding after major hepatectomy (\> 3 hepatic segments).


Eligibility criteria: Inclusion Criteria:

* Signature of the consent form
* Patients with hepatic lesion needing a major hepatectomy (≥ 3 hepatic segments)

Exclusion Criteria:

* Absence of signature of the consent form
* Patient with cirrhosis
* Minor hepatectomy (\< 3 hepatic segments)
* Hepatectomy associated with vascular resection
* Contraindication of tranexamic acid : history of arterial or venous thrombosis , disseminated intravascular coagulation, severe renal insufficiency, history of epilepsies , intrathecal or intraventricular injection
* Pregnant or lactation

Primary outcomes:
measure: The volume of compensated blood loss with the formula: [TBV x (initial hematocrit - final hematocrit ) + number of transfused RBC unit] with TBV=Total Blood Volume and RBC= red blood cell (1 RBC unit = 500 ml with hematocrit=30%).
timeFrame: at day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens, Hôpital Nord
city: Besançon
country: France
facility: Chirurgie digestive et transplantation, Hôpital de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux (Hôpital Haut- Lévêque et Hôpital Saint-André)
city: Strasbourg
country: France
facility: Chirurgie Viscérale et transplantation, Hôpital de Hautepierre , CHU Strasbourg
Study officials:
affiliation: CHU strasbourg
name: Patrick Pessaux
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04922684: Can Mimic Emotional Expression Training Help Improve Emotion Processing
Official title: Can Mimic Emotional Expression Training Help Improve Emotion Processing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Mimic facial expression training
Autistic trait
Mirror neuron system
Emotion processing
Emotion recognition
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 90
Sex: MALE
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of the present study is to investigate whether mimicking emotional expressions training via FaceReader software can improve emotional processing and recognition in healthy subjects, especially individuals with hityer autistic traits.

Detailed description: Some mood and trait questionnaires such as Autism Spectrum Quotient, Social Responsiveness Scale,State-Trait Anxiety Inventory,Beck's Depression Inventory etc are asked to complete. 90 healthy male subjects will receive 16 times (4 times a week , 4 weeks) of mimicking emotional expressions training via Facereader. During training, 3 times of fNIRS (t2,t9 and t16) were recorded simultaneously. fMRI scanning, including emotion processing and emotion recognition tasks, 7 minutes resting data, ans DTI data will be collected before and after the training. After fMRI scaning, behavioral ratings (i.e. intensity and valence) and eye-tracking data will be collected.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury;
* pregnant, menstruating, taking oral contraceptives;
* medical or psychiatric illness.

Primary outcomes:
measure: Intensity score of subjects' mimic facial emotions
timeFrame: an average of 4 weeks
measure: Valence score of subjects' mimic facial emotions
timeFrame: an average of 4 weeks
measure: Arousal score of subjects' mimic facial emotions
timeFrame: an average of 4 weeks
measure: Task-dependent functional MRI data
timeFrame: an average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Weihua Zhao, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01465984: Efficacy of Intravenous (IV) Paracetamol for Treatment of Acute Pain
Official title: Comparison of IV Paracetamol With Intravenous Morphine Sulfate in Treatment of Acute Pain Due to Limb Trauma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain
Keywords: Paracetamol
Morphine sulfates
Acute pain
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Iv paracetamol is as effective as Iv Morphine sulfate on control of the acute pain in Patient with limb trauma.

Detailed description: Limb trauma is a painful condition that requires urgent analgesic treatment . Intravenous Opioids and NSAIDs are used extensively to control pain; both of them are with side effects. Paracetamol is a safe and effective analgesic that is used by oral or rectal routs for pain control, and in therapeutic doses has less side effects than Morphine and NSAIDs, and approved as a safe and effective analgesic in emergency department.

recently Iv Paracetamol has become available in European countries and also in Iran.

efficacy and safety of IV Paracetamol has been studied in post operation conditions and asserted but in emergency setting it has been studied only in renal colic situation.

Therefore, the investigators want to study the efficacy of IV Paracetamol in limb trauma and compare it with Iv Morphine sulfate.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute limb trauma
* Age\>=18 years
* Acute pain of score 3 or greater on visual analogue scale

Exclusion Criteria:

* Unstable hemodynamic (Systolic blood pressure under 90 mmHg)
* Known sensitivity to opioids or paracetamol
* Any other known contraindication to Morphine Sulfate or Iv Paracetamol (including severe allergy to these drugs, acute bronchial asthma, upper respiratory tract obstruction)
* Previous administration of analgesic during 6 hours ago
* Pregnant women
* previous inclusion to the study
* diagnosed heart failure
* renal failure
* pulmonary failure or hepatic failure

Primary outcomes:
measure: Change in pain severity/score
timeFrame: after 30 minutes
Secondary outcomes:
measure: Need for rescue analgesia
timeFrame: After 30 minutes
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: TUMS
Study officials:
affiliation: TUMS
name: Mohammad Jalili, MD
role: STUDY_DIRECTOR
References: