louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01599468: Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery
Official title: Effects of Tranexamic Acid on Post Partum Hemorrhage by Uterine Atony After Cesarean Section Delivery: a Randomized, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Partum Hemorrhage
Keywords: post partum hemorrhage
transfusion
tranexamic acid
Lead sponsor: Hédi Chaker Hospital
Sponsor class: OTHER
First posted: 2012-05-16
Enrollment: 74
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.

This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.


Eligibility criteria: Inclusion Criteria:

* ASA1 parturients
* aged from 20 to 40
* correct preoperative haemostatic status (prothrombine ratio \> 60 % and platelet rate \> 100 000),
* cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

Exclusion Criteria:

* abnormal placentation
* severe pre-eclampsia
* coagulopathy and uterine rupture
* the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.

Primary outcomes:
measure: volume blood loss
timeFrame: within 5 days after delivery
Secondary outcomes:
measure: transfusion rates.
timeFrame: within 5 days after delivery
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Hedi Chaker University Hospital of Sfax, Department of Anesthesiology and Intensive Care
Study officials:
affiliation: hedi chaker university hospital of sfax, tunisia
name: mohamed ayedi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ducloy-Bouthors AS, Jude B, Duhamel A, Broisin F, Huissoud C, Keita-Meyer H, Mandelbrot L, Tillouche N, Fontaine S, Le Goueff F, Depret-Mosser S, Vallet B; EXADELI Study Group; Susen S. High-dose tranexamic acid reduces blood loss in postpartum haemorrhage. Crit Care. 2011;15(2):R117. doi: 10.1186/cc10143. Epub 2011 Apr 15.
Clinical trial NCT05798468: Effectiveness of Augmented Reality in the Teaching of Health University Students.
Official title: Comparative Study of Augmented Reality in the Teaching of Health University Students.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education
Keywords: Augmented reality
Usability
Competencies
Lead sponsor: University of Malaga
Sponsor class: OTHER
Collaborators: name: Alejandro Vega Morales
name: María Jesús Viñolo Gil
First posted: 2023-04-04
Enrollment: 203
Sex: ALL
Minimum age (years): 17
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The exponential growth of new technologies has meant that the educational field has had to update itself. From the educational point of view, there are some studies that have promoted the implementation of new technologies. These facts have raised the need to implement augmented reality in the university environment, especially among students of health sciences. The use of augmented reality can mean a new approach to teaching by teachers and better learning by students. Objetive: To compare the degree of usability of the two augmented reality applications and to analyse the academic performance of the control group and the experimental group at the Universities of Cadiz and Malaga. The existence of significant differences and relationships between the two variables will be observed.

Detailed description: This research has followed the SPIRIT statement and the ethical and legal aspects of the Principles of the Declaration of Helsinki. An intervention was carried out using two augmented reality applications in the subject of General Procedures in Physiotherapy II at the Universities of Malaga and Cadiz.

Eligibility criteria: Inclusion Criteria:

* Students who belong to the degree of Physiotherapy and who are enrolled in the subject General Procedures in Physical Therapy II.

Exclusion Criteria:

* Non-university students.
* Non-university students from outside the health care field.

Primary outcomes:
measure: Demographic variables
timeFrame: 3 months
measure: Rating variable
timeFrame: 3 months
measure: Usability variable
timeFrame: 3 months
Secondary outcomes:
measure: Correlatión between usability and rating variable
timeFrame: 3 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Rocío Martín-Valero
Study officials:
affiliation: University Malaga
name: Rocío Martín Valero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02717468: Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
Official title: Comparative Noninvasive Continuous Cardiac Output by the Clearsight With Invasive Monitoring by Pulsioflex in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Output Measurement
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In high-risk patients, it is now recommended to guide the intraoperative volume replacement via the stroke volume.

Today, the most commonly used technique for estimating the stroke volume is the arterial waveform analysis in the radial artery. This technique has the disadvantage of being invasive and increasing the time dedicated to anesthesia during the surgery.

The future is the non-invasive monitoring of stroke volume. Thus, Edwards Life Science has developed a continuous monitoring technology and non-invasive arterial pressure, cardiac output and stroke volume using a digital sensor (ClearSight®). The continuous monitoring of blood pressure by this technique was validated in cardiothoracic surgery but studies about monitoring cardiac output or stroke volume are inconclusive and contradictory.

The objective of this study is to compare the use of non-invasive monitoring of stroke volume by Clearsight® with the arterial waveform analysis in the radial artery by Pulsioflex® in major surgery.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo major surgery
* Patients monitored by a Pulsioflex® device

Exclusion Criteria:

* Patients with heart rhythm disorder
* Patients with Raynaud's disease or vasculitis
* Emergency surgery
* Significant edema fingers

Primary outcomes:
measure: Stroke Ejection Volume (SEV) measure by ClearSight®
timeFrame: 24 hours
measure: Stroke Ejection Volume (SEV) measure by Pulsioflex®
timeFrame: 24 hours
Secondary outcomes:
measure: Cardiac Output (CO) measure by ClearSight®
timeFrame: 24 hours
measure: Cardiac Output (CO) measure by Pulsioflex®
timeFrame: 24 hours
measure: Stroke Ejection Volume Variations (SVV) measure by ClearSight®
timeFrame: 24 hours
measure: Stroke Ejection Volume Variations (SVV) measure by Pulsioflex®
timeFrame: 24 hours
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Matthieu BOISSON
Study officials:
References:
Clinical trial NCT01362868: Water Drinking Test During Intraocular Pressure Fluctuation (IOP) Monitoring
Official title: Water Drinking Test (WDT) During Continuous Recording of Intraocular Pressure Fluctuation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Subjects
Keywords: Glaucoma
Triggerfish
Water drinking test
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the investigational device capacity to detect an intraocular pressure increase (IOP)induced by water intake.

Detailed description: 32 subjects will be enrolled in the investigation. Eligible subjects will receive one session of 4-6-hour continuous IOP monitoring with SENSIMED Triggerfish® following water drinking test (WDT). SENSIMED Triggerfish® will be installed randomly on right or left eyes and the IOP recording will be initiated as soon as the adaptation of the device on the subject's eye is satisfying. Sensor fitting in the eye will then be evaluated every 60 minutes, until no more spontaneous Sensor movement and rotation are observed. Then IOP will be measured on the contra lateral eye using Goldmann tonometer and the subjects will be asked to drink 1 liter of water within 5 minutes.

After the water drinking, IOP will be measured on the contra lateral eye 10 minutes after the beginning of the test then every 5 minutes until returned to normal. The IOP will be measured again every 20 minutes until 2 hours after the water drinking.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer without previous ocular medical history
* 18 years or more at inclusion
* Maximal weight: 100kg
* BMI lower or equal to 30 kg/m2
* Subjects having provided informed consent

Exclusion Criteria:

* Silicone allergy
* Cardiovascular disease
* Diabetes
* Narrow or closed iridocorneal angle

Primary outcomes:
measure: SENSIMED Triggerfish® signal increase when Goldman IOP increase is ≥ 3 mmHg following WDT
timeFrame: 30-45 min after WDT
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Unité de Glaucome, Clinique de Montchoisi
Study officials:
affiliation: Clinique de Montchoisi
name: André Mermoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04439968: Neonatal Brain Oxygenation Study
Official title: Targeted Cerebral Saturations in Extremely Preterm Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cerebral Hypoxia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 100
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring
Primary purpose: DIAGNOSTIC

Brief summary: Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.


Eligibility criteria: Inclusion Criteria:

* Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks
* Less than 6 hours of age

Exclusion Criteria:

* Skin integrity insufficient to allow placement of NIRS sensors
* Decision not to provide full intensive care support
* Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment

Primary outcomes:
measure: Neurodevelopmental outcome
timeFrame: 22-26 months of age
Secondary outcomes:
measure: Death
timeFrame: from birth until hospital discharge, an average of 3 months.
measure: Retinopathy of prematurity
timeFrame: from birth until hospital discharge, an average of 3 months.
Other outcomes:
measure: Burden of Cerebral hypoxia or hyperoxia
timeFrame: From birth until first 7 days of life
Locations:
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital Stanford
state: California
Study officials:
References:
Clinical trial NCT00601068: Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis
Official title: Proposal For The Development Of A Well Defined Database For Patients With Oral Bisphosphonate-Related Osteonecrosis of the Jaws (BON)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis
Keywords: osteonecrosis, jaws, bisphosphonate, fosamax, alendronate
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-25
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who develop exposed bone in their mouth and are on an oral bisphosphonate

Brief summary: In cooperation with Merck \& Co, Inc. we will identify and form a database of 35 patients who have developed osteochemonecrosis of the jaws related to oral bisphosphonate use. We will study the triggers, associated medical conditions and medications, location of the lesion(s), and patient outcomes.

Detailed description: This study is an observational study, and not a comparative trial. The major outcome is represented by the fraction of subjects with long term healed lesions.

Eligibility criteria: Inclusion Criteria:

* Exposed bone in the oral cavity of greater than 6-8 weeks duration unresponsive to therapy

Exclusion Criteria:

* Pregnant patients
* Patients less than 30 yrs of age or greater than 90 yrs of age
* Mentally incompetent individuals

Primary outcomes:
measure: establish complete database and publish descriptive paper
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Donald M Cohen, DMD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869568: Institut Paoli Calmettes Ovarian Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of ovarian Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer


Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of ovarian cancer

Exclusion Criteria:

* Diagnosis of fallopian tube cancer

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT03376568: Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
Official title: Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Narcolepsy
REM Sleep Behavior Disorder
Keywords: polysomnographic
multiple sleep latency test
fMRI
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study will need about 40 narcoleptic patients with /without RBD between 10 and 65 years of age,and about 20 age- and gender-matched control subjects.

Brief summary: This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD

Detailed description: Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.

Functional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)

This study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.

Eligibility criteria: Inclusion Criteria:

* Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .

Exclusion Criteria:

History of heart disease History of central nervous system organic psychosis AHI\>15次/h History of alcohol dependence and drug abuse

Primary outcomes:
measure: video-polysomnographic(PSG)
timeFrame: up to 100 weeks
Secondary outcomes:
measure: multiple sleep latency test (MSLT)
timeFrame: up to 100 weeks
measure: functional magnetic resonance imaging (fMRI)
timeFrame: up to 100 weeks
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shan
Study officials:
References:
Clinical trial NCT03536468: Psychological Impact of Tooth Loss
Official title: Short Term Psychological Impact of Tooth Loss in Patients Consulting in a University Dental Clinic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Edentulous Mouth
Partial Edentulism
Keywords: Tooth loss, edentulousness, psychology, oral health-related
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients pending complete tooth extraction within the groupe hospitalier Pitie Salpétrière

Brief summary: Tooth loss impact on daily living, mood and self-perceived well-being. However, psychological impact of teeth loss has not been evaluated. Present study aims to evaluate the psychological conditions of patients pending complete tooth extraction before and shortly after tooth loss using Hospital Anxiety and Depression scale (HAD) and Geriatric Oral Health Assessment Index (GOHAI).

Detailed description: Patients will be interviewed concerning their psychological conditions (HADS) and their oral health related quality of life (GOHAI) before tooth extraction and one month after complete tooth loss.

Eligibility criteria: Inclusion Criteria:

* willing to participate to the study
* dental status identified

Exclusion Criteria:

* uncooperative ou patient not able to complete the questionary
* adult patients under protection

Primary outcomes:
measure: Change in Hospital anxiety and depression (HAD) score
timeFrame: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
Secondary outcomes:
measure: Change in General oral health assessment index (GOHAI)
timeFrame: 1 month (change in score from baseline (before tooth extraction) to 1 month after tooth extraction)
measure: Gender
timeFrame: at date of inclusion (up to 24h)
measure: Age
timeFrame: at date of inclusion (Up to 24h)
measure: Educational level
timeFrame: at date of inclusion (Up to 24h)
measure: Income
timeFrame: at date of inclusion (Up to 24h)
measure: General health
timeFrame: at date of inclusion (Up to 24h)
measure: Dental status
timeFrame: at date of inclusion (Up to 24h)
Other outcomes:
Locations:
city: Paris
country: France
facility: Pôle odontologie Hôpital Rothschild
Study officials:
affiliation: APHP
name: Adeline Braud
role: STUDY_DIRECTOR
References:
Clinical trial NCT02426268: FORE-SIGHT Tissue Oximeter During Cardiac Surgery
Official title: CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgical Patients
Keywords: cardiac surgery
cerebral oximetry
lower extremity oximetry
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: CAS Medical Systems, Inc.
First posted: 2015-04-24
Enrollment: 55
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: Cardiothoracic surgical population at UCLA

Brief summary: The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

Detailed description: The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion.

Two sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.

Eligibility criteria: Inclusion Criteria:

* Subjects where cerebral oximetry is monitored during their surgery

Exclusion Criteria:

* Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid

Primary outcomes:
measure: Cerebral Oxygen Saturation
timeFrame: Duration of the surgery (~5-7 hours)
Secondary outcomes:
measure: Non-Cerebral Oxygen Saturation
timeFrame: Duration of the surgery (~5-7 hours)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Department of Anesthesiology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Emily Methangkool, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: