louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02097784: Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Official title: Interest of the Echocardiography in the Management of Cirrhotic Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Hepatorenal Syndrome
Acute Kidney Injury
Diastolic Function
Keywords: cirrhosis
hepatorenal syndrome
acute kidney injury
diastolic function
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 28
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: This prospective study focuses on the interest of the echocardiography for cirrhotic patients, who present acute kidney injury corresponding to the criteria of hepatorenal syndrome. This echocardiography will be done before the volemic expansion and the final diagnostic of hepatorenal syndrome or prerenal azotemia. The primary endpoint is to describe the hemodynamic characteristics of this population at the time of acute kidney injury and their association with diagnostic of hepatorenal syndrome or prerenal azotemia. Patients with elevated filling pressure, predicting poor outcome of volemic expansion will be excluded of the study after the echocardiography and will not undergo volemic expansion but appropriate management.


Eligibility criteria: Inclusion Criteria:

* patients \> 18 years
* written consent for the participation of the study
* cirrhosis with portal hypertension and ascite
* acute kidney injury according to AKIN criteria (rapid increase of creatinine (48 hours) \> 26.4 µmol or \> 50% comparing with baseline). Baseline creatinine is the last value of creatinine before admission or creatinine at the admission if stable during 5 days.
* absence of argument for acute tubular necrosis or other organic acute renal injury
* absence of argument for shock

Exclusion Criteria:

* pregnant women
* volemic expansion before echocardiography
* portal thrombosis
* presence of TIPSS
* history of cardiac or renal pathology
* atrial fibrillation
* cardiac valvulopathy
* technical limitation due to echogenicity

Primary outcomes:
measure: Hemodynamic features assessed by echocardiography before the volemic expansion of cirrhotic patients with acute renal injury corresponding to the criteria of hepatorenal syndrome.
timeFrame: At Day0 : at the time of diagnostic of acute kidney injury, before volemic expansion.
Secondary outcomes:
measure: Tolerance of volemic expansion, as recommended by international guidelines
timeFrame: After 48 hours of volemic expansion
measure: Response to vasoconstrictor treatment of hepatorenal syndrome, in case of diagnostic of hepatorenal syndrome
timeFrame: 1 month after inclusion
measure: Mortality
timeFrame: 1 month after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Fanny LEBOSSE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04042584: Visio-conference for Pre-hospital Triage of Stroke Suspicions
Official title: Pre-hospital Optimization of Triage of Stroke Suspicions: Bringing an Embedded Visio Conference Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Acute
Stroke, Ischemic
Cerebrovascular Disorders
Keywords: Stroke
Mechanical thrombectomy
Tele-evaluation
Emergency medical service
Pre hospital
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 215
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: Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

Detailed description: The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.

OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.

Theoretical and effective therapeutic decision will be compared a posteriori

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old
* Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

* Stupor or coma requiring orotracheal intubation
* Rankin pre stroke \> 4
* Severe cognitive impairement
* Contraindication to the realiszation of angiographic imaging
* Participation refusal
* Patient under legal protection

Primary outcomes:
measure: Final effective therapeutic decision
timeFrame: Day 0
Secondary outcomes:
measure: Therapeutic conviction
timeFrame: Day 0
measure: Remote evaluation failure
timeFrame: Day 0
measure: Theoretical therapeutic decision
timeFrame: Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References:
Clinical trial NCT05805384: Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Official title: Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.


Eligibility criteria: Inclusion Criteria:

* At least 12 years of age.
* Be post-lingually deafened cochlear implant recipients with at least 6 months experience regardless of manufacturer.
* The PI must also deem the child to be developmentally able to complete the experiments.

Exclusion Criteria:

• Anyone who is not a cochlear implant user or is aged under 12 years.

Primary outcomes:
measure: Percent of Words Correctly Recognized in Noisy Conditions with SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 1.1)
measure: Percent of Words Correctly Recognized in Noisy Conditions without NR
timeFrame: Up to Year 2 (Completion of Experiment 1.1)
measure: Percent of Words Correctly Recognized in Quiet Conditions with SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 1.1)
measure: Percent of Words Correctly Recognized in Quiet Conditions without NR
timeFrame: Up to Year 2 (Completion of Experiment 1.1)
measure: Visual Analogue Scale (VAS) Rating of SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 1.2)
measure: Percent of Words Correctly Recognized in Noisy Conditions with Clinical NR
timeFrame: Up to Year 2 (Completion of Experiment 2)
measure: Percent of Words Correctly Recognized in Quiet Conditions with Clinical NR
timeFrame: Up to Year 2 (Completion of Experiment 2)
measure: Percent of Words Correctly Recognized with no SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 4)
measure: Percent of Words Correctly Recognized with Standard SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 4)
measure: Percent of Words Correctly Recognized with Low-Computation SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 4)
measure: Percent of Words Correctly Recognized with Very Low-Computation SEDA NR
timeFrame: Up to Year 2 (Completion of Experiment 4)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Tisch Hospital
state: New York
Study officials:
affiliation: NYU Langone Health
name: David M. Landsberger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674684: ROTEM Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation
Official title: Rotational Thromboelastometry (ROTEM) Assessment of Modern Crystalloid, Hydroxyethyl Starch and Gelatin Effect on Coagulation in Vivo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulopathy
Keywords: hydroxyethyl starch, gelatin, ROTEM, coagulation
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy patients undergoing knee arthroscopy

Brief summary: Modern crystalloid and colloid solutions are balanced solutions which are increasingly used in perioperative period. However, studies investigating their negative effect on whole blood coagulation are missing. The aim of our study was to assess the effect of modern balanced crystalloid and colloid solutions on whole blood coagulation in vivo using rotational thromboelastometry.

Detailed description: Blood samples were obtained from 30 patients during knee arthroscopy before and after administration of 500 ml of modern balanced crystalloid, hydroxyethyl starch (HES) or gelatin. Rotational thromboelastometry (EXTEM, INTEM and FIBTEM tests) were performed to assess negative effect of fluid solutions on whole blood coagulation.

Eligibility criteria: Inclusion Criteria:

* healthy patients undergoing knee arthroscopy

Exclusion Criteria:

* receiving antiplatelet drugs

Primary outcomes:
measure: thromboelastometry assessment of coagulation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: University Hopital Motol
Study officials:
affiliation: Second Medical Faculty, Charles University and University Hospital Motol
name: Miroslav Durila
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sevcikova S, Durila M, Vymazal T. [Rotational thromboelastometry assessment of ballanced crystalloid, hydroxyethyl starch and gelatin effects on coagulation: a randomized trial]. Braz J Anesthesiol. 2019 Jul-Aug;69(4):383-389. doi: 10.1016/j.bjan.2019.03.009. Epub 2019 Aug 9.
Clinical trial NCT06317584: Empowerment-based Complementary and Alternative Medicine (ECAM)
Official title: The Establishment of "Empowerment-based Complementary and Alternative Medicine (ECAM) " Educational Program to Improve Complementary and Alternative Medicine(CAM) Health Literacy in Patients With Diabetes: Dilemma Analysis, Integration Into Practice and Outcome Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Complementary and Alternative Medicine (CAM)
Patient Education
Empowerment
Health Literacy
Application
Diabetes
Lead sponsor: Chang Gung University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
name: Chang Gung Memorial Hospital
First posted: 2024-03-19
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized trail method
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This phase study will use a randomized trial method to evaluate the performance of the ECAM educational app in the promotion of CAM health literacy and communication among patients with diabetes.

Detailed description: The objectives of this phase study are to (1) implement the ECAM educational app to empower patients with diabetes in their management of diabetes alongside CAM use; (2) examine the impact of the ECAM educational app on patient empowerment, CAM health literacy, risk management of CAM use, CAM communication and diabetes quality of life in patients with diabetes; and (3) collect feedback from both patients and nurses on how to improve the ECAM educational app for dissemination and implementation.

Eligibility criteria: Inclusion Criteria:

* People over the age of 20
* diagnosis of diabetes at least 12 months before the interview; and
* The use of CAM at least 3 months
* Sufficient mental ability to understand the informed consent form and sign it.

Exclusion Criteria:

* Participants will be excluded by an assistant researcher if they serious physical condition and hard of hearing and seeing.

Primary outcomes:
measure: Understanding the benefits-risks of complementary therapies (CTs) use scale Alternative Medicine (CAM) use questionnaire
timeFrame: Pre-test (baseline), 2, 3 months after intervention
measure: Quality of life questionnaire
timeFrame: Pre-test (baseline), 2, 3 months after intervention
measure: Diabetes Empowerment scale
timeFrame: Pre-test (baseline), 2, 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: CHENG GUNG MEMORIAL HOSPITAL, Linkou
state: Guishan District
Study officials:
affiliation: Chang Gung University of Science and Technology
name: Chang Hsiao Yun, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03547284: the Role of Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
Official title: The Role of Sugarless Gum Chewing in Regaining Bowel Motility in Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effect of Gum Chewing on Regaining Bowel Motility After Cesarean Section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 162
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Aim:to evaluate the efficacy of postoperative gum chewing on the recovery of bowel motility after cesarean section.

Detailed description: this study will be conducted on 162 patients undergoing cesarean section in obstetrics and gynecology department at Kasr el Ainy Hospital,Kairo university.

Eligibility criteria: Inclusion Criteria:

* Age 18-35

  --Spinal anesthesia
* Pfannensteil incision

Exclusion Criteria:

* History of drug consumption especially opioids
* water and electrolyte disturbance
* History of abdominal surgery except cesarean section
* Intra and severe post operative complications
* diabetes
* Pre-eclampsia
* Hypothyroidism
* Muscular and neurological disorder
* Inability to chew gums

Primary outcomes:
measure: first bowel sound in hours
timeFrame: 4-6 hours
Secondary outcomes:
measure: first passage of flatus in hours,the first defecation in hours
timeFrame: 4-6 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospital,obstetrics and gynecology departement, Egypt
city: Cairo
country: Egypt
facility: Woman's Health University Hospital, Egypt
Study officials:
References:
Clinical trial NCT02654184: Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
Official title: Right Lateral Positioning and Its Effect on Induction of General Anesthesia for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anesthesia
Keywords: Right lateral
Induction
Children
Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The quality of induction with sevoflurane, along with its ability to generate optimal conditions for Laryngeal Mask Airway (LMA) insertion without supplemental opioids or muscle relaxants, has also been well documented. An ideal inhalation induction technique besides being rapid and comfortable for the patient should be economical. To achieve rapidity, use of vital capacity breaths with 8% sevoflurane is a more popular method of induction compared with the conventional incremental induction.

Detailed description: 100 pediatric patients (age range, 1 to 8 years) scheduled for lower abdominal surgery under anesthesia will be included. All children in both groups will be premedicated with midazolam, 0.5 mg/kg orally, about 30 minutes before the induction of anesthesia. A parent or guardian accompanied the child into the operating room to allow the child to remain calm and cooperative for inhalation induction. Before induction, pulse oximetry and electrocardiogram monitoring will be attached. For each group, inhalation induction was initiated using a face mask using "tidal volume" and "vital capacity" breathing in high sevoflurane concentration (8%).

Eligibility criteria: Inclusion Criteria:

* Children aged 1 years to 8 years
* Children with ASA class I/II and their willingness to participate in the study

Exclusion Criteria:

* Known seizure disorder
* Craniofacial abnormalities/difficult airway
* Cardiopulmonary or neuromuscular defects
* Hepatic or renal insufficiency
* Expected difficult intravenous (IV) cannulation (eg, dark complexion, obese)
* Catching colds during the past four weeks

Primary outcomes:
measure: Induction time
timeFrame: an expected 30 minutes
Secondary outcomes:
measure: LMA trials (Number of patients in each group required insertion of an LMA more than once)
timeFrame: an expected 60 minutes
measure: Blood pressure
timeFrame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
measure: Heart rate
timeFrame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
measure: Oxygen saturation
timeFrame: Duration of from starting induction of anesthesia till LMA an expected average of 60 minutes
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: associate professor
name: sayed abd elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05583084: Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis
Official title: Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: sex differences
ohca
women
SIR
CPR
Lead sponsor: Prehospital Center, Region Zealand
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 27000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All emergency medical services treated resuscitations in Denmark between 2016 and 2021 registered in the national electronic based Danish OHCA registry

Brief summary: The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences.

The main questions it aims to answer are:

* are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency medical services (EMS)?
* are there differences in the presence of shockable initial rhythm (SIR) and survival rates after OHCA at successive stages of treatment? Researchers will compare all emergency medical services treated resuscitations in Denmark between 2016 and 2021 to see if there are possible differences between sexes.

Detailed description: This analysis will be based on data from the national electronic based Danish OHCA registry. Data on OHCAs with resuscitative attempts in Denmark have been collected in the electronic based Danish Medical Service report system since 2016. The registry covers detailed data including the EMS report, executive entries, and advanced text searches of prehospital charts. All cases go through an elaborate validation process where all identified events are read through manually by an external verification team. This ensures high quality of data, collected according to the Utstein recommendations, throughout the approximately 5400 cases of OHCA in Denmark annually. During this verification process, supplementary sources of data are linked to each OHCA, among others information about survival, localization, initiation of bystander CPR and EMS personnel operation.

Eligibility criteria: Inclusion Criteria:

- All emergency medical services treated resuscitations in Denmark between 2016 and 2021

Exclusion Criteria:

- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.

Primary outcomes:
measure: 30-days survival
timeFrame: 30 days from OHCA
Secondary outcomes:
measure: Cardiopulmonary Resuscitation (CPR)
timeFrame: 2016-2021
measure: Presence of shockable initial rhythm (SIR)
timeFrame: 2016-2021
measure: Return of spontaneous circulation (ROSC) at any time
timeFrame: 2016-2021
Other outcomes:
Locations:
Study officials:
References: