louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04371263: How Dose Election Event Will Induce Emotion Change of Emergency Room and Critical Unit
Official title: How Dose Election Event Will Induce Emotion Change of Emergency Room and Critical Unit and What is the Influence of Emotional Change in the Daily Duty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emotional Problem
Keywords: emotional change
emotional labor
emotional control
Lead sponsor: St. Martin De Porress Hospital
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nursing Manpower in Emergency and Critical Unit

Brief summary: In response to the emergence of injuries and illnesses, the manpower of the acute and critical medical team has the requirements. The election keen is rare to see in recent years. The results of the election event will inevitably bring to the emergency and critical unit nursing staff and on-site counter personnel. Certain emotional changes is noted and this study is to understand the impact of the emotional adjustment of personnel in acute and critical units on their own work, to understand the situation of on-site personnel, and to avoid excessive planning of manpower, which will help hospital manpower deployment

I

Detailed description: In 20181124, the mayor of the county and the 2020 president election, after the election, the mood changes of the nursing staff of the emergency and critical unit and the staff of the on-site counter medical department were filled out with a questionnaire to understand the mood changes of the nursing staff and on-site counter staff in each unit and how to adjust Analysis of the impact on clinical work. Exclude those who complete the questionnaire data incompletely, the statistical method used is to calculate the Cronbach's α and correlation coefficient for the questionnaire sample verification.

Eligibility criteria: Inclusion Criteria:

* Nursing Manpower in Emergency and Critical Unit

Exclusion Criteria:

* Incomplete questionnaire filled in

Primary outcomes:
measure: The Emotional Change of Nursing Manpower in Emergency and Critical Unit After Keen Election Impaction And What's The Influence of Emotional Change
timeFrame: through study completion, an average of 1 and half year
Secondary outcomes:
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: St. Martin De Porres Hospital
Study officials:
References:
Clinical trial NCT00714363: Comparison of LASIK and SBK
Official title: Comparison of Laser-Assisted in Situ Keratomeleusis (LASIK) vs Sub-Bowman's Keratomileusis (SBK): Assessment of Visual Function and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-07-14
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to compare clinical outcomes from LASIK and SBK using FDA-approved laser technology on the same patient

Detailed description: Patients undergoing bilateral refractive surgery on the same day will have one eye randomized to LASIK and the fellow eye assigned to SBK treatment.

Eligibility criteria: Inclusion Criteria:

* Patients deemed to be suitable candidates for bilateral LASIK surgery

Exclusion Criteria:

* Patients who desire monovision correction rather than bilateral distance correction

Primary outcomes:
measure: Visual acuity
timeFrame: 6 months
Secondary outcomes:
measure: Manifest refraction
timeFrame: 6 months
measure: Wavefront aberration value
timeFrame: 6 months
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah, John Moran Eye Center
state: Utah
Study officials:
affiliation: University of Utah
name: Majid Moshirfar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503763: Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Official title: Open -Label Phase IIa Trial of the Efficacy and Safety of Statin on the Course of Progressive Smoldering Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Smoldering Multiple Myeloma
Keywords: Smoldering multiple myeloma
Simvastatin
Paraprotein
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of statin administration on the course of progressive Smoldering Multiple Myeloma.

Detailed description: In vitro data indicate that statins affect myeloma cells, mainly by inducing cell death and growth suppression.

This is a national, multicenter, phase IIa, single arm (not controlled), open label clinical trial of Simvastatin 80mg p.o. /day in a population of patients with progressive SMM. Patients will be treated with Simvastatin 40 mg and if no side effect will be seen the dose will be escalated to 80 mg for up to 18 months. All further treatment decisions after completion of the study are at the discretion of the investigator.Approximately 15 patients will be enrolled.

Eligibility criteria: Inclusion Criteria:

1. Patients fulfilling the criteria of SMM. (see Appendix I)
2. Patients with progressive smoldering Myeloma. (see Appendix II)
3. Age 18-80 years.
4. Signed informed consent prior to patient recruitment.

Exclusion Criteria:

1. Patients fulfilling diagnostic criteria of active MM .(see Appendix I)
2. Patients fulfilling diagnostic criteria of: solitary myeloma or non secreting myeloma or oligosecretory myeloma or light chain myeloma.
3. Patients on statin treatment on the day of recruitment.
4. Patients on chemotherapy or receiving steroids.
5. Patients with any contraindication to statin treatment:

   * Known intolerance or hypersensitivity to statin.
   * SGOT or SGPT above 1.5 times of upper normal level (UNL).
   * CPK above UNL
   * Concomitant treatment with macrolides and or antifungal agents (ketoconazole)
   * Creatinine level above 1.5 mg%
   * Any severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
6. Patients with second primary malignancy (except for non melanoma skin malignancy) unless they have been disease free for at least five years.
7. Patients who have a history of alcohol or drug abuse.
8. Patients who are mentally or physically unable to comply with all aspects of the study.
9. Participation to an investigational drug trial

Primary outcomes:
measure: Paraprotein level
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Michael Lishner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01734863: Post-operative Radiotherapy in Poor Responders Ewing's Sarcoma Patients
Official title: Post-operative Radiotherapy Randomization in Poor Responders Ewing's Sarcoma Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Ewing's Sarcoma
Lead sponsor: Children's Cancer Hospital Egypt 57357
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Local recurrence after surgical resection is a complex phenomenon. An important predictive factor is the response to chemotherapy. Central site of disease may be a second independent predictive factor (Lin et al. 2007). Patients with more than 10% viable tumour cells at surgery following neo-adjuvant chemotherapy had a less favourable outcome with an Event-free Survival \[EFS\] of 47% after 10 years. Patients with good histological response (\< 10% viable tumour cells) after chemotherapy alone had a prognosis of about 70% after 10 years.

However, further studies are necessary to determine the merit of adjuvant radiation for high-risk patients (poor responders). Taking into consideration that the toxicity and morbidity of combined surgery and radiation is greater than either alone and must be closely monitored.


Eligibility criteria: Inclusion Criteria:

* Age \< 18 years old.
* Non-metastatic Ewing Sarcoma patients who will undergo surgery and show poor histologic response to neo-adjuvant chemotherapy.
* Negative surgical margins.
* Patients show good safety profile and acceptable performance status.

Exclusion Criteria:

* Patients who show progressive disease and undergo surgery before the time of local control.
* Patients who undergo Amputation or Rotationplasty will be excluded.
* Post-surgical complications that may hinder the administration of radiotherapy

Primary outcomes:
measure: improved Local Relapse-free Survival (LRFS)
timeFrame: five year event free survival
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Children's Cancer Hospital Egypt 57357
Study officials:
affiliation: Children's Cancer Hospital Egypt 57357
name: Mohamed s zaghloul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587763: Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest
Official title: Late Biomarkers in Adult Survivors After Out-of-hospital Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest, Out-Of-Hospital
Keywords: Biomarkers
Brain injury
Inflammation
Dementia
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Helsinki University Hospital, Finland
name: Lund University
First posted: 2024-09-19
Enrollment: 400
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: Adult patients with an out-of-hospital cardiac arrest who survived to six months follow-up

Brief summary: Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Detailed description: Blood samples are collected at six months follow-up from adult survivors after out-of-hospital cardiac arrest. Patients will be informed about the study and if they consent to participation, venous blood will be drawn by authorised medical personnel. Plasma, serum and PAX-RNA will be collected (ca 15 ml in total), processed and frozen for analysis after trial completion.

Samples will be analysed in batch for biomarkers of brain injury, inflammation etc.

Primary outcome is functional outcome (modified Rankin Scale 4-6) at six months after cardiac arrest.

Secondary outcomes are neurocognitive function according to the Montreal Cognitive Assessment (MoCA), Symbol Digits Modalities Test (SDMT).

Eligibility criteria: Inclusion Criteria:

* Survivors of out-of-cardiac arrest who participate in the extended follow-up study of the STEPCARE trial at selected sites only

Exclusion Criteria:

* Patients not participating in the extended follow-up at participating sites

Primary outcomes:
measure: Functional outcome
timeFrame: 6 months
Secondary outcomes:
measure: Neurocognitive outcomes
timeFrame: 6 months
measure: Neurocognitive outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
city: Lund
country: Sweden
facility: Skåne university hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
References:
Clinical trial NCT05564663: Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
Official title: Testing a PTSD m-Health Intervention to Improve Alcohol Treatment Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Alcohol Use Disorder
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-10-03
Enrollment: 300
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 learn whether a mobile health application (mHealth App) for posttraumatic stress disorder (PTSD) with brief support can help individuals who are in treatment for alcohol problems.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years old
* Currently in addictions treatment
* Meet criteria for a current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) AUD diagnosis
* A score of 33 or greater on the PTSD Checklist (PCL-5)
* Own a smart phone or other type of Wi-Fi-enabled device with App capabilities

Exclusion Criteria:

* Injection drug use in the past year
* Patients who are unable to speak and/or understand English
* Patients who are currently engaged in specific therapy for PTSD (Prolonged Exposure Therapy, Cognitive Reprocessing Therapy, EMDR)

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5) Change
timeFrame: Baseline, 1-, 3-, 6-, and 12-months
measure: Timeline Followback (TLFB) for Alcohol Change
timeFrame: Baseline, 1-, 3-, 6-, and 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Pine Rest Christian Mental Health Services
state: Michigan
Study officials:
affiliation: Michigan State University
name: Kipling Bohnert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608763: What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
Official title: What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem Drinking
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 804
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.


Eligibility criteria: Inclusion Criteria:

* problem drinkers as measured by an AUDIT score of 8 or more

Exclusion Criteria:

* none

Primary outcomes:
measure: Drinks in a typical week
timeFrame: 3 months
measure: AUDIT-C score
timeFrame: 3 months
measure: Highest number of drinks on one occasion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham JA, Murphy M, Hendershot CS. Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial. Addict Sci Clin Pract. 2014 Dec 10;10(1):1. doi: 10.1186/s13722-014-0022-1.
Clinical trial NCT07001163: Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
Official title: Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Acquired Pneumonia
Keywords: VAP, NICU
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the preventive value of probiotics on VAP among ventilated neonates.

Detailed description: MV is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. However, its use is associated with an increased risk of VAP, a serious nosocomial lung infection. VAP is defined as a pneumonia diagnosed in patients undergoing MV for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. Its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.Given the complex pathophysiology of VAP, numerous prevention strategies have been proposed for NICUs.Among these strategies, probiotics have emerged.

Eligibility criteria: Inclusion Criteria:

* All term neonates who required mechanical ventilation with ETT for more than 48 hours.

Exclusion Criteria:

1. Early-onset neonatal sepsis
2. Pre-existing pneumonia
3. A patient who was unfit for enteral intake.
4. Prematurity \<37 gestational weeks.
5. Surgical causes of mechanical ventilation
6. Multiple congenital anomalies and suspected chromosomal anomalies.

Primary outcomes:
measure: VAP incidence rate
timeFrame: one year
Secondary outcomes:
measure: GIT manifestations
timeFrame: one year
measure: Duration of MV and NICU stay
timeFrame: one year
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine, Tanta University
state: Q2x2+cp Tanta 2, Egypt,
Study officials:
References:
citation: Bondarev DJ, Ryan RM, Mukherjee D. The spectrum of pneumonia among intubated neonates in the neonatal intensive care unit. J Perinatol. 2024 Sep;44(9):1235-1243. doi: 10.1038/s41372-024-01973-9. Epub 2024 May 2.
citation: Iqbal F, Siva N, Kolibylu Raghupathy M, Edward S Lewis L, Barche A, Purkayastha J, S Nayak B. Probiotic effect in preterm neonates with sepsis - A systematic review protocol. F1000Res. 2024 Jul 5;11:913. doi: 10.12688/f1000research.122226.3. eCollection 2022.
citation: Rangelova V, Kevorkyan A, Raycheva R, Krasteva M. Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit-Incidence and Strategies for Prevention. Diagnostics (Basel). 2024 Jan 23;14(3):240. doi: 10.3390/diagnostics14030240.
Clinical trial NCT02899663: MRI Detection of Microbleeds in Glioma Patients
Official title: Detection of Microbleeds With MRI (SWI Sequences) in Glioma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-14
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients suffering from brain glioblastoma

Brief summary: Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Diagnosed with brain glioblastoma
* Receiving treatment with cranial radiotherapy and/or chemotherapy
* Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence

Exclusion Criteria:

* Underage
* Absence of formal diagnosis of glioblastoma
* No available medical imaging file with MRI susceptibility weighted imaging sequence

Primary outcomes:
measure: Number of microbleeds diagnosed with MRI (susceptibility weighted imaging sequence)
timeFrame: At the time of each MRI conducted within 5 years after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03372863: Validation of Automated Cardiac Output Measurement
Official title: Validation of Automated Ultrasound Method for Measurement of Cardiac Output: A Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Surgery
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-12-14
Enrollment: 50
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: Postoperative cardiac surgery patients

Brief summary: Automated software analysis now allows for quick estimation of cardiac output from the echocardiographic 5-chamber view. This study will validate the automated software method against pulmonary artery thermodilution and against conventional cardiac output measurement with echocardiography.


Eligibility criteria: Inclusion Criteria:

* Postoperative cardiac surgery patient
* Pulmonary artery catheter in situ
* Extubated

Exclusion Criteria:

* No echocardiographic image available
* No consent
* Moderat-severe aortic insufficiency
* Moderat-severe tricuspid insufficiency
* Moderat-severe mitral valve insuffficiency
* Arythmia Intracardiac shunt Moderat-severe hemodynamic instability

Primary outcomes:
measure: Accuracy of cardiac output measurement
timeFrame: 10 minutes
Secondary outcomes:
measure: Trending ability
timeFrame: 120 minutes
measure: Accuracy of cardiac output measurement
timeFrame: 10 minutes
measure: Trending ability
timeFrame: 120 minutes
measure: Accuracy of cardiac output measurement
timeFrame: 10 minutes
measure: Trending ability
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
citation: Juhl-Olsen P, Smith SH, Grejs AM, Jorgensen MRS, Bhavsar R, Vistisen ST. Automated echocardiography for measuring and tracking cardiac output after cardiac surgery: a validation study. J Clin Monit Comput. 2020 Oct;34(5):913-922. doi: 10.1007/s10877-019-00413-w. Epub 2019 Nov 1.