louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02044718: Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals
Official title: Medical Record Study on Adverse Events Requiring a Higher Level of Care in Flemish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis, Cancer, Heart Attack, Heart Failure, Abdominal Surgery, Trauma, Diabetes, Lung Disease, Gynaecology, Fertility, Cardiac Surgery,
Keywords: adverse events
unplanned admission intensive care
chart review
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
name: Algemeen Ziekenhuis Vesalius
name: Sint-Franciscus Ziekenhuis
name: Regionaal Ziekenhuis Sint-Trudo
name: Ziekenhuis Maas en Kempen
name: Ziekenhuis Oost-Limburg
First posted: 2014-01-24
Enrollment: 878
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: An adverse event (AE) is defined as unintended injury or complication, which results in disability, death or prolongation of hospital stay, and is caused by healthcare management (including omissions) rather than the patient's disease. Retrospective record reviews in several countries have shown that 2,9% to 16,6% of patients in acute hospitals experience one or more AEs. A patient with an AE may require a higher level of care. Although all AEs are important, preventable AEs that result in an upgraded level of patient care are of particular concern. In this study it's defined as an unplanned admission to intensive care unit (ICU) or a Mobile Emergency Team (MET) intervention. The objectives of this study are to determine the incidence of (preventable) adverse events requiring ICU admission or MET intervention and to assess the level of harm of each AE.


Eligibility criteria: Inclusion Criteria:

* All patients being transferred to a higher level of care during the study period (November 2011 - May 2012)
* In practice, the higher level of care means
* (1) (re)admission to the Intensive Care Unit from other care units in the hospital providing lower intensity care,
* (2) to an intervention by a Medical Emergency Team due to an unanticipated change in the patient's clinical status

Exclusion Criteria:

-

Primary outcomes:
measure: Incidence of adverse events requiring a higher level of care
timeFrame: 6 months
measure: The number of participants with preventable adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Type adverse events
timeFrame: 6 months
measure: Clinical impact of adverse events in terms of outcome
timeFrame: 6 months
measure: Quality of the chart review
timeFrame: 6 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Kristel Marquet, drs
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Arthur Vleugels, prof. dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05156918: The Effects of High-Intensity Exercise on Biological Age
Official title: The Effects of High-Intensity Exercise on Biological Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this graduate student research study is to determine if a high-intensity exercise program can slow or reverse biological (transcriptomic) aging and shed light on the underlying transcriptomic pathways involved.

Detailed description: 24 males and 24 females will be randomly assigned to either the control group or the exercise group. Baseline measures will be obtained, including questionnaires (on stress, sleep, depression, activity level, and fitness), body composition measures, vital signs, and a blood draw. Control group participants will make no modifications to regular diet or exercise habits for 30 days. Exercise group participants will perform supervised high intensity exercise three times per week at the LLU department of physical therapy laboratory utilizing treadmills, stationary bicycles, and rowing machines. Results will be collected following conclusion of the 30-day study protocol.

Eligibility criteria: Inclusion Criteria:

1. Sex: Both Males and Females
2. Age: 40-65 years old
3. Physical Fitness: Below average scores on the Self report fitness questionnaire
4. Physical Activity: Low as measured by the International Physical Activity Questionnaire

Exclusion Criteria:

1. Prior (within the last 5 years) or current history of cardiovascular disease, stroke, unexplained weight loss, clinical depression, congestive heart failure, cancer, arrythmia, respiratory disease, or other serious medical conditions that would make exercise unsafe or prevent full participation in the exercise protocol.
2. Any self-reported significant increase or decrease in activity levels within the past thirty days.
3. Current use of the following medications: antibiotics, glucocorticoids, anticoagulants, narcotics, antiepileptic medications, antipsychotics, antidepressants, and hypoglycemic agents.
4. Current self-reported pregnancy

Primary outcomes:
measure: venipuncture procedure
timeFrame: Change between baseline and 30 days
Secondary outcomes:
measure: Perceived stress scale survey
timeFrame: Change between baseline and 30 days
measure: Pittsburgh Sleep Quality Index
timeFrame: Change between baseline and 30 days
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Gurinder Bains, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05420818: Inversion and Fixation of the Transversalis Fascia in Laparoscopic Inguinal Hernia Repair
Official title: Does Inversion and Fixation of the Transversalis Fascia Prevent Postoperative Seroma Formation in Patients Undergoing Laparoscopic Inguinal Hernia Repair?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Keywords: Inguinal Hernia
TEP
Seroma
Laparoscopic Hernia
Transversalis fascia inversion
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the EHS classification, at least 80 patients who will undergo TEP repair for the first time with the diagnosis of M2 and M3 direct inguinal hernia will be randomized into 2 groups. After direct hernia reduction in the patients in the first group, the transversalis fascia at the hernia site will be pulled inward and fixed to the Cooper ligament with 2 or 3 absorbable tackers. Standard surgery will then be continued. The patients in the second group will undergo standard surgery without any seroma prevention procedure. Demographic data, clinical/radiological seroma rate, postoperative pain (VAS values),quality of life(SF36 questionnaire), recurrence and other complications at postoperative 1st, 7th day, 3rd and 6th month will be monitored. When the desired number of patients and the follow-up period are reached, the data in the 2 groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Clinical or/and radiological diagnosis of primary inguinal hernia
* EHS type M2 and M3 direct hernias
* Laparoscopic totally extraperitoneal (TEP) repair

Exclusion Criteria:

* Indirect hernias
* M1 direct hernias
* Recurrent hernias
* Patients with previous groin operations on same side
* Pregnant women
* Patients who did not accept to participate in the study
* ASA score of 3 or higher,

Primary outcomes:
measure: Seroma formation rate
timeFrame: 3 month
Secondary outcomes:
measure: Chronic pain and quality of life measures
timeFrame: 3 month
measure: Pain levels
timeFrame: 7 day
measure: Postoperative pain levels
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Research and Training Hospital
state: Fatih
Study officials:
References:
Clinical trial NCT06999018: Humeral Shaft Fractures : Outcomes of Straight Percutaneous Intramedullary Nailing With Dynamic Distal Locking
Official title: Humeral Shaft Fractures : Outcomes of Straight Percutaneous Intramedullary Nailing With Dynamic Distal Locking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Coronavirus Infections
Seroprevalence
Vaccination
Health Care Workers
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients who underwent surgical treatment for closed, isolated, and displaced fractures of the humeral shaft. These patients were treated with percutaneous anterograde intramedullary nailing using dynamic distal locking between January 2008 and June 2018. The population includes both men and women, with a mean age of approximately 53 years. Only patients with fractures classified as type A, B, or C according to the AO/OTA classification and who were available for follow-up evaluation were included. Patients with open fractures, non-isolated or non-displaced fractures, or those lost to follow-up were excluded.

Brief summary: This study looks at how many healthcare workers at CHSD have developed antibodies against COVID-19 after the second and third waves of the pandemic and following vaccination. By testing blood samples, we want to understand how well healthcare workers are protected, which work areas might be more at risk, and how immunity changes over time after infection or vaccination.


Eligibility criteria: Inclusion Criteria:

* Patients operated between January 2008 and June 2018
* Closed, isolated, displaced fractures of the humeral shaft
* Treatment by percutaneous anterograde intramedullary nailing with dynamic distal locking
* Availability for follow-up and evaluation (e.g., Constant score assessment in June 2018)

Exclusion Criteria:

* Open fractures
* Fractures that are not isolated or not displaced
* Patients lost to follow-up at the June 2018 evaluation (18 excluded)
* Lack of Constant score evaluation (patients not reviewed)

Primary outcomes:
measure: The seroprevalence of SARS-CoV-2 antibodies among healthcare workers at CHSD following COVID-19 vaccination and previous infection.
timeFrame: January 2008 - June 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: France
Study officials:
References:
Clinical trial NCT01064518: Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Official title: A Phase 2, Double-Blind, Randomized, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of RT001, a Botulinum Toxin Type A Topical Gel, for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lateral Canthal Lines
Crow's Feet
Facial Wrinkles
Keywords: Lateral Canthal Lines
Crow's Feet Wrinkles
Facial Wrinkles
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if an investigational drug, called RT001 Botulinum Toxin Type A Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called crow's feet, also known as lateral canthal lines.

Detailed description: RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001is more effective than placebo gel by examining the effect on the improvement of crow's feet by both the patient and physician.

Eligibility criteria: Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a woman of childbearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study

Primary outcomes:
measure: The number of subjects who show improvement based on the investigator global and patient assessments.
timeFrame: Week 4
Secondary outcomes:
measure: The number of subjects who show improvement based on the investigator global and patient assessments.
timeFrame: Week 8
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Dermatology Research Institute, LLC
state: Florida
Study officials:
affiliation: Dermatology Research Institute, LLC
name: Fredric Brandt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05046418: Synbiotics Cohort Study
Official title: A Prospective, Observational, Cohort Study Investigating the Clinical Impact of Hypoallergenic Formulae With Synbiotics in Infants With Cow's Milk Allergy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cows Milk Allergy
Keywords: synbiotics
paediatrics
gut microbiome
Lead sponsor: Nutricia UK Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 0
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Exclusively or partially formula fed infants with confirmed or suspected CMA who have been prescribed hypoallergenic formula containing synbiotics for the management of CMA as part of clinical care.

Brief summary: Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

Detailed description: A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged \<13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy

Eligibility criteria: Inclusion Criteria:

* Aged \<13 months
* Confirmed or suspected CMA- based on healthcare professional (HCP) judgement
* At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding
* Recently prescribed a hypoallergenic formula containing synbiotics

Exclusion Criteria:

* Exclusively breastfed infants
* Primary lactose intolerance
* Enterally fed infants
* Premature infants (born \<37 weeks) with a corrected age of less than 1 month
* Infants with contraindications to the use of hyopallergenic formula containing synbiotics
* Major hepatic or renal dysfunction
* Investigator concern around the ability of family to comply with protocol and requirements of study

Primary outcomes:
measure: Healthcare use
timeFrame: 6 months
Secondary outcomes:
measure: Clinical impact and acceptability
timeFrame: 12 months post initiation of hypoallergenic formula containing synbiotics
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: Adam Practice
Study officials:
affiliation: Nutricia UK
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05543018: Effect of Intraocular Tamponade on Visual Perception
Official title: Effect of Intraocular Tamponade on Visual Function in the Human Eyes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinal Detachment
Optic Neuropathy
Glaucoma
Keywords: Vitrectomy
Retinal detachment
Intraocular Tamponade
Silicon oil
Air tamponade
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intraocular tamponade used in vitrectomy operations may affects retinal function in various mechanisms.

Detailed description: Various intraocular tamponade are being used in vitrectomy operations as gases, fluids and silicon oil. The effects of these intraocular tamponade may affects the final visual outcome of the surgery.

Eligibility criteria: Inclusion Criteria:

* primary retinal detachment patients.
* patients eligible for 23 gauge pars-plana vitrectomy operation.

Exclusion Criteria:

* patients with axial length more than 30 millimeter that may have severe chorioretinal degenerations that may affects retinal function.
* patients with macular diseases that may affects final visual outcome as macular holes and choroidal neovascular membranes.

Primary outcomes:
measure: Visual acuity
timeFrame: Baseline and monthly after surgery till 6 months of follow up.
measure: Retinal function amplitude
timeFrame: Baseline and monthly after surgery till 6 months of follow up.
measure: Retinal function implicit time.
timeFrame: Baseline and monthly after surgery till 6 months of follow up.
Secondary outcomes:
measure: Intraocular pressure
timeFrame: Baseline and monthly after surgery till 6 months of follow up.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Benha
Study officials:
affiliation: Benha University
name: Ahmed A Tabl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02615418: Non Invasive Brain Stimulation Treatment for CLBP
Official title: A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain (CLBP)
Lead sponsor: NIBS NeuroScience Technologies
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 80
* CLBP as defined by the European guidelines.
* low back pain first week average NPRS\>4.

Exclusion Criteria:

1. Acute low back pain (duration of less than 6 months) first week average NPRS\> 4
2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)
3. Psychiatric disease other than mood disorders
4. Current chronic use of medications with pro-epileptic properties
5. Known alcohol dependency
6. Use of alcohol within the previous 24 hours
7. History of loss of consciousness
8. Epilepsy or epilepsy in a first degree relative
9. Medical implants
10. Pregnancy
11. Illicit drug use or within the previous month

Primary outcomes:
measure: Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline to week 6 .
Secondary outcomes:
measure: Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)
timeFrame: Baseline to 6 weeks
measure: Change CLBP quality of life -Roland-Morris questionnaire
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01392118: Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change
Official title: Recurrent ESBL-producing Enterobacteriaceae Bacteremia: Risk Factor, Molecular Character and Susceptibility Change
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteremia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-07-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In a tertiary care hospital, every adult patient with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010 will be recruited into this study. Patients who died within 48h after first episode of ESBL-EK bloodstream infection will be excluded.

Brief summary: The purpose of this study is to investigate the risk factor, molecular character and susceptibility change for recurrent ESBL-producing Enterobacteriaceae bacteremia

Detailed description: 1. To characterize the genotypes of the pathogens isolated from recurrent ESBL-EK bacteremia versus non-recurrent ESBL-EK bacteremia to differentiate relapse from reinfection

   * recurrent versus non-recurrent
   * relapse versus reinfection
2. To correlate the patient characteristics, clinical manifestations, severity of illness (the modified Pitt bacteremia score), diagnosis of deep-site infection, co-morbid conditions (including diabetes mellitus, hepatic and renal dysfunction), length of stay in ICU/hospitalization, the presence of invasive procedures, source of pathogen (community acquired or nosocomial infection), antimicrobial regimen (i.e carbapenems versus non-carbapenems(flomoxef or quinolones), microbiological characteristics (E coli and Kleb. pneumoniae) and outcome endpoints (clinical outcome and mortality) with ESBL recurrence and genotypes

Eligibility criteria: Inclusion Criteria:

* Adult patients (age\>=18 years) with at least one episode of ESBL-EK bloodstream infection from August 2004 to July 2010

Exclusion Criteria:

* Patients who died within 48h after first episode of ESBL-EK bloodstream infection

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation, Kaohsiung Branch
Study officials:
affiliation: Chang Gung Medical Foundation, Kaohsiung Branch
name: Chen-Hsiang Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: