louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00302783: Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents
Official title: Randomized Controlled Trial of Multi-Source Feedback to Pediatric Residents: The Formative Value of an ACGME Competency-Based Assessment Tool.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Education, Medical
Education, Competency-Based
Feedback
Communication
Humanism
Keywords: Education, Medical
Education, Competency-Based
Multi-Source Feedback
Communication
Professionalism
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Ambulatory Pediatric Association
First posted: 2006-03-15
Enrollment: 36
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The purpose of this study is to test whether multi-source feedback, including self-assessment and tailored coaching, improves resident communication skills and professionalism. We hypothesize that residents who are assigned to receive multi-source feedback, in addition to receiving standard feedback, will improve significantly more than residents receiving standard feedback alone, as measured by parent and nurse ratings of specific behaviors over time.


Eligibility criteria: Inclusion Criteria:

* Residents entering their first year of training
* Scheduled for the two pediatric inpatient rotations where parent and nurse evaluations would be collected

Exclusion Criteria:

* Residents from combined Internal Medicine/Pediatric training programs

Primary outcomes:
measure: The difference between groups in the change in parent and nurse ratings of specific communication skills and professionalism behaviors from baseline to follow-up (average 5 months later)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: William B Brinkman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brinkman WB, Geraghty SR, Lanphear BP, Khoury JC, Gonzalez del Rey JA, Dewitt TG, Britto MT. Effect of multisource feedback on resident communication skills and professionalism: a randomized controlled trial. Arch Pediatr Adolesc Med. 2007 Jan;161(1):44-9. doi: 10.1001/archpedi.161.1.44.
Clinical trial NCT01934283: Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
Official title: Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Small Bowel Obstruction
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 125
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: Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery.

Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction.

The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction.

In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.


Eligibility criteria: Inclusion Criteria:

* older than 18 , diagnosis of small bowel obstruction

Exclusion Criteria:

* younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia

Primary outcomes:
measure: intra abdominal pressure
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT00307983: Effect of Malnutrition on the Prognosis in Hemodialysis Patients
Official title: Effect of Malnutrition on the Prognosis in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Renal Failure
Hemodialysis
Malnutrition
Lead sponsor: University of Shizuoka
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to examined the effect of malnutrition and/or inflammation on atherosclerosis and prognosis in hemodialysis.

Detailed description: Malnutrition is known to affect their prognosis in hemodialysis patients. Furthermore, recent studies indicate that malnutrition is associated with inflammation and atherosclerosis in these patients. In this study we examine the effect of malnutrition and/or inflammation on atherosclerosis and 5-year survival rate in 600 hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* hemodialysis for at least 6 months

Exclusion Criteria:

* disabled patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamamatsu
country: Japan
facility: Maruyama Hospital
state: Shizuoka
city: Iwata
country: Japan
facility: Iwata City Hospital
state: Shizuoka
Study officials:
affiliation: University of Shizuoka
name: Hiromichi Kumagai, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05175183: Epidemiology of Speed Skating-related Injuries
Official title: Epidemiology of Speed Skating-related Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Injury
Keywords: Prevalence
Multidirectional Sport
Injury prevention
Athletic injuries
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-01-03
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Speed skaters competing in the spanish national championship

Brief summary: Speed skating is a sport in which there´s a lack of epidemiological studies. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Through an online survey filled by semiprofessional athletes, it is posible to obtain all this important information. This way, it will be possible to fulfill a gap in the literature and take action in the near future in order to reduce the prevalence of injuries in this sport.

Detailed description: A retrospective study will be performed in speed skaters. 100 speed skaters will be recruited. Data of all injury along a whole season will be collected. Patients' information, including age, number of years playing, skill level and injured body part, will be analysed

Eligibility criteria: Inclusion Criteria:

* Being a speed skater and having competed in the 2018 spanish national championship

Exclusion Criteria:

* Being unable to understand the questionaire, do not accept on participating in the study.

Primary outcomes:
measure: 1.Injury prevalence
timeFrame: [Time Frame: January 2018-December 2018]
Secondary outcomes:
measure: Injury burden
timeFrame: [Time Frame: January 2018-December 2018]
measure: Injury prevalence according to occurrence
timeFrame: [Time Frame: January 2018-December 2018]
measure: Injury prevalence by mechanism of injury
timeFrame: [Time Frame: January 2018-December 2018]
measure: Injury prevalence according to location
timeFrame: [Time Frame: January 2018-December 2018]
measure: Injury prevalence according to tissue affected
timeFrame: [Time Frame: January 2018-December 2018]
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Universidad de Oviedo
state: Asturias
Study officials:
affiliation: Universidad de Oviedo
name: Hugo Olmedillas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00965783: Predictors of the Metabolic Effect of Sleep Loss
Official title: Predictors of the Metabolic Effect of Sleep Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apnea
Obstructive Sleep Apnea (OSA)
Obesity
Keywords: Sleep, Apnea, OSA, obese, middle-aged
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To test whether baseline levels of slow wave activity (SWA) during sleep are lower in obese adults, and even lower in persons with sleep disordered breathing (SDB) compared to lean adults.

To compare levels of SWA in individuals in relation to their sleep time, blood pressure, heart rate, and markers of glucose metabolism.


Eligibility criteria: Inclusion Criteria:

* healthy,
* normal sleepers,
* lean, overweight,
* obese,
* pre menopausal

Exclusion Criteria:

* no shift workers or night-shift workers,
* no mental health disorders,
* no acute or chronic health conditions (stable, well controlled hypertension are accepted),
* no hormonal treatments,
* no substances that may interfere with sleep,
* problems with sleep

Primary outcomes:
measure: Correlation between SWA, sleep duration,sleep architecture, and biomarkers of the metabolic syndrome in lean, obese with and without obstructive sleep apnea.
timeFrame: study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT03747497: Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Official title: A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Contezolid Acefosamil Compared to Linezolid Administered Intravenously and Orally to Adult Subjects With Acute Bacterial Skin and Skin Structure Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Diseases, Bacterial
Gram-Positive Bacterial Infections
Keywords: ABSSSI
Acute bacterial skin and skin structure infection
Lead sponsor: MicuRx
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether contezolid acefosamil is as safe and effective as linezolid in the treatment of adult patients with acute bacterial skin and skin structure infections


Eligibility criteria: Inclusion Criteria:

* Patients with systemic signs of infection diagnosed with acute bacterial skin and skin structure infection (ABSSSI)
* Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

Exclusion Criteria:

* Uncomplicated skin infections
* Severe sepsis or septic shock
* ABSSSI solely due to Gram-negative pathogens
* Prior systemic antibiotics within 96 hours of randomization

Primary outcomes:
measure: Early Clinical Response at the Early Assessment Visit (ITT Population)
timeFrame: 48 to 72 hours after the start of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: MicuRx Site #106
state: California
city: La Mesa
country: United States
facility: MicuRx Site #103
state: California
city: Long Beach
country: United States
facility: MicuRx Site #102
state: California
city: Stockton
country: United States
facility: MicuRx Site #104
state: California
city: Butte
country: United States
facility: MicuRx Site #107
state: Montana
city: Las Vegas
country: United States
facility: MicuRx Site #105
state: Nevada
city: Las Vegas
country: United States
facility: MicuRx Site #108
state: Nevada
Study officials:
References:
Clinical trial NCT01816997: The Statins on Glucose Homeostasis in Subjects With Impaired Fasting Glucose
Official title: The Influence of Statins on Glucose Homeostasis and the Biomarkers of Diabetes in Subjects With Impaired Fasting Glucose
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Keywords: Statins
Glucose homeostasis
Diabetes
Impaired fasting glucose
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2013-03-22
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Detailed description: Statin therapy effectively reduces cardiovascular events. However, trial data1 and meta-analyses suggest that statins also confer increased risk of development of diabetes. In order to elucidate whether statins increase risk of diabetes, investigators conducted this study to evaluate the effects of rosuvastatin (maybe the highest diabetogenic) and pravastatin (seems to be protective) on the glucose homeostasis and other biomarkers in subjects with impaired fasting glucose.

Eligibility criteria: Inclusion Criteria:

1. Age 35-70 years old
2. Fasting blood glucose 100-125 mg/dL

Exclusion Criteria:

1. A1C \>7.0%
2. 2hr glucose during OGTT \>200 mg/dL
3. Total cholesterol \>280 mg/dL
4. Previous diabetic history, coronary artery disease
5. Allergy to rosuvastatin or parvastatin
6. Baseline ALT more than 3 times UNL
7. Serum Cr \> 2.0 mg/dL
8. Pregnancy, breast feeding or plan to be pregnant woman.

Primary outcomes:
measure: Glucose homeostasis
timeFrame: 6 months
Secondary outcomes:
measure: Some biomarkers of diabetes
timeFrame: 6 months
measure: Progression of glucose homeostasis
timeFrame: 5 to 10 years.
measure: Chronic complications of diabetes
timeFrame: Up to 10 years
measure: Incidence of diabetes
timeFrame: 5 to 10 years.
measure: Chronic complications of diabetes
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Harn-Shen Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03980197: Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU
Official title: Strategy to Prevent Transmission of Multidrug-resistant Gram-negative Organisms in ICU - Evaluation of Effect of Active Surveillance Test
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antibiotic Resistant Infection
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 2500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 1. Objective of study The purpose of this study was to investigate whether the active surveillance and preemptive isolation of multidrug-resistant Gram-negative bacteria in the intensive care unit affected the reduction of the rate of acquisition of multidrug- resistant Gram-negative bacteria (MDRGNB).
2. Background Treatment option for MDRGNB (Carbapenem-resistant P. aeruginosa, Carbapenem-resistant A. baumannii, Carbapenem-resistant Enterobacteriaceae) is limited. Development of infection due to MDRGNB is common in ICU. Strategy to prevent transmission of MDRGNB is needed, and there is two approaches; First, antimicrobial stewardship program, and second, infection control strategy.The investigators aimed to figure out the role of active surveillance test and preemptive isolation of MDRGNB in reduction of acquisition rate of MDRGNB.
3. Methods Pragmatic cluster randomized, crossover, controlled trial During first period (6 months), intervention group (randomized 3 ICUs) perform daily chlorhexidine bathing, active surveillance test and preemptive isolation and contact precaution. Control group (randomized 3 ICUs) perform standard precaution with daily chlorhexidine bathing, and start contact precaution when clinical isolates reveals MDRGNB.

After 1 month washout period, intervention group and control group cross over for next 6 months.


Eligibility criteria: Inclusion Criteria:

* Enroll all patients who admit to the ICUs during the study period

Exclusion Criteria:

* Patients who discharge within 2 days after admission to ICUs

Primary outcomes:
measure: The number of patients who acquired MDRGNB in ICU per 1000 patient-days
timeFrame: through study completion, an average 6 months
Secondary outcomes:
measure: Rate of bloodstream infection due to MDRGNB
timeFrame: through study completion, an average 6 months
measure: Hand hygiene compliance rates (%) of healthcare workers
timeFrame: through study completion, an average 1 year
measure: Days of ICU stay
timeFrame: through study completion, an average 6 months
measure: 28-day mortality rate
timeFrame: 28-days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT05009797: PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation
Official title: PROSPective Evaluation of Outcome After CatheTer Ablation in Atrial Fibrillation : LONGITUDINAL STUDY OF PATIENTS UNDERGOING RADIOFREQUENCY ABLATION OF ATRIAL FIBRILLATION.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Catheter ablation
Arrhythmia
Biomarkers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Lille University Hospital for schedulled Atrial fibrillation catheter ablation

Brief summary: Atrial fibrillation ablation is the most common intervention performed worldwide. Up to 20 to 45% of patients show recurrence of AF within 12 month after catheter ablation, however its determinant are incompletely understood.

The aim of the PROSPECT-AF study is to assess the predictors of AF recurrence within the 3 years following ablation using clinical variables and innovative biomarkers in a prospective cohort of 750 patients undergoing atrial fibrillation catheter ablation.

The secondary aims are to assess the incidence of major adverse cardiovascular outcomes (MACE) and the incidence of major bleeding within the 3 years Wolfing catheter ablation.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing atrial fibrillation catheter ablation
* Able to give their consent

Exclusion Criteria:

* Childs
* Patient under guardianship
* Patients unable to give their consent
* Pregnancy

Primary outcomes:
measure: Incidence of atrial fibrillation recurrence.
timeFrame: At 3 years
Secondary outcomes:
measure: Incidence of major adverse cardiovascular events (MACE) including hospitalization for acute heart failure, cardiovascular death, stroke, myocardial infarction
timeFrame: At 3 years
measure: Incidence of major bleeding (defined by BARC≥3 bleeding)
timeFrame: At 3 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Institut Coeur-Poumon, CHU
Study officials:
affiliation: University Hospital, Lille
name: Sandro Ninni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00532597: Effects of On-Line Hemodiafiltration(HDF) on Vascular Health in Chronic Hemodialysis Patients
Official title: Effects of On-Line Hemodiafiltration(HDF) on Endothelial Dysfunction in Chronic Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End Stage Renal Disease
Hemodialysis
Keywords: Vascular Endothelium-Dependent Relaxation
Hemodialysis
Hemodiafiltration
Lead sponsor: Eulji General Hospital
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether on-line hemodiafiltration ameliorate the endothelial dysfunction compared with the low flux hemodialysis in end stage renal disease patients on maintenance hemodialysis.

Detailed description: 1. On-line hemodiafiltration(OL-HDF) is a technique that combines diffusion with convection in which the large substitution fluid is produced directly from the dialysate. It offers many advantages aside from its safe inflammatory profile, which is attributable to the use of ultrapure dialysate and highly biocompatible dialysis membranes. Due to an improved convective clearance, significantly increased removal of large or protein-bound uremic retention solutes can be achieved, with a potential benefit on cardiovascular morbidity and mortality.
2. Endothelial dysfunction, almost universal in end stage renal disease, is important risk factor for cardiovascular events, and can be evaluated by brachial artery endothelium-dependent vasodilation (flow-mediated dilation) to reactive hyperemia following 5 min of forearm ischemia.
3. The stable HD patients will receive 8-week treatment on OL-HDF or conventional low flux HD and then crossed over to opposite treatment arm. The FMD will be measured by one sonographer, and at the same time whole blood and serum will be sampled and stored for further analysis. The timepoint for measurement is 4-week interval after baseline evaluation.

Eligibility criteria: Inclusion Criteria:

* end stage renal disease on maintenance hemodialysis for more than 3 months

Exclusion Criteria:

* diagnosis of active cardiovascular diseases in 6 months
* elevation of liver enzymes over two fold of upper normal limit in 3 months
* admission for acute infection in 3 months
* untreatable stenosis of vascular access

Primary outcomes:
measure: endothelial dysfunction measured by flow-mediated vasodilation
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji General Hospital
Study officials:
affiliation: Department of Internal Medicine, College of Medicine, Eulji University
name: SuAh Sung, M.D.,PhD.
role: STUDY_CHAIR
References: