louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04848168: Comparison of PRISM III, PIM2 and PELOD Scoring Systems
Official title: Comparison Of PRISM III, PIM2 And PELOD Scoring Systems In Predicting Mortality For Patients Undergoing Congenital Cardiac Surgery In Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: PRISM III
PIM2
PELOD
STAT
mortality
congenital heart disease
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Haydarpasa Numune Training and Research Hospital
First posted: 2021-04-19
Enrollment: 116
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients younger than 18 years of age who had undergone congenital heart surgery

Brief summary: PRISMIII(Pediatric Risk of Mortality III), PIM2(Pediatric Index of Mortality 2) and PELOD(Pediatric Logistic Organ Dysfunction) are frequently used for predicting mortality and morbidity in general pediatric ICUs(Intensive Care Units). However, the effectiveness of these scoring sistems in a specific group patients undergoing congenital heart surgery(CHS) is unknown. In this study, the investigators aimed primarily to evaluate the success of these scoring systems in predicting mortality and morbiditiy in this specific group and to compare the scoring systems with eachother, and secondly to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category


Eligibility criteria: Inclusion Criteria:

* Patients younger than 18 years of age who had undergone congenital heart surgery

Exclusion Criteria:

* emergency operations Patients staying in intensive care unit for less than 24 hours

Primary outcomes:
measure: evaluate the success of PRISMIII, PIM2 and PELOD scoring systems in predicting mortality and morbidity
timeFrame: 3 months
measure: morbidity indicators
timeFrame: 3 months
measure: clinical outcomes
timeFrame: 3 months
Secondary outcomes:
measure: to evaluate the relationship of these systems with the STAT(STS-EACTS CHS Mortality Score) category
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: siyami ersek TRH
Study officials:
References:
Clinical trial NCT00658268: Bisphosphonates and Impaction Grafting in Hip Revision
Official title: Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aseptic Loosening of the Hip Prosthesis
Keywords: Surgical procedures operative
Prosthesis implantation
Arthroplasty replacement
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.

Detailed description: Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.

We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.

Eligibility criteria: Inclusion Criteria:

* Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique
* Obtained informed consent
* Pregnancy excluded in women of childbearing age

Exclusion Criteria:

* Patients with known renal disease or S-creatinine \>175 mcmol/L
* Patients with S-calcium 2.75 mmol/L
* Patients with diagnosed Rheumatoid arthritis
* Patients with active primary hyperparathyroidism

Primary outcomes:
measure: Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)
timeFrame: 12 months
Secondary outcomes:
measure: Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
affiliation: Department of Orthopaedics, Lund University Hospital,Lund, Sweden
name: Magnus Tagil, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06720168: Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Official title: Air Polishers With Erythritol in the Treatment of Dental Black Stain of Bacterial Origin
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Black Stain
Black Plaque
Keywords: dental black stain
dental prophylaxis
erythritol air polisher
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Black stains on the teeth, caused by the accumulation of chromogenic microorganisms that produce iron compounds, are more common in the pediatric population and have a negative impact on dental aesthetics and patients' self-esteem. The etiology of these stains remains unclear and is not related to oral hygiene. Currently, there is no definitive treatment that prevents the reappearance of these stains, and they can only be removed by mechanical removal, which can cause injuries to the tooth structure. This study aims to evaluate the effectiveness of erythritol powder air polishers, which have antimicrobial properties, compared to conventional prophylaxis in preventing the recurrence of stains.

A randomized clinical trial will be carried out with a follow-up of 12 months, during which patient satisfaction and duration of treatment will be assessed. The results of this study could provide valuable information to improve treatment and management strategies for dental stains in the affected population, thus contributing to the emotional well-being of patients and reducing damage to their tooth enamel.


Eligibility criteria: Inclusion Criteria:

* Patients with 2 or more teeth with black stain

Exclusion Criteria:

* Sistemic diseases
* Patients with physical and/or cognitive impairment which prevents participation in a dental prophylaxis.
* Use of oral antibiotics fifteen days before the intervention
* Allergy to erythritol

Primary outcomes:
measure: Recurrence of dental black stain
timeFrame: 3, 6, 9 and 12 months
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Alfara del Patriarca
country: Spain
facility: Universidad CEU Cardenal Herrera
state: Valencia
Study officials:
affiliation: Cardenal Herrera University
name: María del Mar Jovani-Sancho, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02882568: Analysis of Immune Response In Bacterial Infection of Obese Subject
Official title: Analysis of Immune Response In Bacterial Infection of Obese Subject
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 15
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: SUPPORTIVE_CARE

Brief summary: Improve knowledge of the immune response to sepsis in obese patients. Define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude


Eligibility criteria: Inclusion Criteria:

* between18 and 80 years
* obesity: BMI \> 30
* presumed bacterial infection:

  * pneumonitis (documented or probably)
  * pyelonephritis / acute prostatitis
  * soft tissue / skin infection (except for bedsore)
  * cholecystitis / angiocholitis
  * meningitis
  * clostridium colitis
  * surgical site infection
* signed consent

Exclusion Criteria:

* patients with viral, parasitic or mycotic documented infection
* patients with bacterial infection with treatment\> 4 weeks (ex. endocarditis; osteo- articular infections)
* patients with prior antibiotic treatment (\< 14 days)
* intensive care unit patients
* patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded)
* patients with systemic disease
* Known diagnosis of human immunodeficiency infection (DICV, HIV...)
* immunosuppression treatment during last month including corticotherapy
* pregnancy
* 3 months follow up not possible
* non signed consent

Primary outcomes:
measure: Patterns of inflammatory and immunological markers in obese patients in sepsis and post- sepsis ("normal") situation
timeFrame: T 0 and at 1 month
Secondary outcomes:
measure: Evaluation of sepsis; correlation with inflammatory and immunological parameters
timeFrame: T 0 and at 1 month
measure: Analysis of leptine polymorphism
timeFrame: 1 month
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Ch de Versailles
Study officials:
References:
Clinical trial NCT00118768: A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C
Official title: A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of the Combination of Pegylated Interferon Alfa Plus NM283 (Valopicitabine) in Treatment-Naive Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Genotype-1, Chronic Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-07-12
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).


Eligibility criteria: Inclusion Criteria:

* Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
* Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patient is pregnant or breastfeeding
* Patient is co-infected with HIV or Hepatitis B
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: San Diego
country: United States
state: California
city: San Mateo
country: United States
state: California
city: Lakewood
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Laurel
country: United States
state: Maryland
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Alburquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
Study officials:
References:
Clinical trial NCT04298268: The CUSA Clarity Soft Tissue Removal Study
Official title: Clinical Performance Investigation of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Soft Tissue Removal During Urological and General Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign, Malignant Tumors or Other Soft Tissue Removal
Nephrectomy or Partial Nephrectomy With Parenchyma Removal
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 100
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: Patient requiring removal of soft tissue with an ultrasonic aspirator during urological or general surgery

Brief summary: To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures. This will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and Incidence of Adverse Device Effects.


Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 years of age
* Subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery
* Subject is an appropriate candidate to receive use of the CUSA® Clarity Ultrasonic Surgical Aspirator System product for soft tissue removal during surgery, per the study surgeon
* Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable.

Exclusion Criteria:

* Subject is currently pregnant or plans to become pregnant prior to the study index surgery
* Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
* Subject's surgical plan includes utilizing CUSA® Clarity Ultrasonic Surgical Aspirator System for the removal of uterine fibroids
* Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.
* Intra-operative exclusion criteria : Surgeon does not utilize the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgery.

Primary outcomes:
measure: Effectiveness of soft tissue removal per surgeon assessment.
timeFrame: During the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Klinikum Dortmund
city: Milano
country: Italy
facility: Niguarda Hospital
city: Palermo
country: Italy
facility: ISMETT
city: Roma
country: Italy
facility: Hopital Gemelli U.O.C. Chirurgia Generale ed Epatobiliare
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Integra LifeSciences
name: Jason Marzuola
role: STUDY_DIRECTOR
References:
Clinical trial NCT01238068: Comparison of the Results of Treatment by Gamma Nail Versus Dynamic Hip Screw for Unstable Intertrochanteric Hip Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intertrochanteric Fractures of the Hip
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-11-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study hypothesis is the the results of the use of Gamma nail will be superior to the use of Dynamic hip screw for unstable intertrochantric hip fracture.


Eligibility criteria: Inclusion Criteria:

* patients diagozied with acute intertrochantric unstable fracture
* a minimum minimental score of 6
* ability to walk 500 meters indepedently

Exclusion Criteria:

* pathological fracture
* multiple fractures
* neurological conditions

Primary outcomes:
measure: hip function score
timeFrame: 1 year
Secondary outcomes:
measure: x-ray, surgical outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical center
Study officials:
References:
citation: Lewis SR, Macey R, Gill JR, Parker MJ, Griffin XL. Cephalomedullary nails versus extramedullary implants for extracapsular hip fractures in older adults. Cochrane Database Syst Rev. 2022 Jan 26;1(1):CD000093. doi: 10.1002/14651858.CD000093.pub6.
Clinical trial NCT03743168: Static Stretching on Postural Sway and Plantar Pressures
Official title: The Acute Effects of Intermittent Versus Continuous Bilateral Ankle Plantar Flexors Static Stretching on Postural Sway and Plantar Pressures During Standing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Stretching Exercise; Postural Balance; Stabilometry; Platform
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 48
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: Risk for falls has been associated with falls efficacy and postural balance. The objective was to compare the effects on the footprint and the stabilometry of the continuous stretch and the intermittent. Subjects were randomly assigned to an intermittent stretching protocol group or continuous stretch group both of them loading passive plantar flexor stretching. Static footprint and stabilometry were measured before and after both protocols.


Eligibility criteria: Inclusion Criteria:

* Non-trained individuals
* Healthy subjects

Exclusion Criteria:

* Previous surgery on the lower extremities
* Injuries
* Musculoskeletal conditions

Primary outcomes:
measure: Foot plantar pressure
timeFrame: Change from foot plantar pressure at 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ricardo Becerro de Bengoa Vallejo
Study officials:
References:
citation: Martinez-Jimenez EM, Losa-Iglesias ME, Gonzalez-Martin S, Lopez-Lopez D, Roca-Dols A, Rodriguez-Sanz D, Becerro-de-Bengoa-Vallejo R, Calvo-Lobo C. A 120-second stretch improves postural control and plantar pressure: quasi-experimental study. Sao Paulo Med J. 2022 May-Jun;140(3):341-348. doi: 10.1590/1516-3180.2021.0255.23072021.
Clinical trial NCT05899868: Utilization of Airway Stabilizing Rod
Official title: Utilization of Airway Stabilizing Rod to Assist With LMA Guided Fiberoptic Intubation in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Complication of Anesthesia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Testing of device for success during endotracheal intubation
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The pediatric airway is known to be more challenging than the adult airway when performing endotracheal intubation. When a patient cannot be ventilated and/or intubated, the guidelines for airway management dictate that a laryngeal mask airway (LMA) be used as a rescue device to oxygenate and ventilate the patient. While an excellent device the LMA is seen as temporary and ultimately needs to be replaced by an endotracheal tube (ETT).

Detailed description: The objective is to study this device in patients with difficult airway to assess the success rate and time to intubation for placing an endotracheal tube using this device.

Eligibility criteria: Inclusion Criteria:

* Ages 5-18 years
* Requiring intubation
* Known difficult airway
* LMA placement possible

Exclusion Criteria:

* Known normal airway
* Procedure not requiring endotracheal intubation
* Parental refusal
* Patient dissent

Primary outcomes:
measure: Overall time in the airway
timeFrame: 5 minutes
measure: Total time to intubation
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hosppital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Arvind Chandrakantan, MD
role: PRINCIPAL_INVESTIGATOR
References: