louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04349319: Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Official title: Development of Three Dimensional Preoperative Planning System for the Osteosynthesis of Distal Humerus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Humerus Fracture
Lead sponsor: Tokyo Medical University
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A case control study
Primary purpose: TREATMENT

Brief summary: To reproduce anatomical reduction and appropriate implant placement/choices during osteosynthesis for elbow fractures, a 3D preoperative planning system was developed. To assess the utility of 3D digital preoperative planning for the osteosynthesis of distal humerus fractures, the reproducibility of implant reduction shapes and placements in patients with distal humerus fractures will be evaluated.

Detailed description: 3D preoperative planning will be applied for four distal humerus fracture cases . The preoperative planning will be performed in order to determine the reduction, placement and choices of implants. After the operation, the accuracy of the reduction and implants choices and placements will be verified. The reductions will be evaluated with an angle between the diaphysis axis and a line connecting the medial epicondyle with the lateral epicondyle and an angle between the diaphysis axis and the articular surface in the coronal plane and distance between the anterior diaphysis and the anterior articular surface in the sagittal plane for the 3D images of distal humerus. The reproducibility will be evaluated by the differences of the parameters between pre- and post-operative images.

Eligibility criteria: Inclusion Criteria:

* Distal humerus fracture patients

Exclusion Criteria:

* Patients with a previous history of traumatic injuries to the elbow

Primary outcomes:
measure: Reduction shape
timeFrame: 1 year
measure: Implant placement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ami
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
Study officials:
References:
Clinical trial NCT03540719: Surgical Management of Posterior Tibial Plateau Fractures
Official title: Surgical Management of Posterior Tibial Plateau Fractures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibial Fractures
Keywords: classification
questionnaires
open reduction
internal fixation
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient at emergency room and clinic of the department of traumatology.

Brief summary: This protocol concerns an academic, multicentric, and prospective clinical trial. In this study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open reduction and internal fixation and buttressing of the posterior proximal tibial column via a posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a safe technique with adequate visualisation of the posterior tibial surface. The investigators will thoroughly evaluate all important clinical, radiological and functional variables. The functional outcome will be reported in patient reported outcome measures by means of the validated Knee injury and Osteoarthritis Outcome Score (KOOS).


Eligibility criteria: Inclusion Criteria:

* Tibial plateau fracture with involvement of posterior proximal tibial plateau (according to revised three-column classification), requiring osteosynthesis

Exclusion Criteria:

* Absent contact information
* living abroad and cannot participate in the follow-up visits
* non-functional leg prior to treatment/injury
* pathological fractures
* bilateral fractures

Primary outcomes:
measure: Subjective evaluation: outcome
timeFrame: 1 year
measure: Subjective evaluation: pain
timeFrame: 1 year
measure: Clinical evaluation
timeFrame: 1 year
measure: Radiographic evaluation
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1-7 days post-operatively, 8 weeks, 12 weeks, 6 months, 9 months, 1 year
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven
city: Rotterdam
country: Netherlands
facility: Erasmus MC Rotterdam
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital Luzern
Study officials:
affiliation: UZ Leuven
name: Harm Hoekstra, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147119: Radial Artery Function Following Trans-radial Cardiac Catheterisation
Official title: Radial Artery Function Following Trans-radial Cardiac Catheterisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2014-05-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable outpatient population attending for angiography

Brief summary: The investigators will study Radial artery injury and endothelial function following trans-radial cardiac catheterisation. Radial artery injury will be quantified pre- and post- angiography using Optical Coherence Tomography. The participants will also have radial endothelial function assessed using flow-mediated dilatation at baseline, 24 hours, one week, one month and three months post- angiography. Blood will be taken pre and 24 hours post angiography for characterisation of endothelial progenitor cell numbers and function. The hypothesis is that trans-radial catheterisation will cause a reduction in flow-mediated dilatation which peaks at 24 hours and recovers at three months. The investigators hope to correlate the rate of this recovery with peri-procedural progenitor cell numbers.


Eligibility criteria: Inclusion Criteria:

* Stable outpatient population aged between 18-85 attending for trans-radial cardiac catheterisation

Exclusion Criteria:

* Recent myocardial infarction (\<3 months)
* Severe aortic stenosis
* Chronic renal failure (eGFR\<30)
* Inability to give informed consent

Primary outcomes:
measure: Change in Flow-mediated dilatation
timeFrame: baseline, 24 hours, one week, four weeks and three months post-angiography
Secondary outcomes:
measure: Radial artery injury
timeFrame: Baseline and up to 1 hour Post angiograpy sheath insertion
measure: Endothelial progenitor cell number an function Endothelial progenitor cell number and function
timeFrame: Baseline and at 24 hours post-angiogram
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Clinical research facility University Royal Infirmary of Edinburgh
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Andrew J Mitchell, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitchell A, Fujisawa T, Mills NL, Brittan M, Newby DE, Cruden NLM. Endothelial Progenitor Cell Biology and Vascular Recovery Following Transradial Cardiac Catheterization. J Am Heart Assoc. 2017 Oct 28;6(11):e006610. doi: 10.1161/JAHA.117.006610.
Clinical trial NCT06130319: Correlation of Disease Management and Quality of Life in Patients With Chronic Heart Failure and Their Family Caregivers
Official title: Correlation of Disease Management and Quality of Life in Patients With Chronic Heart Failure and Their Family Caregivers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Heart Failure
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients in the department of cardiology of a tertiary hospital in Guangzhou

Brief summary: This study intends to investigate the current status of disease management and quality of life of patients with chronic heart failure and their family caregivers, explore the relationship between the two sides of disease management and quality of life, help nurses identify the influencing factors of quality of life of patients with chronic heart failure and their family caregivers, and carry out family-centered care in the future. This study intends to investigate the current status of disease management and quality of life of patients with chronic heart failure and their family caregivers, explore the relationship between disease management and quality of life of both sides, and help nurses identify the influencing factors affecting the quality of life of patients with chronic heart failure and their family caregivers, so as to carry out family-centered care in the future. To provide theoretical basis for improving the quality of life of both parties.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria of Chinese Guidelines for the diagnosis and treatment of heart failure
2. the duration of chronic heart failure was ≥3 months;
3. have certain reading, comprehension and expression ability, and can complete the questionnaire independently or with the guidance of the researcher;
4. Informed and agreed to participate in the investigation

Exclusion Criteria:

* In the acute stage of the disease, such as acute heart failure attack or complicated with severe pulmonary infection, liver and kidney function damage, etc.

Primary outcomes:
measure: the quality of life questionnaire
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Study officials:
References:
Clinical trial NCT00727519: The Effect of Pomegranate Juice on Oxidative Stress in Hemodialysis Patients
Official title: A Randomized Clinical Trial for Estimating the Effects of Pomegranate Juice Consumption by Hemodialysis Patients on Oxidative Stress, Infections, Cardiovascular Events and Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Hemodialysis
Keywords: Hemodialysis
Nephrology
Pomegranate Juice
Israel
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2008-08-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Pomegranate juice (PJ) consumption by hemodialysis patients will reduce the oxidative stress and the incidence of infections, cardiovascular events and mortality.

Detailed description: The mortality rate in patients with end stage renal failure is substantially higher than in the general population, and deaths are mainly attributable to cardiovascular diseases and infections. There is accumulating evidence that supports the role for oxidative stress in damaging the immune system and in the pathogenesis of cardiovascular diseases in hemodialysis patients, therefore antioxidative treatment, which will reduce oxidative stress, may be beneficial.

Pomegranate juice contains antioxidants such as soluble polyphenols, tannins and anthocyanins and was shown to have anti-inflammatory, anti- bacterial and anti-atherosclerotic properties in mice and humans. However,the effects of pomegranate juice on oxidative stress, infections and cardiovascular events in hemodialysis patients are still not documented.

This is a randomized preventive intervention trial on hemodialysis patients from one dialysis centre in Israel. The patients will be enrolled and randomized to receive pomegranate juice or placebo. Patients will be followed for one year. The objective of this study is to investigate the effects of pomegranate juice (PJ) consumption by hemodialysis patients on the changes in oxidative stress and the incidence of infections, cardiovascular events and mortality.

Eligibility criteria: Inclusion Criteria:

* End Stage Renal Disease, stable chronic hemodialysis \> 3 months
* Informed Consent.
* Man and women over 18 years.

Exclusion Criteria:

* Hemodialysis \< 3 months
* Participation in other clinical trial
* Not eligible according to physician decision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee hospital
Study officials:
References:
citation: Shema-Didi L, Kristal B, Sela S, Geron R, Ore L. Does Pomegranate intake attenuate cardiovascular risk factors in hemodialysis patients? Nutr J. 2014 Mar 4;13:18. doi: 10.1186/1475-2891-13-18.
Clinical trial NCT03343119: Epidemiology of Resistant Microbial Strains Among Different Groups of People (Healthy, Infected and Exposed to Animals)
Official title: Transfer Routes of Antibiotic Resistance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESBL Producing E.Coli
ESBL Producing K.Pneumoniae
Multidrug Resistant P.Aeruginosa
Carbapenem Resistant P.Aeruginosa
Methicillin Resistant Staphylococcus Aureus (MRSA)
Vancomycin (Glycopeptide) Resistant Enterococcus (VRE)
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Estonian University of Life Sciences
First posted: 2017-11-17
Enrollment: 708
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: I group All individuals who have been hospitalised and have been diagnosed carriage or infection with multiresistant bacteria listed above.

II group Children \>6 months of age and all adults who have not been hospitalised or received antibacterial treatment in previous 3 months.

Brief summary: This study investigates carriage rate and risk factors for acquiring multiresistant bacteria (ESBL producing E.coli and K.pneumoniae, carbapenem-resistant and multidrug resistant P.aeruginosa, MRSA and VRE) in hospitalised patients and healthy volunteers.


Eligibility criteria: I group Hospitalised patients Inclusion Criteria

* MDR bacteria (listed above) isolated from clinical specimen
* hospitalisation to the Tartu University Hospital or North Estonia Medical Centre or West Tallinn Central Hospital or East-Tallinn Central Hospital or The Hospital of Reconstructive Surgery

II group Healthy volunteers Inclusion Criteria

* age \>6 months
* have not received any antibacterial treatment in previous 3 months
* have not been hospitalised in previous 3 months

III group Dog owners Inclusion Criteria

* age \>6 months
* have not received any antibacterial treatment in previous 3 months
* have not been hospitalised in previous 3 months
* owning a dog

IV group veterinarians Inclusion Criteria

* have not received any antibacterial treatment in previous 3 months
* have not been hospitaliZed in previous 3 months
* working as a veterinarian

V group pig farmers Inclusion Criteria

* have not received any antibacterial treatment in previous 3 months
* have not been hospitalized in previous 3 months
* occupation as a pig farmer

Primary outcomes:
measure: Colonization rate with multiresistant (MDR) bacteria in hospitalized patients
timeFrame: March 2012 - March 2014
measure: Colonization rate with multiresistant (MDR) bacteria in healthy humans
timeFrame: March 2012 - March 2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Tartu
name: Tanel Tenson, PhD
role: STUDY_DIRECTOR
References:
citation: Telling K, Laht M, Brauer A, Remm M, Kisand V, Maimets M, Tenson T, Lutsar I. Multidrug resistant Pseudomonas aeruginosa in Estonian hospitals. BMC Infect Dis. 2018 Oct 11;18(1):513. doi: 10.1186/s12879-018-3421-1.
Clinical trial NCT03357718: Oral Dexmedetomidine vs Midazoam For Premedication
Official title: Oral Dexmedetomidine vs Midazoam For Premedication And Emergence Delirium in Children Undergoing Dental Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Premedication
Keywords: premedication
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 52
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospective clinical trial
Primary purpose: PREVENTION

Brief summary: The aim of this study was to compare the effect of 2 µg/kg of oral dexmedetomidine (DEX) and 0.5 mg/kg dormicum as premedication among children undergoing dental procedures.

Detailed description: The study involved 52 children between 3-7 years of age, ASA I , who underwent full-mouth dental rehabilitation. The DEX group (n=26) received 2 µg/kg DEX in apple juice, and the control group (n=26) received 0.5 mg/kg midazolam in apple juice.

The patients' scores on the Ramsey sedation scale (RSS), parental separation anxiety scale, mask acceptance scale, post-anesthesia emergence delirium scale (PAEDS), and hemodynamic parameters were recorded. The data were analyzed using chi-square test, Fisher's exact test, student t test, and analysis of variance in SPSS.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria is age between 3 to 7 years and American Society og Anesthesiology (ASA) grade 1.

Exclusion Criteria:

* The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

Primary outcomes:
measure: Ramsey Sedation Scale
timeFrame: 45 minutes after premedication
Secondary outcomes:
measure: Parental Separation Anxiety Scale
timeFrame: Preoperative
measure: Mask Acceptance Score
timeFrame: Before induction
Other outcomes:
Locations:
Study officials:
affiliation: Adnan Menderes University Faculty of Dentistry Aydın
name: Sultan KELES, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumari S, Agrawal N, Usha G, Talwar V, Gupta P. Comparison of Oral Clonidine, Oral Dexmedetomidine, and Oral Midazolam for Premedication in Pediatric Patients Undergoing Elective Surgery. Anesth Essays Res. 2017 Jan-Mar;11(1):185-191. doi: 10.4103/0259-1162.194586.
Clinical trial NCT01115218: The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Official title: The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Trabeculectomy
Wound Healing
Keywords: Glaucoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2010-05-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the University Eye Hospital of Cologne

Brief summary: The aim of the study is to investigate whether it is possible to predict the success of trabeculectomy in patients with glaucoma through the examination of mediators of wound healing in anterior chamber fluid. The success rate of trabeculectomy with mitomycin C in the literature is about 75%. This leads on the question why 25% of the patients received trabeculectomy are not sufficient treated and have not a long-term IOP reduction. Precisely this question is to be examined by the study.


Eligibility criteria: Inclusion Criteria:

* patients with glaucoma with a trabeculectomy required
* 60 eyes of 60 patients, The ratio of female / male is not involved.
* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
* age of at least 18 years

Exclusion Criteria:

* all patients not included in the group of inclusion criteria.
* less than 50yl anterior chamber fluid could be collected during the operation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Eye Hospital, University of Cologne
state: NRW
Study officials:
References:
Clinical trial NCT01354119: Long-term Benefit of Aortic Stent-graft in Patients With Distal Aortic Dissection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aortic Dissection
Aortic Aneurysm
Stent-graft
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 7
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Aortic stent-graft is useful to occlude intimal tear and prevent further dilatation of the false lumen in patients with aortic dissection. The long-term benefit of aortic stent-graft in patients with uncomplicated distal aortic dissection has not been well demonstrated, especially in patients at high risk of aneurysmal change and death.

Purpose: The purpose of the study is to evaluate long-term clinical benefit of stent-graft insertion performed just after the acute phase into the descending thoracic aorta in patients with distal aortic dissection and at high risk of aneurysmal change of the dissected aorta.


Eligibility criteria: Inclusion Criteria:

* Uncomplicated distal aortic dissection
* Initial false lumen diameter \>= 22 mm

Exclusion Criteria:

* Old age (\> 75 years old)
* Other comorbidity or malignancy with life expectancy \< 5 years
* Complicated dissection requiring aortic surgery or intervention
* Sudden death in acute phase
* Marfan syndrome

Primary outcomes:
measure: Aortic aneurysm and death
timeFrame: 4 years
Secondary outcomes:
measure: Events and complications
timeFrame: 4 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: