louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04303208: Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
Official title: Sirtuin 3 and Sirtuin 7 in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Detailed description: Systemic sclerosis (SSc) is a systemic autoimmune disease in which inflammation and fibrosis play a crucial role and lead to severe damage and failure of multiple organs such as the skin, joints, tendons, gastrointestinal tract, lungs, heart, blood vessels, and kidneys. It primarily affects women but disease is often more severe in males.

Sirtuins are a class of nicotinamide adenine dinucleotide-consuming enzymes that are implicated in numerous biological pathways .

Sirtuins are considered among the most promising targets for modulating aging-associated cellular and molecular processes and disease pathologies , The majority of studies have shown decreased SIRT expression in tissues and fibroblasts from patients with SSc compared to controls and in experimental fibrosis in mice .

Decreased SIRT3 levels and activity were observed in fibrotic areas of SSc and IPF lung tissues and SSc skin biopsies and explanted fibroblasts compared to controls , Wyman et al investigated the expression of all seven mammalian SIRTs in lung tissues and fibroblasts from patients with SSc and IPF and found a tendency for SIRTs to be decreased in patients with fibrosis compared to controls , with a particularly notable decline in SIRT7 .

Eligibility criteria: Inclusion Criteria:

* Patients with systemic sclerosis diagnosed by 2013 ACR\\EULAR classification criteria of systemic sclerosis
* Patients' age \>18
* 25 rheumatoid arthritis patients as a control .

Exclusion Criteria:

-Overlap or mixed connective tissue diseases.

Primary outcomes:
measure: : To measure circulating Sirt 3 and Sirt 7 levels in patients with systemic sclerosis and their relation with different clinical manifestations
timeFrame: 2 years
measure: Influence of Sirt 3 and Sirt 7 in fibrosis in Systemic sclerosis
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04058808: MOTIVATE AF Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
Official title: Motivational Support for Patients With Atrial Fibrillation to Promote Weight Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to look at the impact that support and motivation has on patients with Atrial Fibrillation's ability to lose weight and maintain this. We believe that weight loss has a positive impact on the reduction of symptoms of atrial fibrillation and can decrease the likelihood of the arrhythmia returning following cardio version.

This study is designed for patients who have a diagnosis of Atrial Fibrillation and have a Body Mass Index greater than 27.

In the study, we plan to provide support and motivation to patients with atrial fibrillation to encourage weight loss. There are several weight loss strategies available to follow. Information will be provided about each strategy to encourage informed choices. If the initial strategy chosen is not working, this can be change to a more suitable one as required. Follow up will be by telephone at 2 and 4 weeks then every month thereafter where you will be asked your weight and to clarify the weight loss strategy you are following. You will be seen at 6 and 12 months where you will have an ECG, BP check and your weight measured. A final telephone assessment will take place at 24 months.

We hope that the research will in the future help patients with Atrial Fibrillation manage and maintain their weight loss to improve their symptoms and prevent recurrence of the arrhythmia. The results of this study could potentially change practice in our centre by providing more structured weight loss clinics for patients with Atrial Fibrillation


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* BMI\>27
* Symptomatic AF
* Committed to monthly follow up phone calls and bi annual visits.

Exclusion Criteria:

* Any co morbidity that would reduce life expectancy to within the year.
* Unable to commit to follow up.
* Patients recruited to weight loss studies that are on going

Primary outcomes:
measure: Weight loss of at least 3% at end of year 1
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05704608: Effects of Aerobic Training Program On Liver Functions
Official title: Effects of an Aerobic Training Program on Liver Functions in Male Athletes - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Functions
Keywords: Fatty liver
Physical activity
Treadmill
Exercises
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 30
Sex: MALE
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The liver plays a central role in energy exchange, protein synthesis as well as the elimination of waste products from the body. The optimal functioning of the liver is essential for athletic performance. It becomes necessary to maintain the enzymes of the liver at an optimal level so that liver cells can be protected from inflammation or damage. This paper investigated the effects of a twelve-week aerobic exercise program on the liver function of adult athletes. A total of thirty (30) healthy male athletes aged 21 to 24 were recruited for this study and kept in two equal groups. The control group was kept under rigorous supervision and did not participate in any special activities. The experiment group was well-versed in their assigned training program and solely performed the experimental procedure for twelve (12) weeks. Evaluation of all patients in both experimental and control groups was carried out before and after the treatment program by measuring the levels of (Alkaline phosphate, AST/SGOT, ALT/SGPT, Bilirubin Total/indirect/direct, Albumin, Globulin, and Total protein) respectively using standard methods by collecting blood samples, 5 mls each of baseline into lithium heparin containers for estimation of above biochemical parameters at the pathology laboratory accredited by National Accreditation Board for Testing and Calibration Laboratories accredited (NABL, India).


Eligibility criteria: Inclusion Criteria:

* Male
* Age: 21-24 years
* Healthy
* Athletes

Exclusion Criteria:

* history of severe illness,
* surgery, or damage to liver,
* fatty liver disease,
* cirrhosis,
* blood infections,
* neuromuscular illnesses,
* or the presence of any disorders such as fever, high blood pressure, high blood sugar

Primary outcomes:
measure: Bilirubin-Total
timeFrame: 12 weeks.
measure: Serum aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT)
timeFrame: 12 weeks.
measure: Serum alanine transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT)
timeFrame: 12 weeks.
measure: Alkaline Phosphatase
timeFrame: 12 weeks.
measure: Protein-Total
timeFrame: 12 weeks.
measure: Albumin
timeFrame: 12 weeks.
measure: Globulin
timeFrame: 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Masood Khan, M.P.Th
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03079908: Comparison of da Vinci Simulator vs LapSim Simulator
Official title: Comparison of the da Vinci Skills Simulator and the LapSim Laparoscopy Simulator for Conventional Laparoscopic Skills Improvement: a Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Laparoscopy Training
Robotic Surgery Training
Keywords: Laparoscopy
Surgery
Training
Virtual reality
Simulation
Robotic Surgery
Da Vinci
Lead sponsor: Klinik für Allgemein- und Viszeralchirurgie, Department Chirurgie, Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Virtual reality surgical simulators (VRSS) are gaining popularity for general surgery training, both for conventional laparoscopic and robotically-assisted surgery. Although numerous studies have analysed the impact of VRSS training on surgical skills, there is a lack of data regarding the comparison of robotic VRSS (RVRSS) and laparoscopic VRSS (LVRSS) training on conventional laparoscopic skills among subjects with no prior surgical experience. The hypothesis of the present study is that RVRSS could improve conventional laparoscopic skills as much as laparoscopic LVRSS among naïve subjects


Eligibility criteria: Inclusion Criteria:

* Healthy medical students aged 20 to 30 years old

Exclusion Criteria:

* No prior surgical, laparoscopic or robotic experience
* No previously known severe learning disability or mental deficiency
* No handicap limiting the usage of one or both upper limb(s)

Primary outcomes:
measure: Exercises times
timeFrame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Secondary outcomes:
measure: Objects drops
timeFrame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
measure: Objects out of view
timeFrame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
measure: Instruments collisions
timeFrame: Within 1 day after randomization / data will be presented after completion of the study (an average of 9 months)
Other outcomes:
Locations:
city: Luzern
country: Switzerland
facility: Luzern Kantonsspital Luzern
Study officials:
affiliation: Luzerner Kantonsspital Luzern, Switzerland
name: Andreas Scheiwiller, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02003508: Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Official title: Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus
Keywords: Prevalence
HPV
Human papillomavirus
Vaccination
Lead sponsor: The Alfred
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2013-12-06
Enrollment: 345
Sex: MALE
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males aged 17-19 recruited from sexual health clinics and community sources

Brief summary: This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Detailed description: Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Eligibility criteria: Inclusion Criteria:

* Male
* Aged 17 to 19
* Able to complete study requirements
* Residing in Australia from 12 years of age

Exclusion Criteria:

-Males reporting sex with males in the past 12 months

Primary outcomes:
measure: Prevalence of Penile HPV Genotypes
timeFrame: Single study visit (one time point per participant)
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
Study officials:
affiliation: Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University
name: Marcus Y Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04693208: Analgesic Effect of Laser Therapy in Children
Official title: Analgesic Effect of Laser Therapy in Paediatric Patients Undergoing Tonsillectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Pain
Tonsillectomy
Laser Therapy
Photo-biomodulation
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain management after tonsillectomy could be challenging, with different protocols and various outcome depending on individual patient; moreover, odynophagia due to surgery can, in extreme cases, lead to block oral fluid intake, ending in dehydration and thus hospitalization. A small pilot study demonstrated efficacy of photo-biomodulation (PBM) in managing pain after tonsillectomy and it suggests that PBM can be included in clinical practice. The present research aims to confirm and expand the findings from this study, being the first step in including PBM in clinical routine after tonsillectomy. Use of this treatment, which is non-damaging, non-toxic and easy to supply to patients, could greatly improve individual quality of life after a surgical treatment; its use in the clinical practice could represent an advantage for the institute, leading to more patients' satisfaction, due to the lower pain sensation after surgery and quicker recovery time.


Eligibility criteria: Inclusion Criteria:

Tonsillectomy or adenotonsillectomy due to apneic chronic snoring and/or obstructive sleep apnea and/or recurrent tonsillitis

Exclusion Criteria:

1. American Society of Anesthesiologists (ASA) Score \> 2
2. Neuropsychiatric co-morbidity
3. Pro-hemorrhage coagulation disorders

Primary outcomes:
measure: Reduction in pain score, age 3-7 years
timeFrame: After 24 hours
measure: Reduction in pain score, age 8-18 years
timeFrame: After 24 hours
Secondary outcomes:
measure: Reduction in pain score, age 3-7 years
timeFrame: After 4 hours
measure: Reduction in pain score, age 3-7 years
timeFrame: After 6 hours
measure: Reduction in pain score, age 8-18 years
timeFrame: After 4 hours
measure: Reduction in pain score, age 8-18 years
timeFrame: After 6 hours
measure: Frequency of use of pain killer drugs
timeFrame: Within 24 hours
measure: Reduction in pain score evaluated by parents
timeFrame: 7 days after discharge
measure: Quality of sleep
timeFrame: 7 days after discharge
measure: Mean daily food intake.
timeFrame: 7 days after discharge
measure: Frequency of use of pain killer drugs
timeFrame: 7 days after discharge
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Raffaella Sagredini, MD
role: STUDY_CHAIR
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Eva Orzan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03817008: Changes in Elastic Properties of Descending Thoracic Aorta After Ascending Aorta Replacement
Official title: Impact of Ascending Aorta Replacement by Graft on Elastic Properties of Descending Thoracic Aorta Evaluated by Cardiac Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Surgery
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
Collaborators: name: JAZAYERI Aline
name: BOUCHOT Olivier
name: JAZAYERI Saed
name: MALAPERT Ghislain
name: PETROSYAN Andreanik
First posted: 2019-01-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 19 patients operated in Cardiac Surgery unit of DIJON Hospital between September 2014 and December 2017.

Brief summary: The aim of our study was to evaluate the impact of aortic root replacement by a graft on the elastic properties of the descending thoracic aorta using cardiac Magnetic Resonance Imaging (MRI) and automatic post-processing.

Nineteen patients were operated on an aortic root aneurysm and a cardiac MRI allowing aortic compliance measurement was performed before and after surgery. Images were acquired with a 1.5 T MRI with only one additional sequence to a conventional aortic MRI protocol.

Detailed description: Observational and retrospective trial on medical data only. The patients are operated of planned aortic root aneurysm without additional intervention.

The pre and postoperative cardiac MRI are planned in standard of care.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Elective patient
* Ascending aorta replacement with graft

Exclusion Criteria:

* Prior cardiac surgery
* Contraindication to performing cardiac MRI

Primary outcomes:
measure: Aortic compliance of descending aorta (mm2/mmHg)
timeFrame: post-operative cardiac MRI performing between 12 and 24 months
Secondary outcomes:
measure: Aortic compliance of ascending aorta (mm2/mmHg)
timeFrame: post-operative cardiac MRI performing between 12 and 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: Morgant MC, Miteran J, Lin S, Laubriet A, Cochet A, Lalande A, Bouchot O. Impact of ascending aorta replacement by graft on elastic properties of descending thoracic aorta evaluated by cardiac magnetic resonance imaging. MAGMA. 2020 Oct;33(5):641-647. doi: 10.1007/s10334-020-00829-5. Epub 2020 Jan 31.
Clinical trial NCT04509908: Eating and Physical Activity Patterns of the Population Working in the Uruguayan State Electrical Company.
Official title: Eating and Physical Activity Patterns of the Population Working in the Uruguayan State Electrical Company.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diet Habit
Weight, Body
Keywords: Diet
Work related
physical activity
Lead sponsor: Administración Nacional de Usinas y Transmisiones Eléctricas
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
name: Universidad de la Republica
name: Universidad de Granada
First posted: 2020-08-12
Enrollment: 1964
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will include all the officials who joined the company from January 1, 2010 to December 31, 2017. They are 1964 aged between 18 and 65 years old.They are living in Montevideo and 416 are women and 1,548 are men.

Brief summary: Stuydy of eatin and physical activity patterns in Uruguayan workers and association with obesity, overweight, and tasks.

Detailed description: A sample of workers from the electrical company will be studies as to eating and physical activity patterns, weight variations, and assigned tasks.

Eligibility criteria: Inclusion Criteria:

* It will include all the officials who joined the company from January 1, 2010 to December 31, 2017, of whom they are between 18 and 65 years old, and the total was from 1964.

Exclusion Criteria:

* On the other hand, regarding the officials who meet the inclusion criteria, the following exclusion criteria are established. Therefore, those officials who:

  * Do not have a medical check-up at admission and at least one checkup between one year and two years after entering the company
  * Officials who no longer continue to work at the institution at the date of the study.
  * Participants who do not have weight and height recorded in the medical record

Primary outcomes:
measure: Weight
timeFrame: 2010 at 2020
measure: Height
timeFrame: 2010 at 2020
measure: Body mass index
timeFrame: 2010 at 2020
Secondary outcomes:
measure: Diet by 24 hours recall
timeFrame: 2020
measure: Diet by frequency of food consumption
timeFrame: 2020
Other outcomes:
measure: Physical activity
timeFrame: 2020
measure: Acelerometer
timeFrame: 2020
measure: Typs of job
timeFrame: 2010 at 2020
Locations:
city: Montevideo
country: Uruguay
facility: Servicio Medico - UTE
Study officials:
affiliation: Servicio Medico UTE - Sta Fe 1041, 11800 Montevideo, Uruguay
name: Carlos Lecot, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Medina-Vadora MM, Severi C, Lecot C, Ruiz-Lopez MD, Gil A. Study of Food Intake and Physical Activity Patterns in the Working Population of the Uruguayan State Electrical Company (UTE): Design, Protocol and Methodology. Nutrients. 2021 Oct 9;13(10):3545. doi: 10.3390/nu13103545.