louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06386484: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout
Official title: Selective Head-and-neck Cooling on Biomarker Levels and Symptom Rating Following a Boxing Bout- Protocol for an Exploratory Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Repetitive Head Impact
Selective Head and Neck Cooling
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The PolarCap System consists of a high-powered portable cooling system, designed to reduce brain temperature by controlled cooling of the scalp and neck with a circulating coolant (PolarCap Coolant, PolarCool AB, Lund, Sweden). The coolant is maintained at 0°C and flows through a silicone-based head cap. An insulating neoprene cover is put on top of the cap for isolation.
Primary purpose: PREVENTION

Brief summary: Young, healthy elite boxers ≥ 18 years old are recruited. Prior to, and immediately after a competitive boxing bout over 3x2 or 3x3 minutes, blood samples are drawn. Boxers are randomized to intervention or control management by 1:1 allocation prior to baseline testing. After the initial post-fight blood sample is drawn and symptom rating using the sports concussion assessment tool-5 (SCAT-5) has been collected, the boxers receive either acute selective head-and-neck cooling for 45 min, or routine post-fight management. The number of head impacts are counted in all boxers on match video recordings. In both groups, blood samples are drawn 45 minutes after the initial post-bout blood sample, as well as 3 and 6 days post-fight.


Eligibility criteria: Inclusion Criteria:

1. Male and female elite boxers ≥18 years old
2. Cleared for participation by the medical staff of the Swedish Boxing Association.
3. Informed consent by each participant prior to the competitive event
4. No boxing fights or match sparring during the initial 6 days after their last boxing fight
5. Signed informed consent.

Exclusion Criteria:

1. \>40 years old or \<18 years old
2. Participation in competitive fights, match-sparring or any training causing additional head impacts during the first six post-fight days after being included in the study.
3. History of autoimmune neurological diseases or a neurodegenerative disorder.
4. History of previous traumatic brain injury resulting in an intracranial haemorrhage.

Primary outcomes:
measure: Selective head-and-neck cooling in boxing attenuates the release of brain injury biomarkers such as NFL and GFAP post fight.
timeFrame: 6 days
Secondary outcomes:
measure: Selective head-and-neck cooling improves symptom rating post fight in boxing, using the Sports Concussion Assessment tool- 5 (SCAT-5).
timeFrame: 6 days
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Clinical Sciences Lund, Department of Neurosurgery, Sweden
state: Skane
Study officials:
References:
Clinical trial NCT05862584: Impact of Air Pollution on the Course of Inflammatory Rheumatism
Official title: Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis)

To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days

Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient.

The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.


Eligibility criteria: Inclusion Criteria:

* Patients with RA according to ACR/EULAR 2010 criteria, or spondyloarthritis according to ASAS criteria.
* Patients older than 18 years of age
* Patients with RA or spondyloarthritis considered stable (no change in background or biological therapy for at least 3 months) and in low activity (SAR 28 CRP \< 3.2 for RA and BASDAI \< 4 for 3 months).
* Patient treated with biological therapy

Exclusion Criteria:

* Patient with no fixed abode
* Patient planning to move within 6 months.
* Patient unable to read or understand the non-opposition notice.

Primary outcomes:
measure: Show that there is a difference in average exposure to regulated pollutants according to the occurrence or non-occurrence of inflammatory rheumatism (RA or APS).
timeFrame: Every week for 6 months
Secondary outcomes:
measure: Relationship between average exposure to regulated pollutants and severity of SPA/PR.
timeFrame: Every week for 6 months
measure: Correlations between average exposure to regulated pollutants and biological severity of SPA/PR.
timeFrame: Every week for 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT01511484: You Are What You Eat: A Randomised Controlled Trial of an Appearance-based Dietary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fruit and Vegetable Consumption
Keywords: fruit
vegetables
appearance
skin color
carotenoids
diet
Lead sponsor: Perception Lab
Sponsor class: OTHER
Collaborators: name: Unilever R&D
First posted: 2012-01-18
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigated whether illustration of the facial appearance benefits of fruit and vegetable consumption is able to motivate increased intake of this food group. The investigators hypothesize that individuals witnessing illustrations of the impact of a healthy diet will exhibit improvements in diet relative to a control group receiving only information on the health-benefits of this food group.


Eligibility criteria: Inclusion Criteria:

* Student or staff member at University of St Andrews
* Has access to email account to receive link to weekly online questionnaire.

Exclusion Criteria:

* Exited study before completion
* Unable to make dietary changes due to a medical condition

Primary outcomes:
measure: Fruit and vegetable consumption
timeFrame: up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: St Andrews
country: United Kingdom
facility: Perception Lab, School of Psychology, University of St Andrews
state: Fife
Study officials:
affiliation: University of St Andrews
name: Ross D Whitehead, MSc
role: STUDY_DIRECTOR
References:
citation: Stephen ID, Coetzee, V, Perrett D. Carotenoid and Melanin Pigment Coloration Affect Perceived Human Health. Evolution and Human Behaviour.32(3): 216-227. 2011.
citation: Stephen ID, Law Smith MJ, Stirrat MR, Perrett DI. Facial Skin Coloration Affects Perceived Health of Human Faces. Int J Primatol. 2009 Dec;30(6):845-857. doi: 10.1007/s10764-009-9380-z. Epub 2009 Oct 26.
citation: Whitehead RD, Ozakinci G, Stephen ID, Perrett DI. Appealing to vanity: could potential appearance improvement motivate fruit and vegetable consumption? Am J Public Health. 2012 Feb;102(2):207-11. doi: 10.2105/AJPH.2011.300405. Epub 2011 Dec 15.
citation: Whitehead RD, Ozakinci G, Perrett DI. A randomized controlled trial of an appearance-based dietary intervention. Health Psychol. 2014 Jan;33(1):99-102. doi: 10.1037/a0032322. Epub 2013 Mar 25.
Clinical trial NCT05577884: Ultra-low-dose Whole-body CT Using AI-based CT Reconstruction in Patients With Multiple Myeloma
Official title: Noise Reduction and Image Quality Improvement in Ultra-low-dose Whole-body CT Scans Using AI-based CT Reconstruction Program (ClariCT.AI) in Patients With Multiple Myeloma: A Prospective, Single-center Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 19
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: Patients who are referred to Hemoatooncology department with suspicion of multiple myeloma

Brief summary: This prospective study aims to perform intra-individual comparison of the image quality between ultra-low-dose whole-body CT with deep learning reconstruction and conventional low-dose whole-body CT with iterative reconstruction in patients with suspected multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* patients with suspected multiple myeloma and scheduled for noncontrast-enhanced low-dose whole-body CT
* patients who have no previous history of chemotherapy for multiple myeloma

Exclusion Criteria:

* patients who do not agree to the protocol
* non-Korean patients
* pregnancy

Primary outcomes:
measure: Contrast-to-noise ratio
timeFrame: 3 months after the CT scan
Secondary outcomes:
Other outcomes:
measure: Noise
timeFrame: 3 months after the CT scan
measure: Signal-to-noise ratio (SNR)
timeFrame: 3 months after the CT scan
measure: Edge rising distance
timeFrame: 3 months after the CT scan
measure: Subjective overall image quality
timeFrame: 3 months after the CT scan
measure: Conspicuity of bone structure
timeFrame: 3 months after the CT scan
measure: Conspicuity of soft tissue
timeFrame: 3 months after the CT scan
measure: Lesion detectability
timeFrame: 3 months after the CT scan
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Dong Chae, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06126484: Neonatal Transcatheter Cardiac Interventions at Sohag University Hospital
Official title: Outcomes of Transcatheter Cardiac Interventions in Neonates With Congenital Heart Disease at Sohag University Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Neonatal Cardiac Interventions
Keywords: Catheter, neonates, congenital heart disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is performed to assess the safety, efficacy and outcome of transcatheter cardiac interventions in neonates with critical congenital heart disease at Sohag University Hospital

Detailed description: This study includes neonates with critical congenital heart diseases that require early interventions Patients with untreated sepsis and coagulopathy are excluded.

Methods:

A) Clinical data: age, body weight and oxygen saturation B) Echocardiographic data: cardiac anatomical diagnosis. C) Catheterization data: vascular access, description of the defects, type of the device used, fluoroscopy time, radiation time, related complications and added interventions in the same setting.

D) Procedural details:

* All procedures will be performed under general anesthesia. procedures will be performed are;

  1. Balloon atrial septostomy.
  2. PDA stent implantation.
  3. Pulmonary valvuloplasty.
  4. Aortic valvuloplasty.
  5. Balloon angioplasty of coarctation.
  6. PDA device closure for preterm neonates.

     E) Post-procedure details:
* All the patients will be transferred to NICU.
* Prophylactic antibiotic therapy will be given to all patients.
* In patients with PDA stent; heparin infusion will be maintained for at least for 24-48 hours then acetylsalicylic acid: Dose; 5mg/kg/day will be added when oral feeding could be established until undergoing second-stage palliation or repair.

Eligibility criteria: Inclusion Criteria:

* Neonates with critical congenital heart diseases that require early intervention

Exclusion Criteria:

* Untreated sepsis and coagulopathy.

Primary outcomes:
measure: procedure related complications
timeFrame: 1 day
Secondary outcomes:
measure: Postprocedure NICU admission
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
affiliation: Faculty of Medicine, Sohag University
name: Somaia S Mahmoud, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04845984: Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Four Hospital of the Alpine Region
Official title: Evaluation of the Prevalence of SARS-CoV-2 Infection in the Healthcare Workers (HCWs) in Five Hospital of the Alpine Region
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Health Care Worker
Lead sponsor: Centre Hospitalier Annecy Genevois
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be proposed to all the staff of participating hospitals, who have been tested for SARS-CoV-2 (serology) and who have not objected to the use of their health data.

Brief summary: The PACAAP study aims to report the seroprevalence of SARS-CoV-2 IgG antibodies among HCWs testing during the massive campaign screening set up in France by French ministry of Health and national authorities in four hospital of the Alpine region.

Detailed description: In France during the first wave of the pandemic, 30,230 symptomatic healthcare workers had been reported positive. Yet, the prevalence of the infection in French healthcare workers remains unknown as it mostly reflect symptomatic infections.

Also, the prevalence of infection was reported being higher in male healthcare workers, and in those having patients' facing roles. However, the impact of the level of exposure to SARS-CoV-2, the use of personal protective equipment and hospital organization to prevent infection and spread remains unclear.

Our study aims to report the seroprevalence of SARS-CoV-2 infection among French healthcare workers after the first wave of the pandemic. It also aims to explore the impact of the type of occupations and the level of exposure to the viruses on the seroprevalence of infection.

Eligibility criteria: Inclusion Criteria:

* Hospital staff employee
* Employed in one of the participating centers
* Volunteers to perform SARS-CoV-2 serology
* Permanent or occasional staff (temporary workers, short contracts)
* Caregivers or not (medical, paramedical, administrative, technical staff)

Exclusion Criteria:

* Staff who are not working at a participating center while participating in the study
* Person under guardianship or curatorship
* Opposition to data collection

Primary outcomes:
measure: SARS-CoV-2 prevalency among hospital health care professionals
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Pringy
country: France
facility: Ch Annecy Genevois
Study officials:
References:
Clinical trial NCT05368584: Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR
Official title: Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Keywords: STEMI
GPCR
PCI
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography in patients with non-coronary heart disease.

Brief summary: This study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI patients after emergency PCI.

Detailed description: This study mainly observed the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI by measuring autoantibodies; and the changes of autoantibodies in STEMI patients compared with coronary angiography-negative patients. At the same time, combined with different cardiovascular antibody levels and various indicators, the effect of ischemia-reperfusion injury and prognosis after emergency PCI in STEMI patients was evaluated. The correlation between autoantibody changes and imaging indicators in STEMI patients was evaluated by cardiac color Doppler ultrasound and CMR.

Eligibility criteria: Inclusion Criteria:

* STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)"; ②STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University; ③ The selected patients were able to complete the MRI and STE examinations; ④ They agreed to be enrolled in the trial and signed the informed consent.

Exclusion Criteria:

* Past myocardial infarction or revascularization (PCI or CABG); ②Congestive heart failure LVEF\<40%; ③Atrial fibrillation; ④Renal insufficiency (GFR\<30 ml/min); disease; ⑥ rheumatic immune system disease; ⑦ malignant tumor; ⑧ claustrophobia; ⑨ contraindication to CMR;

Primary outcomes:
measure: β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA OD values
timeFrame: Admission Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
Study officials:
References:
Clinical trial NCT00945984: Laparoendoscopic Single-site Radical Nephrectomy for Localized Renal Cell Carcinoma
Official title: Comparison of Laparoendoscopic Single-site Radical Nephrectomy With Conventional Laparoscopic Radical Nephrectomy for Localized Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Localized Renal Cell Carcinoma
Keywords: Localized renal cell carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-07-24
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care center

Brief summary: Surgical resection is the only potential curative treatment available for renal cell carcinoma. The purpose of this study is to clarify the surgical and oncologic outcomes of laparoendoscopic single-site radical nephrectomy for localized Renal Cell Carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients with localized renal cell carcinoma

Exclusion Criteria:

* Patients with lymph node or distant metastasis

Primary outcomes:
measure: Surgical outcomes such as operative time, estimated blood loss
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyeon Hoe Kim, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01195584: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
Official title: Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Lumbar Disease
Keywords: complication rate in 3 cohorts (BMI < 25, > 25 and > 30)
Lead sponsor: General Hospital Amstetten
Sponsor class: OTHER
First posted: 2010-09-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery.

Brief summary: The study concerns a retrospective analysis of all subjects operated as of 1st Jan 2008 using Minimal Access Surgical Technique (MAST). The study is descriptive in nature and will present the observation of all cumulated patients operated with MAST.

The study data will include the general health information of the subjects prior to surgery, information on the surgery such as OP time, blood loss, and the postoperative wound healing process (until discharge), which is on average the 10th postoperative day.


Eligibility criteria: Inclusion and Exclusion Criteria:

* all patients who underwent minimal access spinal surgery for degenerative lumbar disease fusion surgery
* patient older than 18 years
* all products have been used within intended use

Primary outcomes:
measure: Postoperative Complications in the BMI Groups During Post Operative Hospitalization.
timeFrame: at hospital discharge
Secondary outcomes:
measure: Operation Duration
timeFrame: after surgery
measure: Blood Loss
timeFrame: after surgery
measure: Number of Spine Segments
timeFrame: peri operative
measure: Drainage
timeFrame: at hospital discharge
measure: Days of Hospitalization
timeFrame: at hospital discharge
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: General Hospital Amstetten
Study officials:
affiliation: General Hospital Amstetten
name: Wolfgang Senker, MD
role: PRINCIPAL_INVESTIGATOR
References: