louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05651438: Pain, Fatigue and Sleep Quality of E-Athletes
Official title: Investigation of Factors Associated With Pain, Fatigue and Sleep Quality in E-Athletes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: E-Athletes
Keywords: E-Athletes
pain
fatigue
sleep quality
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: E-sports players over the age of 18 who have participated in professional matches for at least one year will be included in the study.

Brief summary: E-Sports, which attract great attention in the media and social networks, brings health problems and some risks, depending on the attractiveness of games and the time spent in the digital world. When the investigators examine the literature, although different studies are showing that E-Athletes experience pain and sleep problems, no study examines the factors related to pain and sleep quality together. Therefore, our study was planned to examine the factors associated with pain, fatigue, and sleep quality in E-Athletes.


Eligibility criteria: Inclusion Criteria:

* Be over 18 years old
* Take part in professional matches for at least one year
* Have an e-sports license
* Volunteer

Exclusion Criteria:

* Be retired,
* Having any systemic, orthopedic or neurological disease

Primary outcomes:
measure: Pain assessment
timeFrame: baseline
measure: Fatigue severity
timeFrame: baseline
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline
measure: Epworth Sleepiness Scale
timeFrame: baseline
Secondary outcomes:
measure: Demographic information
timeFrame: baseline
measure: E-sports year
timeFrame: baseline
measure: Daily and weekly game time
timeFrame: baseline
measure: Game branch
timeFrame: baseline
measure: Type of game
timeFrame: baseline
measure: Reasons for interest in e-sports
timeFrame: baseline
measure: Where they prepare for tournaments
timeFrame: baseline
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Melike Sumeyye Ozen
state: Balıkesir
Study officials:
References:
Clinical trial NCT01195038: Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults
Official title: A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Avian influenza, H5N1, pandemic, recombinant HA vaccine
Lead sponsor: UMN Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-03
Enrollment: 87
Sex: ALL
Minimum age (years): 21
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).


Eligibility criteria: Inclusion Criteria:

* Subjects who completed a priming study (JPIP501-01a, NCT00980447)
* Male and female healthy adults
* Written informed consent obtained from the subject before study entry

Exclusion Criteria:

* History of H5N1 influenza or vaccination of other H5N1 influenza vaccines
* Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder
* Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus
* Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines)
* Treatment with disallowed drugs including other study drugs
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)
timeFrame: Day 21
Secondary outcomes:
measure: Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses
timeFrame: Days 7, 21
measure: Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination
timeFrame: 21 days
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: UMN Investigational Site
city: Tokyo
country: Japan
facility: UMN Investigational Site
Study officials:
References:
Clinical trial NCT04469738: Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
Official title: Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed Back Surgery Syndrome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: the eNose company
First posted: 2020-07-14
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.

Exclusion Criteria:

* Patients with a diagnosis of cancer.
* Patients with major psychiatric problems.
* Patients with an underlying respiratory disease.

Primary outcomes:
measure: Exhaled breath changes
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Secondary outcomes:
measure: Pain intensity scores using the Visual Analogue Scale
timeFrame: Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Maarten Moens, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00768638: Study of Atorvastatin Dose Dependent Reduction of Proteinuria
Official title: The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2008-10-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Age of 18 and over
* Stage 3 or 4 chronic kidney disease (modified MDRD)
* proteinuria of \> 1g/d on ACEi and/or ARB, or proteinuria of \> 1g/d with intolerance or contraindication to ACEi and/or ARB
* blood pressure \< 130/80 mmHg or \< 140/90 mmHg in patients with five or more antihypertensive drugs
* stable renal function

Exclusion Criteria:

* rapid progression of renal failure
* immunosuppressive therapy within the past 3 months
* need a renal replacement therapy within 8 months
* definite history of chronic liver disease, or abnormal liver function
* evidence of active inflammatory muscle disease
* definite previous adverse reaction to a statin
* concurrent treatment with a contraindicated drug (fibrate, macrolide antibiotic, systemic use of imidazole or triazole antifungals, protease-inhibitors, ciclosporin)
* child bearing potential
* known to be poorly compliant with clinic visits or prescribed medication

Primary outcomes:
measure: proteinuria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hôtel-Dieu de Québec Hospital
Study officials:
affiliation: Laval University
name: Mohsen Agharazii, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04810338: Study Evaluating the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis
Official title: Evaluation of the Pronostic Value of Vascular Refilling Rate on Mortality in Chronic Kidney Disease Patients on Dialysis (Stage 5D)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease patient on dialysis (stage 5D)
Extracorporeal purification
Sodium
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 250
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: Patients issued from dialysis units (non profit dialysis centers)

Brief summary: Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) during an observational period of 3 years:

* the prognostic value of vascular refilling rate on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
* the prognostic value of interdialytic weight gain on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number
* the prognostic value of perdialytic weight loss on mortality and on the occurrence of i) cardiovascular events and ii) hospitalization number.


Eligibility criteria: Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D) since at least september 2017 (3 months prior to study start date)
* Anuric patient

Exclusion criteria:

- Chronic Kidney Disease patient on dialysis with residual kidney function

Primary outcomes:
measure: Prognostic value of vascular refilling rate on mortality
timeFrame: 2 years after inclusion
measure: Prognostic value of vascular refilling rate on mortality
timeFrame: 3 years after inclusion
measure: Prognostic value of vascular refilling rate on mortality
timeFrame: 3 years after inclusion
measure: Prognostic value of vascular refilling rate on mortality
timeFrame: 2 years after inclusion
Secondary outcomes:
measure: Prognostic value of interdialytic weight gain
timeFrame: 2 years after inclusion
measure: Prognostic value of interdialytic weight gain
timeFrame: 3 years after inclusion
measure: Prognostic value of perdialytic weight loss
timeFrame: 2 years after inclusion
measure: Prognostic value of perdialytic weight loss
timeFrame: 3 years after inclusion
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: UH MONTPELLIER
name: Jean-Paul CRISTOL, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06796738: Advancing Cervical Cancer Screening Through the Emergency Department - IIS
Official title: Advancing Cervical Cancer Screening Through the Emergency Department
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Cancers
HPV
Keywords: HPV
Cervical Cancer
Cancer Screening
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cervical cancer screening in the Emergency Department

Detailed description: This will be an effort to deploy HPV self-sampling among Emergency Department patients. Emergency Department patients, in the US and worldwide, are disproportionally under-screened for cervical cancer relative to the general population.

Eligibility criteria: Inclusion Criteria:

* Cisgender women and transgender/non-binary individuals with a cervix,
* Age 25-65,
* Able to demonstrate decisional capacity to participate.

Exclusion Criteria:

* Past hysterectomy with cervical removal,
* Known infection with HIV (as screening recommendations for people with HIV differ from the general population),
* Non-English speaking.

Primary outcomes:
measure: Uptake of Cervical Cancer Screening
timeFrame: 150 days post initial intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References:
Clinical trial NCT05118438: Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
Official title: Development of a Health Promotion Nursing Intervention for Post-traumatic Stress Women Based on Swanson's Theory of Caring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women Who Have Experienced Trauma
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 14
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Objectives: We aimed to (1) develop a caring program for health promotion among women who experienced trauma and (2) evaluate its effect on post-traumatic stress, depression, health-promoting behaviors, and self-esteem.

Methods: We conducted a quasi-experimental study using a group pre-test/post-test design. Data were collected from 14 women recruited from a self-sufficiency support center for sexually exploited women who experienced trauma, during December 2019-May 2020. Participants were assessed at pre-test, post-test, and at a one-month follow-up. We analyzed changes in outcome variables over time using repeated-measures analysis of variance and paired t-tests.


Eligibility criteria: Inclusion Criteria:

1. women aged over 18 years who had experienced a traumatic event, and
2. a PTS score of 64 or lower on the PTSD checklist for DSM-5 (PCL-5) developed by Weathers et al. (1993), revised by Weathers et al. (2013), and translated into Korean by Kim et al. (2017).

Exclusion Criteria:

1. presence of psychiatric conditions with hallucinations and delusions, and
2. diagnosis of an intellectual disability that would make understanding the intervention procedure difficult. Although a standard cut-off was not present in the PCL-5, women who exceeded 80% (64 points) of the total score were excluded to rule out high-risk women with severe trauma.

Primary outcomes:
measure: post-traumatic stress
timeFrame: one month after the intervention
measure: depression
timeFrame: one month after the intervention
measure: health-promoting behaviors
timeFrame: one month after the intervention
measure: self-esteem
timeFrame: one month after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: College of Nursing and Mo-Im Kim Nursing Research Institute, Yonsei University
name: Go-Un Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950338: Deep Dry Needling for the Management of Post-stroke Spasticity
Official title: CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the leading cause of physical disability, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. The investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. The investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.


Eligibility criteria: Inclusion Criteria:

* First-ever unilateral stroke;
* hemiplegia resulting from stroke;
* unilateral equinovarus gait with independent walk;
* able to ambulate without supporting devices.

Exclusion Criteria:

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
* not independent in the basic activities of daily living
* severe cognitive deficits;
* progressive or severe neurologic diseases;
* fear to needles;
* any contraindication for dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Primary outcomes:
measure: Changes in spasticity before and after the intervention
timeFrame: Baseline and immediate after the inetrvention
Secondary outcomes:
measure: Changes in pressure pain sensitivity before and after the intervention
timeFrame: Baseline and immediate after the inetrvention
measure: Changes in baropodometry outcomes before and after the intervention
timeFrame: Baseline and immediate after the inetrvention
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Jaime Salom, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos
name: César Fernández-de-las-Peñas, PT, DO, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05862038: Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation
Official title: Biomarkers in Pulsed Field Ablation Versus Cryoballoon Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes patients who are diagnosed with symptomatic paroxysmal or persistent atrial fibrillation and who are scheduled to undergo catheter ablation.

Brief summary: Our study will include consecutive patients undergoing pulsed field ablation (PFA) or cryoballoon (CBA) ablation. Tissue injury and inflammation markers will be measured before and after the procedure.

Detailed description: Study population:

The participants with symptomatic atrial fibrillation scheduled for PFA or CBA procedures Biomarkers of interest: high-sensitive troponin, CRP, NT-proBNP Data collection: Blood samples will be collected at baseline, immediately after the procedure, 24 hours after, and three months after.

Statistical analysis:

Comparisons of biomarker levels between PFA and CBA groups.

Results:

Comparison of biomarker levels between PFA and CBA groups at each time point. Changes in biomarker levels over time within each group. Correlation analysis between biomarker levels and clinical outcomes, such as AF recurrence, LA stiffness, complications, and hospitalization.

Eligibility criteria: Inclusion criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation.
* Age between 18 and 75 years.

Exclusion criteria:

* Prior atrial fibrillation ablation.
* History of significant bleeding or thromboembolic events within the last 6 months.
* History of severe renal or liver disease.
* History of malignancy within the last 5 years.
* History of autoimmune disease or immunodeficiency.
* Significant mitral stenosis or other significant valvular heart disease.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: To see if PFA vs CBA increase left atrium stifness by measuring NT-proBNP values after procedures
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: UH Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Ana Jordan
role: PRINCIPAL_INVESTIGATOR
References: