louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01974453: RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)
Official title: RAdiation Dose In percutANeuos Coronary Procedures Through Transradial Approach (RADIANT Observational Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Exposure
Keywords: Radiation dose, transradial approach, percutaneous coronary interventions, coronary angiography
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 2028
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical operators that performe diagnostic and interventional coronary procedures

Brief summary: Radiation issue during percutaneous coronary interventions is an important issue for operators due to the long term stochastic risk of cancer induction, but is often under-evaluated. Many factors may be associated with the radiation dose adsorbed by operators. In particular the most important are the position taken by the operator, the use of dedicated X-ray shield and the duration of the procedure. However other factors (as operator height or the angulation of the radiation tube) might have some important effects but are often under-evaluated .

Aim of our observational study is to evaluate the most important determinants of the radiation dose adsorbed by operators during different coronary procedures (diagnostic coronary angiography or percutaneous coronary interventions) and through different vascular accesses (right or left transradial approach or transfemoral approach).

All patients who underwent to percutaneous coronary diagnostic or interventional procedures will be enrolled in this observational study.

Each operator will be equipped with dedicated dosimeters placed at left wrist, at thorax level outside the lead apron and at head level to evaluate the radiation dose at crystalline. Effective doses delivered to patients will be expressed as dose area product (DAP) and measured in Gycm2.


Eligibility criteria: Inclusion Criteria:

All patients who underwent to percutaneous coronary diagnostic or interventional procedures

Exclusion Criteria:

hemodynamic instability, age \<18 years

Primary outcomes:
measure: Radiation Dose adsorbed by operators
timeFrame: Periprocedural
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ospedale Sandro Pertini - ASL RMB
state: RM
Study officials:
References:
Clinical trial NCT03076853: Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System
Official title: Medication Assessment Through Real Time Information eXchange - Distributed Pharmaceutical Record System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With Pharmaceutical Record
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Anesthesia, Emergency and Geriatric departments with Pharmaceutical Record

Brief summary: The aim of MATRIX-DPRS is to assess the clinical and organizational impacts of the use of the medication record, opened, filled and managed by pharmacists (from private office and hospital units) by hospital physicians in private and public healthcare establishments (volunteers), for three clinical contexts: anaesthesiology visit before surgery, medications abuse and emergency hospitalization, medications and elderly hospitalisations.

Detailed description: As part of the national 2012 PREPS call for proposals, a multidisciplinary research team was set up to design and develop methods in order to evaluate the efficiency and the performance of health data information systems. This team is composed of physicians and researchers in medical informatics, hospital information systems, biostatistics, process analysis and management in healthcare, ergonomics and usability. This study was aimed to evaluate the clinical and organizational impacts of the use of a new source of information brought by the pharmaceutical record, promoted by the national committee of pharmacists. This record is opened and filled for each patient by the pharmacist. It contains all the medication sold (prescribed by physician and OTC) by the patient. This record is used by almost all the private pharmacists. The French Health Ministry was looking for an evaluation of this new source of information by hospital physicians in order to be applied by any healthcare institution or organization wishing to evaluate the added value of its investments or recommendations (example: ARS (French Regional Health Agency), DGOS (French Directorate General of Health Services), etc.) in the information system.

Eligibility criteria: Inclusion Criteria:

Concerning Anesthesia department:

* Patients in pre-anesthesia consultation for scheduled intervention.

Concerning Emergencies department:

* Patients admitted for fainting fit

Regarding patients hospitalized in geriatrics:

* Patients admitted to geriatrics

Exclusion Criteria:

* Minors
* Patients without administrative or judicial freedom if the authorization of the legal representative can not be collected.

Primary outcomes:
measure: Modification of the medical prescription linked to the use of the pharmaceutical record
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
Clinical trial NCT00483353: Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
Official title: A Pilot Study to Explore the Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers in Subjects With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The current study will investigate nasal inflammatory markers obtained by filter paper collection techniques, in subjects with allergic rhinitis, determining the most appropriate time points and handling conditions, prior to running a larger study with subjects with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects with allergic rhinitis, that have a positive skin prick response to Phleum pratense.

Exclusion Criteria:

* Subjects with a history of asthma. Current smokers, or recent ex-smokers and subjects that have had a respiratory tract infection in the previous 4 weeks.

Primary outcomes:
measure: Post allergen challenge nasal inflammatory markers at 1, 5, 15, 30, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Secondary outcomes:
measure: Post allergen challenge effects on acoustic rhinometry and symptoms at 16, 31, 45 min, 1, 2, 3, 4, 5, 6, 7, 8 hours post allergen challenge.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Pfizer Investigational Site
state: England
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02742753: Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
Official title: Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Otitis Media
Otitis Media
Keywords: Otitis
Vaccine
Sweden
Database
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 1
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children living in the county councils of VGR and Skåne during the study period.

Brief summary: The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish children by collecting and analyzing patient level observational data already available in existing regional and national databases.


Eligibility criteria: Inclusion Criteria:

Data from all children ≤ 5 years old in VGR and Skåne in each year during the study period (2004 - 2013)

Exclusion Criteria:

Not Applicable

Primary outcomes:
measure: Assessment of the impact of PCVs by describing, separately for Skåne and VGR (Västra Götalandsregionen), trends over time in the incidence of OM and AOM among children during the pre-PCV, PCV7, and Synflorix®/PCV13-eras
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
Secondary outcomes:
measure: Assessment of the impact of PCVs by describing trends over time in the rate of antibiotics dispensed for OM and AOM diagnoses among children with OM or AOM
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
measure: Assessment of the the impact of PCVs by describing trends over time in the rate of tympanostomy tube insertions among children with OM and AOM
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
measure: Assessment of the impact of PCVs by describing the trends over time in the incidence of severe AOM (Medical Products Agency 2010, Lieberthal 2013) among children
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
measure: Assessment of the Costs for OM and AOM-related healthcare resource utilization
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
measure: Assessment of possible individual-level predictors for the time to the first OM or AOM diagnosis
timeFrame: During 10 years: from January 1, 2004 to December 31, 2013
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Edmondson-Jones M, Dibbern T, Hultberg M, Anell B, Medin E, Feng Y, Talarico C. The effect of pneumococcal conjugate vaccines on otitis media from 2005 to 2013 in children aged </=5 years: a retrospective cohort study in two Swedish regions. Hum Vaccin Immunother. 2021 Feb 1;17(2):517-526. doi: 10.1080/21645515.2020.1775455. Epub 2020 Jun 23.
Clinical trial NCT02876653: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Official title: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
Aging
Telomere length
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 53
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility criteria: Inclusion Criteria

Patient:

* Men aged 20 to 65 years
* Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
* With an AHI \> 5 / h

Healthy volunteers:

* Men aged 20 to 65 years
* With an AHI ≤ 5 / h

Exclusion Criteria

All subjects:

* Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
* Known cardiovascular disease associated (heart failure, rhythm disorder ...)
* Known respiratory diseases
* Known neoplastic pathology, known chronic inflammatory disease
* Psychiatric pathology treated
* Medication
* Not affiliated to the French social health care system
* Major protected person
* Private person of liberty
* People in emergency situation
* Patient refusing to participate in the study

Primary outcomes:
measure: Telomere length of circulating leukocytes
timeFrame: 4 weeks
Secondary outcomes:
measure: Carotid-femoral pulse wave velocity
timeFrame: 4 weeks
measure: Bone density
timeFrame: 4 weeks
measure: Correlation between biological parameters and neuropsychological assessment
timeFrame: 4 weeks
measure: Markers of oxidative stress: Malondialdehyde, heme oxygenase-1
timeFrame: 4 weeks
measure: Markers of inflammation: hs-CRP, IL-6, IL-8, MCP-1
timeFrame: 4 weeks
measure: Markers of growth hormone axis (GH, IGF-1, IGFBP)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Boyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04720053: Evaluating Mindfulness-Based Interventions With New Fibromyalgia Patients
Official title: A Feasibility Study Evaluating Mindfulness-Based Intervention Assessing- A Wearable Wellness Brain Sensing Device (Muse-S) in Newly Diagnosed Fibromyalgia Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the feasibility of a wearable brain sensing wellness device to provide mindfulness training to fibromyalgia patients who have failed medical therapy.

Detailed description: All study participants will receive a wearable brain sensing wellness device, and demonstration of the mindfulness sessions. Participants will be asked to complete study surveys/questionnaires. During the first part of study, participants will be asked to complete the intervention. After completion of the intervention they will enter a follow-Up Phase, where they will be contacted and asked to complete surveys and gauge satisfaction with the study.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent.
* Diagnosed with Fibromyalgia.
* Not pregnant by subject self-report at time of consent.
* Have the ability to provide informed consent.
* Have the ability to complete all aspects of this trial.
* Have access to a iPhone, iPad, Android device.
* Has no contraindicating comorbid health condition as determined by the clinical investigators.

Exclusion Criteria:

* Used or been enrolled in any treatments for fibromyalgia, or pain within the past 30 days.
* Used an investigational drug within the past 30 days.
* Currently (within the past 3 weeks) been practicing mindfulness training on a weekly/regular basis.
* Currently (within the past 3 weeks) been undergoing an additional program (e.g. CAM) to improve quality of life.
* Currently (within 3 weeks) been enrolled in another clinical or research program (e.g. CAM) which intervenes on the patients' QOL, or stress.
* An unstable medical or mental health condition as determined by the physician investigator.

Primary outcomes:
measure: Change in Widespread Pain Index (WPI)
timeFrame: Baseline to end of treatment (day 90)
measure: Change in Perceived Stress Scale
timeFrame: Baseline to end of treatment (day 90)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sanjeev Nanda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972153: Device to Reduce Surgery Site Contamination
Official title: Reduction of Airborne Particulate in the Surgical Field Using Directed Local Airflow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Decrease in CFU density at surgery site
Decrease in airborne particulate at surgery site
Lead sponsor: Nimbic Systems, LLC
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 29
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to determine whether the Air Barrier System device reduces airborne particulate and airborne colony forming units present at a surgery site.

Detailed description: The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne contamination. This study examines the hypothesis that the Air Barrier System can reduce the presence of airborne colony-forming units (e.g. bacteria colonies) and particulate at the surgery site.

Eligibility criteria: Inclusion Criteria:

* Candidate for primary total hip arthroplasty

Exclusion Criteria:

* Prior history of infection
* Revision arthroplasty
* Screens positive for MRSA
* Undergoing hemiarthroplasty or resurfacing

Primary outcomes:
measure: Surgery Site CFU Density
timeFrame: Ten minute intervals throughout surgery
Secondary outcomes:
measure: Surgery Site Particulate Density (Size >10 Micrometer)Per Cubic Meter
timeFrame: Ten minute intervals throughout surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Orthopedic Hospital
state: Texas
Study officials:
affiliation: Fondren Orthopaedic Group
name: Gregory Stocks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stocks GW, Self SD, Thompson B, Adame XA, O'Connor DP. Predicting bacterial populations based on airborne particulates: a study performed in nonlaminar flow operating rooms during joint arthroplasty surgery. Am J Infect Control. 2010 Apr;38(3):199-204. doi: 10.1016/j.ajic.2009.07.006. Epub 2009 Nov 12.
Clinical trial NCT03530553: Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance
Official title: Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: Penn Medicine Princeton Health
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: There are two arms in this study. One group will receive the HMS and the other will not and will receive standard of care.
Primary purpose: TREATMENT

Brief summary: In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.

Detailed description: Obesity is rising at alarming rates, currently at nearly 40%. There are very few tools, specifically questionnaires, for healthcare providers to help their patients lose weight or maintain their weight loss. The Hunt Motivational Scale is one such tool to help patients identify areas that need improvement in order to aid in weight loss and weight maintenance. The HMS is designed to motivate patients to track, plan, and practice other healthy weight loss and weight maintenance practices so that they will have success.

In this study, approximately 75 subjects in the Penn Medicine Princeton Health weight management program will be randomly assigned to either receive the HMS or not (standard of care). They will be followed for a period of six months at the end of which it will be determined whether the group that received the HMS lost more weight than the control group.

Eligibility criteria: Inclusion Criteria:

* patient in weight management program at Penn Medicine Princeton Health

Exclusion Criteria:

* does not have a visit every three to four weeks
* not in active weight loss phase of the program
* diminished intellectual capacity to complete questionnaire i.e. Down's syndrome

Primary outcomes:
measure: Weight loss
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Plainsboro
country: United States
facility: Penn Medicine Princeton Health
state: New Jersey
Study officials:
References:
Clinical trial NCT04496453: Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
Official title: Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Refusal
Keywords: childhood vaccines
vaccine hesitancy
vaccination
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-08-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
* Fluent in English

Exclusion Criteria:

* Unable to understand the study objectives, procedures, risks, and benefits
* Unable to consent for themselves

Primary outcomes:
measure: Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
timeFrame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
measure: Change in Acceptability of Childhood Vaccinations
timeFrame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Lavanya Vasudevan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: