louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01126021: Using Technology to Promote Mental Acuity
Official title: Using Technology to Promote Mental Acuity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Mental Acuity
Keywords: Senior citizens
mental acuity
memory
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Carnegie Mellon University
First posted: 2010-05-19
Enrollment: 600
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study plans to test the effectiveness of behavioral economics based incentives to promote the daily use of computer programs designed to improve memory and mental acuity. Subjects will be recruited from the Pittsburgh metropolitan area. The primary objective is to determine the impact of structured financial incentives on the number of computer-based cognitive exercises completed during a 3 month intervention period.


Eligibility criteria: Inclusion Criteria:

* 55-80 years old

Exclusion Criteria:

* Unable to read or understand the informed consent form

Primary outcomes:
measure: Number of activities completed
timeFrame: 6 weeks
measure: Performance on activities completed
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Carnegie Mellon University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05356221: Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
Official title: BC112 Cross-sectional Evaluation of the Subjective Performance and Satisfaction With Ponto Sound Processors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Loss
Hearing Loss, Conductive
Hearing Loss, Unilateral
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users fitted with a Ponto sound processor

Brief summary: The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software.

Detailed description: The study is a non-interventional, observational, cross-sectional, study on users of Ponto sound processors. The purpose of this study is to evaluate subjectively assessed hearing performance and satisfaction with Oticon Medical's sound processors fitted with the Genie Medical fitting software. Subjects fitted with one or two Ponto sound processors will be invited to participate in an online survey. The survey contains questions about the subjectively experienced performance and satisfaction of the device. The survey can be filled out on computer, tablet or mobile phone and should take the participants about 10 minutes to fill out.

Eligibility criteria: Inclusion Criteria:

Online consent form filled out Has been fitted with at least one Ponto Sound Processor

Exclusion Criteria:

No exclusion criteria

Primary outcomes:
measure: Overall IOI-HA score
timeFrame: at enrollment
Secondary outcomes:
measure: Factor 1 IOI-HA score
timeFrame: at enrollement
measure: Factor 2 IOI-HA score
timeFrame: at enrollment
measure: Per item IOI-HA score
timeFrame: at enrollment
measure: Usage
timeFrame: at enrollment
measure: Upgrade
timeFrame: enrollment
Other outcomes:
Locations:
city: Somerset
country: United States
facility: Oticon Medical
state: New Jersey
Study officials:
affiliation: Oticon Medical
name: Marianne Philipsson
role: STUDY_DIRECTOR
References:
Clinical trial NCT02721121: Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.


Eligibility criteria: Inclusion Criteria:

* Patients with persistent Atrial fibrillation (20\~80 years)
* LA diameter \<55mm
* patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

* Structural cardiac disease
* Contraindication to brain perfusion CT
* Catheter ablation history for AF,
* Cardiac surgery for AF
* active internal bleeding
* Impossible to anticoagulation or antiarrhythmic drug
* valvular AF (MA\> GII, Mechanical valve, Mitral valve replacement)
* Patients with severe medical disease
* Expected survival \< 1year
* Severe alcoholics, drug addiction

Primary outcomes:
measure: Recurrence of atrial fibrillation after catheter ablation
timeFrame: 12 month
Secondary outcomes:
measure: procedure time
timeFrame: 1 day
measure: procedure related complication rate
timeFrame: 12 month
measure: rate of hospitalization
timeFrame: 12 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
citation: Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30.
Clinical trial NCT01447121: User Study of an Investigational Blood Glucose Monitoring System
Official title: Tatsu/Tradewind System User Performance Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes
* 18 years of age and older
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Previously participated in a study using this investigational system
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Pregnancy
* Hemophilia or any other bleeding disorder
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* A condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).

Primary outcomes:
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010621: Complementary Medicine Approaches to TMD Pain Management
Official title: Complementary Medicine Approaches to TMD Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Joint Disorders
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether selected complementary approaches to temporomandibular joint (TMJ) pain management-acupuncture are as effective as usual care.

Detailed description: Temporomandibular disorders are characterized by pain and tenderness in the muscles of mastication and/or the (TMJ), limitations of jaw opening often accompanied by deviations in mandibular path, and clicking, popping or grating TMJ sounds. This study will compare the effectiveness of the complementary therapies chiropractic therapy and bodywork therapy to the standard of care for TMJ pain. If these complementary interventions are shown to be effective, the goal is to design and implement a Phase III clinical trial to further evaluate the health consequences and cost of these therapies.

Participants will be evaluated at baseline, and 6 and 12 months post-intervention. Clinical examinations, saliva samples to assess salivary cortisol levels, and a series of questionnaires to assess pain and grade of dysfunctional pain, psychological functioning, and other physical symptoms will be used to assess outcomes. The investigators will passively monitor health care utilization within KPNW using clinical, research, and administrative databases.

Eligibility criteria: Inclusion Criteria:

* Psychologically functional TMD patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Health Research
state: Oregon
Study officials:
affiliation: Center for Health Research (CHR), Kaiser Foundation Hospitals
name: Alex White
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00041821: Nasal Irritation Study: Individual Factors in Nasal Irritant Sensitivity
Official title: Individual Factors in Nasal Irritant Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic, Nonseasonal
Keywords: rhinitis
irritation
trigeminal
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study seeks to document differences in nasal irritant sensitivity within the population. The investigators are interested in knowing whether age, gender, and allergy status (nasal allergies) predict nasal irritant sensitivity. This is important in understanding symptom reporting patterns in air pollution situations (particularly in so-called "problem buildings"), as well as in understanding the reflex mechanism of a response of the nose to irritants (e.g., nasal congestion).


Eligibility criteria: Inclusion Criteria:

* Non-smokers
* 18-69 years of age
* With or without allergic rhinitis (hay fever)
* In good general health and with no prior history of asthma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Upper Airway Biology Laboratory
state: California
Study officials:
References:
citation: Shusterman DJ, Murphy MA, Balmes JR. Subjects with seasonal allergic rhinitis and nonrhinitic subjects react differentially to nasal provocation with chlorine gas. J Allergy Clin Immunol. 1998 Jun;101(6 Pt 1):732-40. doi: 10.1016/S0091-6749(98)70302-1.
citation: Shusterman D, Murphy MA, Balmes J. The influence of sex, allergic rhinitis, and test system on nasal sensitivity to airborne irritants: a pilot study. Environ Health Perspect. 2001 Jan;109(1):15-9. doi: 10.1289/ehp.0110915.
Clinical trial NCT01491321: Bee Venom Acupuncture for the Treatment of Chronic Low Back Pain
Official title: Clinical Trial to Evaluate the Efficacy of Bee Venom Acupuncture on Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Low Back Pain
Keywords: chronic low back pain
bee venom acupuncture
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
First posted: 2011-12-14
Enrollment: 54
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: The purpose of this study is to evaluate the efficacy of bee venom acupuncture on pain intensity, functional status and quality of life of patients with chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* nonspecific, chronic low back pain over 3 months
* Must have LBP of more than VAS 4

Exclusion Criteria:

* cancer, vertebral fracture, spinal infection, inflammatory spondylitis
* spinal operation
* radicular pain
* other musculoskeletal pain
* physicological or mental disorders
* allergic history to BV therapy or insect bite

Primary outcomes:
measure: Visual Analogue Scale for bothersomeness
timeFrame: Changes from baseline in VAS at 1 month
Secondary outcomes:
measure: Visual Analogue Scale for pain intensity
timeFrame: Changes from baseline in VAS at 1 month
measure: Disability scores on Oswestry Disability Index
timeFrame: Changes from baseline in ODI at 1 month
measure: Quality of Life scores on EQ-5D
timeFrame: Changes from baseline in EQ-5D at 1 month
measure: Depression scores on Beck Depression Inventory
timeFrame: Changes from baseline in BDI at 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Spine Center, Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Spine Center, Kyung Hee University Hospital at Gangdong
name: Jun-Hwan Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Spine Center, Kyung Hee University Hospital at Gangdong
name: Byung-Kwan Seo
role: STUDY_DIRECTOR
affiliation: Spine Center, Kyung Hee University Hospital at Gangdong
name: Dae-Jin Cho
role: STUDY_DIRECTOR
References:
citation: Seo BK, Lee JH, Sung WS, Song EM, Jo DJ. Bee venom acupuncture for the treatment of chronic low back pain: study protocol for a randomized, double-blinded, sham-controlled trial. Trials. 2013 Jan 14;14:16. doi: 10.1186/1745-6215-14-16.
Clinical trial NCT01175421: Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Official title: Development and Validation of a Multidimensional System as Predictor of Outcomes in Obstructive Sleep Apnea: The OSA-SCORE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Snoring
Sleep Apnea
Keywords: snoring
sleep apnea
sleep study
cardiovascular outcomes
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sleep Clinic

Brief summary: Purpose:

In a retrospective cohort the investigators will validate, the goodness of a multidimensional index to classified the severity of patients with sleep disordered breathing that has been previously developed in a prospective longitudinal cohort.

Detailed description: Methods. In the developing study, three variables were found as predictors of mayor outcomes and were incorporated in a multidimensional index: the apnea-hypopnea index, the severity of daytime sleepiness as quantified by the Epworth questionnaire and the presence of current cardiovascular disease. The index (OSA-SCORE) has a value between 0 (less risk) to 5 (more risk). For each point, a significant increment in the risk of death was found. In the retrospective validation study, a number of potential variables will be recorded, all of them also predictors of major outcomes. Data will be recorded by trained personnel on-site at the respiratory Sleep Units around the country. The final cohort will include 1100 subjects aged \> 18 years . The observation time will be considered since the time at diagnosis to fatal event and the patient will be censored when non-invasive ventilation was started or at the recorded time if the patient is alive. The primary outcome is all-cause death.

Eligibility criteria: Inclusion Criteria:

* Adults patients (\> 18 years)

Exclusion Criteria:

* Under 18 years old
* Unable to complete sleep study

Primary outcomes:
measure: All cause mortality
timeFrame: Five years
Secondary outcomes:
measure: Cardiovascular events
timeFrame: Five years
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Miguel Servet
name: Jose M Marin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01243021: Validation of an Early Warning Score Based Triage System in the Emergency Department
Official title: Nurse Administered Early Warning Score System Can be Used for Emergency Department Triage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2010-11-18
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: When arriving at the emergency department patients are divided into on of three groups (red, blue nd white) according to the severity of their condition based on common regional guidelines. Red patients are the most servelery ill or injured patients. A random sample of "red" patients are included in this study

Brief summary: At Bispebjerg Hospital we have introduced an Early Warning Score based triage system , called Bispebjerg Early Warning Score (BEWS), in order to identify critically ill patient on arrival at the emergency department. The purpose of this study is to validate our triage system.


Eligibility criteria: Inclusion Criteria:

* "Red" patient
* Seen in our emergency department between 1. april 2009 and 30. september 2009

Exclusion Criteria:

* None

Primary outcomes:
measure: Critical illness
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Dorthea Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christensen D, Jensen NM, Maaloe R, Rudolph SS, Belhage B, Perrild H. Nurse-administered early warning score system can be used for emergency department triage. Dan Med Bull. 2011 Jun;58(6):A4221.
Clinical trial NCT05325021: Correction of Anisometropic Amblyopia in Children.
Official title: Correction of Anisometropic Amblyopia in Children at School Age.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amblyopia
Anisometropic Amblyopia
Anisometropia and Aniseikonia
Refractive Errors
Keywords: amblyopia
axial refractive error
anisometropia
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of a Banha city that were diagnosed as anisometropic amblyopia and are seeking refractive error corrections.

Brief summary: Anisometropic amblyopia among children in school age may affects quality of life and educational progress of children.

Detailed description: Correction of anisometropic amblyopia depends on type of refractive error and axial length of the eye.

In this study, we will asses the types of anisometropia found in children at school age and investigate possible ways for correction of this type of amblyopia.

Eligibility criteria: Inclusion Criteria:

* Anisometropic amblyopia.
* Children at school age ranged from 4 to 12 years old.

Exclusion Criteria:

* Emmetropia children.
* Children had undergone any intraocular surgeries.
* Other types of amblyopia.

Primary outcomes:
measure: Axial length of both eyes.
timeFrame: Immediately after optical biometry test for each eye.
Secondary outcomes:
measure: Incidence of refractive errors in anisometropic amblyopia
timeFrame: Immediately after autorefractometer test for each eye.
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy Tabl
state: Benha
Study officials:
affiliation: Benha University
name: Ahmed A Tabl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05588921: LensAge to Reveal Biological Age
Official title: A Deep Learning-based Indicator to Reveal Biological Age Using Lens Photographs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmology
Lens Opacities
Biological Age
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 20 to 90 have anterior segment photographs, baseline information, and medical records.

Brief summary: Assessment of aging is central to health management. Compared to chronological age, biological age can better reflect the aging process and health status; however, an effective indicator of biological age in clinical practice is lacking. Human lens accumulates biological changes during aging and is amenable to a rapid and objective assessment. Therefore, the investigators will develop LensAge as an innovative indicator to reveal biological age based on deep learning using lens photographs.


Eligibility criteria: Inclusion Criteria:

* ages from 20 to 100 years
* have anterior segment photographs
* have ophthalmic and physical examination records

Exclusion Criteria:

* have a history of previous eye surgery, eye trauma, or ocular diseases that can cause complicated cataracts
* baseline information missing

Primary outcomes:
measure: The difference between LensAge and chronological age
timeFrame: Baseline
Secondary outcomes:
measure: Correlation between the LensAge difference and age-related health parameters
timeFrame: Baseline
measure: Mean absolute error (MAE) of the DL age estimation model.
timeFrame: Baseline
measure: Mean error (ME) of the DL age estimation model.
timeFrame: Baseline
measure: R-squared (R2) of the DL age estimation model.
timeFrame: Baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
name: Haotian Lin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: