louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01873781: A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lenses, Intraocular
Contrast Sensitivity
Visual Acuity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young healthy subjects

Brief summary: Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL).

As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information.

As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.


Eligibility criteria: Inclusion Criteria:

Men and women aged between 18 and 35 years

* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, between -1 and +1 diopters

Exclusion Criteria:

* \> 0,5 diopters of cylinder
* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Primary outcomes:
measure: Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score
timeFrame: 1 study day
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT00976781: Identifying the Gaps in the Diagnosis and Management of Hepatitis C
Official title: Identifying the Gaps in the Diagnosis and Management of Hepatitis C
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hepatitis C
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hepatitis C

Brief summary: The purpose of this study is to identify the gaps in diagnosing and managing hepatitis C infected patients so that interventions can be targeted to address these problem areas in order to optimize care of these patients.


Eligibility criteria: Inclusion Criteria:

* Every patient diagnosed with hepatitis C

Exclusion Criteria:

* Patients younger than 18 years old

Primary outcomes:
measure: This is a retrospective observational study. The outcome measure would be the number of patients who are actually followed and treated for hepatitis C after they have been diagnosed
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Hnery Ford Hospital
state: Michigan
Study officials:
References:
Clinical trial NCT01071681: Survey to Assess Why People Are Not Responding to Treatment in Hypertension
Official title: Observational Survey Assessing the Factors of Treatment Intensification in Uncontrolled Hypertensive Patients Under a Combination Therapy, Either Fixed or Not, of a Renin-Angiotensin System Blocker (RASB) and Hydrochlorothiazide (HCTZ), According to Their Level of Cardiovascular Risk.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Hypertension
Keywords: Arterial hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: International Clinical Trials Association
First posted: 2010-02-19
Enrollment: 1589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Uncontrolled hypertensive patients under a combination therapy, either fixed or not, of a renin-angiotensin system blocker and hydrochlorothiazide

Brief summary: This study will describe the factors influencing the physician in face of elevated blood pressure in already treated patients


Eligibility criteria: Inclusion Criteria:

* Men or women over 18
* Hypertensive patients
* Uncontrolled hypertension (blood pressure \>/=140/90 mmHg on the day of consultation or \>/=130/80 mmHg in diabetic patients or in patients suffering from kidney failure, or in elderly patients with a systolic blood pressure \>/=150 mmHg (in the absence of orthostatic hypotension)
* Patients treated with a combination, fixed or not, of Renin-Angiotensin System Blocker (RASB) + Hydrochlorothiazide (HCTZ)
* Patients examined in common medical care practice, whatever the reason for consultation
* Patients informed of the study

Primary outcomes:
measure: Percentage of patients, according to the level of cardiovascular risk, who, at the end of the visit:- do not present any modification of hypertension treatment (therapeutic inertia) - present a change in the hypertension therapeutic
timeFrame: on day 1
Secondary outcomes:
measure: Analyses of the factors that had an impact on the therapeutic decision
timeFrame: on day 1
Other outcomes:
Locations:
city: Many Locations
country: France
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03650881: The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne
Official title: The Comparative Efficacy of an Over the Counter Light Therapy Mask vs Over the Counter Topical Benzoyl Peroxide 2.5% and Used in Combination With Over the Counter Adapalene Gel 0.1% for Mild to Moderate Acne
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acne
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center prospective study of two standard-of-care treatments to evaluate the efficacy of the Neutrogena® Light Therapy Acne Mask an Over the Counter (OTC) Blue/Red light LED mask, as compared to the combination of topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel, for the treatment of mild-to-moderate facial acne. This will be an investigator-blinded, randomized, 12-week study to observe these over the counter treatments. The two arms will be: (1) Neutrogena® Light Therapy Acne Mask (MASK), (2) topical OTC benzoyl peroxide 2.5% gel and OTC adapalene 0.1% gel (TOP). Both treatment groups in this study will also receive and use standardized, non-medicated cleansing and moisturizing products. All products will be purchased through commercial sources.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acne vulgaris as determined by the study physician
* Mild-to-moderate acne defined as a grade 2 or 3 on the FDA Investigator Global Acne Assessment (IGA) for Acne vulgaris (Appendix 1)19
* If female,

  * Negative urine pregnancy test at the time of enrollment and negative urine pregnancy tests at follow up visits
  * Agreement to comply with medically acceptable forms of birth control with heterosexual intercourse
* Agreement to comply with the study protocol and attend all study visits

Exclusion Criteria:

* Is unwilling to participate in the survey
* Outside of specified age range
* Patients with clear, almost clear acne, or severe acne defined as grade 0-1 or 4 on the IGA Scale
* Females who are pregnant or breastfeeding
* Known allergy to any ingredients in the test products or history of photosensitivity
* Pre-existing facial dermatologic conditions including excoriations that could interfere with the outcome of this study and quantification of acne lesions
* Excessive facial hair or scarring that could interfere with quantification of acne lesions
* Does not have decision making capacity

Primary outcomes:
measure: change in the Investigator Global Assessment (IGA)
timeFrame: 12 Weeks
Secondary outcomes:
measure: change in Acne Q4 quality of life index score
timeFrame: 12 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03416881: Older HIV-infected Adults and Drug Interactions: French Cross-sectional Study
Official title: Older HIV-infected Adults and Drug Interactions: Nationwide Cross-sectional Study Based on French National Health Insurance Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV infection
antiretroviral
aging population
drug interactions
cross-sectional study
SNIIRAM
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 13225
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French older HIV-infected adults (over than 65 years)

Brief summary: Drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied HIV-population is ageing. The referential of interactions is the Liverpool base.

Detailed description: Filters in the French social security system database, 2016 :

* Code of Pathology "Human Immunodeficiency Virus (HIV) infection" Age ≥ 65 years
* Treatment with an antiretroviral between January 1, 2016 and December 31, 2016

Eligibility criteria: Inclusion Criteria:

* Men and women over than 65 years with an HIV infection and insured at the French Primary Health Insurance fund

No exclusion Criteria

Primary outcomes:
measure: frequency of major drug-drug interactions
timeFrame: between Jan, 1st 2016 and Dec, 31st 2016
Secondary outcomes:
measure: costs associated with major drug-drug interactions
timeFrame: during 2016
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05686681: Connect ME: Improving Social Connectedness
Official title: Improving Social Connectedness in Homebound Older Adults by Integrating a Brief Evidence-Based Telehealth Intervention Into Area Agency on Aging Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Connectedness
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To assess the reach and effectiveness of a behavioral activation intervention for older adults experiencing low social connectedness by Area Agency on Aging Staff.


Eligibility criteria: Inclusion Criteria:

* Older adults (age\>60) will be enrolled because they are the target population served by the home-delivered meals program and the target sample for this study.

Exclusion Criteria:

* Clinically significant depression (Patient Health Questionnaire; PHQ-9 ≥ 10) or active suicide risk (Columbia Suicide Severity Rating Scale; C-SSRS), or Cognitive Impairment (Blessed Orientation-Memory-Concentration Test\>9)
* Clients who score 1 or greater on question 9 of the PHQ-9 will be further assessed for suicide risk using the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Clients will meet exclusion criteria for a positive response to any item
* We will exclude older adults with uncorrectable hearing or vision impairment rendering them unable to use the tele-conferencing equipment.
* Those who cannot speak English and have impaired decision-making capacity
* Adults unable to consent will be excluded
* Individuals who are not yet adults (infants, children, teenagers) will be excluded
* Pregnant women will be excluded
* Prisoners will be excluded

Primary outcomes:
measure: Social Connectedness A, Baseline
timeFrame: before the intervention
measure: Social Connectedness A, Change from Baseline to Post Intervention
timeFrame: immediately following the intervention
measure: Social Connectedness A, Change from Post Intervention to Follow Up
timeFrame: 12 weeks post intervention
measure: Social Connectedness B, Baseline
timeFrame: before the intervention
measure: Social Connectedness B, Change from Baseline to Post Intervention
timeFrame: immediately following the intervention
measure: Social Connectedness B, Change from Post Intervention to Follow Up
timeFrame: 12 weeks post-intervention
Secondary outcomes:
measure: Intervention Reach
timeFrame: 12 Months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Renée L Pepin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01504581: Safety, Pharmacokinetic, Pharmacodynamic Study of LAPS-IFNa in Healthy Adult Subjects
Official title: A Randomized, Double-Blind, Placebo- And Active-Controlled Study Of The Pharmacokinetics, Pharmacodynamics And Safety Of Single Ascending Doses Of HM10660A (LAPS-INTERFERON ALPHA-2B) In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2012-01-05
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study design:

This is a randomized, double-blind, placebo- and active-controlled, single-dose study in 4 groups of 12 healthy male subjects each. In each group, 8 subjects will receive a dose of HM10660A, 2 subjects will receive a single dose of placebo and 2 subjects will receive a single dose of a currently marketed PEG-interferon.

Detailed description: Primary objective:

to study the safety and tolerability of HM10660A, including immunogenicity, as compared to PEG-interferon alpha-2a

Secondary objective:

to study the pharmacokinetics and pharmacodynamics of HM10660A as compared to PEG-interferon alpha-2a

Eligibility criteria: Inclusion Criteria:

* Age: 18 - 45 Years, Inclusive
* BMI: 18.0 - 28.0 kg/m2
* Are Non-smokers or Smoker of Fewer Than 5 Cigarettes Per Day as Determined by History

Exclusion Criteria:

* Mental Handicap
* Evidence of Clinically Relevant Pathology
* History of Type 1 Diabetes or Thyroid Disease

Primary outcomes:
measure: Number of participants with AE occurrence, clinically significant clinical lab, vital sign, and/or ECG change
timeFrame: 43 days
Secondary outcomes:
Other outcomes:
Locations:
city: Netherlands
country: Netherlands
facility: Hanmi clinical
Study officials:
References:
Clinical trial NCT02012881: LCoMotion. Learning, Cognition and Motion. Effect of a Four Month School-based Cluster-randomized Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Denmark
First posted: 2013-12-16
Enrollment: 870
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effect of a four months school-based physical activity intervention on cognition, academic achievement, physical activity and aerobic fitness in 12-15 year old adolescents.


Eligibility criteria: Inclusion Criteria:

* six or seventh grader in a Danish public school
* participating in normal math lessons

Exclusion Criteria:

* private school
* receiving extra math lessons because of special needs

Primary outcomes:
measure: Executive function accuracy
timeFrame: Up to 8 months
Secondary outcomes:
measure: Academic achievement
timeFrame: November 2013 -June 2014
measure: Physical activity
timeFrame: November 2013-June 2014
measure: Aerobic fitness
timeFrame: November 2013 - June 2014
measure: Anthropometric measures
timeFrame: November 2013 - June 2014
measure: Questionnaire
timeFrame: November 2013 - June 2014
Other outcomes:
measure: SMS tracking
timeFrame: November 2013- June 2014
Locations:
city: Odense
country: Denmark
facility: Institute of Sports Science and Clinical Biomechanics
Study officials:
References:
citation: Tarp J, Domazet SL, Froberg K, Hillman CH, Andersen LB, Bugge A. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial. PLoS One. 2016 Jun 24;11(6):e0158087. doi: 10.1371/journal.pone.0158087. eCollection 2016.
citation: Bugge A, Tarp J, Ostergaard L, Domazet SL, Andersen LB, Froberg K. LCoMotion - Learning, Cognition and Motion; a multicomponent cluster randomized school-based intervention aimed at increasing learning and cognition - rationale, design and methods. BMC Public Health. 2014 Sep 18;14:967. doi: 10.1186/1471-2458-14-967.
Clinical trial NCT05651581: Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
Official title: Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monkey Pox
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. Surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. The purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from Rainbow Health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.


Eligibility criteria: Inclusion Criteria:

* Individuals who are 18 years and older
* Individuals able to read and write in English

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Efficacy of intervention
timeFrame: baseline
measure: Efficacy of intervention
timeFrame: immediately after intervention
measure: Acceptability
timeFrame: immediately after intervention
Secondary outcomes:
measure: risk perception
timeFrame: baseline
measure: risk perception
timeFrame: immediately after intervention
measure: intention to vaccinate
timeFrame: baseline
measure: intention to vaccinate
timeFrame: immediately after intervention
measure: confidence in public health initiatives
timeFrame: baseline
measure: confidence in public health initiatives
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Matthew Mansh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246581: Two-period 21 Day Cross-over Study to Compare the Pharmacokinetics of Tiotropium From Two Inhalers
Official title: Protocol With Amendments 1 and 2: Phase I Randomised, Two-period 21 Day Crossover Study in Healthy Male and Female Volunteers to Compare the Steadystate Pharmacokinetics of Tiotropium Delivered From a Test pMDI Product With Spiriva Respimat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: inhalation
anticholinergic
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: Simbec Research
name: 3M
First posted: 2017-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.

Detailed description: Healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. Plasma tiotropium levels will be measured predose and over 24 hours postdose on days 1 and 28.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: 3M Health Care
Study officials:
affiliation: 3M
name: Victoria Sessions, PhD
role: STUDY_CHAIR
References: