louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05826561: Developing a Childhood Asthma Risk Passive Digital Marker
Official title: Developing a Childhood Asthma Risk Passive Digital Marker
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Asthma
Keywords: Pediatric Asthma
Early Detection
Screening
Passive Digital Marker
Risk Factors
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Underdiagnosis and undertreatment is a major problem in childhood asthma management, especially in preschool-aged children. Current prognostic approaches using risk-score based tools have poor-to-modest accuracy, are impractical, and have limited evidence of efficacy in clinical settings and hence are not widely used in practice.

The objective of the study is to determine the usability, acceptability, feasibility, and preliminary efficacy of the childhood asthma passive digital marker (PDM) among pediatricians. The study will include practicing pediatricians within the IU Health Network.


Eligibility criteria: Inclusion Criteria:

• Practicing pediatricians within the IU Health Network

Exclusion Criteria:

• Non-practicing pediatricians within the IU Health Network

Primary outcomes:
measure: Perceived PDM acceptance
timeFrame: 8 to 12 months
measure: Perceived PDM usability
timeFrame: 8 to 12 months
measure: Study feasibility
timeFrame: 8 to 12 months
Secondary outcomes:
measure: Prognostic accuracy
timeFrame: 3 to 12 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
References:
Clinical trial NCT04093661: Electroencephalogram Dynamics in Children <=1 Year During Anesthetic Procedures
Official title: Retrospective Analysis of Intraoperative Electroencephalography Characteristics in Children Under One Year of Age
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Anesthesia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 125
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children \<= 1 year undergoing surgery procedure with Electroencephalography Monitoring.

Brief summary: As part of the clinical routine of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin at Campus Virchow-Klinikum intraoperative electroencephalography data and clinical routine data are recorded and evaluated in surgical children (\<=1 year).


Eligibility criteria: Inclusion Criteria:

• Children \<= 1 year undergoing surgery procedure

Exclusion Criteria:

* Incomplete patient record documentation
* Pre-existing neurological/psychological conditions

Primary outcomes:
measure: Electroencephalography monitoring changes
timeFrame: 06/2017 - 06/2019
Secondary outcomes:
measure: Anesthetic depth
timeFrame: 06/2017 - 06/2019
measure: Medication
timeFrame: 06/2017 - 06/2019
measure: Emergence Delirium
timeFrame: 06/2017 - 06/2019
measure: Pain
timeFrame: 06/2017 - 06/2019
Other outcomes:
measure: Duration of anesthesia
timeFrame: 06/2017 - 06/2019
measure: Type of surgery
timeFrame: 06/2017 - 06/2019
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Study officials:
affiliation: Department of Anesthesiology and Operative Intensive Care Medicine, Campus Charité Mitte and Campus Virchow-Klinikum, Charité - Universitätsmedizin Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01489683: Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine
Official title: Effect of Tracheal Lidocaine on Intubating Conditions During Propofol-remifentanil TCI Without Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Usage
Keywords: intubating conditions
propofol
remifentanil
topical lidocaine
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: When not using neuromuscular blocking agent, even at optimal dosage, target-controlled infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on the intubating conditions for tracheal intubation during anesthesia induction of propofol and remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.

Detailed description: Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of 5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was instilled to larynx and trachea, following intubation was performed.

Eligibility criteria: Inclusion Criteria:

* ASA I, II patients undergoing general anesthesia for reduction of nasal bone fracture

Exclusion Criteria:

* bronchial asthma,
* COPD,
* hypertension,
* anticipated difficult airway

Primary outcomes:
measure: Overall acceptable conditions for tracheal intubation
timeFrame: baseline from 5 min of TCI was maintained
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: STUDY_DIRECTOR
References:
citation: Bulow K, Nielsen TG, Lund J. The effect of topical lignocaine on intubating conditions after propofol-alfentanil induction. Acta Anaesthesiol Scand. 1996 Jul;40(6):752-6. doi: 10.1111/j.1399-6576.1996.tb04523.x.
Clinical trial NCT01756261: EYLEA [AMD-QOL(Age-Related Macular Degeneration-Quality of Life)] Post-marketing Surveillance in Japan
Official title: Special Drug Use Investigation of EYLEA for Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: EYLEA
Age-Related Macular Degeneration
QOL
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2012-12-25
Enrollment: 757
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subfoveal choroidal neovascular age-related macular degeneration

Brief summary: The objective of this survey is to evaluate effectiveness of EYLEA on Quality of Life (QOL). The QOL is evaluated by using Japanese version (v.1.4 - interviewer administered format) of National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) and compared at baseline and at the 6 and 12 months after start of EYLEA treatment.


Eligibility criteria: Inclusion Criteria:

* Patients who have been determined to start EYLEA treatment
* Patients who are registered to Special drug use investigation of EYLEA for AMD(Trial Number 15858)
* Patients who have agreed with the patient informed consent

Exclusion Criteria:

* Patients who have already received EYLEA

Primary outcomes:
measure: Changes in mean NEI-VFQ-25 overall scores of patients after the first intravitreal(ITV) injection of EYLEA
timeFrame: From baseline to 6 and 12 months
Secondary outcomes:
measure: Changes in mean NEI-VFQ-25 subscale scores of patients after the first ITV injection of EYLEA
timeFrame: From baseline to 6 and 12 months
measure: Changes in mean NEI-VFQ-25 overall scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc
timeFrame: From baseline to 6 and 12 months
measure: Changes in mean NEI-VFQ-25 subscale scores after the first ITV injection of EYLEA in subpopulations of patient background characteristics and status of EYLEA treatments, ie. Frequency, visual acuity, etc
timeFrame: From baseline to 6 and 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02841761: A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects
Official title: A Single-center, Open-label, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Midazolam and Its Metabolite 1-hydroxy Midazolam in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests

Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Primary outcomes:
measure: Maximum observed plama concentration (Cmax)
timeFrame: Midazolam PK sampling on Days 1, 2, 6 and 7
measure: Area under the plasma concentration-time curve from zero to infinity (AUC0-∞)
timeFrame: Midazolam PK sampling on Days 1, 2, 6 and 7
measure: Time to reach Cmax (tmax)
timeFrame: Midazolam PK sampling on Days 1, 2, 6 and 7
measure: Terminal half-life (t1/2)
timeFrame: Midazolam PK sampling on Days 1, 2, 6 and 7
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: From Day 1 to Follow-up (for up to 38 days)
measure: Number of subjects with serious adverse events
timeFrame: From Screening to Follow-up (for up to 59 days)
Other outcomes:
Locations:
city: Newark
country: United States
facility: Investigator Site
state: New Jersey
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT04222361: KDIGO Bundle to Prevent AKI in Sepsis
Official title: Prevention of Acute Renal Injury in the Septic Patient by Implementing the KDIGO Guideline in High-risk Patients Identified by Biomarkers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Acute Kidney Injury
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Summary: Controlled, prospective, randomized and randomized clinical trial of two intervention groups (standard care vs. preventive recommendations the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for AKI) of patients diagnosed with sepsis and abdominal post-surgical septic shock with positive results in the risk determination of acute renal injury by NephroCheck® Test that integrates the urinary biomarkers TIMP-2 and IGFBP-7.

Hypothesis: The implementation of a package of preventive measures proposed by the KDIGO guide can reduce the occurrence and severity of acute renal injury in the high-risk abdominal post-surgical septic patient detected by urinary biomarkers for early detection.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years.
* Patients (or their informed family members) who accept and sign the informed consent.
* Patients diagnosed with sepsis or abdominal post-surgical septic shock.

Exclusion Criteria:

* Patients under 18 years.
* Patients (or their authorized relatives) who refuse to sign the informed consent.
* Patients diagnosed with sepsis or non-surgical septic shock.
* Patients diagnosed with sepsis or septic shock of origin other than abdominal.
* Patients with AKI stages KDIGO 2 and 3 and / or renal replacement therapy.
* Patients with chronic renal failure and glomerular filtration \<30 ml / min and / or undergoing treatment with dialysis or previous renal transplantation.
* Patients with AKI of origin other than the diagnosed septic, such as glomerulonephritis or interstitial nephritis, renal artery occlusion and / or postrenal obstruction.

Primary outcomes:
measure: Compare the incidence of moderate-severe acute renal injury
timeFrame: 72 hours
Secondary outcomes:
measure: Compare mortality from any cause
timeFrame: 90 days
measure: Compare the number of participants in need of renal replacement therapy
timeFrame: 90 days
measure: Compare the number of participants with persistent renal dysfunction
timeFrame: 90 days
measure: Compare the number of days of stay in the Surgical ICU
timeFrame: 90 days
measure: Compare the number of days of stay in the hospital
timeFrame: 90 days
measure: Measure the incidence of development of AKI in patients at low risk of AKI determined by NephroCheck® Test
timeFrame: 72 hours
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Surgical Intensive Care Unit of the General University Hospital of Elche
state: Alicante
Study officials:
References:
Clinical trial NCT05881083: Nicotine Replacement Therapy Sampling for Smokers in the Community
Official title: Building Capacity and Promoting Smoking Cessation in the Community Via "Quit to Win" Contest 2023: a Randomised Controlled Trial of 1-week Nicotine Replacement Therapy Sampling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Keywords: smoking
tobacco
nicotine replacement therapy
lay counsellor
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Council on Smoking and Health
First posted: 2023-05-31
Enrollment: 1014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to test the effectiveness of 1-week nicotine replacement therapy sampling delivered by lay counsellors in promoting smoking cessation in smokers in the community.


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents aged 18 years or above
2. Smoke cigarette or heated tobacco product or e-cigarette daily in the past 3 months
3. Exhaled carbon monoxide level ≥4 part per million or a positive salivary cotinine test
4. Able to communicate in and read Chinese
5. Have a local contact number

Exclusion Criteria:

1. Participating in another smoking cessation programme or using any smoking cessation drug or nicotine replacement therapy
2. Pregnant or breastfeeding
3. Recent (≤ 2 weeks) angina, cardiac arrhythmia or heart attacks

Primary outcomes:
measure: Biochemically validated tobacco abstinence
timeFrame: 6 months
Secondary outcomes:
measure: Biochemically validated tobacco abstinence
timeFrame: 3 months
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 3 months
measure: Self-reported 7-day point-prevalence tobacco abstinence
timeFrame: 6 months
measure: Self-reported 24-hour quit attempt
timeFrame: 3 months
measure: Self-reported 24-hour quit attempt
timeFrame: 6 months
measure: Self-reported use of nicotine replacement therapy product
timeFrame: 3 months
measure: Self-reported use of nicotine replacement therapy product
timeFrame: 6 months
measure: Self-reported use of smoking cessation service
timeFrame: 3 months
measure: Self-reported use of smoking cessation service
timeFrame: 6 months
Other outcomes:
measure: Self-reported reduction of tobacco consumption
timeFrame: 3 months
measure: Self-reported reduction of tobacco consumption
timeFrame: 6 months
measure: Change in motivation to quit from baseline through 3-month follow-up
timeFrame: 3 months
measure: Change in motivation to quit from baseline through 6-month follow-up
timeFrame: 6 months
Locations:
city: Hong Kong
country: Hong Kong
facility: Community sites
Study officials:
affiliation: The University of Hong Kong
name: Tzu Tsun Luk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991783: A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Official title: A Clinical Trial to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: Fimasartan
Drug interaction
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.


Eligibility criteria: Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and digoxin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Primary outcomes:
measure: AUC, Cmax, Tmax, CL
timeFrame: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 15, 24 hours at 7 day and 28 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05102383: Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens
Official title: Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.


Eligibility criteria: Inclusion Criteria:

* Must be a current wearer of Comfilcon A contact lenses
* Distance visual acuity of 20/25 or better with current contact lenses
* Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits.
* Either gender.
* Any racial or ethnic origin.

Exclusion Criteria:

* No current ocular inflammation or infection.
* Not currently pregnant or lactating

Primary outcomes:
measure: Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
affiliation: The Ohio State University College of Optometry
name: Jennifer Fogt, OD MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00616083: Percent Body Fat in Breast Fed Infants
Official title: Developing Normative Body Composition Data in Early Infancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Breast Feeding
Body Composition
Body Fat
Infant
Diet
Healthy Infants
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
name: United States Department of Agriculture (USDA)
name: Life Measurement Inc.
name: University of Oklahoma
name: MetroHealth Medical Center
name: University of Milan
First posted: 2008-02-15
Enrollment: 190
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Helathy breast fed infats, less than a week old living in the Little Rock area.

Brief summary: The purpose of this study is to learn about normal body composition (% body fat) during the first six months of life in healthy breast-fed babies.


Eligibility criteria: Inclusion Criteria:

* Term birth
* Infant must weigh at least 5.5# at birth
* Single birth
* Healthy mother/infant as determined by the investigator
* Intention to breast feed

Exclusion Criteria:

* Significant perinatal morbidity
* Having health, environmental, or economic constraints on growth
* Infants of a mother with diabetes or gestational diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Milano
country: Italy
facility: Universita degli Studi di Milano
Study officials:
affiliation: University of Arkansas
name: Aline Andres, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: