louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02322528: Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax
Official title: Evaluation of Ocular Surface Inflammatory Mediators and Ocular Surface Metrology Effected by Lotemax
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Disease
Keywords: Non-invasive instruments
Environment
Wavefront
Placido Disk
Ellipsometer
Thermal Imaging
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2014-12-23
Enrollment: 10
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).


Eligibility criteria: INCLUSION CRITERIA:

* Age 50-70
* Diagnosed with Sjogren's Disease
* Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits
* Either gender
* Any racial or ethnic origin

EXCLUSION CRITERIA:

* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
* Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection.
* Subjects who have had cataract surgery less than one year ago
* Use of soft or hard contact lenses.
* Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions).
* Inability to provide analyzable data

Primary outcomes:
measure: Ocular Surface Temperature of Both Eyes
timeFrame: baseline, 30 minutes, week 1, week 2
measure: Visual Quality
timeFrame: baseline, 30 minutes, week 1, week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Flaum Eye Institute at the University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: James V Aquavella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01928628: Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients
Official title: A Randomized, Multicenter, Parallel Design Phase III Clinical Study to Evaluate the Efficacy and Safety of the Combination of Lercanidipine/Valsartan in Hypertensive Patients Who Are Not Adequately Controlled on Lercanidipine 10mg Monotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 449
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare and assess the efficacy and the safety of the combination agent of Lercanidipine and Valsartan and monotherapy of Lercanidipine alone in patients with essential hypertension


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 20 to ≤75 years old
* Patient with essential hypertension

Exclusion Criteria:

* When the BP level measured at screening was sitDBP\>120 mmHg or sitSBP \>180 mmHg
* Patient with difference in repeatedly measured blood pressures from the selected arm at screening was sitSBP≥ 20mmHg or sitDBP ≥ 10mmHg

Primary outcomes:
measure: Change in mean sitDBP from week 0 to week 40
timeFrame: 40 weeks
Secondary outcomes:
measure: Response rate at week 4 and 8
timeFrame: 4 weeks and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Na SH, Lee HY, Hong Baek S, Jeon HK, Kang JH, Kim YN, Park CG, Ryu JK, Rhee MY, Kim MH, Hong TJ, Choi DJ, Cho SW, Cha DH, Jeon ES, Kim JJ, Shin JH, Park SH, Lee SH, John SH, Shin ES, Kim NH, Lee SY, Kwan J, Jeong MH, Kim SW, Jeong JO, Kim DW, Lee NH, Park WJ, Ahn JC, Won KH, Uk Lee S, Cho JH, Kim SK, Ahn T, Hong S, Yoo SY, Kim SY, Kim BS, Juhn JH, Kim SY, Lee YJ, Oh BH. Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial. Clin Ther. 2015 Aug;37(8):1726-39. doi: 10.1016/j.clinthera.2015.05.512. Epub 2015 Jul 8.
Clinical trial NCT00434928: Dietary Intake and Nutrient Status of Children With ADHD
Official title: Dietary Intake and Nutrient Status of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: observational
dietary intake
nutrient status
serum assessors
Attention-Deficit/Hyperactivity Disorder (ADHD)
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2007-02-14
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Assess the dietary intake of children aged 6-12 years by means of a 24-hour recall and 3-day food record and asses the nutrient status of Vitamin B6, serum ferritin, serum zinc and serum copper of the same children by means of standard laboratory assessments.

Detailed description: * To document the use of vitamin and vitamin-mineral supplements
* To determine the percent consumption of low nutrient density (LND) foods
* To compare the dietary intake of ADHD children with the established standards of the Dietary Reference Intakes (DRIs)
* To compare the dietary intake of children with ADHD to the dietary recommendations of Canada's Food Guide for Healthy Eating
* To determine whether dietary intake is moderated by drug treatment
* To assess the pyridoxal-5'-phosphate (PLP), serum ferritin, serum zinc, and serum copper status of ADHD by standard laboratory blood test
* to measure height and weight in ADHD children

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ADHD
* Age 6-12 years inclusive

Exclusion Criteria:

* No use of medication that affects dietary intake (eg. Risperdal)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Provincial ADHD Program, BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Margaret D. Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07014228: Evaluation of Post-operative Pain During Retreatment in Different Visits
Official title: Evaluation of Post Operative Pain in Non-surgical Endodontic Retreatment in Single vs Multiple Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Armed Forces Institute of Dentistry, Pakistan
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided into two equal groups and given two different interventions (single vs. multi-visit reendo).
Primary purpose: PREVENTION

Brief summary: Endodontic retreatment is performed to alleviate symptoms of recurring infection, post-treatment disease after primary endodontic therapy. Retreatment can be performed in either single or multiple visits. and have their own implications. it is important to compare the patient response and post-op pain after single vs multi-visit reendo treatment.

Detailed description: Introduction:

Treating endodontic failure cases has always been a challenge for the clinician due to the complex nature of disease which includes resistant microorganisms, iatrogenic errors and cleaning and shaping of un-instrumented areas. Endodontic retreatment can be done in either single or multiple visits. Multiple visits have the added advantage of placement of intracanal medicament resulting in decreased bacterial load and reduced pain, whereas single visit endodontic retreatment reduces chances of inter appointment microbial contamination. This study aims to evaluate post operative pain among both groups.

Objective:

To evaluate frequency of post-operative pain in endodontic retreatment cases after single vs multiple (two) visits root canal therapy.

Materials and Methods:

STUDY SETTING: Department of Operative Dentistry, AFID Rawalpindi.

Eligibility criteria: Inclusion Criteria:

* Patients with unremarkable/ noncontributory medical history
* Age range between 15-45 years
* Cases of failed endodontic treatment resulting from inadequate root filling
* No systemic disease
* No periodontal disease

Exclusion Criteria:

* Patients having teeth with periodontal pathology
* root fractures
* Immature root apices
* Endodontic posts
* Root perforations
* Immunocompromised health were excluded from the study.

Primary outcomes:
measure: Post operative pain after re-endo
timeFrame: 6 hours - 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Armed Forces Institute of dentistry
state: Punjab
Study officials:
References:
Clinical trial NCT03131128: The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Official title: A Pilot Study of the Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mindfulness
Weight Loss
Workplace
Health Promotion
Keywords: Mindfulness-based intervention
Weight loss
Workplace health promotion
Obesity
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
Collaborators: name: Changhua Christian Hospital
First posted: 2017-04-27
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The workers with overweight or obesity provided by the company will be randomly assigned to Group A (by MBI) or Group B (by the intervention of health education).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight.

Detailed description: The study will adopt a longitudinal research design with randomized quasi- experimental trial. The workers with overweight or obesity (BMI≧24) provided by the company will be randomly assigned to Group A (four lessons of dietary behavior and six lessons of MBI) or Group B (four lessons of dietary behavior and six lessons of mental health). There will be 100 participants in each group. Data will be collected five times. The research questionnaire includes basic information (including BMI, waist circumference, etc), Perceived Stress Scale, The Five Facet Mindfulness Questionnaire, Food Cravings Questionnaire, the scale of physical activity and information regarding dietary behavior.

Eligibility criteria: Inclusion Criteria:

1. adults aged 20 to 65 years old;
2. full-time workers with BMI ≧ 24;
3. motivated to participate in the study;

Exclusion Criteria:

1. suffering from mental illness or in an acute episode;
2. suffering from life threatening or other major physical illness;
3. no motivation to participate in the study.

Primary outcomes:
measure: Body Weight
timeFrame: Up to 10 months
Secondary outcomes:
measure: Dietary Behavior
timeFrame: Up to 10 months
measure: Food Cravings
timeFrame: Up to 10 months
measure: Perceived Stress
timeFrame: Up to 10 months
measure: The level of Mindfulness
timeFrame: Up to 10 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
affiliation: Changhua Christian Hospital
name: Feng-Cheng Tang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154128: The Influence of a Stabilization Splint on the Body Posture
Official title: The Influence of of a Stabilization Splint on the Body Posture in TMD Cases and Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Temporomandibular Disorders
Craniomandibular Disorders
Arthromyalgia
Chronic Disease
Occlusal Appliance
Keywords: temporomandibular disorder
craniomandibular disorder
occlusal appliance
clinical trial
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to investigate a possible influence of an occlusal stabilization splint on the body posture in TMD cases and controls. Interocclusal appliances or occlusal splints are therapeutic devices that are most frequently used in the treatment of TMD. Changes of the mandibular position and occlusal equilibrations are assumed to have an impact on the general body posture.

Detailed description: Thirty TMD cases and 10 controls were included in the study. All participants were recruited from the School of Dentistry, University of Greifswald. All subjects gave their written consent to participate in the study. They then completed a TMD history questionnaire and underwent a clinical examination. The examination included palpation of the masticatory muscles and the TMJs, range of mandibular motion measurements, and assessment of joint noises. The TMD cases were required to have a diagnoses of myofascial pain and/or arthralgia. Controls had to be free of pain symptoms in their masticatory muscles and TMJs. Body posture was measured during five minutes of walking using an ultrasound-distance measuring device (sonoSens® Monitor) with small sensors placed on the skin that continually record changes in the distance between them. A static posture evaluation was performed with a contactless, and radiation-free static measurement of the back surface and spine using a 3D measurement system (formetric II). A second measurement was performed after insertion of the occlusal appliance and a third one after 7 days of treatment.

The occlusal appliances were inserted after the first examination and all participants were instructed to use it at night and during examinations.

Eligibility criteria: Inclusion Criteria:

* TMD cases: diagnoses of myofascial pain and/or arthralgia

Exclusion Criteria:

* TMD cases: chronic systemic diseases, cardiac pacemakers

Primary outcomes:
measure: changes in body posture
Secondary outcomes:
measure: score of compliants
measure: number of tender muscles and TMJs
Other outcomes:
Locations:
Study officials:
affiliation: School of Dentistry, University of Greifswald, Germany
name: Georg Meyer, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dentistry, University of Greifswald
name: Georg Meyer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01825928: An Study of Paliperidone Extended-Release Tablets in the Treatment of Methamphetamine Dependence
Official title: Randomized, Double-blind, Placebo-controlled Trial of Paliperidone Extended-Release Tablets for The Treatment of Methamphetamine Dependence in Chinese Patients After Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine
paliperidone
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 80
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: Methamphetamine substance use is common worldwide. No approved pharmacologic treatments for methamphetamine dependence exist. paliperidone are Second generation antipsychotics，and have effects of blocking dopamine2(D2) and 5-hydroxytryptamine 2A(5-HT) receptors neurotransmitters.To determine whether mirtazapine would reduce methamphetamine use among methamphetamine addicts.

Detailed description: Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 years to 60 years
* Met the Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for METH dependence with psychosis
* Completing inpatient METH detoxification (≤30 days) with psychotic symptoms disappeared
* Beoff any anti-psychotic medication for 7 days after discharging from hospital were enrolled at clinical site
* Participants were interesting in reducing or stopping METH use
* Every patient also had a significant other (eg., spouse or relative) who supervised their compliance with the visit schedule and study procedures
* Women of childbearing potential agreed to use contraception during the study.

Exclusion criteria:

* Pregnancy or breastfeeding;
* Significant medical conditions (eg., acute renal failure, endocarditis, and tuberculosis); hepatic failure; past or present history of an AIDS-indicator disease; active hepatitis or aspartate amino transferase or alanine aminotransferase more than three times the upper limit of normal
* Known intolerance or hypersensitivity to paliperidone ER; other psychosis; present dependence on substances other than METH or poly-substance abuse.

Primary outcomes:
measure: Abstinent time of Methamphetamine addict
timeFrame: up to 84 days
Secondary outcomes:
measure: Time (day) to first psychosis relapse from baseline to 84 days
timeFrame: up to 84 days
measure: Change from baseline in CGI-S scores at 84 days
timeFrame: up to 84 days
measure: Change from baseline in Visual Analogue Scale (VAS) at 84 days
timeFrame: up to 84 days
measure: number of treatment day which calculated from randomization to the last visiting point
timeFrame: up to 84 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central University
state: Hunan
Study officials:
affiliation: Central South University
name: Wei Hao, MD., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05558228: Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Official title: Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Flosonics Medical
First posted: 2022-09-28
Enrollment: 35
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: Patients 18+ years of age in atraumatic cardiac arrest with an arterial line placed in the emergency department during resuscitation.

Brief summary: The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. FloPatch FP120 data will be compared with arterial line blood pressure to assess for accuracy of pulse checks among cardiac arrest patients in the emergency department.

Detailed description: The FloPatch FP120 device is indicated for use for the noninvasive assessment of blood flow in the carotid artery. The FloPatch FP120 device uses ultrasound and the Doppler effect to non-invasively assess the flow of flood. In this study, the FloPatch FP120 will be applied to the neck at the location of the carotid artery on cardiac arrest patients in the emergency department. This study will determine the peak systolic velocity, as measured by the FLoPatch FP120 device, that is associated with a systolic blood pressure of ≥60 mmHg on a femoral arterial line in cardiac arrest patients during a pulse check. The associated accuracy, sensitivity, and specificity of the calculated pulse systolic velocity to detect return of spontaneous circulation with a systolic blood pressure ≥60 mmHg in cardiac arrest.

Eligibility criteria: Inclusion Criteria:

* 18+ years of age
* In cardiac arrest at the North Shore University Hospital emergency department
* Arterial line placed during cardiac arrest resuscitation

Exclusion Criteria:

* Traumatic cardiac arrest
* Patients without bilateral lower extremities

Primary outcomes:
measure: Number of Patients with Return of Spontaneous Circulation
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital
name: Allison Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903628: The Model Building and Empirical Research of Eye Health Interventions for Children
Official title: Vice-president, Nurse, Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: myopia
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 1517
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether Eye Health Intervention can obviously reduce and delay myopia onset and development and improved the awareness rate of knowledge apparently .


Eligibility criteria: Inclusion Criteria:

* primary 1-3 grade students

Exclusion Criteria:

* ocular inflammation
* eye injury
* dysgnosia

Primary outcomes:
measure: Prevalence of Myopia
timeFrame: every 6 months, total 3 years
Secondary outcomes:
measure: health of eyes knowledge
timeFrame: every 6 months, total 3 years, questionnair
measure: health of eyes behavior
timeFrame: every 6 months, total 3 years, questionnaire
Other outcomes:
Locations:
Study officials:
affiliation: Wenzhou Medical University
name: yan yan chen, master
role: STUDY_CHAIR
References:
citation: Leo SW, Young TL. An evidence-based update on myopia and interventions to retard its progression. J AAPOS. 2011 Apr;15(2):181-9. doi: 10.1016/j.jaapos.2010.09.020.
citation: Saw SM, Shih-Yen EC, Koh A, Tan D. Interventions to retard myopia progression in children: an evidence-based update. Ophthalmology. 2002 Mar;109(3):415-21; discussion 422-4; quiz 425-6, 443. doi: 10.1016/s0161-6420(01)00972-1.
citation: Schaeffel F. [Myopia update 2011]. Klin Monbl Augenheilkd. 2011 Sep;228(9):754-61. doi: 10.1055/s-0031-1281584. Epub 2011 Jul 27. German.
citation: Adler D, Millodot M. The possible effect of undercorrection on myopic progression in children. Clin Exp Optom. 2006 Sep;89(5):315-21. doi: 10.1111/j.1444-0938.2006.00055.x.
citation: Seet B, Wong TY, Tan DT, Saw SM, Balakrishnan V, Lee LK, Lim AS. Myopia in Singapore: taking a public health approach. Br J Ophthalmol. 2001 May;85(5):521-6. doi: 10.1136/bjo.85.5.521. No abstract available.