louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00621218: A Study to Determine the Safety and Efficacy of Atralin (Tretinoin 0.05%) Gel for the Treatment of Rosacea
Official title: A Pilot Study to Compare Tretinoin Gel, 0.05% to Tretinoin Gel Vehicle When Dosed Once or Twice Daily in Female Subjects With Classical Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Keywords: tretinoin, efficacy, safety, rosacea
Lead sponsor: Coria Laboratories, Ltd.
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 36
Sex: FEMALE
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: To compare the efficacy and safety of tretinoin gel 0.05% to its vehicle when dosed once or twice daily in female subjects with rosacea.


Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-65
* Diagnosed with classical, centrofacial, erythemato-telangiectatic rosacea

Exclusion Criteria:

* Male, females less than 18 years
* Females over 65 years
* No diagnosed rosacea

Primary outcomes:
measure: Improvement in signs and symptoms of rosacea
timeFrame: 16 weeks
Secondary outcomes:
measure: Changes in various skin parameters
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Conshohocken
country: United States
facility: Product Investigations, Inc.
state: Pennsylvania
Study officials:
name: Morris V Shelanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505218: Propofol Patient-controlled Sedation for Endoscopic Retrograde Cholangiopancreatography
Official title: Patient-controlled Propofol Sedation for Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: Sedation
propofol
patient-controlled
safety
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Propofol sedation with opioids is used for endoscopic retrograde cholangiopancreatography (ERCP). Combination of sedatives and opioids is associated with increased morbidity/mortality. Delivery of only propofol using a patient-controlled delivery system (patient-controlled sedation, PCS) could be an alternative for this purpose. Comparative studies with PCS for ERCP are few. Therefore, the main objective of this randomized controlled trial was to compare propofol PCS to sedation managed by nurse anaesthetists during ERCP.


Eligibility criteria: Inclusion Criteria:

* Need for ERCP
* Able to speak and read swedish

Exclusion Criteria:

* Allergy to propofol
* Severe cardiopulmonary disease (ASA IV)
* Confusion or dementia

Primary outcomes:
measure: treatability
timeFrame: one day (per-procedural)
Secondary outcomes:
measure: Vital signs
timeFrame: one and a half year
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University Hospital
Study officials:
affiliation: Dept of Anaesthesia and Intensive Care, Linköping University Hospital, 581 85 Linköping, Sweden
name: Folke Sjöberg, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01578018: Tumor Markers in Lung Cancer: DCAMLK-1LK-1
Official title: Tumor Markers in Lung Cancer: DCAMLK-1LK-1: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Smoking
Keywords: lung cancer
smoking
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 49
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: DCAMLK1 is a Ca2+ - ca/modulin (CaM) - dependent protein kinase that is a marker of stem cells in colonic crypts. Mutations within the stem cell population are thought to be responsible for the development of most colorectal carcinomas and studies have shown that DCAMLK1 is highly expressed in these tumors. Since the lung is an embryological development of the foregut, the investigators speculate that DCAMLK1 will also be upregulated in lung cancers.

The aim of this pilot study is to measure DCAMLK1 levels in the blood of patients with suspected malignant and benign lung diseases, and to correlate DCAMKL1 levels with smoking status.

Detailed description: In the investigators' preliminary study DCAMKL1 antigen was detected not only in malignant tissue, but also in BAL fluid from patients with benign lung disease. This suggests that DCAMKL1 expression might be induced by smoking or benign lung diseases. To examine this hypothesis, the investigators will compare DCAMLK1 expression in blood from patients with lung cancer to controls who are current or former smokers with benign lung disease.

Previous work has showed that DCAMLK1 is not detectable in the blood of healthy non smoking individuals. To determine whether smoking and or pulmonary inflammation induce DCAMLK1 expression, the investigators will obtain serum samples from 20 control patients with lung disease who are seen in the Chest Clinic at the Oklahoma City VAMC. Smoking histories will be obtained for all participants and DCAMLK1 levels will be correlated with smoking status.

Eligibility criteria: Inclusion Criteria:

* \>45 years of age

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Tumor Markers in Lung Cancer:
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VAMC-OKC
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Kellie Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01402518: Per-Oral Endoscopic Myotomy
Official title: Observational Study of the Per-Oral Endoscopic Myotomy (POEM) Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Achalasia
Keywords: achalasia
myotomy
endoscopic myotomy
difficulty swallowing
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic with the diagnosis of achalasia will be offered participation in this study.

Brief summary: This is a prospective chart review/data collection study of the per oral endoscopic myotomy (POEM) procedure, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a POEM procedure. Data will be collected and reviewed through 12 months post-op.


Eligibility criteria: Inclusion:

1. Diagnosis of achalasia
2. Age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a POEM procedure

Exclusion:

1. Pregnant women
2. Any prior surgical treatment for achalasia

Primary outcomes:
measure: To evaluate the outcomes of the per-oral endoscopic myotomy (POEM) procedure for the treatment of achalasia
timeFrame: 1 year
Secondary outcomes:
measure: To assess the quality of life, pain, and complications of the POEM approach
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: UCSD
name: Santiago Horgan, M.D., FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05268718: Au-Ag-Cu2O NG With PTT Anti Drug-resistant Microbial Keratitis
Official title: Gold-silver-cuprous Oxide (Au-Ag-Cu2O) Composite Nanogel Combined With Photothermal Therapy in the Treatment of Severe Drug-resistant Microbial Keratitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Keratitis, Ulcerative
Antibiotic Resistance, Microbial
Photothermal Therapy
Keywords: Photothermal Therapy
Keratitis, Ulcerative
Antibiotic Resistance, Microbial
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study was conducted to evaluate the efficacy and safety of gold-silver cuprous oxide composite nanogels combined with photothermal therapy system in the treatment of severe drug-resistant bacterial keratitis ineffective by traditional antibiotic treatment in human eyes, and to provide translational applications. Based on the clinical evidence, a more effective and safe innovative treatment plan for corneal diseases has been developed.


Eligibility criteria: Inclusion Criteria:

1. The monocular cases of severe infectious keratitis admitted to our center were diagnosed as fungal keratitis according to their medical history, physical signs and surface secretions smear examination of corneal ulcer lesions (severe was defined as subjects with visual acuity \< 0.15, deep stromal infiltration or involvement diameter \>2mm, with extensive infiltration around or with extensive suppuration)
2. After more than 2 weeks of active treatment with antibiotics, there was no effect
3. The researchers communicated with the subjects in detail, and the subjects cooperated well and they voluntarily participated and signed informed consent

Exclusion Criteria:

1. Allergic to the drug in this test.
2. Pregnant and lactating women.
3. The medical history suggests serious heart, lung, liver, kidney dysfunction.
4. Patients with other factors that would affect the results of this result.
5. No signed informed consent.

Primary outcomes:
measure: Anterior segment photography
timeFrame: 1 month
measure: confocal microscopy
timeFrame: 1 month
Secondary outcomes:
measure: eye pressure
timeFrame: 1 month
measure: visual acuity
timeFrame: 1 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Ke Yao, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03554018: Ibuprofen With or Without Acetaminophen for Low Back Pain
Official title: Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized clinical trial comparing two interventions for acute low back pain:

1. Ibuprofen + acetaminophen
2. Ibuprofen + placebo

Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.


Eligibility criteria: Inclusion Criteria:

Present to emergency room primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included.

* Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the emergency room visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal low back pain.
* Patient is to be discharged home.
* Age 18-69
* Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern.
* Pain duration \<2 weeks (336 hours).
* Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month.
* Non-traumatic LBP: no substantial and direct trauma to the back within the previous month
* Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire

Exclusion Criteria:

* Not available for follow-up
* Pregnant
* Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis
* Allergic to or intolerant of investigational medications

Primary outcomes:
measure: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
timeFrame: Baseline and one week after discharge from emergency department
Secondary outcomes:
measure: Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
timeFrame: 7 days after discharge from emergency department
measure: Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
timeFrame: 7 days after discharge from emergency department
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06228118: Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
Official title: Clinical Trail of the Lay User Study and Method Comparison Study of Human Chorionic Gonadotropin (HCG) Test System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Pregnancy
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-29
Enrollment: 502
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 502 subjects with ages from 18-55 years old were enrolled . Among the 502 total subjects, 369 subjects aged between 18 and 55 years old voluntarily participated in the Lay User Study.

Brief summary: This clinical trial consisted of lay user study and method comparison study. Method comparison study: evaluate the clinical performance by comparing the results of new device and FDA cleared device (the comparator) tested on the same sample by professionals.

Lay user study: evaluate the usability of by comparing the results of new device on the same sample tested by professionals and lay user, and by lay users complete the questionnaire.


Eligibility criteria: Inclusion Criteria:

1. Method comparison study exclusion criteria

   * Female；
   * 18-55 years of age；
   * Voluntary and sign informed consent form.
2. Lay user study inclusion criteria

   * Female；
   * 18-55 years of age；
   * Voluntary and sign informed consent form；
   * Willingness to perform self-test of investigational device；
   * Have the ability to read English.

Exclusion Criteria:

1. Method comparison study exclusion criteria

   * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
   * Within 8 weeks of childbirth or abortion；
   * The investigator has reason to believe that it is inappropriate for subjects to participate in the study.
2. Lay user study inclusion criteria

   * Use of hCG-containing fertility medications (e.g., Pregnyl, Profasi, Novarel, Ovidrel)；
   * Within 8 weeks of childbirth or abortion；
   * The investigator has reason to believe that it is inappropriate for subjects to participate in the study；
   * Background in a medical or laboratory testing.

Primary outcomes:
measure: Comparison results
timeFrame: 30minute
Secondary outcomes:
measure: Evaluate the usability and user comprehension of investigational device
timeFrame: 30minute
Other outcomes:
Locations:
city: Tianjin
country: China
facility: First Teaching hospital of Tianjin University of Traditional Chinese Medicine
Study officials:
References:
Clinical trial NCT06466018: Research Into Diagnostic and Prognostic Molecular and Imaging Biomarkers of Ocular Disorders Associated With Neurovascular Deregulation: Biocor Cohort
Official title: Recherche de Biomarqueurs moléculaires et d'Imagerie Diagnostiques et Pronostiques Des Atteintes Oculaires associées à Des dérégulations Neurovasculaires : Cohorte Biocor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ocular Rosacea
Pachychoroid Disease
Lead sponsor: Clinact
Sponsor class: OTHER
Collaborators: name: Association CRO - Tous unis pour la vision
First posted: 2024-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: BIOCOR is an interventional clinical trial whose main objectives are Objectif are identify molecular biomarker(s) of ocular rosacea and pachychoroid. Endpoints are : Correlation between pachychoroidosis (defined by choroidal phenotype parameters in OCT and autofluorescence) or the stage of ocular rosacea (ROSCO(29) definition) and biological markers selected on the basis of preclinical work (animal model) and by unbiased methods (proteomics, metabolomics, meibum lipidomics). The study of circulating, ocular and functional biomarkers would enable us to confirm our hypothesis and identify patients who could benefit from treatments that regulate the ANS and/or mineralocorticoid pathways.


Eligibility criteria: Inclusion Criteria:

* Male or female \> 18 years of age, of European origin, with signed ± genetic consent
* Clear ocular media for OCT and autofluorescence imaging
* Signed consent form
* Be affiliated to a health insurance scheme
* Control patients are patients scheduled for cataract surgery or visual assessment.

Exclusion Criteria:

* High myopia \> 6D
* Diabetic retinopathy, hereditary retinal dystrophy, untreated retinal detachment, choroidal ocular tumor, choroidal hemangioma
* Epithelial or stromal keratopathy other than ocular rosacea
* Corneal surgery less than 3 months old, keratoplasty
* Deprived of liberty or under guardianship or curatorship

Primary outcomes:
measure: Clinical phenotype of ocular rosacea
timeFrame: Screening visit, visits A1, A2, and end-of-study visit
measure: Pachychoroid clinical phenotype
timeFrame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
Secondary outcomes:
measure: Evolvolution of clinical profile of each phenotype in the cohort
timeFrame: From inclusion to end of study (Inclusion, year 1, year 2, year 3)
measure: Heart rate
timeFrame: At inclusion and end of study (Inclusion, year 3)
Other outcomes:
Locations:
city: Paris Cedex 14
country: France
facility: Departement of Ophthalmology, COCHIN Hospital
Study officials:
References:
Clinical trial NCT02866318: Learning Curve CUSUM of LV Ejection Fraction by Visual Estimation in Novice Practitioners
Official title: CUSUM Analysis in the Assessment of Novice Practitioners' Visual Estimation in LV Ejection Fraction With Echocardiographic Images
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file.

Brief summary: This retrospective, cross-sectional cohort study was conducted to investigate the novice practitioners' learning curve of visual estimation of LV ejection fraction (%) through a echocardiographic video files at the academic emergency department (ED) in tertiary urban hospital.

Detailed description: Eight EM residents who have no experience of echocardiography prior to the study were recruited as analysis of the echocardiographic image file. They received echocardiography interpretation skill training which included one hour of lecture. Twenty echocardiography videos files were provided during training session, they were instructed how to estimate EF by looking at the LV contractility without taking any measurement.

This procedure took less than 2 minutes in each case. An evaluation form was completed by each EP. EF is estimated qualitatively (Normal / Global hypokinesia), RWMA and quantitatively (%) by EP with echocardiographic certification(cardiologist). An each echocardiography has been performed with M7R® model ultrasound machine was reported by experienced echocardiographers as using MSM. The echocardiography results were reported blinded to our study.

A participant estimated the EF based on a complete assessment of LV wall motion including parasternal long-axis, short-axis, and apical four chamber view except for MSM.

And, participants wrote down EF(%) and a region of WMA as visual assessment and checked Normal wall motion or Global hypokinesia in EF reporting paper.

Eligibility criteria: Inclusion Criteria:

* EM residents who have no experience of echocardiography

Exclusion Criteria:

* They do not want to participate this study

Primary outcomes:
measure: Learning curve
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Gyeonggi-do
Study officials:
affiliation: Hanyang University
name: YOONJE LEE, M.D.
role: PRINCIPAL_INVESTIGATOR
References: