louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129488: Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Biotrue ONEday Contact Lenses
Official title: 2 Hour Dispensing Evaluation of Biotrue ONEday Contact Lenses With EPG03 Packaging Solution Compared to Commercially Available Biotrue ONEday Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wearer
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2021-11-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Approximately 30 habitual soft contact lens wearing subjects will be enrolled in this two-hour randomized, contralateral, double-masked (subject and investigator masked), repeated measures dispensing study.
Primary purpose: TREATMENT

Brief summary: The objective of this 2 hour study is to evaluate the clinical performance of Biotrue ONEday lenses with an alternate packaging solution (EPG03) compared to commercially available Biotrue ONEday lenses. This novel contact lens packaging solution contains known elements in the ophthalmic industry and is safe for use.

Detailed description: Approximately 30 habitual soft contact lens wearing subjects will be enrolled in this two-hour randomized, contralateral, double-masked (subject and investigator masked), repeated measures dispensing study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If subjects satisfy all eligibility criteria and none of the exclusion criteria, subjects will be dispensed study lenses according to unique randomization schedules that will be provided to each Investigator.

Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.

Primary outcomes:
measure: Normalized logMAR Visual Acuity
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch and Lomb Site 01
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jeffery Schafer, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00697788: Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Official title: Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Burns
Sedation
Keywords: pediatric
burn
sedation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-06-16
Enrollment: 8
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

Detailed description: This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Eligibility criteria: Inclusion Criteria:

* pediatric patient
* \>25% total body surface area (tbsa) burn and \< 90% tbsa
* opioid requirements \> 0.1 mg/kg/hour of morphine (or equivalent)
* midazolam requirement \> 0.1 mg/kg/hour
* treatment team determined that patient should be started on dexmedetomidine

Exclusion Criteria:

* hemodynamically unstable patients (epinephrine \> 1.0 ug/kg/min, levophed \> 0.75 ug/kg/min, dopamine \> 10 ug/kg/min)
* pregnant patients
* patients with history of heart block
* patients with congenital heart disease
* patients with significant hepatic dysfunction
* patients with urine output \< 0.5 ml/kg/hour \[averaged\] over past 24 hours

Primary outcomes:
measure: Percent Change in Mean Arterial Pressure (MAP)
timeFrame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Secondary outcomes:
measure: Presence of Arrhythmias.
timeFrame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
measure: Oxygen Saturation
timeFrame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
measure: Heart Rate
timeFrame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration
Other outcomes:
Locations:
city: Boston
country: United States
facility: Shriners Burn Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Erik S Shank, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302688: Accurate Classification System for Patients With COVID-19 Pneumonitis
Official title: Accurate Classification System for Patients With COVID-19 Based on Prognostic Nomogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonitis
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 669
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with novel coronavirus pneumonia, and all cases were collected from the People's Hospital of Wuhan University.

Brief summary: The COVID-19 has a clustering morbidity trend and older people with chronic diseases are more likely to die, such as chronic renal insufficiency and chronic cardiovascular disease. We set up a COVID-19 pneumonia grading scale. The COVID-19 score system was validated to predict the clinical outcome of a patient.

Detailed description: 1. First we collect the medical records, according to the time sequence, the patients were divided into two groups, one is the model group, and the other is the validate group.
2. Responsible for the risk factor of regression equation according to the model. The patients were divided into three groups according to their total score of risk responsibility.
3. Compared with SEPSIS and CURB-65 grading system with the grading system we established.

Eligibility criteria: Inclusion Criteria:

* Patients with novel coronavirus pneumonia should be examined and diagnosed by CT and swab test of viral nucleic acid.

Exclusion Criteria:

* Patients who should have died during the course of the disease, but the cause of death was unrelated to viral pneumonia.
* Suspected patient review refers to the negative nucleic acid test.

Primary outcomes:
measure: survival status
timeFrame: 10 December 2019 to 10 February 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Qiong Gong, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01822288: The Impact of Hormone Therapy on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Official title: The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Menopausal Syndromes
Keywords: Menopause
Tibolone
Estradiol
Hormone therapy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 125
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Menopausal syndromes includes somatic symptom, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. Hormone therapy (HT) is widely used for controlling menopausal symptoms. Common HT for menopausal syndrome with intact uterus includes tibolone, estradiol valerate (E2V) 1mg \& medroxyprogesterone acetate (MPA) 2.5 mg, and conjugated equine estrogens \& MPA.

However, only a few literatures mentioned about the therapeutic effect of tibolone, but lack of comparison research about their therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms. The knowledge of the above therapeutic effects should be important for choosing a suitable medication. Therefore, the aim of this study is to assess the therapeutic effect on somatic symptoms, psychosomatic symptoms, sexual dysfunction and even urinary symptoms between tibolone and E2V/MPA.


Eligibility criteria: Inclusion Criteria:

* All female patients with intact uterus who seek for medical treatment for menopausal syndrome

Exclusion Criteria:

* patients with gynecologic or breast cancers

Primary outcomes:
measure: Menopausal symptoms
timeFrame: 12 weeks
Secondary outcomes:
measure: sexual function
timeFrame: 12 weeks
measure: lower urinary tract symptoms
timeFrame: 12 weeks
measure: psychosomatic symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT01252888: Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents
Official title: A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two Trabecular Micro-bypass Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Subjects With Primary Open-angle Glaucoma (POAG)
Keywords: Open angle
Glaucoma
Surgery
Glaucoma Open-Angle
Ocular Hypertension
Eye Diseases
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

Detailed description: This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subjects on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: mean diurnal IOP reduction of greater than or equal to 20% at Month 12 vs baseline
timeFrame: 12 months
Secondary outcomes:
measure: Mean diurnal IOP < 18 mmHg at month 12
timeFrame: 12 months
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: S.V. Malayna's Ophthalmology Centre
Study officials:
References:
citation: Ahmed II, Katz LJ, Chang DF, Donnenfeld ED, Solomon KD, Voskanyan L, Samuelson TW. Prospective evaluation of microinvasive glaucoma surgery with trabecular microbypass stents and prostaglandin in open-angle glaucoma. J Cataract Refract Surg. 2014 Aug;40(8):1295-300. doi: 10.1016/j.jcrs.2014.07.004.
citation: Chang DF, Donnenfeld ED, Katz LJ, Voskanyan L, Ahmed II, Samuelson TW, Giamporcaro JE, Hornbeak DM, Solomon KD. Efficacy of two trabecular micro-bypass stents combined with topical travoprost in open-angle glaucoma not controlled on two preoperative medications: 3-year follow-up. Clin Ophthalmol. 2017 Mar 15;11:523-528. doi: 10.2147/OPTH.S121041. eCollection 2017.
Clinical trial NCT00696488: Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Official title: Measuring Adherence To Topical 5-Fluorouracil in a Clinic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Actinic Keratosis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to measure adherence to the study drug (Carac) for the treatment of actinic keratoses.

Detailed description: The purpose of this research study is to measure adherence to the study drug for the treatment of actinic keratoses. The study drug is 5-Fluorouracil (Carac®); it will be used in this study to treat actinic keratoses on the face and anterior scalp. This proposed study will evaluate adherence to topical Carac® in 20 adults age 50 or greater with actinic keratoses from a clinic population. Adherence data will be collected by the MEMS cap (Medication Event Monitoring System

Eligibility criteria: Inclusion Criteria:

* Any male or female 50 years of age or older with moderate to severe actinic keratoses of the face and anterior scalp diagnosed by a dermatologist will be eligible for participation.

Exclusion Criteria:

* Age less than 50.
* Known allergy or sensitivity to topical Carac® in the subject.
* Inability to complete all study-related visits.
* Introduction of any other prescription medication, topical or systemic, for actinic keratosis while participating in the study.
* Subjects should not receive surgical or cryotherapy while participating in the study.
* Pregnant women, women who are breast feeding, or women of child bearing potential who are not practicing two acceptable methods of birth control

Primary outcomes:
measure: Adherence to Carac® in Subjects With Moderate to Severe Actinic Keratosis.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steve Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yentzer B, Hick J, Williams L, Inabinet R, Wilson R, Camacho FT, Russell GB, Feldman SR. Adherence to a topical regimen of 5-fluorouracil, 0.5%, cream for the treatment of actinic keratoses. Arch Dermatol. 2009 Feb;145(2):203-5. doi: 10.1001/archdermatol.2008.562. No abstract available.
Clinical trial NCT03803488: Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
Official title: Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needle Stick
Keywords: needlestick
needlestick injury
pen needle
sharps injury prevention
Lead sponsor: HTL-Strefa S.A.
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A simulated clinical use testing on the DropSafe safety pen needle

Detailed description: This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.

Eligibility criteria: Inclusion Criteria:

1. Minimum of age 18.
2. Able to understand and provide signed consent for the study.
3. Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
4. Have no concerns about the ability to perform the simulated injections.
5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).

Exclusion Criteria:

1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.

Primary outcomes:
measure: The true failure rate of DropSafe safety pen needle.
timeFrame: At time of testing, about an hour
Secondary outcomes:
measure: Ease of use
timeFrame: At time of testing, about an hour
measure: Ability to follow the instructions for use
timeFrame: At time of testing, about an hour
measure: Ease of understanding the instructions for use
timeFrame: At time of testing, about an hour
measure: Problems associated with the device
timeFrame: At time of testing, about an hour
Other outcomes:
Locations:
city: Golden Valley
country: United States
facility: NAMSA
state: Minnesota
city: Minneapolis
country: United States
facility: NAMSA
state: Minnesota
Study officials:
References:
Clinical trial NCT04753788: Evaluation of a LAMP Assay for T. Pallidum. Pertenue
Official title: Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Yaws
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Pasteur Institute abidjan
name: Centre Pasteur du Cameroun
name: Noguchi Memorial Institute for Medical Research
name: University of Freiburg
name: MAST Group - Germany
name: Friedrich-Loeffler-Institut
name: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
First posted: 2021-02-15
Enrollment: 563
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with clinically suspected yaws lesions in Ghana, Cote d'Ivoire and Cameroon will be screened using the DPP Syphilis Screen and Confirm RDT. If positive samples will be taken for PCR and LAMP testing.

Brief summary: This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws


Eligibility criteria: Inclusion Criteria:

* Lesion consistent with yaws
* Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT

Exclusion Criteria:

* Unable to give consent

Primary outcomes:
measure: Sensitivity of LAMP vs qpCR
timeFrame: 15 Months
measure: Specificity of LAMP for Yaws
timeFrame: 15 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre Pasteur
city: Abidjan
country: Côte D'Ivoire
facility: Institut Pasteur
city: Accra
country: Ghana
facility: Noguchi Memorial Institute of Medical Research
Study officials:
References:
citation: Handley BL, Gonzalez-Beiras C, Tchatchouang S, Basing LA, Hugues KA, Bakheit M, Becherer L, Ries C, Njih Tabah E, Crucitti T, Borst N, Luert S, Frischmann S, Haerpfer T, Landmann E, Amanor I, Sylla A, Kouame-Sina MS, Ndzomo-Ngono JP, Tano A, Arhinful D, Awondo P, Ngazoa Kakou S, Eyangoh S, Addo KK, Harding-Esch EM, Knauf S, Mitja O, Marks M. LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification - protocol for a cross-sectional, observational, diagnostic accuracy study. BMJ Open. 2022 Mar 29;12(3):e058605. doi: 10.1136/bmjopen-2021-058605.
Clinical trial NCT02957188: Metabolism of Omega-3 and Omega-6 During Healthy Aging
Official title: Metabolism of Uniformly Labelled 13C Eicosapentaenoic Acid and 13C Arachidonic Acid During Healthy Aging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Eicosapentaenoic acid
Arachidonic acid
Metabolism
Healthy aging
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Healthy Aging Research Network
First posted: 2016-11-06
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young and elderly healthy participants

Brief summary: The purpose of this study is to determine the kinetics of 13C-eicosapentaenoic acid (EPA) and 13C-arachidonic acid (AA) in young and older participants


Eligibility criteria: Inclusion Criteria:

* six young (18-30 y old) and six older (≥ 70 y old)
* healthy non medicated participants.

Exclusion Criteria:

* Tobacco,
* malnutrition (assessed from blood albumin, haemoglobin and lipids), -
* participants taking an EPA+DHA supplements or consuming more than 2 fish meals per week,
* severe gastro-intestinal problems,
* medication for diabetes,
* thyroid disease,
* renal failure,
* cancer,
* psychiatric difficulties or depression,
* cardiovascular disease,
* glucose intolerance (\>8 mmol/L in fasted samples)
* chronic immune condition or inflammation (CRP \> 10 mg/l, white cell count),
* recent major surgery or cardiac event,
* dementia,
* ongoing or past severe drug or alcohol abuse,
* ongoing or past intensive physical training.

Primary outcomes:
measure: Kinetics of 13C-EPA and 13C-AA
timeFrame: Plasma incorporation of 13C-EPA or 13C-AA was measured from the area under the curve in young and older participants over 28 days post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Leveille P, Chouinard-Watkins R, Windust A, Lawrence P, Cunnane SC, Brenna JT, Plourde M. Metabolism of uniformly labeled 13C-eicosapentaenoic acid and 13C-arachidonic acid in young and old men. Am J Clin Nutr. 2017 Aug;106(2):467-474. doi: 10.3945/ajcn.117.154708. Epub 2017 Jun 28.