louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05781997: Prevalence of Refractive Errors in Primary School Children
Official title: Prevalence of Refractive Errors in Primary School Children in The New Valley
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Refractive Errors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary school children aged 6-12 in New Valley, Egypt not complaining from any diseases .

Brief summary: The study aim to determine the prevalence of refractive errors in primary school children aged 6-12 in The New Valley , Egypt .

Detailed description: The refractive state of the eye changes as the eye's axial length increases and the cornea and lens flattens. In general, eyes are hyperopic at birth, and become slightly more hyperopic until the age of 7, at this point we see a myopic shift toward Plano until the eyes reach their adult dimensions, usually by about the age of 16.

Eligibility criteria: Inclusion Criteria:

Age: 6 -12-year-old Myopia :- 0.5 D to -10D Hypermetropia: 1 D to 8 D Astigmatism: 0 to 6 D Distance correction: 0.1 logs MAR (20/25 ) or better

Exclusion Criteria:

Retinopathy, Prematurity, history of genetic disease, connective tissue diseases (e.g. Stickler or Marfan syndromes, any ocular diseases, Glaucoma, Cataract, Squint.

Primary outcomes:
measure: prevalence of refractive error in primary school children
timeFrame: baseline
Secondary outcomes:
measure: Degree of Visual aquity improvement of children.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: supervisor
name: Omar Mo Ali, Professor
role: STUDY_DIRECTOR
affiliation: supervisor
name: Ahmed Mh fahmy, AssProfessor
role: STUDY_DIRECTOR
affiliation: supervisor
name: Mohammed An Sayed, Lecturer
role: STUDY_DIRECTOR
affiliation: Investigator
name: Doaa An Mohammed, Resident
role: PRINCIPAL_INVESTIGATOR
References:
citation: Donahue SP. Prescribing spectacles in children: a pediatric ophthalmologist's approach. Optom Vis Sci. 2007 Feb;84(2):110-4. doi: 10.1097/OPX.0b013e318031b09b.
citation: Glascoe FP. Parents' evaluation of developmental status: how well do parents' concerns identify children with behavioral and emotional problems? Clin Pediatr (Phila). 2003 Mar;42(2):133-8. doi: 10.1177/000992280304200206.
citation: Friedman DS, Repka MX, Katz J, Giordano L, Ibironke J, Hawes P, Burkom D, Tielsch JM. Prevalence of decreased visual acuity among preschool-aged children in an American urban population: the Baltimore Pediatric Eye Disease Study, methods, and results. Ophthalmology. 2008 Oct;115(10):1786-95, 1795.e1-4. doi: 10.1016/j.ophtha.2008.04.006. Epub 2008 Jun 5.
Clinical trial NCT02823483: 18348-Human Phototoxicity Test
Official title: Human Phototoxicity Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-06
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine the phototoxic potential of a topically applied article in human subjects


Eligibility criteria: Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products

Primary outcomes:
measure: Intensity of skin reactions will be evaluated using the 5 point
timeFrame: Up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06063083: Tell Me More ("Dime Mas")
Official title: Addressing Latino Men Who Have Sex With Men (MSM) Health Disparities by Increasing Engagement With Behavioral and HIV Prevention Services: An Implementation Science Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
Mental Health Issue
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2023-10-02
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be used to develop a program to help Latino men who have sex with men obtain pre-exposure prophylaxis (PrEP), HIV testing, and behavioral health services. The project will then involve a pilot test of this program with a community partner.


Eligibility criteria: Inclusion Criteria:

* Identify as Latino/Hispanic
* identify as a sexual minority man (e.g., gay, bisexual) and/or a man who has sex with men
* age 18 years or older
* English and/or Spanish speaking
* self-report an HIV-negative or unknown HIV status
* currently reside in the greater Miami area
* PrEP eligible (based on Centers for Disease Control (CDC) criteria) and not currently taking PrEP adherently
* self-report experiencing one or more clinically significant behavioral health concerns (mental health, substance use) and/or are not currently receiving behavioral health services or self-report an unmet need for behavioral health services

Exclusion Criteria:

* Unable to provide consent
* Opinion of the PI that the participant would be at risk for harm to self or others
* Have a medical or psychiatric condition that would interfere with ability to participate in study procedures in the opinion of the PI
* Involvement in any other HIV prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the PI on a case-by-case basis)

Primary outcomes:
measure: Change in PrEP Engagement, as measured by the PrEP cascade questionnaire
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in Behavioral Health Treatment Engagement, as measured by the Behavioral health cascade questionnaire (based on the Psychosocial Treatment Inventory)
timeFrame: Baseline, 3 months, 6 months
measure: Change in Recent (within the last 3 months) HIV testing
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Audrey Harkness, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06411483: Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite
Official title: Determining the Physiological Mechanisms Behind the ObeEnd Device on Factors Regulating Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Obesity, Metabolically
Obesity
Keywords: acupuncture
obesity
appetite
weight
Lead sponsor: Concordia University, Montreal
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 27
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: An active device arm will be compared to an inactive device (placebo) arm
Primary purpose: OTHER

Brief summary: In Canada, over 60% of adults are classified as overweight and obese resulting in a public health crisis including increasing health care costs and negatively impacting the well-being of many Canadians. To overcome these barriers, the ObeEnd device, manufactured by WAT Medical Enterprise, is a new and innovative wellness technology that uses electrical pulses to stimulate acupressure point PC6 to help control appetite. PC6 stimulation could potentially modulate appetite and restore gastric dysfunction, which are important factors that contribute to obesity. If PC6 electrostimulation facilitates the normalization of appetite and restoration of gastric dysfunction in those with obesity, then the device could be a potentially helpful aid to weight loss.

To measure the change of appetite hormones and enzymes related to appetite regulation after using the ObeEnd device. The investigators hypothesize that, compared to placebo, electrostimulation of PC6 an acupuncture spot on the wrist over a two-week period will result in changes in enterogastic hormones in a direction that decreases appetite. The investigators also hypothesize that these changes will not affect physical activity levels but will correspond to changes in appetite and diet. This study will provide the first evidence of the effects of electrostimulation at PC6 on factors affecting body weight regulation providing insight into the utility of the ObeEnd device for weight control.


Eligibility criteria: Inclusion Criteria:

* BMI \>30 kg/m2
* no history of chronic illness or disease
* premenopausal

Exclusion Criteria:

* pregnant, breastfeeding
* medications that may affect outcomes
* chronic disease or conditions that may affect outcomes
* smoking or use of nicotine containing products

Primary outcomes:
measure: Factors involved with appetite regulation
timeFrame: after 2 weeks of wearing the band
measure: Dietary assessment
timeFrame: after 2 weeks of wearing the band
measure: Physical activity
timeFrame: after 2 weeks of wearing the band
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: School of Health, Concordia University
state: Quebec
Study officials:
affiliation: Concordia University, Montreal
name: Sylvia Santosa, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03412383: Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Official title: A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
HER2 Gene Mutation
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase II Study of Pyrotinib in Metastatic HER2 Non-amplified But HER2 Mutant Breast Cancer


Eligibility criteria: Inclusion Criteria:

Able to understand and willing to sign an Institutional Review Board（IRB） approved written informed consent document.

At least 18 years of age. Histologically or cytologically confirmed HER2-negative (0 or 1+ by immuno-histochemical (IHC) or non-amplified by FISH) breast cancer that is stage IV.

There is no standard therapy. At least one measurable disease by RECIST 1.1 is required. Karnofsky performance status (KPS)\>70, life expectancy \> 12 weeks

Exclusion Criteria:

Lack of adequate organ function as defined below within 2 weeks of registration:

Absolute neutrophil count (ANC)\<1.5×109/L，platelet counts (PLT)\<75×109/L or hemoglobin (Hb)\<100g/L Total bilirubin (TBiL)\>2×upper limit of normal (ULN); Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)\>2.5×ULN（or\>5 x ULN for patients with liver metastases）; Alkaline phosphatase (ALP)\>2.5×ULN; serum creatinine concentration (Scr)\>140umol/L Pregnant and/or breastfeeding. History of significant cardiac disease, cardiac risk factors, or uncontrolled arrhythmias.

Having a history of uncontrolled paroxysmal diseases, including central nervous system diseases or mental disorders which may have an impact on the understanding and signature of informed consent Uncontrolled acute infection Currently receiving any other investigational agents or systemic cancer therapy.

Allergy to any investigational drug ; Any other condition that investigator considers inappropriate to participate in this trail

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 36 months
Secondary outcomes:
measure: Adverse events (AEs)
timeFrame: up to 36 months
measure: Overall Response rates (ORR)
timeFrame: up to 36 months
measure: Clinical Benefit rate (CBR)
timeFrame: up to 36 months
measure: Time to Progression (TTP)
timeFrame: up to 36 months
measure: Quality of Life(QoL)
timeFrame: up to 36 months
measure: Overall survival (OS)
timeFrame: up to 52 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fei Ma
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Fei Ma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103583: Hydroxyurea in Primary Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: S. Andrea Hospital
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The pathogenesis of MS remain elusive, however some studies have linked the disease with infection by Epstein-Barr virus; therefore the use of drugs with immunosuppressive or immunomodulating action alone may be less suitable for primary progressive MS.This study will evaluate treatment with hydroxyurea (HU) in primary progressive MS. Hydroxyurea act by inhibiting the synthesis of deoxynucleotides essential for viral transcription,HU has recently been used in combination with antiretroviral drugs in HIV and has been shown to limit immune activation and suppress viral load by both antiviral and cytostatic activities. Furthermore has been demonstrated experimentally that HU suppressed the expression of EBV. For these reasons HU could be useful in primary progressive MS with cytostatic and antiviral action , confirming the role of EBV in the pathogenesis of MS.


Eligibility criteria: Inclusion Criteria:

* sign written informed consent
* 18 to 60 years of age inclusive
* diagnosis of PP-MS according to McDonald criteria
* EDSS score at screening of 2-7 inclusive

Exclusion Criteria:

* hypersensitivity to hydroxyurea
* patients who were treated with immunosuppressive drugs or steroid three month before
* respiratory or urinary infections
* history or presence of malignancy
* pregnancy or lactation
* low compliance to the therapy

Primary outcomes:
measure: the evaluation of safety and tolerability of hydroxyurea
timeFrame: two years
Secondary outcomes:
measure: the evaluation of efficacy of hydroxyurea in primary progressive multiple sclerosis
timeFrame: two yeras
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Centre for Experimental Neurological Therapies (CENTERS), Tor Vergata University Hospital
city: Rome
country: Italy
facility: Centre for Experimental Neurological Therapies (CENTERS), S.Andrea Hospital
Study officials:
References:
Clinical trial NCT06711783: Treatment of Adolescent Anorexia Nervosa
Official title: VISAN - Vårdkedja I Samverkan För Unga Patienter Med Anorexia Nervosa (collaborative Chain of Care in Adolescnt Anorexia Nervosa Treatment)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Eating Disorders
Keywords: anorexia nervosa
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: VISAN is a naturalistic study of family based treatment of Anorexia nervosa in adolescnet girls.


Eligibility criteria: Inclusion Criteria:

* Having been diagnosed with f500 or f501 and being planned for family based therapy at the unit.

Exclusion Criteria:

* being subjected to care by the social welfare system

Primary outcomes:
measure: Remission
timeFrame: End of treatment (assessed up to 1 year)
Secondary outcomes:
Other outcomes:
Locations:
city: Orebro
country: Sweden
facility: Orebro eating disorder unit
Study officials:
References:
Clinical trial NCT03893383: Knowledge- Attitude- Practice (KAP) of Post Exposure Prophylaxis for Fifth Year Dental Students of a Private Egyptian University
Official title: Knowledge- Attitude- Practice (KAP) of Post Exposure Prophylaxis for Fifth Year Dental Students of a Private Egyptian University: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Exposure
Keywords: knowledge attitude practice questionnaire post exposure prophylaxis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: fifth year dental students in a Private Egyptian University

Brief summary: considering the increase number of occupational injuries, The aim of this study is to assess the current level of knowledge, attitude and practice of fifth year dental students as regards post exposure prophylaxis.

Detailed description: Injuries from occupational accidents are associated with agents of biological risk, as they are the gateway to serious and potentially lethal infectious diseases. Several studies have demonstrated that dental students are among the most vulnerable to blood-borne exposure due to both their limited and restricted working area and developing skills level. This situation makes the use of post exposure prophylaxis is very important. Therefore, this study is conducting to evaluate the awareness level of fifth year dental students regarding post exposure prophylaxis.

Eligibility criteria: Inclusion Criteria The fifth year dental students studying at a Private Egyptian University. Dental students who agree to participate. Dental students irrespective of age and sex.

Exclusion Criteria:

• Refusal of participation from the students.

Primary outcomes:
measure: Knowledge, attitude and practice (KAP) of fifth year dental students regarding Post Exposure Prophylaxis.
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03274583: Mobile Phone Detection of Atrial Fibrillation
Official title: Mobile Phone Detection of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Arrhythmia
Keywords: atrial fibrillation
smartphone
detection
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in the wards of Heart Center and Acute Internal Medicine of Turku University Hospital, Turku Finland between April and September 2017.

Brief summary: The aim of this study is to evaluate the reliability of smartphone seismocardiographic detection of AF in comparison to the gold standard of continuous telemetry ECG recording.

Detailed description: In the this case-control study, 300 patients being treated in the wards of Heart Center and Department of Acute Internal Medicine of Turku University Hospital in Turku, Finland between April and September 2017 were included in the study. Patients were assigned to two groups according to the prevalent heart rhythm (sinus rhythm or atrial fibrillation). A smartphone equipped with an inbuilt accelerometer and a gyroscope was placed on the patient's chest to obtain a seismocardiographic recording. Simultaneous telemetry electrocardiography was obtained to assess the reliability of seismographic rhythm recordings. Results will be analyzed to describe the specificity and sensitivity of the method.

Eligibility criteria: Inclusion Criteria for patients with FA:

* ≥18 years of age
* telemetry ECG available
* being treated in Turku University Hospital Heart Center / Acute internal medicine ward
* atrial fibrillation

Inclusion Criteria for patients with sinus rhythm:

* ≥18 years of age
* telemetry ECG available
* being treated in Turku University Hospital Heart Center / Acute internal medicine ward
* sinus rhythm
* gender and age matching pair in FA group

Exclusion Criteria:

* ≤18 years of age
* paced rhythm
* cardioversion during preceding 7 days
* informed consent not signed

Primary outcomes:
measure: Sensitivity and specificity of seismocardiography in diagnosing atrial fibrillation
timeFrame: 2017-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
state: Länsi-Suomen Lääni
Study officials:
References:
Clinical trial NCT04379583: HairDx Analytical Validation Study
Official title: HairDx Analytical Validation Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hair Loss
Hair Loss/Baldness
Female Pattern Baldness
Androgenetic Alopecia
Lead sponsor: Applied Biology, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects recruited from an online advertisement approved by the IRB

Brief summary: The HairDx Test reports genetic variants associated with the development of FPHL.

Detailed description: The HairDx Test reports genetic variants associated with the development of FPHL. The variants are detected from a saliva sample collected at home. The HairDx Test report is designed to help individuals understand the meaning of their results and encourage a conversation with a healthcare professional. The information provided by the HairDx Test report is not intended to start, stop or change any course of treatment. The purpose of this study is to collect DNA samples from subjects. The DNA samples will be used for the analytical validation of the HairDx Test. The results of this study will not be shared with the subjects.

Eligibility criteria: Inclusion Criteria:

* Females over the age of 18
* Overall good health
* Able to give informed consent
* Willing to collect saliva sample

Exclusion Criteria:

* Xerostomia (dry mouth)
* Inability to provide informed consent in English
* Inability to follow instructions for saliva sample collection
* Non US resident

Primary outcomes:
measure: Determination of the accuracy of the HairDx Test
timeFrame: Baseline
measure: Determination of the precision and reproducibility of HairDx Test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Applied Biology, Inc.
state: California
Study officials:
affiliation: Applied Biology, Inc.
name: John McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Redler S, Birch P, Drichel D, Hofmann P, Dobson K, Bohmer AC, Becker J, Giehl KA, Tazi-Ahnini R, Kruse R, Wolff H, Miesel A, Fischer T, Bohm M, Nuwayhid R, Garcia Bartels N, Lutz G, Becker T, Blume-Peytavi U, Nothen MM, Messenger AG, Betz RC. The oestrogen receptor 2 (ESR2) gene in female-pattern hair loss: replication of association with rs10137185 in German patients. Br J Dermatol. 2014 Apr;170(4):982-5. doi: 10.1111/bjd.12756. No abstract available.