louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04213430: Development and Validation of a Deep Learning System for Multiple Ocular Fundus Diseases Using Retinal Images
Official title: Development and Validation of a Deep Learning System for Multiple Ocular Fundus Diseases Using Retinal Images: a Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ophthalmological Disorder
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 300000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Retinal images were collected from different health care institutes all over China and other countries around the world.

Brief summary: Retinal images can reflect both fundus and systemic conditions (diabetes and cardiovascular disease) and firstly to be used for medical artificial intelligence (AI) algorithm training due to its advantages of clinical significance and easy to obtain. Here, the investigators developed a single network model that can mine the characteristics among multiple fundus diseases, which was trained by plenty of fundus images with one or several disease labels (if they have) in each of them. The model performance was compared with those of both native and international ophthalmologists. The model was further tested by datasets with different camera types and validated by three external datasets prospectively collected from the clinical sites where the model would be applied.


Eligibility criteria: Inclusion Criteria:

* The quality of fundus images should clinical acceptable. More than 80% of the fundus image area including four main regions (optic disk, macular, upper and lower retinal vessel archs) are easy to read and discriminate.

Exclusion Criteria:

* Images with light leakage (\>30% of area), spots from lens flares or stains, and overexposure were excluded from further analysis.

Primary outcomes:
measure: Area under the receiver operating characteristic curve of the deep learning system
timeFrame: baseline
Secondary outcomes:
measure: Sensitivity of the deep learning system
timeFrame: baseline
measure: Specificity of the deep learning system
timeFrame: baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
References:
citation: Lin D, Xiong J, Liu C, Zhao L, Li Z, Yu S, Wu X, Ge Z, Hu X, Wang B, Fu M, Zhao X, Wang X, Zhu Y, Chen C, Li T, Li Y, Wei W, Zhao M, Li J, Xu F, Ding L, Tan G, Xiang Y, Hu Y, Zhang P, Han Y, Li JO, Wei L, Zhu P, Liu Y, Chen W, Ting DSW, Wong TY, Chen Y, Lin H. Application of Comprehensive Artificial intelligence Retinal Expert (CARE) system: a national real-world evidence study. Lancet Digit Health. 2021 Aug;3(8):e486-e495. doi: 10.1016/S2589-7500(21)00086-8.
Clinical trial NCT02123030: A Micro/Nano Device for Exhaled Breath Analysis
Official title: A Micro/Nano Device for Exhaled Breath Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Pulmonary Disease
Keywords: Lung cancer
pulmonary disease
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2014-04-25
Enrollment: 728
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those fitting inclusionary criteria between 20 and 85 years of age, with or without history of pulmonary disease or cancer.

Brief summary: Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.

Detailed description: Will use Fourier Transform Mass Spectrometry (FT-MS) and Gas Chromatography-Mass Spectrometry (GC-MS) to analyze concentrated VOCs. The purpose of this study is to search for disease-related markers in the breath in subjects with known or suspected lung or other cancer, or pulmonary disease.

Eligibility criteria: Inclusion Criteria:

* For controlled (healthy) subjects - we are seeking persons who do not have a known history of cancer or pulmonary disease.
* Both smokers and nonsmokers are invited to participate as control subjects.
* For experimental subjects, we are seeking persons with pulmonary disease but no known history of cancer, as identified by the investigators during routine clinic or office visits.
* Additionally for experimental subjects, we are seeking persons with known or suspected lung or other cancers, as identified by the investigators during routine clinic or office visits.

Exclusion Criteria:

Primary outcomes:
measure: Detection of disease related markers (biomarkers) from concentrated volatile organic compounds in breath samples
timeFrame: 1 day (After sample collection)
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center-University of Louisville
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center
name: Xiao-An Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05995730: Effect of Lavender Inhalation on Dysmenorrhea
Official title: Effect of Lavender Inhalation on Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned to determine the effect of lavender inhalation on primary dysmenorrhea and its symptoms.

Detailed description: The research is a randomized controlled trial and an experimental research design will be used. The research will be carried out with two groups as experimental (lavender) and control (placebo) groups.

Eligibility criteria: Inclusion Criteria:

* Having primary dysmenorrhea (degrees II and III),
* Single,
* Who have never been pregnant before,
* Having a regular menstrual cycle
* Without any genital organ disorder (such as fibroids, fibroadenoma, endometriosis, metrorrhagia, ovarian cyst, pelvic inflammatory disease, chronic pelvic pain, other pelvic pathologies)
* Not using contraceptive method,
* Having a normal sense of smell
* People who can smell odors and are not allergic to odors will be included in the study.

Exclusion Criteria:

* Married,
* Having a disease that causes dysmenorrhea,
* Regularly using a pharmacological and non-pharmacological method to relieve
* Dysmenorrhea pain during the study,
* Having a previous or unconcluded pregnancy,
* Having a chronic disease (diabetes, endometriosis, uterine congenital anomalies, epilepsy, etc.),
* Using drugs that affect the menstrual cycle or dysmenorrhea,
* Persons who fill in the data collection form incompletely or not at all will not be included in the study.

Primary outcomes:
measure: Dysmenorrhea Symptom Assessment Form
timeFrame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
measure: Numerical Pain Scale
timeFrame: to assess post-intervention change; It is applied on the 1st, 2nd and 3rd days of the menstrual cycle during 2 menstrual cycles.
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya Training and Research Hospital
Study officials:
References:
Clinical trial NCT04632030: Shrinking the Size of the Tobacco Power Wall
Official title: Shrinking the Size of the Tobacco Power Wall and Restricting the Number of Tobacco Products Displayed to Reduce Adolescent Tobacco Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Lead sponsor: RAND
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 275
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall aim of this research is to experimentally evaluate the extent to which reducing the size of the tobacco power wall and the number of tobacco product units displayed influences tobacco use risk in adolescents.

Detailed description: This experiment will take place in the RAND StoreLab (RSL), a life-sized replica of a convenience store that we developed to evaluate how altering aspects of tobacco promotion at POS influences tobacco use risk during simulated shopping experiences. The study will use a between-subjects design, in which adolescents are randomly assigned to shop in the RSL under one of three conditions: (1) Large power wall/ multiple product units displayed; (2) Medium-sized power wall/multiple product units displayed; and (3) Small power wall/single product units displayed. We will consider the effect of these power wall alterations on risk of use of four classes of tobacco products: cigarettes, electronic nicotine delivery devices, cigarillos, and smokeless tobacco.

Eligibility criteria: Inclusion Criteria:

* between the ages of 11 and 20

Exclusion Criteria:

* any medical or psychological condition that would make participation in the procedures of the study difficult (based on self-report).

Primary outcomes:
measure: Proportion at Risk for Cigarette Smoking
timeFrame: within 5 minutes of the intervention
measure: Proportion at Risk of Using Electronic Nicotine Delivery Devices (ENDS)
timeFrame: within 5 minutes of the intervention
measure: Proportion at Risk of Using Smokeless Tobacco
timeFrame: within 5 minutes of the intervention
measure: Proportion at Risk of Using Little Cigar/Cigarillos (LCC)
timeFrame: within 5 minutes of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: RAND
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03029130: Catheter Extension Trial for Early Vesicovaginal Fistula Repair Failures
Official title: Does Extending Catheterization Improve Outcomes in Early Vesicovaginal Fistula Repair Failures? A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vesico Vaginal Fistula
Keywords: vesicovaginal fistula
urinary catheter
catheter extension
Lead sponsor: Evangel VVF Centre
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 232
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the use of extending time of continual urinary drainage (using transurethral foley catheter) for patients with early failures of vesicovaginal fistula repairs. Half of those included will be randomized to replacement of foley catheter for a length of 14 additional days, while the other half will be discharged (no intervention). Both groups will be examined for outcomes at 3 months post-repair.

Detailed description: At present, there is no standard of care nor consensus for the proper management of repaired vesicovaginal fistulas that begin leaking prior to or immediately after scheduled catheter removal. In the past, extension of time with catheterization has been tried, with patients becoming fully healed by the time of catheter removal. However, some patients who are discharged with a fistulous leak later return at follow up completely dry, with a closed and healed fistula. This study will compare, in a prospective, randomized manner, extension of catheterization vs no intervention, to see if in such patients extending catheterization will improve their likelihood of complete fistula healing.

Eligibility criteria: Inclusion Criteria:

* Women who present with a vesicovaginal fistula for surgical repair AND who, at the time of initial catheter removal (7 or 14 days post-repair), have demonstrable fistulous leak on dye test

Exclusion Criteria:

* HIV infection,
* concomitant bladder stone(s),
* one or more ureters outside of the bladder,
* urethrovaginal fistula,
* multiple fistulas (more than one),
* dye leak / fistulous leak present at end of surgical procedure,
* radiation-induced fistula,
* fistula caused by cancer or infection (such as lymphogranuloma venereum),
* continence procedures being performed (such as pubovaginal sling),
* rectovaginal fistula,
* pregnancy,
* fistula breakdown of greater than 2cm identified on postoperative dye test.

Primary outcomes:
measure: Fistula closure
timeFrame: 3 months post-repair
Secondary outcomes:
measure: Urinary continence
timeFrame: 3 months post-repair
measure: Closure and continence at hospital discharge
timeFrame: Date of discharge (7-28 days post-repair)
measure: Complications
timeFrame: Duration of hospitalization (minimum 7 days, maximum 28 days post-repair)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04906330: Oncoliq: Test for Early Breast Cancer Detection.
Official title: Oncoliq: Test for Early Breast Cancer Detection.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Liquid biopsy, breast cancer, early detection, microRNAs.
Lead sponsor: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Sponsor class: OTHER
Collaborators: name: Instituto Nacional del Cáncer, Argentina
First posted: 2021-05-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients, without a personal history of oncological pathology, who attend for gynecological and mammographic control.

Brief summary: Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test will allow improving the accuracy of cancer detection which will impact on health, reducing the patient mortality and health costs.

To develop this test, it has been finished the preclinical PHASE I: in laboratory animals; PHASE II: exploratory clinical phase for the discovery of candidate biomarkers in breast cancer patients and PHASE III: clinical validation of biomarkers showing that Oncoliq has 91% of sensitivity.

Currently it is been setting up a "pilot test" for breast cancer to enrol 500 woman volunteers without previous cancer diagnosis that go to the annual medical control. The results of the pilot test will give the accuracy for early breast cancer detection.


Eligibility criteria: Inclusion Criteria:

* Women patients performing gynecological control
* Between 50-70 years old
* Without personal history of oncological disease
* Informed consent signed

Exclusion Criteria:

* Patients who don´t meet the inclusion criteria.
* Active infection with SARS-CoV-2 (COVID-19).

Primary outcomes:
measure: miRNA levels in plasma
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Hospital Militar Central
state: Buenos Aires
Study officials:
affiliation: IBYME-CONICET
name: Adriana De Siervi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543530: Pediatric Expanded Access Program-Oral Solution (0831-908)
Official title: A Noncomparative,Open, Multisite Study to Monitor the Safety and Tolerability of Efavirenz Oral Solution Given in Combination Antiretroviral Therapy (ART) in ART-naive or Experienced HIV-1 Infected Patients Age 3 to 16 Years Who Have Failed Therapy or Are Intorerant to Their Current ART Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: HIV
Treatment Experienced
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Not tolerating current ART regime laboratory status is stable
* Able to take oral liquid medications but have difficulty swallowing capsules
* Weigh at least 10 kg (22 lbs)

Exclusion Criteria:

* Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to taking study drug
* Have taken another investigational drug 30 days before starting this study
* Have a history of drug or alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05612230: A Lifecourse Map of Diseases in China
Official title: A Lifecourse Map of Common Diseases and Rare Diseases in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Common Diseases
Rare Diseases
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: National Health Medical Data (North Center)
First posted: 2022-11-10
Enrollment: 40000000
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: All inpatients within the period of January 1, 2017 to December 31, 2021.

Brief summary: The purpose of this study is to form a chronological map of common diseases and rare diseases in Chinese population by determining the prevalence of different diseases in each age group.

Detailed description: Studying the distribution of various diseases in specific populations can help explore the causes of diseases, elucidate the distribution patterns, and develop preventive and control measures. Based on an overall assessment of prevalence, the combination of relevant results with age at diagnosis for multiple diseases is important for further understanding of the distribution of diseases at the population level. Therefore, this study aims to form a chronological map of common diseases and rare diseases in Chinese population by determining the prevalence of different diseases in each age group, thus providing a reference for more effective prevention, diagnosis and treatment of diseases.

Eligibility criteria: Inclusion Criteria:

1. All inpatients within the period of January 1, 2017 to December 31, 2021.
2. Patients with discharge diagnosis.
3. Patients with accurate gender and age records.

Exclusion Criteria:

1. Morbidity and mortality due to external causes, i.e. injuries, poisonings and other adverse events due to external environment and accidents.
2. Pregnancy-related conditions.
3. Symptoms, signs, abnormal clinical and laboratory findings.
4. Traditional Chinese Medicine diagnosis records.
5. Patients with incorrect or missing disease codes.

Primary outcomes:
measure: age-specific prevalence rate
timeFrame: between January 1, 2017 and December 31, 2021
measure: sex-specific prevalence rate
timeFrame: between January 1, 2017 and December 31, 2021
Secondary outcomes:
measure: total cost of hospitalization
timeFrame: between January 1, 2017 and December 31, 2021
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT04474730: Physical Activity Monitoring Among BMT Patients
Official title: Physical Activity Monitoring Among Bone Marrow Transplant Patients: An Apple Watch Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Marrow Transplantation
Keywords: Bone Marrow Transplantation
Mobile Health
Symptom Management
Physical Activity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, we conduct a small randomized controlled trial to study the feasibility of an Apple Watch app developed to monitor bone marrow transplant patients' physical activities at their initial hospitalization.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to evaluate the feasibility of an apple watch-based application to promote physical activity among bone marrow transplant (BMT) patients.

Detailed description: The research objective is to test the feasibility of using an Apple Watch-based system with the capacity to monitor BMT patients' physical activity and other patient reported outcomes at an ongoing basis within the inpatient BMT setting at the University of Kentucky Markey Cancer Center (UKMCC). The central hypothesis in this project is that the Apple Watch-based system designed based on user-centered design principles and the proposed study method will yield high feasibility.

Eligibility criteria: Inclusion Criteria:

* Design Phase: Post 100 days BMT patients, family caregivers and providers
* Trial Phase: New BMT patients

Exclusion Criteria:

* under 18 years old;
* can't communicate, read or write in English;
* having any communicable infection or showing the signs of it, including coughing, fever, or rash;
* and incapable of completing the assigned research activities.

Primary outcomes:
measure: Feasibility - Recruitment
timeFrame: The day of recruitment
measure: Feasibility - Study completion
timeFrame: From enrollment to 30 day post transplant or at hospital discharge
measure: Feasibility - Usability
timeFrame: 30 day post transplant or at hospital discharge
Secondary outcomes:
measure: Physical Activity
timeFrame: 30 days post intervention or at hospital discharge
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Ming-Yuan Chih, PhD
role: PRINCIPAL_INVESTIGATOR
References: