louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05723965: Using Artificial Intelligence to Predict Rectal Cancer Outcomes
Official title: Using CNN Image Recognition to Predict Rectal Cancer Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer Stage III
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 720
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rectal cancer diagnosed during 2010.10.1-2022.7.31. clinical T3-4 lesion. with high quality CT images with contrast.

Brief summary: Investigator retrospective collect cases during 2010-2021 diagnosed as rectal adenocarcinoma with high quality CT images. Local advanced rectal cancer cases were labeled as "disease". Nor were defined " normal".

Using artificial intelligence CNN on jupyter notebook with open phyton code to train and develop models capable to recognizing local advanced rectal cancer. Modify the phyton code for better predict rate and help physician to quickly evaluate disease severity for fresh rectal cancer cases.

Detailed description: From 2010.10.1\~2021.12.31, rectal cancer patients with cT3-4 lesion was included. Collect high quality CT images with DICOM files in tumor segment. cT1-2, low rectal lesions, non-CRC cases were not included. Non-contrast and artificial defect images were also excluded. CT images were labeled as" diseased " when CRM were threatened (\<2mm). All images were labeled according to judgment of 2 specialist. The data were separated into 2 parts. One for AI model training and testing, another for external validation. The training testing dataset was achieved by deep learning neural network and evaluating model accuracy performance. Then the model was applied into external validation dataset for real-world testing, evaluating coherent rate between AI and the Dr. decision. Furthermore, to see the cancer survival outcomes according to AI model prediction results.

Eligibility criteria: Inclusion Criteria:

* clinical staging T3-4 with high quality CT images.

Exclusion Criteria:

* 1. not primary malignancy lesion
* 2. not localizing rectum
* 3. T1-2 lesion
* 4. non contrast or poor quality images

Primary outcomes:
measure: accuracy of artificial intelligence with experienced physician
timeFrame: 1 week after images done.
Secondary outcomes:
measure: real life survival outcome of diagnosis by artificial intelligence.
timeFrame: 5 years after diagnosed
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Verterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: ChunuYu Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04464265: Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Official title: Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Music
Propofol
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-07-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to better understand the systems-level neuronal mechanisms by which general anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress consciousness by disrupting the functioning of large-scale brain networks that support information integration in the brain.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy, non-smoking, no or minimal alcohol use
* Right-handed
* Body mass index (BMI) of less than 30
* English speakers

Exclusion Criteria:

* Medical contraindication to Magnetic Resonance Imaging (MRI) scanning
* Unable to undergo MRI scanning because of possible pregnancy
* BMI over 30
* Tattoos in the head or neck region
* Unwilling to abstain from alcohol for 24 hours prior to dosing

Primary outcomes:
measure: Blood Oxygen Level Dependent (BOLD) Response to Sensory Stimuli During Sedation
timeFrame: 60 minutes
Secondary outcomes:
measure: Average Squeeze Pressure Over 60 Minutes
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Anthony Hudetz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02659865: A Study of LY3039478 in Healthy Participants
Official title: A Single Ascending Dose Study for the Evaluation of the Effects of LY3039478 on the QT/Corrected QT Interval in Healthy Subjects and Pilot Relative Bioavailability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-01-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to investigate the safety of the study drug known as LY3039478 and evaluate two different formulations of LY3039478 in healthy participants. Part A has three periods. Either LY3039478 or placebo will be given once by mouth in each period. Part B has two periods. Participants will receive both formulations of LY3039478, by mouth, over the course of the study. Both parts of the study will also explore how much LY3039478 gets into the bloodstream and how long it takes the body to get rid of it. Information about any side effects will also be collected. Participants may only enroll in one part. The study will last at least 33 days, not including screening. Screening must be performed up to 30 days before enrollment.

Part B was added by protocol amendment approved in April, 2016.


Eligibility criteria: Inclusion Criteria:

- Body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²)

Exclusion Criteria:

- Known allergies to LY3039478, related compounds or any components of the formulation

* Have previously received LY3039478
* Smokers or who have stopped smoking less than 3 months ago

Primary outcomes:
measure: Mean Time-Matched Difference in QTcF Interval Between LY3039478 (new formulation) Compared To Placebo at the Maximum Concentration (Cmax) of LY3039478
timeFrame: Predose up to 48 hours after administration of study drug in each period
Secondary outcomes:
measure: Pharmacokinetics; Maximum Concentration (Cmax) of LY3039478 (new formulation)
timeFrame: Predose up to 48 hours after administration of study drug in each period
measure: Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) of LY3039478 (new formulation)
timeFrame: Predose up to 48 hours after administration of study drug in each period
measure: Pharmacokinetics; Maximum Concentration (Cmax) of the 2 Formulations of LY3039478
timeFrame: Predose up to 48 hours after administration of study drug
measure: Pharmacokinetics; Area Under the Concentration Versus Time Curve (AUC) for the 2 formulations of LY3039478
timeFrame: Predose up to 48 hours after administration of study drug
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02193165: The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis
Official title: The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Gingivitis
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2014-07-17
Enrollment: 120
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.


Eligibility criteria: Inclusion Criteria:

1. Male and female subjects, ages 21-70, inclusive.
2. Availability for the six-week duration of the study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Use of antibiotics any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
13. History of alcohol or drug abuse

Primary outcomes:
measure: Dental Plaque Scores
timeFrame: Baseline
measure: Dental Plaque Scores
timeFrame: 4 weeks
measure: Dental Plaque Scores
timeFrame: 6 weeks
measure: Gingivitis Scores
timeFrame: Baseline
measure: Gingivitis Scores
timeFrame: 4 weeks
measure: Gingivitis Scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Trujillo Alto
country: Puerto Rico
facility: Centro Comercial Plaza Trujillo
Study officials:
References:
Clinical trial NCT03159065: Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance
Official title: Early Postprandial Efficacy of Probiotic Fruit Beverages on Glucose Tolerance and Insulin Resistance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Consumption of polyphenol-rich fruits and vegetables may improve the postprandial glucose and insulin responses and hence promote well-being. It has previously been observed that consumption of a bilberry drink decreases the postprandial insulin demand. In the present study, the impact of probiotic fruit beverages with different polyphenol profiles on the postprandial levels of glucose and insulin, were investigated.


Eligibility criteria: Inclusion Criteria:

* Healthy, not on medication, non-allergic, individuals aged 18-65 years old, having a BMI between 20-30 kg/m2 and also maintaining stable body weight, i.e. less than 5% weight change in the last three months before the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Efficacy of the study products on the postprandial serum insulin
timeFrame: Incremental area under the curve for serum insulin from 0 min up to 120 min following the ingestion of the study product
Secondary outcomes:
measure: Efficacy of the study products on the postprandial serum glucose
timeFrame: Incremental area under the curve for serum glucose from 0 min up to 120 min following the ingestion of the study product
Other outcomes:
Locations:
Study officials:
affiliation: Lund University
name: Yvonne Granfeldt, Prof
role: STUDY_DIRECTOR
References:
citation: Xu J, Jonsson T, Plaza M, Hakansson A, Antonsson M, Ahren IL, Turner C, Spegel P, Granfeldt Y. Probiotic fruit beverages with different polyphenol profiles attenuated early insulin response. Nutr J. 2018 Feb 27;17(1):34. doi: 10.1186/s12937-018-0335-0.
Clinical trial NCT02493465: Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study
Official title: Effects of Everolimus in Left Ventricular Hypertrophy After Conversion From Azathioprine: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Left Ventricular Hypertrophy
Keywords: everolimus
left ventricular hypertrophy
Lead sponsor: Instituto de Urologia e Nefrologia
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This is a prospective, open label, single-center study, in kidney transplant recipients with stable renal function for 12 and 120 months after transplantation, that are in use use of calcineurin inhibitors, azathioprine, and prednisone. The prevalence of left ventricular hypertrophy will be investigated before and after conversion of azathioprine to everolimus.

This study will evaluate as primary objectives: the prevalence of left ventricular mass hypertrophy in renal transplant recipients with azathioprine therapy. And assess the ability of everolimus to reduce left ventricular mass after conversion from Azathioprine, using sensitive methods such as MRI. And as secondaries objectives: Renal function (measured GFR) at 3 and 6 and 12 months after conversion, number and severity of episodes of acute rejection proven by biopsy, and the proteinuria at 3, 6 and 12 months after conversion.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years (black and white subjects);
* Kidney transplant recipients of living donor or deceased with creatinine clearance (measured / estimated) \> 50 ml /L for at least 12 months, receiving azathioprine with or without calcineurin inhibitor with or without prednisone.

Exclusion Criteria:

* The subject, in the opinion of the investigator, is not able to complete the study protocol;
* Multiple organ transplant recipient;
* Pregnant women
* Breastfeeding and childbearing age without contraceptive method
* Test for Positive immunodeficiency virus (HIV)
* Treatment of acute rejection in the last 3 months
* Glomerulonephritis new relapse
* New or polyomavirus nephropathy
* protein / creatinine ≤ 150 mg / mmol or 24h proteinuria\> 500mg

Primary outcomes:
measure: Progression of left ventricular hypertrophy
timeFrame: 12 months
Secondary outcomes:
measure: renal function
timeFrame: 3,6, 12 months
measure: proteinuria
timeFrame: 3,6, 12 months
measure: acute rejection episodies
timeFrame: 12 months
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Instituto de Urologia e Nefrologia
state: São Paulo
Study officials:
References:
Clinical trial NCT00338065: External Influences Upon Ocular Homeostasis
Official title: External Influences Upon Ocular Homeostasis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Intraocular Pressure
Keywords: Intraocular Pressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Our experiments are designed to test the overall hypothesis that position-dependent or water-dependent intra-ocular pressure (IOP) spikes occur in humans, and that these challenge ocular homeostasis.

Detailed description: Glaucoma is the second leading cause of blindness in the United States, yet its pathogenesis is poorly understood. This is an insidious disorder since the loss of peripheral vision which occurs first usually is not noticed by the victim. Approximately 1 million people in the United States have glaucoma, but are not aware of it. Glaucoma is not always associated with elevated intraocular pressures so that vision screenings which measure just intraocular pressure without assessing the optic nerve will also miss these patients with glaucomatous damage. Therefore, patients are often diagnosed only when they have severe irreversible vision loss. Vascular insufficiency or abnormal autoregulation versus mechanical pressure damage has been proposed as a major factor in the development of glaucoma. Presently, therapy is based upon lowering intraocular pressure. If a contributing intermittent pressure elevation factor can be elucidated and characterized, specific treatment modalities may then be developed and their effectiveness can be monitored.

Eligibility criteria: Inclusion Criteria:

* Patients with autonomic dysfunction
* Patients with open-angle glaucoma
* Patients with normal-pressure glaucoma
* Normal subjects

Exclusion criteria:

* Medical students
* Prisoners
* Pregnant women

Primary outcomes:
measure: Change in Intraocular Pressure
timeFrame: Within 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt Eye Institute
name: Karen Joos, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phillips L, Robertson D, Melson MR, Garland EM, Joos KM. Pediatric ptosis as a sign of treatable autonomic dysfunction. Am J Ophthalmol. 2013 Aug;156(2):370-374.e2. doi: 10.1016/j.ajo.2013.03.009. Epub 2013 Apr 24.
citation: Shibao CA, Joos K, Phillips JA 3rd, Cogan J, Newman JH, Hamid R, Meiler J, Capra J, Sheehan J, Vetrini F, Yang Y, Black B, Diedrich A, Roberston D, Biaggioni I. Familial Autonomic Ganglionopathy Caused by Rare CHRNA3 Genetic Variants. Neurology. 2021 Jul 13;97(2):e145-e155. doi: 10.1212/WNL.0000000000012143. Epub 2021 May 4.
Clinical trial NCT01569165: Effect of Water Rinsing After Topical Fluoride Application on Dental Plaque pH
Official title: Effect of Water Rinsing After APF Application on Dental Plaque Acidogenicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Acidogenicity
Acidulated phosphate fluoride
dental plaque
water rinsing
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine whether rinsing with water or cleansing teeth after topical fluoride therapy affect the dental plaque pH.


Eligibility criteria: Inclusion Criteria:

* healthy people (Without any systemic disease)
* normal unstimulated salivary rate

Exclusion Criteria:

* Active dental caries
* taking any medication with any effect on saliva rate
* taking antibiotic (or antibacterial mouth rinses) during last 4 weeks
* usig fluoride mouth rinses during last 2 weeks.

Primary outcomes:
measure: dental plaque PH
timeFrame: the pH of 48-hour dental plaque was measured using plaque sampling method before (baseline pH) and after sucrose challenge at 5, 10,15,20,30 minutes
Secondary outcomes:
measure: maximum pH drop
timeFrame: 5,10,15,20 and 30 min after sucrose chalenge
measure: pH recovery time
timeFrame: within 30 min after sucrose challenge
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Dental School - Mashhad University of Medical Siences
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Siences
name: fatemeh mazhari, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02380365: QT-Prolongation in Lung Transplantation
Official title: QT-Prolongation in Lung Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Disorder Related to Lung Transplantation
Keywords: lung transplantation
electrocardiography
macrolides
QTc interval
arrhythmia
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 720
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: Follow-up Patients after lung transplantation

Brief summary: Experimental intervention: electrocardiography. Control intervention: none

Duration of intervention per patient/subject:

5 min, observation 6 months

Key inclusion criteria:

* outpatients after lung transplantation (single, double or combined)
* outpatients on the wait list for lung transplantation

Key exclusion criteria:

• no informed consent

Detailed description: Primary endpoint:

• prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

Key secondary endpoint(s):

* prevalence of any QTc-interval prolongation (\>440 msec ) after lung transplantation
* prevalence of PQ prolongation (200 msec sec or above) after lung transplantation
* prevalence of QRS prolongation (120 msec or above) after lung transplantation
* prevalence of QTc-prolonging drugs in drug regimen before and after lung transplantation
* influence of long-term neo-macrolide (e.g. azithromycin) on QTc interval after lung transplantation
* intra-individual difference of QTc interval before and after lung transplantation
* incidence of any QTc-interval prolongation(\>440 msec ) after lung transplantation
* incidence of any QTc-interval prolongation (\>440 msec or increase by 50msec or above) after initiation of new QTc prolonging drugs (especially neo-macrolides)
* reversal of QTc-interval prolongation (440 msec or lower or decrease by 50msec or above) after stopping any QTc prolonging drug
* Assessment of safety:
* Incidence of new onset heart rhythm disorder during 6 months of follow-up

Eligibility criteria: Inclusion Criteria:

* outpatients after lung transplantation (single, double or combined)
* outpatients on the wait list for lung transplantation

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Department of Respiratory Medicine, Medizinische Hochschule Hannover
Study officials:
affiliation: Hannover MS, Dpt Respiratory Medicine
name: Jens Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References: