louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05731765: SVP Detection Using Machine Learning
Official title: Automated Detection of Spontaneous Venous Pulsations Within Fundal Videos Using Machine Learning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Pressure Increase
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged ≥18 years with presumed normal ICP or suspected raised ICP

Brief summary: This diagnostic study will use 410 retrospectively captured fundal videos to develop ML systems that detect SVPs and quantify ICP. The ground truth will be generated from the annotations of two independent, masked clinicians, with arbitration by an ophthalmology consultant in cases of disagreement.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years with presumed normal ICP undergoing routine dilated OCT scans.
* Patients undergoing a LP or continuous ICP monitoring with implanted transcranial pressure transducer devices at in- or out-patient neurology, neurosurgery or neuro-ophthalmology services.

Exclusion Criteria:

* Glaucoma diagnosis or glaucoma suspects in either eye.
* Bilateral restricted fundal view, e.g. advanced bilateral cataracts.
* Bilateral retinal vein or artery occlusion.

Primary outcomes:
measure: Area-under-the receiver operating characteristic (AUROC) for spontaneous venous pulsations detection
timeFrame: 1 year
Secondary outcomes:
measure: Localisation of spontaneous venous pulsations
timeFrame: 1 year
measure: Quantification of intracranial pressure
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
Clinical trial NCT00536965: Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
Official title: Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemias
Atherosclerosis
Coronary Heart Disease
Carotid Stenosis
Peripheral Vascular Diseases
Diabetes Mellitus
Keywords: Hyperlipidemia
Need-to-treat
NIS
Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female type II diabetics with: coronary disease with event: acute coronary syndrome, status post MI, PTCT, CABG, angiographically verified), or proven atherosclerotic progression (PAVK min. IIb or S.p. revascularization, stroke/TIA, carotis-plaque: asymptomatic min. 70% or S.p. revascularization)

Brief summary: A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<100mg/dl for patients with high risk and \<70mg/dl for patients at very high risk) are screened (office-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility criteria: Inclusion Criteria:

* Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Patients who do not receive cholesterol-lowering therapy

Primary outcomes:
measure: Lipid profile
timeFrame: At screening and 8-5 weeks after screening
measure: HbA1c profile
timeFrame: At screening and 8-5 weeks after screening
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Research Site
Study officials:
affiliation: Chair of the Austrian Atheroslerosis Society
name: Josef Patsch, MD
role: STUDY_CHAIR
affiliation: Co-Chair of the Austrian Atheroslerosis Society
name: Bernhard Foger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06600165: Intraoperative Confocal Laser Scanning Microscopy with Use of AI for Optimized Surgical Excision of Basal Cell Carcinoma
Official title: Intraoperative Confocal Laser Scanning Microscopy and Artificial Intelligence for Optimized Surgical Excision of Basal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Basal Cell Carcinoma
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Basal Cell Carcinoma undergoing biopsy or surgery

Brief summary: The aim is to use AI to assist surgeons in analyzing CLSM tissue slide images obtained during BCC surgeries with the aim to integrate it in real time. We plan to use AI to analyze CLSM images of BCCs and distinguish between tumor tissue, inflammatory tissue, and non-tumor/non-inflammatory tissue. This approach would provide surgeons with real-time feedback and automated image analysis, leading to a more targeted and efficient approach to tissue analysis. By improving the accuracy and speed of tissue analysis, our proposal could ultimately improve operative patient outcomes and benefit healthcare professionals.


Eligibility criteria: Inclusion Criteria:

* Patients with Basal Cell Carcinoma

Exclusion Criteria:

* Patient unable to consent

Primary outcomes:
measure: Ex vivo confocal laser scanning microscopy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04447248: qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses
Official title: Quantitative Cardiotocography and Doppler Ultrasound in the Detection of Hypoxia Among Growth-restricted Fetuses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Late-onset Fetal Growth Restriction
Lead sponsor: Orthogyn Medical Center, Bulgaria
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 1714
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bulgarian population (caucasian)

Brief summary: To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of fetal hypoxia (pH \< 7.20) among late-onset growth restricted (SGR) fetuses


Eligibility criteria: Inclusion Criteria:

* estimated fetal weight below the 10th centile of the reference curve for the Bulgarian population (11);
* absence of sonographic and laboratory evidence of structural anomalies;
* absence of severe maternal complications;
* documented birth weight \< 10th centile;
* full follow-up documentation

Exclusion Criteria:

* multiple pregnancies;
* congenital malformations and any chromosomal malformations known before labor and delivery;
* severe maternal complications;
* documented birth weight \> 10th centile;
* pregnancy loss;
* failure to obtain full follow-up documentation

Primary outcomes:
measure: Occurence of hypoxia (pH<7.20) at birth
timeFrame: up to 5 minutes after delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01042548: Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
Official title: Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and Serum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Proteomics
Breast Cancer Markers
Tissue Interstitial Fluid
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: David Scaife Foundation
First posted: 2010-01-05
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: All patients who are receiving or seeking medical care at the UPMC St. Margaret for breast cancer will be invited to participate in the research study. Patients undergoing surgery for breast nodules suspected of being cancer or high risk lesions, breast tissue reduction, or prophylactic mastectomy will also be asked to participate.

Brief summary: The current study is a case control study involving comparisons of tissue interstitial fluid from breast cancer and adjacent non-cancerous tissue as well as that from benign breast lesion and its adjacent non-diseased tissue for a distinguishable breast cancer profile. The purpose of this research is to collect fresh breast nodule/cancer and surrounding non-cancerous tissue for proteomic studies of the interstitial fluid to identify a profile distinguishing breast cancer which will also permit future research on stored interstitial fluid, blood or tissue samples. Specific markers identified from interstitial fluid study will be investigated in blood samples to develop serum markers for breast cancer diagnosis and prognosis. Additionally, we will perform both prospective and retrospective research on breast cancer involving clinical, demographic, epidemiologic information, treatment, follow-up and outcomes on breast nodule/cancer cases collected.


Eligibility criteria: Inclusion Criteria:

* All subjects ≥ 18 years of age undergoing surgery for indeterminate breast nodules, breast tissue reduction, prophylactic mastectomy, and all subjects with newly diagnosed invasive breast cancer will be eligible to participate. If invasive breast cancer or suspicion of invasive breast cancer, target lesion must measure ≥ 1.0 cm on breast imaging before core biopsy.

Exclusion Criteria:

* Anyone \< 18 years of age.
* Multiple synchronous primary malignancies from different organ systems.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC St. Margaret
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02196948: Electrolysis Percutaneous Therapeutic (EPTE) for Supraspinatus Tendinopathy
Official title: Electrolysis Percutaneous Therapeutic (EPTE) for the Management of Supraspinatus Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supraspinatus Tendinopathy
Keywords: Supraspinatus, tendinopathy, pain, disability, EPTE
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2014-07-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Therapeutic management of supraspinatus tendinopathy is conflicting. There is evidence that eccentric exercise protocols can be effective for this condition. The inclusion of other therapeutic modalities could help to the management of these patients. A new therapeutic approach, called Electrolysis Percutaneous Therapeutic (EPTE) has been clinically developed. The objective of this randomized clinical trial is to determine the effectiveness of the inclusion of EPTE into a eccentric exercise protocol for the management of patients with unilateral supraspinatus tendinopathy


Eligibility criteria: Inclusion Criteria:

* Unilateral supraspinatus tendinopathy
* Shoulder pain from at least 3 months
* Shoulder pain of more than 4 points on a NPRS
* Positive findings of supraspinatus tendinopathy on MRI

Exclusion Criteria:

* bilateral shoulder symptoms
* younger than 18 or older than 65 years
* history of shoulder fractures or dislocation
* cervical radiculopathy
* previous interventions with steroid injections
* fibromyalgia syndrome
* previous history of shoulder or neck surgery
* any type of intervention for the neck-shoulder area during the previous year

Primary outcomes:
measure: Changes in pain intensity before and after the intervention
timeFrame: Baseline, after 2 weeks of treatment and one week after the last session
Secondary outcomes:
measure: Changes in disability before and after the intervention
timeFrame: Baseline, after 2 weeks of treatment and one week after the last session
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Hospital Universitario Gregorio Marañón-Universidad Rey Juan Carlos
name: Jose Luis Arias Buría, PT, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Rey Juan Carlos
name: César Fernández de las Peñas, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00582348: Physical Activity and Inactivity in Lung Cancer Survivors
Official title: Physical Activity and Inactivity in Lung Cancer Survivors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Survivors
Keywords: Lung Cancer
Survivor
Lung
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2007-12-28
Enrollment: 188
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible lung cancer survivors will be identified by the Thoracic DMT Data Manager from the Thoracic Surgical Database.

Brief summary: The purpose of this study is to learn how often lung cancer survivors exercise. We also want to learn what helps people to be active or prevents them from being active. Learning this will help us to expand services for lung cancer survivors.

Detailed description: Despite the potential benefits of physical activity, particularly for cancer survivors with comorbid pulmonary and cardiac conditions, no previous research has examined the physical activity levels of lung cancer survivors, an underrepresented subpopulation in cancer survivorship research. We address this research gap in the current study, in which a random sample of 200 lung cancer survivors will complete a comprehensive telephone interview or use self-report to complete a questionnaire focusing on physical activity, related covariates, and preferences regarding physical activity counseling and interventions. We estimate the total time for the completion of the interview or self-report questionnaire to be 45-60 minutes. This study will be conducted with survivors of primary lung cancer who are from 1 to 5 years posttreatment and were treated at Memorial Sloan-Kettering Cancer Center (MSKCC).

Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary Stage IA or IB NSCLC;
* Underwent surgical resection for NSCLC at MSKCC;
* From 1 to 5 years post-treatment for NSCLC prior to study recruitment;
* No evidence of disease (NED) at the time of recruitment;
* Can be reached by telephone;
* Able to provide informed consent.

Exclusion Criteria:

* Undergoing active antineoplastic treatment;
* Major psychopathology or cognitive impairment likely in the judgment of the investigator to interfere with participation and compliance with the protocol.

Primary outcomes:
measure: The primary outcomes of this study are physical activity levels and preferences regarding physical activity counseling and interventions
timeFrame: 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00048048: A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.
Official title: An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2002-10-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* not receiving renal replacement therapy.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Primary outcomes:
measure: The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes
timeFrame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary outcomes:
measure: Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen
timeFrame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
measure: Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen
timeFrame: From Baseline (Day -28 to Day 1) to EOIT (Week 19)
measure: Number of Participants With Any Serious Adverse Events and Any Adverse Events
timeFrame: Up to Week 125
measure: Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time
timeFrame: Up to Week 125
measure: Heart Rate Over Time
timeFrame: Up to Week 125
measure: Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
timeFrame: From Baseline (Day -28 to Day 1) to Week 125
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Las Vegas
country: United States
state: Nevada
city: Portland
country: United States
state: Oregon
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Wroclaw
country: Poland
city: Belfast
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02635165: Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Official title: Medico-Economic Analysis of Management of Flail Chest Between Medical Treatment and Surgical Treatment With Stracos
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polytraumatises With Rib Fractures
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optimize the management of polytraumatises with flail chest: surgical treatment Stracos by decreasing the length of stay and the late complications: pain chronicles, quality of life, respiratory function


Eligibility criteria: Inclusion Criteria:

* Patients with flail chest including bifocal fracture of three or more consecutive ribs in at least two places with or without paradoxical movement
* The surgical procedure was performed in the first 48 hours after admission
* pathology with prognosis for survival 6-month-old inferior

Exclusion Criteria:

* Paraplegia or Tetraplegia
* Patients having the necessity of neurosurgical treatment or reanimation of neurosurgical
* Aorta hematoma or rupture
* ß-HCG positive in women
* titanium allergy

Primary outcomes:
measure: Average cost hospitalization
timeFrame: 4 weeks
Secondary outcomes:
measure: length of hospital stays of the intensive care department
timeFrame: 4 weeks
measure: length of hospital stays
timeFrame: 4 weeks
measure: occurence of pulmonary infection
timeFrame: 12 months of follow up
measure: The vital capacity (VC)
timeFrame: visit 3 months, visit 6 months, visit 12 months after the surgery
measure: The expiratory reserve volume (ERV)
timeFrame: visit 3 months, visit 6 months, visit 12 months after the surgery
measure: The total lung capacity (TLC)
timeFrame: visit 3 months, visit 6 months, visit 12 months after the surgery
measure: Residual volume (RV)
timeFrame: visit 3 months, visit 6 months, visit 12 months after the surgery
measure: 6 min walk test (6MWT)
timeFrame: visit 3 months, visit 6 months, visit 12 months after the surgery
measure: Visual analog scorer for pain
timeFrame: at visit 7 days, 28 days, 3 months, 6 months and 12 months
measure: Patient Global Assessment to measure quality of life
timeFrame: at visit 7 days, 28 days, 3 months, 6 months and 12 months
measure: date of return to work
timeFrame: visit 3 months, 6 months and 12 months
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Hospital University of Poitiers
Study officials:
References: