louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02840617: ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
Official title: A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: ICG
prostate cancer
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.

Detailed description: The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed prostate cancer;
* Able to accept total prostatectomy;
* Patient has given its informed consent.

Exclusion Criteria:

* Allergic to ICG or iodine;
* High-grade hepatic insufficiency
* refuse attending the study

Primary outcomes:
measure: sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
timeFrame: 1 week post-surgery
Secondary outcomes:
measure: sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
timeFrame: 1 week post-surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Rongqin Zheng RQ Zheng, doctor
role: STUDY_CHAIR
References:
citation: Greco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7.
Clinical trial NCT04343417: Biorepository to Support Research in Kidney Diseases
Official title: Biorepository to Support Research in Kidney Diseases
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Acute Kidney Injury
Acute Interstitial Nephritis
Kidney Diseases
Keywords: Kidney
Kidney Disease
Acute Kidney Injury
Kidney biopsy
Kidney Biorepository
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-04-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The biorepository is a prospective cohort study of subjects with kidney diseases, who are scheduled to undergo a kidney biopsy at Yale New Haven Hospital (York St. or St. Raphael's campus) as part of the routine clinical care and agree to participate in this study.

Brief summary: To support advances in the understanding of pathophysiology and therapies of kidney diseases by creating a BioBank of kidney tissue, DNA, plasma, and urine from patients with kidney diseases.

Detailed description: A biorepository of human samples to support research to advance understanding of human kidney diseases will be created. Clinically, kidney diseases are detected by blood and urine laboratory tests. However, the underlying cause of kidney disease is often not clear on blood and urine tests. In such cases, a clinician may choose to perform a kidney biopsy to establish the diagnosis. Patients who are scheduled to undergo a kidney biopsy will be invited to participate in this proposed study.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo a clinically indicated kidney biopsy
* English or Spanish speaking

Exclusion Criteria:

* Under 18 years or age
* Known pregnancy
* Additional vulnerable individuals (incarcerated, institutionalized, or otherwise unable to participate in the study)
* Inability to provide informed consent

Primary outcomes:
measure: Histological diagnosis
timeFrame: 5 years
Secondary outcomes:
measure: Occurrence of chronic kidney disease, end stage kidney disease or death
timeFrame: 10 years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital, York Street Campus
state: Connecticut
city: New Haven
country: United States
facility: Yale New Haven Hospital Saint Raphael Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Dennis G Moledina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535217: Explainable Machine Learning for the Assessment of Donor Grafts in Liver Transplantation
Official title: Explainable Machine Learning for the Assessment of Donor Grafts in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: the China Liver Transplant Registry
First posted: 2024-08-02
Enrollment: 5636
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who underwent deceased donor liver transplantation

Brief summary: Clinically, organ evaluation generally performed by the senior surgeons based on their experience and the visual and tactual inspection of the graft during procurement. However, it is proved that transplant surgeons intuition in the evaluation of donor risk and the estimation of steatosis is inconsistent and usually inaccurate. Besides, graft assessment is a dynamic process refer to amount of complex factors, which is considered to be an incredibly complicated relationship that is nonlinear in nature. Unfortunately, the classical statistic techniques in vogue such as multiple regression require the statistical assumption of independent and linear relationships between explanatory and outcome variables, and fail to analyse a large number of variables. We attempted to develop liver graft assessment models by predicting postoperative DGF using several ML techniques. Secondly, the best prediction model was selected by comparing the performance of different AI algorithms and logistic regression. Finally, we sought to explain the decision made by AI algorithms using a visualization algorithm based on the best prediction model, helping clinicians evaluate specific organ and whether to receive that may develop DGF postoperatively.


Eligibility criteria: Inclusion Criteria:

1. Age≥18 years-old
2. Underwent deceased donor liver transplantation

Exclusion Criteria:

1. Underwent living-donor LT;
2. Missing rates of data were more than 80%

Primary outcomes:
measure: Delayed Graft Function (DGF)
timeFrame: Within 7 days after liver transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04065217: The Effectiveness of Diode Laser 980-nm in Iraqi Face Hemangioma: a Randomized Within Patients Trial
Official title: Diode Laser 980-nm in Hemangioma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemangioma
Keywords: Hemangioma
Randomized within patient
Diode laser
Histogram
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 15
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: uni-center, government clinic, randomized within patient trial
Primary purpose: TREATMENT

Brief summary: In an academic, government clinic, uni-center, randomized within patients trial study of the effects of 980-nm diode laser treatment included 15 cases of facial hemangiomas in patients with a history of discomfort due to lesions that were not suitable for removal using traditional methods. The study was carried out at the University of Baghdad/Institute of Laser for Postgraduate Studies/Laser Medicine Research Clinics from 15 October 2018 to 15 April 2019. Primary end-point is improvement of conditions at 6 months. Secondary end-points are quality of life, disappear lesions and safety administration of diode laser. Each patient received 12 sessions at two-week intervals. Lesions were photographed before and after laser treatment and digital image histograms were generated as a graphical representation of the tonal distribution.

Following treatment, the lesions were less elevated, smoother in texture, and the color changed from dark red to light pink.

There is a need to improve the treatment of face hemangiomas. Results from this randomized within patient trial will serve as preliminary evidence of the future role of diode laser in hemangioma treatment and a basis for design and power estimations of future studies. Based on the skin texture, color and elevation of the hemangioma as well as patient satisfaction, this type of laser is a safe and effective modality for the treatment of facial hemangioma in Iraqi patients.


Eligibility criteria: Inclusion Criteria:

1. Comfortable.
2. Superficial lesion.

Exclusion Criteria:

1. Advanced case.
2. Deep lesion.
3. Uncomfortable.

Primary outcomes:
measure: Area of Hemangioma lesions
timeFrame: 4th week
measure: Color of lesion
timeFrame: 4 weeks
measure: Shape of lesion
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Institute of Laser for Postgraduate Studies
Study officials:
References:
Clinical trial NCT01450917: Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
Official title: Diaphragmatic Height Index: the New Diagnostic Test for Phrenic Nerve Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Paralysis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-12
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 220 brachial plexus injured patients who underwent the neurotization and 80 non-brachial plexus injury patients who underwent the orthopaedic operation were retrospectively reviewed. With using nerve electrical stimulator (Aesculap Nerve Stimulator GN 24, Tuttlingen, Germany), in neurotization procedures, phrenic nerve dysfunction is defined by no any diaphragmatic contraction was observed intraoperatively. The enrolled patients were classified into three main groups: (A) BPI patients with phrenic nerve dysfunction group, (B) BPI patients with normal phrenic nerve function group and (C) non-BPI patients group. In group A and B, we further subgroubed into: (1) for the right and (2) for the left side.

Brief summary: Diaphragmatic contraction is controlled by phrenic nerve which consists of anterior rami of 3rd- 5th cervical nerve roots. Usually, It can't be evaluated from history taking and physical examination. Thus the diaphragmatic elevation on chest radiograph is assumed to identify the phrenic nerve dysfunction. Normally, the right diaphragm is higher than the left side about 1.5 ± 0.9 centimeters or 0.5 ± 0.3 time of vertebral height. Although there are several methods to determine the diaphragmatic elevation from previous studies, the accuracy, reliability, intra and inter-observer variation are problem.

Neurotization is the effective procedure to restore upper extremity function in root avulsion type. Phrenic nerve is one of the common donor nerves which used for this procedure. But sometimes, concomitant injury of this nerve can occur. Therefore, the investigators established "Diaphragmatic height index (DHI)" from chest radiograph to use as the diagnostic test for phrenic nerve dysfunction.


Eligibility criteria: Inclusion Criteria:

* Brachial plexus injured patients who underwent the neurotization in our institute between 2005-2008
* Non brachial plexus injured patients who underwent the other orthopedic operation in our institute between April-June 2009

Exclusion Criteria:

* Concomitant pneumothorax and/or hemothorax
* Concomitant pulmonary contusion
* Previous pulmonary disease
* Chest wall deformity
* Thoracic or thoracolumbar scoliosis (\>10 degrees)
* Hepatomegaly
* Incomplete data

Primary outcomes:
measure: The cut-off point of DHI for diagnosis of phrenic nerve dysfunction
timeFrame: upto 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Saichol Wongtrakul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474317: Study of an Investigational Glucose Meter System
Official title: Performance of the G3 Blood Glucose Monitoring System With TATSU Strip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and older
* Type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Pregnancy
* Hemophilia or any other bleeding disorder
* Previously participated in a study using the G3 system
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors.
* A condition, which in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
* Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company.

Primary outcomes:
measure: Percent of Self-Test Fingerstick Blood Glucose Results Within +/- 5to15mg/dL (<100mg/dL) or Within +/- 5to15% (>=100mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Percent of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Percent of Venous Blood Glucose Results Within +/- 5to15mg/dL (<75mg/dL) or Within +/- 5to20% (>=75mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Subjects Able to Perform Given Tasks Using Product Labeling for Instruction
timeFrame: 1 hour
Other outcomes:
Locations:
city: Fairfield
country: United States
facility: Consumer Product Testing Co.
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest Clinical Research Center
state: New Mexico
Study officials:
affiliation: Southwest Clinical Research Center
name: Robert Bernstein, MD, FACE
role: PRINCIPAL_INVESTIGATOR
affiliation: Consumer Product Testing Co.
name: Michael Caswell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890317: Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Official title: Randomized Pilot Study of Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute; Myocardial Infarction, Complications
Cardiogenic Shock
Keywords: Cardiogenic shock
acute myocardial infarction
mild hypothermia
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, single-center, controlled, open-label Pilot-study to investigate whether induction of mild hypothermia in addition to primary percutaneous coronary intervention and optimal medical therapy in myocardial infarction complicated by cardiogenic shock improves cardiac power index after 24 h.


Eligibility criteria: Inclusion Criteria:

* Acute myocardial infarction complicated by cardiongenic shock
* Patients on mechanical ventilation at time of randomization

Exclusion Criteria:

* Out of hospital resuscitation with indication for mild hypothermia
* mechanical complications after acute myocardial infarction
* duration of cardiogenic shock \> 12 hours
* age \> 90 years

Primary outcomes:
measure: Cardiac Power Index after 24 hr.
timeFrame: 24 hours
Secondary outcomes:
measure: 30-days mortality
timeFrame: 30 days
measure: Change of hemodynamics over the first 48 hr.
timeFrame: During first 48 hr
measure: Catecholamine dose and duration of catecholamine support
timeFrame: 30 days
measure: Length of ICU-stay
timeFrame: 30 days
measure: Length of mechanical ventilation
timeFrame: 30 days
measure: SAPS-II-Score
timeFrame: 96 hours
measure: Severe and moderate bleeding complications (GUSTO-definition)
timeFrame: 30 days
measure: Sepsis
timeFrame: 30 days
measure: Pneumonia
timeFrame: 30 days
measure: Stroke
timeFrame: 30 days
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Department of Internal Medicine/Cardiology, University of Leipzig - Heart Center
state: Sachsen
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: STUDY_CHAIR
affiliation: Heart Center Leipzig - University Hospital
name: Georg Fuernau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng W, Fuernau G, Desch S, Freund A, Feistritzer HJ, Poss J, Buettner P, Thiele H. Circulating Monocyte Chemoattractant Protein-1 in Patients with Cardiogenic Shock Complicating Acute Myocardial Infarction Treated with Mild Hypothermia: A Biomarker Substudy of SHOCK-COOL Trial. J Cardiovasc Dev Dis. 2022 Aug 20;9(8):280. doi: 10.3390/jcdd9080280.
citation: Fuernau G, Beck J, Desch S, Eitel I, Jung C, Erbs S, Mangner N, Lurz P, Fengler K, Jobs A, Vonthein R, de Waha-Thiele S, Sandri M, Schuler G, Thiele H. Mild Hypothermia in Cardiogenic Shock Complicating Myocardial Infarction. Circulation. 2019 Jan 22;139(4):448-457. doi: 10.1161/CIRCULATIONAHA.117.032722.
Clinical trial NCT04221217: Long-term Safety and Efficacy Study of MND-2119 in Patients With Hypertriglyceridemia
Official title: Phase 3 Long-term Study to Evaluate the Safety and Efficacy of MND-2119 in Patients With Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertriglyceridemia
Lead sponsor: Mochida Pharmaceutical Company, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of MND-2119 at a dose of 2g/day or 4g/day for 52 weeks in patients with hypertriglyceridemia.


Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed with hypertriglyceridemia.
2. Participants with values of fasting triglyceride level are 150 mg/dL or higher and less than 500 mg/dL.

Exclusion Criteria:

1. Participants who have confirmed myocardial infarction and angina pectoris within 6 months.
2. Participants who have aortic aneurysm or has received aortic aneurysmectomy within 6 months.
3. Participants with, or with a history of, pancreatitis.
4. Participants who have a history or complication of a clinically significant hemorrhagic disease within 6 months.
5. Participants taking both anti-coagulants and anti-platelets.
6. Participants receiving dual antiplatelet therapy (DAPT).
7. Participants taking direct oral anticoagulants (DOAC) or warfarin.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 52 Weeks
Secondary outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: 52 Weeks
measure: Actual Value and Percent Change From Baseline in Triglyceride
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Actual Value and Percent Change From Baseline in Total Cholesterol
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Actual Value and Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Actual Value and Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Actual Value and Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Mochida Investigational sites
Study officials:
affiliation: Mochida Pharmaceutical Company, Ltd.
name: Takuya Mori
role: STUDY_DIRECTOR
References: