louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02433756: RESponders and QUadripolar LV Lead in CRT
Official title: Responders and Quadripolar LV Lead in CRT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Ospedale Santa Croce-Carle Cuneo
Sponsor class: OTHER
First posted: 2015-05-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Failure

Brief summary: The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.

Detailed description: Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.

Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.

To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.

After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).

After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).

Eligibility criteria: Inclusion Criteria:

* Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines
* Successful quadripolar LV lead implant

Exclusion Criteria:

* Less than 18 years of age
* Epicardial Lead
* Life expectancy \< 12 months
* Pregnant or are planning to become pregnant during the duration of the investigation

Primary outcomes:
measure: Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
timeFrame: 6-Months
measure: Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months
timeFrame: 12-Months
Secondary outcomes:
measure: Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: Ciriè
country: Italy
facility: Ciriè Hospital
city: Cuneo
country: Italy
facility: S.Croce e Carle Hospital
city: Torino
country: Italy
facility: Maria Vittoria Hospital
Study officials:
References:
Clinical trial NCT02077556: Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients
Official title: The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Interaction Potentiation
Keywords: tacrolimus, everolimus, pharmacokinetics, drug interaction
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.

Detailed description: Multidrug immunosuppression regimens have synergistic effects which allow the use of lower doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs: cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4 and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.

It is remained to be evaluated whether the pharmacokinetics or clinical efficacy of tacrolimus will be affected when the regimens contain everolimus in clinical practice and the effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs was also assessed.

Eligibility criteria: Inclusion criteria:

* De novo kidney transplants
* 20 - 65 years old
* aspartate aminotransferase/alanine aminotransferase within 2 times the upper limit of normal range

Exclusion criteria:

* Pregnancy
* Tuberculosis
* Hepatitis B or C carrier status
* Human immunodeficiency virus-positive status
* Retransplantation or multiorgan transplantation
* History of rheumatoid arthritis
* Use of drugs that might have enhanced or inhibited CYP3A4 or P-gp activity

Primary outcomes:
measure: Pharmacokinetic profiles
timeFrame: Post-operation day 8-10
Secondary outcomes:
measure: Acute rejection
timeFrame: Within the first 2 weeks post-transplantation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Meng-Kun Tsai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266356: A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)
Official title: A TMU/NIH Integrated Research Project Translation of Basic Research to Clinical Diagnosis and Treatment of Mild Traumatic Brain Injury (mTBI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Keywords: Minor Traumatic Brain Injury
Translation
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 500
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: PROBABILITY_SAMPLE
Study population: Brain Injury Patients

Brief summary: This integrated research project is cooperated by an fully-experienced team of Taipei Medical University and National Institutes of Health. We hope that we can find out the disease of balance, anxiety and sick headaches through the translation of basic research to clinical diagnosis and treatment of Mild Traumatic Brain Injury (mTBI).


Eligibility criteria: Inclusion Criteria:

* willing to accept this research
* age above 17 years old
* brain injury patients who are in Glasgow Coma Scale(GCS) between 13 to 15

Exclusion Criteria:

* age under 16 years old
* serious brain injury patients
* pregnant women
* people who have accepted ears surgery once
* uremia
* Liver Cirrhosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: Wen-Ta Chiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02299856: Cardiac Magnetic Resonance in Acute Myocarditis
Official title: Cardiac Magnetic Resonance in Acute Myocarditis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Keywords: Magnetic Resonance Imaging
Diagnostic Imaging
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 84
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are included in the myocarditis group if they showed clinical evidence of acute myocarditis(acute chest pain, history of viral infection, elevated white blood cell count, ECG changes and/or elevated troponin).

Brief summary: Cardiac magnetic resonance (MR) is an established noninvasive diagnostic tool for detection of acute myocarditis. Diagnosis of myocarditis at 1.5T is currently made with the help of the Lake Louise Criteria (two of three criteria have to be positive in order to establish the diagnosis). Although these criteria are accepted and widely used in clinical routine, several disadvantages exist. Newer parameters like myocardial T1 and T2 mapping, extracellular volume fraction (ECV) and myocardial strain analysis have the potential to complement or even replace some of the Lake Louise Criteria and further enhance the diagnostic performance of cardiac MR in patients suspected of having acute myocarditis. The aim of our study is to evaluate the diagnostic performance of a comprehensive cardiac MR protocol in patients with acute myocarditis.


Eligibility criteria: Inclusion Criteria:

* No past medical history of cardiac disease.
* No cardiovascular risk factors (e.g. diabetes or hypertension)

Exclusion Criteria:

* Contraindications for cardiac MR

Primary outcomes:
measure: Myocardial T1 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial T2 relaxation time
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial ECV measurements
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
measure: Myocardial strain analysis (focussed on longitudinal strain)
timeFrame: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn, Dept. of Radiology
state: NRW
Study officials:
References:
citation: Luetkens JA, Doerner J, Thomas DK, Dabir D, Gieseke J, Sprinkart AM, Fimmers R, Stehning C, Homsi R, Schwab JO, Schild H, Naehle CP. Acute myocarditis: multiparametric cardiac MR imaging. Radiology. 2014 Nov;273(2):383-92. doi: 10.1148/radiol.14132540. Epub 2014 Jun 6.
citation: Luetkens JA, Homsi R, Sprinkart AM, Doerner J, Dabir D, Kuetting DL, Block W, Andrie R, Stehning C, Fimmers R, Gieseke J, Thomas DK, Schild HH, Naehle CP. Incremental value of quantitative CMR including parametric mapping for the diagnosis of acute myocarditis. Eur Heart J Cardiovasc Imaging. 2016 Feb;17(2):154-61. doi: 10.1093/ehjci/jev246. Epub 2015 Oct 16.
Clinical trial NCT01101256: Determination of Residual Anticoagulatory Effects of Fondaparinux
Official title: Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulant Prophylaxis/Therapy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 110
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: Patients with s.c. anticoagulant therapy (fondaparinux)

Brief summary: The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.


Eligibility criteria: Inclusion Criteria:

* Fondaparinux therapy for at least 3 days

Exclusion Criteria:

* Age \< 18 years
* Hemodialysis

Primary outcomes:
measure: antiXa-levels (peak- and through-levels)
timeFrame: between day 3 and day 14 after start of therapy
Secondary outcomes:
measure: thromboembolic or bleeding episodes, HIT
timeFrame: day 14 after start of therapy
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: J.W. Goethe University Hospital Frankfurt/M.
state: Hessen
Study officials:
affiliation: J.W. Goethe University Hospital Frankfurt/M.
name: Marc Schindewolf, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paolucci F, Frasa H, Van Aarle F, Capdevla A, Clavies MC, van Dinther T, Donat F, Hendriks Y, van den Heuvel M, Nadal T, Lagrange F, Necciari J, Perez Y. Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices. Clin Lab. 2003;49(9-10):451-60.
Clinical trial NCT05193656: Bladder Cancer Detection Using Convolutional Neural Networks
Official title: Bladder Cancer Detection Using Convolutional Neural Networks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Machine learning
Artificial intelligence
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with micro or macroscopic hematuria

Brief summary: The investigators aim to experiment and implement various deep learning architectures to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, the investigators are interested in detecting bladder tumors from CT urography scans and cystoscopies of the bladder in this project.

Detailed description: The investigators aim to experiment and implement various deep learning architectures to achieve human-level accuracy in Computer-aided diagnosis (CAD) systems. In particular, the investigators are interested in detecting bladder tumors from CT urography scans and cystoscopies of the bladder in this project. The investigators want to classify bladder tumors as cancer, non cancer, high grade and low grade, invasive and non-invasive, with high sensitivity and low false positive rate using various convolutional neural networks (CNN). This task can be considered as the first step in building CAD systems for bladder cancer diagnosis. Moreover, by automating this task, the investigator scan significantly reduce the time for the radiologists to create large-scale labeled datasets of CT-urography scans and reduce the false-negative and positive that can happen due to human evaluation cystoscopies.

Eligibility criteria: Inclusion Criteria:

* Patients with first time hematuria
* Patients with the control program for previous bladder cancer

Exclusion Criteria:

* Patients with control cystoscope for noncancer suspected disease

Primary outcomes:
measure: Comparing standard technique to Machine Learning
timeFrame: 5 years
Secondary outcomes:
measure: Detecting accuracy of subtypes of bladder cancer
timeFrame: 5 years
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Nessn Azawi, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02321956: Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
Official title: Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric General Anesthesia With Endotracheal Tube
Keywords: ASA class 1,2
age 1-6 years
General anesthesia with ETT
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 93
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

Detailed description: This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Eligibility criteria: Inclusion Criteria:

* Age 1-6 Years
* ASA class 1-2
* Elective Surgery
* GA with oral uncuff endotracheal tube

Exclusion Criteria:

* Potential difficult air way from history and physical exam
* Allergy ti ultrasound gel
* neck mass
* unstable vital sign

Primary outcomes:
measure: Proper size of endotracheal tube
timeFrame: 1 year
Secondary outcomes:
measure: Correlation of subglottic diameter and proper size endotracheal tube
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Raviwon Atisook
state: Bangkoknoi
Study officials:
affiliation: Department of anesthesiology siriraj hospital
name: Raviwon Atisook
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shibasaki M, Nakajima Y, Ishii S, Shimizu F, Shime N, Sessler DI. Prediction of pediatric endotracheal tube size by ultrasonography. Anesthesiology. 2010 Oct;113(4):819-24. doi: 10.1097/ALN.0b013e3181ef6757.
Clinical trial NCT01578356: Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
Official title: Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate cancer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2012-04-16
Enrollment: 100
Sex: MALE
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: Men who were surgically treated or who are being surgically treated for prostate cancer.

Brief summary: For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.


Eligibility criteria: Inclusion Criteria:

* prostate cancer
* radical retropubic prostatectomy or
* robot-assisted laparoscopic surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Biochemical recurrence at follow-up.
timeFrame: 3 months after prostatectomy
measure: Biochemical recurrence at follow-up
timeFrame: 6 months after prostatectomy
measure: Biochemical recurrence at follow-up.
timeFrame: 9 months after prostatectomy
measure: Biochemical recurrence at follow-up.
timeFrame: 1 year after prostatectomy
measure: Biochemical recurrence at follow-up.
timeFrame: 6-monthly follow up between 1 and 5 years after prostatectomy.
Secondary outcomes:
measure: Functional assessment concerning continence.
timeFrame: after 1, 3, 12 and 24 months
measure: Functional assessment concerning potency.
timeFrame: after 1, 3, 12 and 24 months
measure: Functional assessment concerning quality of life.
timeFrame: after 1, 3, 12 and 24 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Nicolaas Lumen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121056: REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations
Official title: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations (REKinDLE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-07-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect on subject functionality as measured by the Health Assessment Questionnaire Disability Index (HAQDI).


Eligibility criteria: Inclusion Criteria: - Subjects with active rheumatoid arthritis as defined by ACR criteria - Able to start Enbrel® or Kineret® therapy (per the approved product monographs) within approximately 30 days of confirmed enrolment Exclusion Criteria: - Active infections at the time of initiating Enbrel® or Kineret® therapy - Malignancy other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years - Known hypersensitivity to E. coli derived products - Known hypersensitivity to Enbrel® or any of its components - Subjects receiving, or who received:\* Enbrel® in the previous 30 days; \* Remicade® in the previous 3 months; \* Humira® in the previous 3 months; \* Kineret® in the previous 15 days. - Subjects beginning Enbrel® therapy, or treated with prior or current treatment using Enbrel® - Subjects beginning Kineret® therapy, or treated with prior or current treatment using Kineret® - Treatment with any investigational therapy in the 30 days prior to enrolment confirmation - Presence of any significant and uncontrolled medical condition which, in the investigator's opinion, precludes the use of Enbrel® - Sepsis or at risk of septic syndrome

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03871556: Diagnostic Ultrasound for Measuring Fat of the Body
Official title: Diagnostic Ultrasound for Measuring Fat of the Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Fat
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 provide information about human subcutaneous fat thickness at different anatomic sites on the body by measuring these thicknesses with a diagnostic ultrasound and also by correlating patient perceptions of body image with measured fat distribution.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.


Eligibility criteria: Inclusion Criteria:

* Males or females 18-85 years old.
* Subjects are in good health as judged by the investigator.
* Subjects with Body Mass Index (BMI) between 18-29.99.
* Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator

Exclusion Criteria:

* Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
* Pregnant or breast feeding
* Uncooperative patients or patients with neurological disorders who are incapable of following directions
* Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients)

Primary outcomes:
measure: Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body
timeFrame: through study completion, 1 day
measure: Gender Differences on Patient Perceptions of Body Image With Measured Fat Distribution
timeFrame: through study completion, 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: