louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05047029: Myocardial Fibrosis and Inflammation in Liver Cirrhosis
Official title: Multiparametric Magnetic Resonance Imaging in Patients With Liver Cirrhosis for Evaluation of Myocardial Fibrosis and Inflammation in Cirrhotic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis, Liver
Cardiomyopathies
Portal Hypertension
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic (Department of Internal Medicine I, University Hospital Bonn, Germany)

Brief summary: The aim of this clinical prospective study is to assess structural and functional myocardial changes in patients with liver cirrhosis after implantation of transjugular intrahepatic portosystemic shunt (TIPS).


Eligibility criteria: Inclusion criteria:

* liver cirrhosis with evaluation of TIPS implantation
* patients who are 18 years of age or older

Exclusion criteria:

* underlying cardiac disease, e.g. known myocardial infarction, previous myocarditis, congenital heart disease, cardiomyopathies of other causes known underlying disease witt potential cardiac involvement, e.g. storage disease (e.g. hemochromatosis, Fabry disease), inflammatory (e.g. sarcoidosis), endocrinological (e.g. diabetes mellitus, hyper-/hypothyroidism), autoimmune (e.g. systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis), therapeutic (chemotherapy).
* patients with contraindication for contrast-enhanced MRI
* pregnant and breastfeeding women

Primary outcomes:
measure: Myocardial T1 relaxation time
timeFrame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Secondary outcomes:
measure: Myocardial T2 relaxation time
timeFrame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
measure: Myocardial ECV
timeFrame: Change after 1 year of transjugular intrahepatic portosystemic shunt insertion.
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
state: NRW
city: Bonn
country: Germany
facility: University Hospital Bonn, Medical Clinic and Polyclinic I
state: NRW
Study officials:
References:
citation: Isaak A, Praktiknjo M, Jansen C, Faron A, Sprinkart AM, Pieper CC, Chang J, Fimmers R, Meyer C, Dabir D, Thomas D, Trebicka J, Attenberger U, Kuetting D, Luetkens JA. Myocardial Fibrosis and Inflammation in Liver Cirrhosis: MRI Study of the Liver-Heart Axis. Radiology. 2020 Oct;297(1):51-61. doi: 10.1148/radiol.2020201057. Epub 2020 Aug 18.
Clinical trial NCT06599229: Perfusion Abnormalities in Hypertrophic Cardiomyopathy
Official title: Myocardial Perfusion Abnormalities in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypertrophic Cardiomyopathy (HCM)
Keywords: hypertrophic cardiomyopathy
myocardial contrast echocardiography
microvascular perfusion
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
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 HCM who are being started on cardiac myosin inhibitor therapy.

Brief summary: The purpose of this study is to investigate whether myocardial microvascular perfusion in patients with hypertrophic cardiomyopathy improved after initiation of cardiac myosin inhibitor therapy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of hypertrophic cardiomyopathy
* Subject being initiated on clinically-indicated cardiac myosin inhibitor therapy

Exclusion Criteria:

* Pregnancy
* Lactation
* Allergy to ultrasound enhancing agent (lipid-stabilized) or regadenoson
* Serious AE to regadenoson
* Hypotension
* Serious bradycardia not addressed by pacemaker
* Moderate or greater reactive airways disease

Primary outcomes:
measure: Peak hyperemic perfusion
timeFrame: 3 months
Secondary outcomes:
measure: Resting myocardial perfusion
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00573729: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths
Official title: Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks: Comparison of 577 nm Versus 595 nm Wavelengths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Port Wine Stains
Keywords: vascular malformation
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-14
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Port wine stain are a congenital, progressive vascular malformation of human skin. The pulsed dye laser is approved by the Food and Drug Administration for the treatment of choice. However, the degree of port wine stain blanching seen following pulsed dye laser treatment remains variable and unpredictable. If the ultimate standard required is complete lesion blanching, the average success rate is below 10%, even after undergoing numerous pulsed dye laser treatments. Moreover, less than 50% of patients achieve 50% fading of their Port wine stain in response to pulsed dye laser therapy.

Detailed description: The researchers' specific aim is to determine whether the use of the pulsed dye laser operating at a wavelength of 577 nm will improve therapeutic outcome as compared to a pulsed dye laser operating at 595 nm.

The researcher can treat port wine stain treated using a pulsed dye laser operating at a wavelength of 577 nm and the other half at a wavelength of 595 nm. The researcher can determine that the 577 nm pulsed dye laser improved port wine stain blanching responses more than the areas treated with 595 nm.

The degree of port wine stain blanching which will determine by visible reflectance spectroscopy skin imaging device measurements. Post-treatment blanching responses can compare with pre-treatment measurements of port wine stain fractional blood volume.

Eligibility criteria: Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 6 months of age; minor will be accompanied in the room by parents or guardians during laser treatment
* Apparent good health as documented by medical history
* Ability to understand and carry out subject instructions

Exclusion Criteria:

* History of photodermatoses or skin cancer
* Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
* Inability to understand and carry out instructions

Primary outcomes:
measure: Improvement in blanching for the 577 nm Pulsed Dye Laser therapy in comparison with 595 nm
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute,University of California,Irvine
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S Nelson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05741229: The Effect Of Nebulizied Nitroglycerin As An Adjuvant Therapy For Persistent Pulmonary Hypertension Of Newborns
Official title: The Effect Of Nebulizied Nitroglycerin As An Adjuvant Drug In Management Of Persistent Pulmonary Hypertension Of Newborns
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Persistent Pulmonary Hypertension of the Newborn
Echocardiography
Respiratory Disease
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This aim of the study is to evaluate the effect of nebulized nitroglycerin on echocardiographic (biventricular function, pulmonary artery pressure, PDA and PFO shunting and tissue doppler imaging) and clinical parameters (Oxygen saturation index, heart rate, blood pressure, mean airway pressure, ventilation setting) in patients with PPHN.


Eligibility criteria: Inclusion Criteria:

* Infants ≤72 hours' old, ≥37 weeks of gestation, ≥50% FiO2 need despite lung recruitment, abnormal oxygen saturation index or echocardiographic signs of PPHN will be enrolled in the trial.

Exclusion Criteria:

* • Diagnosis of PPHN discovered after more than 72 hours.

  * Failure of used medications and need to administrate milrinone

Primary outcomes:
measure: Estimation of Pulmonary artery pressure (PAP)
timeFrame: first 7 days of life
measure: Right ventricular (RV) function in ml/kg/min
timeFrame: first 7 days of life
measure: Left ventricular (LV)function in ml/kg/min
timeFrame: first 7 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Hesham Ghazal, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Aly Mohamed Abdel-Mohsen, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Moataz Shawky Rezk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bethou A. Utility of Nebulized Magnesium Sulfate Therapy for Persistent Pulmonary Hypertension of Newborn. Indian J Pediatr. 2021 Aug;88(8):749-750. doi: 10.1007/s12098-021-03851-0. Epub 2021 Jun 23. No abstract available.
Clinical trial NCT02946229: Data Collection for Next Generation Ultrasound Technology Development
Official title: Data Collection for Next Generation Ultrasound Technology Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endstage Renal Disease
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2016-10-27
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome. All eligible adults (aged 18 or older) will contribute case data from a convenience sample of maintenance hemodialysis population available at the study site and consistent with feasibility assessment of the technology. A relatively large feasibility population is used due to the need to test feasibility of multiple features across variations within this population.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome.

Detailed description: The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome. All eligible adults (aged 18 or older) will contribute case data from a convenience sample of maintenance hemodialysis population available at the study site and consistent with feasibility assessment of the technology. A relatively large feasibility population is used due to the need to test feasibility of multiple features across variations within this population.

Eligibility criteria: Inclusion Criteria:

1. Are adults (aged 18 years of age or older) at the time of consent;
2. Are undergoing maintenance hemodialysis (MHD); AND
3. Are able and willing to provide written informed consent for participation

Exclusion Criteria:

1. Have anatomical characteristics or comorbid medical conditions that prevent completion of ultrasound scanning using the study device; OR
2. Are potentially put at additional risk by participating, in the opinion of the investigator.

Primary outcomes:
measure: Number of Diagnostic Ultrasound Exams
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Evergreen Park
country: United States
facility: Research By Design
state: Illinois
Study officials:
affiliation: Research By Design, LLC
name: Paul Crawford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02125929: Comparative Study of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neoplasms
Official title: Comparative Study of the Efficacy and Safety Outcomes of Robotic, Laparoscopic and Open Surgery for Enucleation of Benign Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neuroendocrine Tumors
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of robotic, laparoscopic and open surgery for enucleation of benign pancreatic neuroendocrine tumors

Detailed description: The study was prospective and retrospective, non-randomized study included patients with benign pancreatic neoplasms. The robotic arm consecutively includes patients underwent robotic enucleation surgery and expected number in this arm is 50. The laparoscopic and open surgery arms retrospectively include case from the year 2004. The number of patients for laparoscopic and open surgery arms are 50 and 100, respectively.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old
* Body Mass Index\<30
* Preoperative diagnosis of resectable benign Pancreatic Neuroendocrine Tumors
* Tumor type: Non-functional pancreatic endocrine tumours and insulinomas
* largest diameter \< 4cm
* Preoperative CT showed no evidence that tumor was connected with main pancreatic duct

Exclusion Criteria:

* Severe cardio/pulmonary complications
* Other pancreatic diseases, including pancreatitis and pancreatic cancer
* Multiple pancreatic neuroendocrine tumors
* Distant metastasis

Primary outcomes:
measure: Pancreatic fistula rate
timeFrame: up to 30 days
Secondary outcomes:
measure: Mortality rate
timeFrame: up to 30 days
Other outcomes:
measure: Intra-operative bleeding volume
timeFrame: intra operative
measure: Operation Time
timeFrame: Intra operative
measure: Conversion rate to open surgery
timeFrame: Intra operative
measure: Quality of life and pain scores
timeFrame: up to 30 days
measure: Delayed gastric emptying rate
timeFrame: up to 30 days
measure: Intra-abdominal bleeding rate
timeFrame: up to 30 days
measure: Postoperative infection rate
timeFrame: up to 30 days
measure: Hospital stay time
timeFrame: up to 30 days
Locations:
city: Beijing
country: China
facility: Department of General Surgery, Peking Union medical school hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yupei Zhao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian F, Hong XF, Wu WM, Han XL, Wang MY, Cong L, Dai MH, Liao Q, Zhang TP, Zhao YP. Propensity score-matched analysis of robotic versus open surgical enucleation for small pancreatic neuroendocrine tumours. Br J Surg. 2016 Sep;103(10):1358-64. doi: 10.1002/bjs.10220. Epub 2016 Aug 2.
Clinical trial NCT01392729: An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)
Official title: An Open Label, Prospective, Observational, Local, Non-interventional Study of BeVacizumab (Avastin) and IntErpherone (IFN) Alpha 2a in Patients With Metastatic and Locally Advanced Renal Cell CAncer (VERA Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with previously untreated metastatic renal cell cancer

Brief summary: This prospective observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with interferon alpha 2a in patients with previously untreated metastatic renal cell cancer. Data will be collected from each patient for up to 4 years.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically confirmed metastatic renal cell cancer, clear cell type
* Eligible for treatment with Avastin and interferon alpha 2a according to local prescribing information

Exclusion Criteria:

* Contraindications for Avastin or interferon alpha 2a treatment according to local Summary of Product Characteristics
* Known hypersensitivity to Avastin and/or interferon alpha 2a or any of its excipients

Primary outcomes:
measure: Progression-free survival
timeFrame: approximately 4 years
Secondary outcomes:
measure: Overall survival
timeFrame: approximately 4 years
measure: Response rate
timeFrame: approximately 4 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 years
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03782129: Five-year Mortality Rate in People With Diabetic Foot Ulcer
Official title: Five-year Mortality Rate in People With Diabetic Foot Ulcer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Diabetic Foot
Diabetes Complications
Keywords: diabetes mellitus
diabetic foot
mortality rate
diabetes complications
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 347
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: Diabetic patients with a DFU diagnosed in 2010

Brief summary: As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU).

This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

Detailed description: Diabetic foot ulcer (DFU) is an economic burden for many countries around the world. It also induces a dramatic decrease in physical, emotional, and social functioning for patients. Oftenly associated with advanced micro and macrovascular complications, high morbidity and a greater risk of premature death (mainly by Ischemic Heart Disease) occure.

Only few studies explored DFU patients' long term survival: the few datas coming from cohorts in the 2000's reported mortality rates around 45% at five years after DFU's diagnosis.

But life expectancy in diabetics patients imporved during last decade. So the main objective of our study is to evaluate the diabetics patients' 5 years mortality rate, in whom DFU was diagnosed in 2010.

Moreover, our secondary objective is to identify the mortality's predictive factors in 2010.

Eligibility criteria: Inclusion Criteria:

* type 1 or 2 diabetes
* consultation for new diabetic foot ulcer during the year 2010

Exclusion Criteria:

None

Primary outcomes:
measure: Mortality rate 5 years after DFU diagnosis
timeFrame: 5 years
Secondary outcomes:
measure: Risks factors correlated to mortality rate among DFU patients diagnosed in 2010
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Study officials:
References:
Clinical trial NCT01092429: 2D and Tissue Doppler Imaging Echocardiography Analysis of Left Ventricular Regional Wall Motion and Prognosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: CAD
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Accoring to recommendation of ACC/AHA, patient had classI indication to perform coronary angiography

Brief summary: Development of myocardial ischemia, and/or myocarditis would induce different changes in myocardial contraction behavior pattern,which maybe very subtle, and may not be detected by the 2D and m-mode echocardiography examinations. According to tissue Doppler imaging(TDI), they can be depicted by different models of echo with higher frame rates. In addition, many studies using TDI have significantly contributed of efforts to evaluate systolic and diastolic function and prognosis.

This study assess the value of the indices of left ventricular function obtained by using TDI in patient with coronary artery disease(CAD). We hypothesized that TDI will add incremental value for regional wall motion abnormality of CAD and its prognosis.


Eligibility criteria: Inclusion Criteria:

1. Angina
2. Acue coronary syndrome
3. Left ventricular systolic dysfunction

Exclusion Criteria:

1. Significant valvular disease
2. Active cancer status
3. Acute Renal failure
4. Contrast allergy history
5. Pregnancy

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Gung Memorial Hospital at Linkou
Study officials:
References: