louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01401218: Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery
Official title: Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Thoracic Aortic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Aortic Surgery
Keywords: thoracic aortic surgery
acute kidney injury
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 799
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent thoracic aortic surgery durung 1994 to 2010 period

Brief summary: Postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network. The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Detailed description: Significant improvement of morbidity and mortality has been achieved during last three decades since developing deep hypothermic circulatory arrest (DHCA). However,postoperative acute kidney injury (AKI) is still one of the serious complications of thoracic aortic surgery, with incidence of 8 to 50 percent. Postoperative AKI significantly increases the morbidity and mortality of patients undergoing thoracic aortic surgery. Previous studies for AKI after DHCA reported confounding results due to different criteria of AKI. Therefore, the investigators tried to evaluate the incidence and risk factors of AKI after thoracic aortic surgery according to the diagnostic criteria and staging system of AKI reported from acute kidney injury network (2007). The investigators also tried to develop a risk model with scoring system of AKI and evaluate the performance of the risk model.

Eligibility criteria: Inclusion Criteria:

* patients who underwent thoracic aortic surgery during 1994 to 2010 period

Exclusion Criteria:

* patients who had previous renal failure before aortic surgery

Primary outcomes:
measure: presence of Acute kidney injury
timeFrame: 1 time, within 48 hours of aortic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Sangmin M. Lee, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06018818: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Official title: BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bradycardia
Heart Failure
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2023-08-31
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.


Eligibility criteria: Inclusion Criteria:

* Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

* Planned for conduction system pacing
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Known pregnancy or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation
* Life-expectancy less than 12 months

Primary outcomes:
measure: SADE-free rate at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: SADE-free rate at 12 months
timeFrame: 12 months
measure: CRT AutoAdapt performance
timeFrame: 12 months
measure: CRT AutoAdapt AV delay
timeFrame: 12 months
measure: Assessment of the CRT AutoAdapt feature (CRT-devices only) by the investigator
timeFrame: 12 months
measure: Auto LV VectorOpt
timeFrame: 12 months
measure: Assessment of the Automatic LV VectorOpt test (CRT-devices only) by the investigator
timeFrame: 2 months
measure: aATP-related ADEs and SADEs
timeFrame: 12 months
measure: Sensing performance of device-based measurements
timeFrame: 12 months
measure: Pacing performance of device-based measurements
timeFrame: 12 months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus Essen
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
Study officials:
affiliation: Kliniken Maria Hilf GmbH
name: Istvan Szendey, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730418: Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia
Official title: A Prospective Study for the Effects of Chronic Use of Doxazosin on Alpha 1-adrenergic Receptors in Men With Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
alpha Adrenergic Blockers
alpha-1 Adrenergic Receptor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 25
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, we investigate the changes of the expression of alpha adrenergic receptor in the prostate tissue during 2-yr medication period in the man with benign prostatic hyperplasia. And we also evaluate the efficacy and safety of 24 mo-treatment with doxazosin (4mg, 8mg)

Detailed description: To compare the expression of alpha-1 adrenergic receptors, we will use various methodologies such as

* Real-time RT-PCR
* Radioligand receptor binding
* Western blot
* Immunohistochemistry

Eligibility criteria: Inclusion Criteria:

* 50 yrs or greater
* International prostatic symptom score \>= 8
* Maximal flow rate \< 15mL/sec
* baseline PSA 2.5-10 ng/mL
* Pathologically proven BPH
* No medication history for BPH
* Able to give fully informed consent

Exclusion Criteria:

* Previous use of alpha-blocker, 5-alpha reductase inhibitor
* Previous surgery for BPH
* Urologic cancer history
* Urethral stricture
* baseline PSA \> 10ng/mL
* BP \< 90/70 mmHg
* Orthotopic hypotension with syncope
* Serum Cr \> 2.0 mg/dl, alanine aminotransferase \> 1.5 times of normal limit
* Bacterial prostatitis within 1 year
* Urinary tract infection(UTI) more than 2 times within 1 year
* Active UTI or prostate biopsy within 1 month
* Unable to void
* Ped use because of incontinence
* Hypersensitivity to alpha-blocker that include quinazoline
* Unstable angina, Myocardial infarction, or cerebrovascular accident within 6 months
* Neurogenic bladder dysfunction (ex. multiple sclerosis, Parkinson's disease, Spinal injury etc.)
* Psychiatric problem
* Alcohol abuse or other drug abuse history
* Severe comorbidities unable to perform long-term trial
* seems not to be appropriate to this study because of any other reasons

Primary outcomes:
measure: Expression of alpha-1 adrenoceptor
timeFrame: before treatment and 12mos and 24 mos after treatment
Secondary outcomes:
measure: International Prostate Symptom Score, Patient perception of bladder condition, Maximal flow rate of urine, Postvoid Residual, Prostate volume, Serum PSA level, Adverse events
timeFrame: before treatment and 3mos, 12mos, and 24mos after treatment
Other outcomes:
Locations:
city: SEoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kru-Sung Lee, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400218: Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)
Official title: Evaluate the Safety and Tolerability of Hyzaar(R) (Losartan 50 Mg/ Hydrochlorothiazide 12.5 Mg) In the Treatment of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Patient is either receiving high blood pressure monotherapy or no treatment
* Patient will have reached the legal age by the time enter the study
* Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal

Exclusion Criteria:

* Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment
* Patients who are hypersensitive to any component of the study medication
* Patients who are hypersensitive to other sulfonamide-derived drugs
* Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance \</= 30 ml/min)
* Unstable diabetes (hba1c \> 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.

Primary outcomes:
measure: Blood pressure over 12 weeks
measure: Safety and Tolerability.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03240718: Pilot Study of the Ablative Fractional CO2 Laser in Hypertrophic Scars in Adult Burn Patients
Official title: Randomized, Controlled, Within-patient, Single-blinded Pilot Study to Evaluate the Efficacy of the Ablative Fractional CO2 Laser in the Treatment of Hypertrophic Scars in Adult Burn Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, within-patient, single-blinded, pilot study that will evaluate the impact of laser treatment on burn HSc relative to self-matched control scars. The studied primary outcomes of treatment are scar pliability, thickness, vascularity, pain, itch and patient satisfaction.

Detailed description: Prior to treatment initiation, two independent scars sites will be selected and an anatomically- on each individual. At the selected treatment site the scar will be treated with the CORE fractional CO2 laser Participants will receive 3 treatment sessions scheduled 4 weeks apart. The scar sites will be evaluated at baseline, immediately before the 3rd treatment and 12 weeks after their final treatment session.

Eligibility criteria: Inclusion Criteria:

* Fitzpatrick skin type \<IV (37),
* Have sustained a thermal burn injury,
* Have at least 2 independent sites that show clinical evidence of HSc,
* Are 2 months or more post-injury.

Exclusion Criteria:

* Subjects with skin phototypes IV or higher,
* With history of keloidal scarring,
* Who have coagulation disorder,
* Are taking immunosuppressive medications,
* If the mechanism of injury is an electrical, chemical, or cold injury,
* Any underlying active skin disease,
* Have taken oral Isotreinoin within the last 6 months,
* Photosensitivity or have taken photosensitizing medications,
* Pregnancy,
* Previous treatment with dermabrasion, chemical peel, laser or intense pulsed light treatment

Primary outcomes:
measure: Skin Characteristics changes
timeFrame: baseline, 12 weeks and 24 weeks
Secondary outcomes:
measure: Satisfaction Questionnaire
timeFrame: baseline, 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: CRCHUM
name: Bernadette Nedelec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02079818: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Official title: CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Visceral Artery Aneurysms
Arteriovenous Malformations
Keywords: visceral artery aneurysms
arteriovenous malformations
Penumbra Ruby Coil System
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.


Eligibility criteria: Inclusion Criteria:

* Patients enrolled in this study must be those treated according to the cleared indication for the Penumbra Ruby Coil System for visceral arterial and venous embolizations.

Exclusion Criteria:

* Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study.

Primary outcomes:
measure: 1. Packing density with the number of coils implanted
timeFrame: During the procedure
measure: 2. Time of fluoroscopic exposure
timeFrame: During the procedure
measure: 3. Procedural device-related serious adverse events at immediate post-procedure
timeFrame: At immediate post-procedure
measure: 4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure
timeFrame: At immediate post-procedure
measure: 5. Occlusion of the aneurysm sac or target vessel at one year post-procedure
timeFrame: One year post-procedure
Secondary outcomes:
measure: 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure
timeFrame: 4 months post-procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Paraq J Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913718: To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fasting Conditions
Official title: Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Health Adult Males Under Fasting Conditions Following Administration of a 40 mg Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride capsules (Pulvules) in healthy adult males under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 86 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Research Center (Cincinnati)
name: Roderick Malone, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03814018: Bronchoreversibility Test in Asthmatic Children and Correlation With Diagnostic Criteria Proposed by the GINA Guidelines
Official title: A Retrospective Study to Verify FEV1 Reversibility Criteria Proposed by the GINA Guidelines, in Asthmatic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Asthma
Keywords: Bronchodilation test
GINA
Reversibility criteria
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 600
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with a physician-base diagnosis of asthma, undergoing a bronchodilation test

Brief summary: Since 2015, GINA (Global INitiative on Asthma) guidelines were modified and adapted to better fit the pediatric population. Asthma diagnosis is mainly based on the results of PFT (Pulmonary Function Tests) and broncho-reversibility test in adult. GINA guidelines modified the requirements to reach a diagnosis of Asthma in children, based on the reversibility test. GINA guideline propose an increase of 12% of the FEV1 is considered as the diagnostic criterium for asthma in pediatrics.

Nevertheless, in clinical practice, most physicians base their diagnosis of asthma in children on the clinical signs presented by the patient and on the efficacy of the prescribed therapy. Also, the spirometric criterium is not sufficiently corroborated by clinical studies. No research has ever looked for the results of bronchoreversibility test in patients receiving a clinical diagnosis of asthma. For this reason, in children with a clinical diagnosis of asthma, the investigators want to look for the results of the bronchoreversibility test and validate that an increase of 12% of the FEV1 correlate with a physician-driven diagnosis of asthma in pediatrics. For further analysis the investigatorswill evaluate also the reversibility of small airways (FEF25-75) and the z-score of the results of the PFT in these children.


Eligibility criteria: Inclusion criteria:

* Children aged between 5 and 18 years
* Children with a diagnosis of asthma undergoing a PFT and a bronchoreversibility test on the day of the diagnosis
* Children evaluated at the University Hospital of Montpellier (France), or at the Pediatric Allergy Unit of the University Hospital of Pavia (Italy)

Exclusion criteria:

* Children not able to perform a PFT
* Children taking drugs that could affect the results of a PFT
* Children included in other trials that don't allow them to be included in the present one

Primary outcomes:
measure: value of FEV1 increase
timeFrame: 1 day
measure: value of FEF 25-75
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Davide CAIMMI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04820218: At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Official title: An Open Label Study to Evaluate At-home Testing Refraction Results With Best Corrected Visual Acuity (BCVA) Outcomes in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Impairment
Myopia
Hyperopia
Astigmatism
Lead sponsor: EyeQue Corp.
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects who had previously tested with an EyeQue ophthalmic refraction device and ordered try-on glasses will be asked to measure their visual acuity with and without their try-on glasses.
Primary purpose: DIAGNOSTIC

Brief summary: This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck.

Detailed description: This study is aimed at examining the BCVA from try-on glasses constructed from measurements from the EyeQue VisionCheck. The refraction measurements that users obtain from the VisionCheck are from testing at-home and without additional guidance other than that normally provided to those purchasing the device.

Eligibility criteria: Inclusion Criteria:

1. Male or Female
2. Ages 30+
3. Had purchased an EyeQue refraction device.
4. Obtained EGN's from the EyeQue refraction device.
5. Ordered Try-On glasses based on EyeQue EyeGlass Numbers.
6. Allow use for this study the VisionCheck refraction and try-on glasses measurements, taken prior to study participation.

Subject Exclusion Criteria, Subjects that by self-report:

1. Do not have a command of the English language.
2. Lack the ability to follow instructions.
3. Lack binocular vision.
4. Are Color-blind.

Primary outcomes:
measure: Visual Acuity with and without try-on glasses
timeFrame: Visit 1: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: EyeQue
state: California
Study officials:
affiliation: EyeQue Corporation
name: Noam Sapiens, PhD
role: PRINCIPAL_INVESTIGATOR
References: