louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00288951: Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 690
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Adult subjects of either sex and any race 18 years or older with open-angle glaucoma or ocular hypertension. Patients with logMAR visual acuity not worse than 0.6 in either eye or any clinically relevant ophthalmic/systemic condition will be excluded.

Exclusion Criteria:

* See Inclusion Criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05739253: Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Official title: Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Ascending Aortic Dilatation
Bicuspid Aortic Valve
Keywords: Transcatheter aortic valve replacement
Ascending aortic diameter
Ascending aortic dilatation
Bicuspid aortic valve
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2023-02-22
Enrollment: 480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The indication to perform transcatheter aortic valve replacement was based on a consensus by the Institutional Heart Team.

Brief summary: The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are:

1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation;
2. the determinants of postoperative ascending aortic dilatation.

Detailed description: Ascending aortic (AA) dilatation occurs frequently in patients with aortic stenosis (AS). For patients who are candidates for transcatheter aortic valve replacement (TAVR), simultaneous repair of a dilatated AA is technically difficult. As the indications for TAVR have extended to low-risk patients and patients with bicuspid aortic valve , AA dilatation should be considered as a new criterion to refine risk stratification in patients undergoing TAVR. In this observational study, we aim to evaluate the changes of AA diameters and identify the determinants post-TAVR AA dilatation.

Eligibility criteria: Inclusion Criteria:

* Severe aortic stenosis defined as an aortic valve area of 1cm2 or less or an indexed aortic valve area of 0.6cm2/m2 or less;
* Presence of clinical symptoms defined as a New York Heart Association functional class of 2 or more;
* High risk of surgical aortic valve replacement;
* Suitability for a transfemoral vascular access.

Exclusion Criteria:

* Dominant aortic regurgitation;
* History of surgical or transcatheter aortic valve replacement;
* History of aortic surgery;
* Connective tissue disorders.

Primary outcomes:
measure: Rate of ascending aortic dilatation
timeFrame: 1-year and 2-year
Secondary outcomes:
measure: Rate of all-cause mortality
timeFrame: 1-year and 2-year
measure: Rate of adverse aortic events
timeFrame: 1-year and 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
References:
Clinical trial NCT01132053: Role of Inflammation in Progressive Multifocal Leukoencephalopathy (PML)
Official title: Role of Inflammation in PML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Progressive Multifocal Leukoencephalopathy
Keywords: JC Virus
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-05-27
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PML patients of 18 years of age or older in the Boston area will be included in this study.

The control groups will include HIV+ and HIV- individuals who need to have a lumbar puncture for their clinical management.

Brief summary: This is a continuation of our previous studies on Progressive Multifocal Leukoencephalopathy (PML). We will focus on the role of inflammation in PML, and define prognostic markers of disease evolution.

Detailed description: To determine precisely what are the host or viral factors that may predict a favorable outcome for PML patients and the role of inflammation in preventing JCV from causing brain disease. One of the goals of this study is to help establish non-invasive markers of PML evolution by studying the brain metabolism in PML lesions using Magnetic Resonance Imaging (MRI), Magnetic Spectroscopy (MRS) and other advanced imaging modalities.

Eligibility criteria: Inclusion Criteria:

* PML patients of 18 years of age or older will be included in this study.

Exclusion Criteria:

1. Presence of opportunistic brain lesions other than PML. ( e.g., toxoplasmosis, lymphoma)
2. Presence of confounding neurological disorder such as brain neoplasm etc.

In addition patients with a contraindication to MRI examination will be excluded from study. Contraindications to the MRI examination include:

1. Medically unstable or hematological, renal, or hepatic dysfunction.
2. Cardiac pacemaker
3. Internal clips,
4. Metal implants, or external clips with 10 mm of the head.
5. Metal in the eyes.
6. Pregnant
7. Claustrophobia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Chen S Tan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429351: Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kwashiorkor
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-01-31
Enrollment: 82
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 82 children aged 6 to 18 months and diagnosed with severe protein-energy malnutrition. By the Wellcome Classification patients will have marasmus (\< 60 % weight/age and no edema), marasmic-kwashiorkor (\< 60 % weight/age plus edema) or kwashiorkor (\< 80 % weight/age plus edema)

Brief summary: This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.


Eligibility criteria: Inclusion Criteria:

* Malnourished children between 6 to 18 months of age.
* To standardize for degree of malnutrition, only patients whose weight is \< 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (\< 60 % weight/age and no edema), marasmic-kwashiorkor (\< 60 % weight/age plus edema) or kwashiorkor (\< 80 % weight/age plus edema).
* Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count \>11,000 cells/dl, temperature at admission \> 99 oF, positive blood or urine cultures.

Exclusion Criteria:

* Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mona
country: Jamaica
facility: Tropical Metabolism Research Unit, University of the West Indies
state: Kingston
Study officials:
References:
Clinical trial NCT05132751: Machine Learning Ventilator Decision System VS. Standard Controlled Ventilation
Official title: Effect of a Machine Learning Ventilator Decision System Versus Standard Controlled Ventilation on in Critical Care: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation
Critically Ill Patients
Lead sponsor: The Second Clinical Medical College of Jinan University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ventilator decision system
Primary purpose: TREATMENT

Brief summary: Ventilator-induced lung injury is associated with increased morbidity and mortality. Despite intense efforts in basic and clinical research, an individualized ventilation strategy for critically ill patients remains a major challenge. However, an individualized mechanical ventilation approach remains a challenging task: A multitude of factors, e.g., lab values, vitals, comorbidities, disease progression, and other clinical data must be taken into consideration when choosing a patient's specific optimal ventilation regime. The aim of this work was to evaluate the machine learning ventilator decision system, which is able to suggest a dynamically optimized mechanical ventilation regime for critically-ill patients. Compare with standard controlled ventilation, to test whether the clinical application of the machine learning ventilator decision system reduces mechanical ventilation time and mortality.


Eligibility criteria: Inclusion Criteria:

1. only the first ICU stay was eligible;
2. adults ≥ 18 years of age on ICU admission;
3. estimate mechanical ventilation time ≥24 hours;

Primary outcomes:
measure: Mechanical ventilation time
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Length of ICU stay time
timeFrame: through study completion, an average of 1 week
measure: Length of hospital stay
timeFrame: through study completion, an average of 2 weeks
measure: In-hospital mortality
timeFrame: through study completion, an average of 2 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02348151: Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With COPD
Official title: Analysis of Metabolic and Ventilatory Demands During the Shuttle Walk Test Performed on a Treadmill Versus a Corridor in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
SWTi
Treadmill
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2015-01-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.

Detailed description: Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).

Eligibility criteria: Inclusion Criteria:

* clinically stable
* not dependent on oxygen to exercise
* diagnosis of COPD according to the GOLD

Exclusion Criteria:

* cognitive deficit or musculoskeletal
* in process of exacerbation
* have performed pulmonary rehabilitation

Primary outcomes:
measure: The distance reached in shuttle walk test
timeFrame: two year
Secondary outcomes:
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Patricia Lira dos Santos
state: São Paulo/Mogi das Cruzes
Study officials:
affiliation: 551198408-4006
name: Patrícia L Santos, Professional
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.
citation: Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. doi: 10.1164/ajrccm.160.5.9808139.
Clinical trial NCT04268251: Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising MR
Official title: Prospective MRI Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cavernous Sinus Invasion by Pituitary Adenoma
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 67
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: Preoperative evaluation of cavernous sinus invasion by pituitary adenoma is critical for performing safe operation and deciding on surgical extent as well as for treatment success. Because of the small size of the pituitary gland and sellar fossa, determining the exact relationship between the pituitary adenoma and cavernous sinus can be challenging. Performing thin slice thickness MRI may be beneficial but is inevitably associated with increased noise level. By applying deep learning based denoising algorithm, diagnosis of cavernous sinus invasion by pituitary adenoma may be improved.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing preoperative brain MR for pituitary adenoma

Exclusion Criteria:

* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* Poor MRI image quality due to artifacts

Primary outcomes:
measure: Cavernous sinus invasion
timeFrame: Within 1 week
Secondary outcomes:
measure: Size of pituitary adenoma (in mm), laterality of pituitary adenoma (unilateral or bilateral) on the MRI
timeFrame: Within 1 week
measure: Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI
timeFrame: Within 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Ho Sung Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Kim HS, Park JE, Park SY, Kim YH, Kim SJ, Lee J, Lebel MR. Thin-Slice Pituitary MRI with Deep Learning-Based Reconstruction for Preoperative Prediction of Cavernous Sinus Invasion by Pituitary Adenoma: A Prospective Study. AJNR Am J Neuroradiol. 2022 Feb;43(2):280-285. doi: 10.3174/ajnr.A7387. Epub 2022 Jan 6.
Clinical trial NCT06882551: Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients
Official title: Comparison of Intravitreal Bevacizumab Injection with Combination of Suprachoroidal Triamcinolone Acetonide Along with Intravitreal Bevacizumab Injection in the Treatment of Diabetic Macular Edema in Pseudophakic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema (DME)
Keywords: intravitreal bevacizumab
suprachoroidal triamcinolone
diabetic macular edema
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 82
Sex: ALL
Minimum age (years): 32
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema

Detailed description: Patients were included in the study who were pseudophakic with center-involved (sub-foveal) diabetic macular edema. Those patients who had glaucoma history or IOP above 21 mm of Hg, Phakic, corneal opacity, vitreous hemorrhage, proliferative diabetic retinopathy, already received anti-VEGF injections, history of pan-retinal photocoagulation for proliferative diabetic retinopathy.

Eligibility criteria: Inclusion Criteria:

* Patients with center involving diabetic macular edema on optical coherence tomography

Exclusion Criteria:

* Raised intraocular pressure
* History of glaucoma
* Corneal opacity
* Vitreous hemorrhage
* Proliferative diabetic retinopathy
* Anti-VEGF injections in last 3 months
* History of pan-retinal photocoagulation
* Contraindications for anti-VEGF

Primary outcomes:
measure: Central macular thickness
timeFrame: 3 months
measure: Visual Acuity
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT00312351: A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)
Official title: An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Macular Degeneration
Keywords: AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
pegaptanib sodium
ERG
specular microscopy
Age-Related Mcular Degeneration (AMD)
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2006-04-10
Enrollment: 262
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.


Eligibility criteria: Inclusion Criteria:

* Subjects of either gender, aged 50 years or greater.
* Subfoveal choroidal neovascularization (CNV) due to AMD.
* Best corrected visual acuity in the study eye between 20/40 and 20/320.
* Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more.

Exclusion Criteria:

* Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose and Throat Associates, P.A.
state: North Carolina
Study officials:
References:
Clinical trial NCT00113451: Radial Artery Bypass Graft Study of Tromsø
Official title: Radial Artery Bypass Graft Study of Tromsø
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Myocardial Infarction
Keywords: radial artery
angina pectoris
infarction
bypass
angiography
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2005-06-08
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to answer, among others, the following questions: 1) What are the outcomes when using the radial artery as a bypass graft in coronary artery bypass surgery (CABG)? 2) Can multidetector computed tomography (CT) be used to reliably evaluate coronary artery bypass graft patency?

Detailed description: Radial arteries have been used as aortocoronary conduits with varying results. The study is based on the first 119 patients operated with this graft at our institution, aiming to answer the following questions:

1. What is the short-term patency (2-3 years) of radial artery bypass grafts in CABG (comparisons are made with saphenous veins and internal thoracic artery grafts)?
2. What complications occur and what in what frequency?
3. What are the clinical outcomes and patient satisfaction after using radial arteries in CABG? (n=119 pt.)
4. Can multidetector CT be used to reliably evaluate coronary artery bypass graft patency? (n=45 pt.)

Methods: Questionnaires, record review, coronary angiography.

Eligibility criteria: Inclusion Criteria:

* Operated with radial artery coronary bypass at our department during April 2001 - October 2004
* Written informed consent

Exclusion Criteria:

* For the angiography procedures, standard contraindications are adhered to

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: The University Hospital of North Norway
Study officials:
References: