louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04391972: Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
Official title: Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Presbyopia
Keywords: depth and focus
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation

Detailed description: In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).

Eligibility criteria: Inclusion Criteria:

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)

Primary outcomes:
measure: Uncorrected distant visual acuity
timeFrame: 3 months
measure: Uncorrected near visual acuity
timeFrame: 3 months
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months
measure: Quality of Vision
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Tae-Young Chung, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03576872: The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
Official title: The GI Binder: A Psychoeducational Intervention for Gastrointestinal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Intestinal Cancer
Keywords: Gastro Intestinal Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating the use of a binder of educational materials with nurse teaching to prepare patients for chemotherapy

Detailed description: This research study is being done to investigate the feasibility of providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients at Dana Farber for chemotherapy. The investigators want to evaluate whether the binder is helpful and usable for patients; and its effect on knowledge.

Eligibility criteria: Inclusion Criteria:

* Able to read, write, and converse in English.
* 18 years or older
* Scheduled for a new chemotherapy start (intravenous) to treat adenocarcinoma of the pancreas or colorectal cancer

Exclusion Criteria:

* Enrolled in a clinical trial for chemotherapy
* Major psychological diagnoses that would limit participation

Primary outcomes:
measure: 80% or higher rate of completing at least 3 of 4 nurse-led encounters with participants
timeFrame: 8 weeks
Secondary outcomes:
measure: An average positive direction of change scores between participants' pre- and post- knowledge scores
timeFrame: 8 weeks
measure: Average score of 24 or higher on the adapted Acceptability E-scale
timeFrame: 8 weeks
measure: 80% or higher on the index of rates for delivery of educational binders
timeFrame: 8 weeks
measure: 80% or higher on the index of rates for pre-chemotherapy teach sessions using the binders
timeFrame: 8 weeks
measure: 80% or higher on the index of rates for teach sessions using the binder on day 1 of chemotherapy
timeFrame: 8 weeks
measure: 80% or higher on the index of rates for follow-up phone calls and binder review prior to cycle 2 of chemotherapy
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Theresa Jabaley, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02165072: Inferior Vena cavaCollapsibility Index in Patients With Acute Kidney Injury
Official title: Inferior Vena Cava Collapsibility Index in Patients With Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Inferior vena cava
Kidney injury
Ultrasound
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects ages 18-89 years with AKI (creatinine of 1.7mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.

Brief summary: This is an observational study that will examine the possibility of determining the type of Acute Kidney Injury (AKI) using bedside ultrasound machines.

Detailed description: The investigators hypothesize that different types of AKI (pre-renal, renal, and post-renal) are associated with different inferior vena cava diameters and collapsibility index. The investigators will include subjects ages 18-89 years with AKI (creatinine of 2mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine). Standard of care treatment will not be different for patients taking part in this study. Participants will have bedside ultrasounds on days 0, 1, and 3, and baseline and follow-up data will be collected from medical records.

Eligibility criteria: Inclusion Criteria:

1. Creatinine of 1.7 mg/100ml or higher for less than 24 hours from baseline creatinine ≤1.2 or with unknown baseline creatinine
2. Age range: 18-89 years
3. Age range ≥ 18

Exclusion Criteria:

1. Only chronic renal disease will exclude a patient from our study regardless of past medical history and medications they are taking. (For the purposes of this study, any patient with creatinine higher than 1.2 mg /100ml for more than 24 hours will be identified as having chronic renal disease.)

Primary outcomes:
measure: Maximum and Minimum Diameters of the Inferior Vena Cava in Patients With Acute Kidney Injury
timeFrame: Day 1 of ICU admission
measure: Percent Collapse of the Inferior Vena Cava in Patients With Acute Kidney Injury
timeFrame: Day 1 of ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech Univrsity Health Science Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Kenneth M Nugent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04571372: Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease
Official title: Prognostic Value of Soluble Urokinase-type Plasminogen Activator Receptor in Valvular Heart Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severe Aortic Stenosis or Severe Aortic Regurgitation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe aortic stenosis or severe aortic regurgitation

Brief summary: This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)


Eligibility criteria: Inclusion Criteria:

* Age ≥ 19 yrs
* Severe aortic stenosis or severe aortic regurgitation
* Agree to consent for self
* Can follow-up for the next 2 years

Exclusion Criteria:

* Pre-existing acute kidney injury
* Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy
* On ECMO or IABP
* Life expectancy \< 12 months
* Pregnancy

Primary outcomes:
measure: Number of participants with adverse clinical outcomes
timeFrame: Immediate post operation
measure: Number of participants with adverse clinical outcomes
timeFrame: 2 years after recruiting
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Study officials:
References:
citation: Koller L, Stojkovic S, Richter B, Sulzgruber P, Potolidis C, Liebhart F, Mortl D, Berger R, Goliasch G, Wojta J, Hulsmann M, Niessner A. Soluble Urokinase-Type Plasminogen Activator Receptor Improves Risk Prediction in Patients With Chronic Heart Failure. JACC Heart Fail. 2017 Apr;5(4):268-277. doi: 10.1016/j.jchf.2016.12.008.
citation: Hayek SS, Sever S, Ko YA, Trachtman H, Awad M, Wadhwani S, Altintas MM, Wei C, Hotton AL, French AL, Sperling LS, Lerakis S, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Chronic Kidney Disease. N Engl J Med. 2015 Nov 12;373(20):1916-25. doi: 10.1056/NEJMoa1506362. Epub 2015 Nov 5.
citation: Hayek SS, Leaf DE, Samman Tahhan A, Raad M, Sharma S, Waikar SS, Sever S, Camacho A, Wang X, Dande RR, Ibrahim NE, Baron RM, Altintas MM, Wei C, Sheikh-Hamad D, Pan JS, Holliday MW Jr, Januzzi JL, Weisbord SD, Quyyumi AA, Reiser J. Soluble Urokinase Receptor and Acute Kidney Injury. N Engl J Med. 2020 Jan 30;382(5):416-426. doi: 10.1056/NEJMoa1911481.
Clinical trial NCT00065572: Exploratory Study to Assess the Biological Activity of ZD6126 in Subjects With Newly Diagnosed Metastatic Renal Cell Carcinoma (Stage IV)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Kidney Neoplasms
Keywords: Kidney Cancer
Metastatic
Newly diagnosed renal cell carcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2003-07-31
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 assess the biological activity of ZD6126 in subjects with newly diagnosed metastatic renal cell carcinoma (stage IV).


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed metastatic renal cell carcinoma
* Suitable for nephrectomy

Exclusion Criteria:

* Prior chemotherapy, biological therapy or radiation therapy for renal cell carcinoma or within the last 3 years for any other cancer
* Significant cardiac event within 3 months of entry
* Any history of coronary angioplasty or history of myocardial infarction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Newark
country: United States
facility: Research Site
state: Delaware
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Lebanon
country: United States
facility: Research Site
state: New Hampshire
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Bronx
country: United States
facility: Research Site
state: New York
city: Rochester
country: United States
facility: Research Site
state: New York
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
Study officials:
References:
Clinical trial NCT01927172: AirSonea Wheeze Detection Study
Official title: AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Asthma
Lead sponsor: iSonea
Sponsor class: INDUSTRY
First posted: 2013-08-22
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.


Eligibility criteria: Inclusion Criteria:

* Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms
* Part II: Volunteer participants without asthma
* Part III: Participants with asthma
* For all parts of study

  * Age: 18 years or older
  * Participant has signed an Informed Consent after having the Study explained to them.

Exclusion Criteria:

* Any medical finding by the physician that would exclude the patient from participating.
* \< than 18 years of age

Primary outcomes:
measure: Device Efficacy
timeFrame: 1 day
Secondary outcomes:
measure: Wheeze Rate break points
timeFrame: Up to 1 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00933972: A Study of RO4998452 in Type 2 Diabetes Patients With Varying Degrees of Renal Impairment
Official title: Effect of Renal Impairment on Pharmacodynamics and Pharmacokinetics of RO4998452: A Multiple-center, Open-label, Parallel Group Study Following Single Oral Dosing of RO4998452 to Type 2 Diabetes Patients With Varying Degrees of Renal Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 4 arm study will investigate the pharmacodynamics and pharmacokinetics of RO4998452 in type 2 diabetes patients with varying degrees of renal impairment. Eligible patients will be divided into 4 groups, with normal renal function, or mild, moderate or severe renal impairment. All patients will receive a single oral dose of RO4998452 in the fasted state.The anticipated time on study treatment is \<3 months (single dose study)and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 40-80 years of age;
* type 2 diabetes;
* normal renal function, or impaired but stable renal function;
* stable with regard to medication or treatment regimen taken for renal impairment or diabetes.

Exclusion Criteria:

* patients with a renal transplant;
* end-stage renal disease, requiring dialysis;
* nephrotic syndrome, or a history of nephrectomy;
* type 1 diabetes mellitus.

Primary outcomes:
measure: Creatinine clearance; Pk parameters; adverse events
timeFrame: Days 1-3
Secondary outcomes:
measure: Blood glucose; meal tolerance test
timeFrame: Days 1-3
Other outcomes:
Locations:
city: Renton
country: United States
state: Washington
city: Moscow
country: Russian Federation
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02674672: A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
Official title: A Safety and Efficacy Study for Implantation and Retrieval Procedures Using the VENATECH® Retrieval Filter System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Thrombo-embolism
Keywords: VenaTech® Retrievable Vena Cava Filter
safety
efficacy
Lead sponsor: B.Braun Médical - CoE Chasseneuil
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To establish the clinical safety and efficacy of the VenaTech® Retrievable Vena Cava Filter


Eligibility criteria: Inclusion Criteria:

* Pulmonary thrombo-embolism with contraindication to anticoagulation.
* Failure of anticoagulant therapy in thrombo-embolic diseases.
* Prevention of pulmonary embolism in patients with a recent history ( \<3 months) of DVT/ PE who need to undergo urgent surgery at high risk of DVT/PE with temporary contra-indication to the use of therapeutic doses of anticoagulants.
* Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced and
* Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

Exclusion Criteria:

* The filter should not be implanted in patients with :

  * A vena cava which has a diameter \< 14 mm or \> 28 mm (due to the risk of device migration)
  * Risk of septic embolism
  * Known allergy to the materials contained in the kit, allergy to contrast media.
  * Severely disabled patients whose life-expectancy, up to 6 months, appears limited according to the investigator's opinion.

In addition, exclusion criteria are also extended to :

* Patients who cannot be regularly followed up by the participating center
* Subject who already has an implanted vena cava filter
* Subject who has a duplicated IVC
* Subject who has a contrast allergy to both iodinated contrast and non-iodinated contrast material
* Subject unable to understand information about participation in the study due to a language barrier, intellectual deficiency, psychiatric problems...
* Subject who has a renal failure (creatinemia clearance \< 30ml/min)

Primary outcomes:
measure: Safety and the efficacy of filter implantation and retrieval by the study of technical success rate of filter placement, and filter removal (when filter removal procedure is schedule) within 12 weeks of implantation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital européen Georges Pompidou
Study officials:
References:
citation: Dean C, Kim YI, Sanchez O, Martelli N, Sapoval M, Pellerin O. Safety and efficacy of the VenaTech Retrievable inferior vena cava filter: a first-in-man single-center prospective study. CVIR Endovasc. 2022 Oct 4;5(1):50. doi: 10.1186/s42155-022-00325-y.
Clinical trial NCT03309072: Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task
Official title: Investigating Accelerated Learning and Memory in Healthy Subjects Using a Face Name Memory Task
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Keywords: transcranial Direct Current Stimulation (tDCS)
accelerated learning
memory
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two groups: (1) active tDCS with Face Name associate memory task (2) sham tDCS with Face Name associate memory task
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate whether we can accelerate learning and improve associative memory performance in healthy subjects by applying transcranial Direct Current Stimulation (tDCS) during a Face Name memory task.

Detailed description: Associative memory refers to remembering the association between two items, such as a face and a name or a word in English and the same word in another language. It is not only important for learning, but it is also one of the first aspects of memory performance that is impacted by aging and by Alzheimer׳s disease. For decades, neuroscientists have investigated associative learning and memory and ways to accelerate and enhance associative learning and memory.

Transcranial Direct Current stimulation (tDCS) is a non-invasive and painless electrical stimulation technique that has demonstrated to accelerate learning and improve memory in some studies. To investigate whether we can accelerate learning and improve associative memory using tDCS, we will compare the performance in a Face Name Associate memory task from 2 groups. The first group will get active tDCS during the study phase of the Face Name Memory task, whereas the second group will get sham tDCS during the study phase of the task.

Eligibility criteria: Inclusion Criteria:

* Age: 18-35 years
* Native English Speaker

Exclusion Criteria:

* History of severe head injuries, epileptic insults, or heart disease.
* Severe psychiatric disorders and severe untreated medical problems.
* Contraindications for tDCS (pregnant women, implanted devices)

Primary outcomes:
measure: Associative Memory Assessed by a Face Name Associate Memory Experiment
timeFrame: Associate Memory is assessed after a 10 minutes break following the study phase
Secondary outcomes:
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas of Dallas
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sven Vanneste, PhD
role: PRINCIPAL_INVESTIGATOR
References: