louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01279122: Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
Official title: Evaluation of Visual Outcomes of Monovision Patients Bilaterally Implanted With Nanoflex Intraocular Lenses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients Who Have Bilateral NanoFlex Implantation at Least 3 Months Previously
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at how well you see the Nanoflex Intraocular lens placed in your eye.


Eligibility criteria: Inclusion Criteria:

* Male or female patients at least 18 years of age.
* Patients who have bilateral NanoFlex implantation at least 3 months previously.
* No significant ocular pathology causing DCVA to be less than 20/25 or causing significant visual loss.
* DCVA of 20/25 or better in both eyes.
* Spherical equivalent in the dominant eye to be +/-.50 or less and in the non-dominant eye to be between-1.00 and -1.87.
* Uncorrected VA in dominant eye 20/25 or better.

Exclusion Criteria:

* History of ocular trauma or prior ocular surgery (minor ocular trauma is allowed such as small superficial corneal scar not effecting vision; some prior ocular surgery is allowable so long as it has not impacted visual acuity.
* Amblyopia or strabismus, significant visual field loss, or posterior capsular opacifcation.
* Known pathology that may affect visual acuity; particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.).

Primary outcomes:
measure: Uncorrected Near Visual Acuity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Kenneth Lipstock
state: Virginia
Study officials:
References:
Clinical trial NCT01761422: Myocardial Inflammation in Systemic Lupus Erythematosus
Official title: Myocardial Inflammation in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: SLE
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18 years and older who are diagnosed with SLE

Brief summary: The goal is to assess for myocardial edema on cardiac MRI during SLE flare to assess for myocardial inflammation.

Detailed description: The over-arching goal of this work is to further the understanding of myocardial damage in systemic lupus erythematosus (SLE) using state of the art CV imaging to investigate a novel potential mechanism of CV injury in SLE, subclinical myocardial inflammation.

Aim 1: Investigate an alternative pathway for CV morbidity in SLE by measuring myocardial edema at time of moderate to severe flare and compare values to post-flare studies and historical healthy controls.

Hypothesis 1: Myocardial edema, measured quantitatively with T2 CMR mapping during moderate to severe SLE flare will be significantly increased compared to 1) historical controls and 2) in SLE patients after resolution of flare.

Aim 2: Perform exploratory analyses investigating relationships between myocardial edema on CMR and markers of SLE disease activity and CV risk factors.

Hypothesis 2: Markers of disease activity including inflammatory makers (ESR and high sensitivity c-reactive protein), complement and autoantibody levels will predict the presence of T2 CMR detected myocardial edema during flare.

Eligibility criteria: Inclusion Criteria:

* • Diagnosis of SLE by American College of Rheumatology Classification Criteria \[21\]

  * Active SLE Flare defined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)\[22\] \> 6 or British Isles Lupus Assessment Group (BILAG) Index A or B.\[23\]

Exclusion Criteria:

* Pregnant
* Allergy to gadolinium
* Severe claustrophobia
* Renal replacement therapy or glomerular filtration rate (GFR) \< 30 mL/min/1.75m²
* Medically unstable for transportation to Ross MRI scanner. Stability will be defined as: not on mechanical ventilation, HR \< 120 BPM, MAP \> 65 mmHg. The treating providers' input on the patient's stability will also be considered in addition to these criteria
* Weight \> 500 pounds
* MR incompatible implanted devices such as neurostimulator pacemakers and implantable defibrillators, presence of intracranial metal or any metal not compatible with CMR

Primary outcomes:
measure: T2 edema on Cardiac MRI
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Stacy Payne Ardoin
state: Ohio
Study officials:
affiliation: Ohio State University
name: Stacy Ardoin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602822: Safety and Acceptability Study of Non-occupational Prophylaxis (PEP) Following Potential Exposure to HIV
Official title: A Phase IV Open-label Evaluation of Safety, Tolerability and Patient Acceptance of Atazanavir Boosted With Ritonavir Combined With a Fixed-dose Formulation of Tenofovir DF and Emtricitabine for nPEP Following Potential Exposure to HIV-1
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV
Keywords: HIV Prevention
Non-occupational Post-Exposure Prophylaxis (NPEP)
Post-Exposure Prophylaxis (PEP)
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Gilead Sciences
name: Abbott
First posted: 2012-05-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label phase IV study of a new regimen for antiretroviral post-exposure prophylaxis
Primary purpose: PREVENTION

Brief summary: This study will evaluate how safe and tolerable a combination of taking three-drugs will be for the purpose of preventing HIV transmission after a high-risk sexual contact exposure in HIV uninfected adults.

Detailed description: Participants are given a regimen containing tenofovir disoproxil fumarate (TDF) 300mg and emtricitabine (FTC) 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily,for 28 days.

Eligibility criteria: Inclusion Criteria:

1. Age of 18 at time of first visit.
2. HIV uninfected on the basis of a negative HIV Rapid Test
3. Possible non-occupational exposure to HIV-1, recent enough to permit receiving the first dose of study medication within 72 hours from the end of the exposure.

Exclusion Criteria:

1. Women who are actively trying to become pregnant.
2. Pregnancy and/or Breastfeeding.
3. Known self report of Chronic Hepatitis B infection or prior antiretroviral therapy for hepatitis B.
4. Known intolerance or allergy to study drugs.

Primary outcomes:
measure: Safety of Regimen - Symptoms
timeFrame: Visit 3- Day 30
measure: Safety of Regimen - Adverse Events/Serious Adverse Events Considered Related
timeFrame: visit 3 - day 30
measure: Safety of Regimen - Unsafe Biological Test
timeFrame: visit 3 - day 30
Secondary outcomes:
measure: Awareness of NPEP
timeFrame: Visit 2- Day 14
measure: Adherence Rate - Overall
timeFrame: Visit 3- Day 30
measure: Prior nPEP Use
timeFrame: Visit 2- Day 14
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Health
state: Massachusetts
Study officials:
affiliation: Fenway Health
name: Kenneth H Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887625: Exenatide Plus Pioglitazone Versus Insulin in Poorly Controlled T2DM
Official title: Efficacy and Durability of Glucagon Like Peptide 1 Receptor Agonists (GLP-1 RA)/Thiazolidinedione Versus Basal Bolus Insulin Therapy in Poorly Controlled Type 2 Diabetic Patients (T2DM) Patients on Sulfonylurea Plus Metformin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare efficacy, safety and durability of combination therapy with pioglitazone plus GLP-1 RA versus basal bolus insulin in poorly controlled T2DM patients on metformin plus sulfonylurea

Detailed description: poorly controlled (HbA1c \>7.5%) T2DM patients (18-75 years of age) on maximal/near maximal dose of sulfonylurea plus metformin who otherwise are healthy will be randomized to receive:

1. exenatide weekly injection (2 mg/week)
2. glargine insulin plus insulin aspart which will be titrated to maintain HbA1c \<7.0%

Eligibility criteria: Inclusion Criteria:

* T2DM poorly controlled (HbA1c \>7.5%) on metformin (\>1700 mg/day) plus sulfonylurea

Exclusion Criteria:

* type 1 diabetes (T1DM) patients receiving therapy with pioglitazone, GLP-1 RA and insulin abnormal kidney, liver or heart function patients with malignancy

Primary outcomes:
measure: HbA1c
timeFrame: 3 years
Secondary outcomes:
measure: percentage of patients who achieve HbA1c <7.0% and <6.5% at 1 year and at 3 years
timeFrame: 3 years
measure: hypoglycemia rate
timeFrame: 3 years
measure: change in the FPG
timeFrame: 3 years
measure: change in body weight
timeFrame: 3 years
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad General Hospital
Study officials:
affiliation: HMC
name: Amin Jayyousi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdul-Ghani M, Migahid O, Megahed A, Adams J, Triplitt C, DeFronzo RA, Zirie M, Jayyousi A. Combination Therapy With Exenatide Plus Pioglitazone Versus Basal/Bolus Insulin in Patients With Poorly Controlled Type 2 Diabetes on Sulfonylurea Plus Metformin: The Qatar Study. Diabetes Care. 2017 Mar;40(3):325-331. doi: 10.2337/dc16-1738. Epub 2017 Jan 17.
Clinical trial NCT00681525: A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the potential PK interaction between ABT-335, atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects

Exclusion Criteria:

* Clinically significant diseases or disorders
* Positive screens for drug and alcohol
* Pregnant or breast-feeding females
* Any history of surgery(ies) that might interfere with the gastrointestinal motility, pH or absorption

Primary outcomes:
measure: PK interaction
timeFrame: Study duration approximately 62 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 8087
state: Florida
Study officials:
References:
Clinical trial NCT00485225: Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain
Official title: An Open-Label, Two-Stage, Phase II Study to Explore the Titration Schedule for Transitioning Opioid-Experienced Patients With Non-Malignant Moderate to Severe Chronic Pain From Current Opioid Therapy to EN3270.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic, Non Malignant Pain
Lead sponsor: Durect
Sponsor class: INDUSTRY
First posted: 2007-06-12
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two stage study looking at different titration schedules in patients with moderate to severe non-malignant chronic pain. Up to 80 patients at approximately 15 centers in the US to be enrolled. Study participation is approximately 3 months.


Eligibility criteria: Inclusion Criteria:

* Opioid experienced
* Hx (min 3 months) of moderate to severe pain of non-malignant that is well controlled with current pain therapy
* On a stable dose of opioid medication for greater than or equal to 14 days
* Have an adequate personal support system including a co-habitant
* Are able and willing to follow verbal and written instructions and provide written informed consent

Exclusion Criteria:

* Are pregnant or lactating
* Have pain secondary to a confirmed or suspected neoplasm
* Have a history or physical examination finding incompatible with safe participation in the study
* Have a history of alcohol or drug abuse
* Have a history or physical examination finding of clinically significant skin abnormalities that would preclude use of a transdermal patch (e.g., psoriasis)
* Have a history of or currently manifesting a clinically significant psychiatric disorder
* Have a known history of allergy that negatively impacts respiratory function to a clinically significant level
* Plan to have an MRI while on the study
* Have any clinically significant condition that would, in the opinion of the investigator, preclude safe study participation
* Are scheduled for surgery requiring general anesthesia within the study period

Primary outcomes:
measure: Safety and minimum titration period
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: United States
facility: Comprehensive Clinical Research
state: New Jersey
Study officials:
References:
Clinical trial NCT01850225: Feasibility Study of Auditory Brainstem Implant in Young Children
Official title: A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Bilateral Cochlear Aplasia
Bilateral Cochlear Nerve Deficiency
Bilateral Cochlear Ossification Secondary to Meningitis
Lead sponsor: House Research Institute
Sponsor class: OTHER
Collaborators: name: House Clinic, Inc.
name: Children's Hospital Los Angeles
First posted: 2013-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.


Eligibility criteria: Inclusion Criteria:

* Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis
* If previously received a cochlear implant, must demonstrate lack of benefit from that device

Exclusion Criteria:

* Medical contraindication to craniotomy/intracranial surgery
* Severe cognitive or developmental delays

Primary outcomes:
measure: Number of Serious Adverse Events
timeFrame: 12-month post-activation
Secondary outcomes:
measure: Access to sound at a level (dB) and within the frequency range (500-4000 Hz), known to be associated with speech
timeFrame: 3 years post-activation
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: House Research Institute CARE Center
state: California
Study officials:
affiliation: House Research Institute
name: Eric Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: House Research Institute
name: Laurie Eisenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04417725: Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada
Official title: Burden of Disease of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada: A Non-interventional Study Using Administrative Health Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Type 2 Diabetes
Lead sponsor: Medlior Health Outcomes Research Ltd
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 588170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CKD will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA diagnostic codes and eGFR/albuminuria laboratory test values.

Patients with T2DM will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA diagnostic codes.

Patients with comorbid T2DM/CKD will be identified among patients identified with prevalent T2DM. CKD comorbidity will be defined as identified CKD within the two years prior or any time after the T2DM index date.

Brief summary: The purpose of the research study is to describe the burden of disease among three different cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with T2DM and comorbid CKD.

Detailed description: Chronic kidney disease (CKD) has been ranked as the 10th leading cause of death in Canada as of 2013, while type 2 diabetes mellitus (T2DM) is one of the fastest growing diseases in Canada. There is a growing body of evidence that has examined these populations in real-world settings in Canada. The study described below will add to the growing body of literature that has examined CKD patients in Alberta and will contribute to an understanding of the epidemiology of CKD by stage, as well as healthcare resource utilization (HCRU) and costs. Furthermore, this study will contribute to a more nuanced understanding of the epidemiology, treatment patterns, HCRU and costs, and adverse events for T2DM patients with and without comorbid CKD in Alberta.

Eligibility criteria: Inclusion Criteria (either of the following):

* Chronic kidney disease identified using laboratory test and health administrative data
* Type 2 diabetes mellitus identified using health administrative data

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Incidence and prevalence
timeFrame: 2010 to 2018 fiscal years
Secondary outcomes:
measure: Comorbidity and complication profiles and rates
timeFrame: 2010 to 2019 fiscal years
measure: Factors that influence the progression of CKD in patients
timeFrame: 2010 to 2019 fiscal years
measure: Healthcare resource use (HCRU) and associated costs for CKD patients
timeFrame: 2010 to 2019 fiscal years
measure: Stage-to-stage progression of CKD across the follow-up years in patients with CKD
timeFrame: 2010 to 2019 fiscal years
measure: Treatment patterns
timeFrame: 2010 to 2019 fiscal years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01673425: Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Official title: Evaluating Immune Response to Seasonal FluMist in Healthy Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Influenza Vaccines
Vaccines, Attenuated
Immunity, Mucosal
Lead sponsor: National Center for Occupational Health and Infection Control
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2012-08-28
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The Live-Attenuated Influenza Vaccine (LAIV), also known as FluMist, has been shown to be effective in children but less effective in adults. Our hypothesis is that this relative failure is due to adults having enough anti-flu IgA antibody in nasal secretions to neutralize the weakened vaccine virus.

Detailed description: This is a VA-based study to evaluate serum and nasal wash antibody responses to seasonal LAIV of healthy Veterans and VA employees between the ages of 20 and 49 years old.

Specific Aims

1. The primary aim of the study is to evaluate whether people with high mucosal IgA antibodies against flu have a lower immune response to the seasonal LAIV.
2. The secondary objective is to determine whether the nasal wash viral neutralization data predicts LAIV immunization failures.

Eligibility criteria: Inclusion Criteria:

* Medically eligible healthy men and women between the ages of 20 to 49 years old.

Exclusion Criteria:

* A medical condition that places them at high risk for complications from influenza, including those with chronic heart or lung disease, such as asthma or reactive airway disease; people with medical conditions such as diabetes or kidney failure; or people with illnesses that weaken the immune system, or who take medications that can weaken the immune system.
* A history of Guillain-Barré Syndrome that occurred after receiving influenza vaccine
* Currently pregnant
* Have a severe allergy to chicken eggs or who are allergic to any of the nasal spray vaccine components
* Have had flu within the current flu season.
* Have had a flu vaccine within the current flu season.
* Have close contact with someone whose immune system is so weak they require care in a protected environment (such as bone marrow transplant unit).

Primary outcomes:
measure: IgA Antibody Titers
timeFrame: Change from baseline in antibody titer at 6 weeks
Secondary outcomes:
measure: Serum Antibody Response to LAIV
timeFrame: Change from baseline in serum antibody response at 6 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Malcom Randall VA Medical Center
state: Florida
Study officials:
affiliation: National Center for Occupational Health and Infection Control
name: Lewis J. Radonovich, MD
role: PRINCIPAL_INVESTIGATOR
References: