louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00064480: Black Pooling Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Coronary Disease
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2003-07-10
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To conduct a person-level meta-analysis by pooling 9 United States studies with both black and white cohorts.

Detailed description: BACKGROUND:

Over the last three decades a sustained and marked decline in death rates from coronary heart disease (CHD) has occurred for all major demographic groups of the US population. Recently, however, the decline has proceeded less rapidly in blacks than in whites, and in women than men. These trends have focused further attention on possible heterogeneity in the risk factor patterns among the demographic sub-groups. As is well recognized, the knowledge on CHD risk factors and statistical models used to predict personal risk of CHD have been based on studies among white populations. In some epidemiological studies with samples from black populations, large variation in the effect of specific factors has been noted. Given the small sample of blacks under investigation, however, low statistical power exists for many of the black-white comparisons. The fundamental obstacle to progress in this area remains the absence of the cohorts of sufficient size that is representative of all four major groups. Hence, a strong rationale exists to undertake a "pooling project" to clarify a set of important unanswered questions in cardiovascular disease epidemiology.

DESIGN NARRATIVE:

Person-level meta-analysis will be conducted by pooling 9 large United States epidemiologic studies with both black and white samples: the First National Health and Nutrition Examination Survey (NHANES I) Epidemiological Follow-up Study, the NHANES II Mortality Follow-up Study, the Charleston Heart Study, the Evans County Heart Study, the Chicago Heart Association Detection Project in Industry, the Atherosclerosis Risk in Communities Study (ARIC), the Follow-up Study of the screenees for the Multiple Risk Factors Intervention Trial (MRFIT), the Follow-up Study of the participants from the MRFIT, and the Follow-up Study of the participants from the Hypertension Detection and Follow-up Program (HDFP). Black-white comparison will be performed on the CHD incidence and mortality, exposure-outcome relationship, patterns of co-morbidity (or coexistence of risk factors) and population attributable risk. Multivariate risk functions will also be examined in blacks and whites in the three contexts: ordering risk, magnitude of relative risks, and estimation of absolute risk.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Daniel Lackland
References:
Clinical trial NCT03339180: Cardiac Injury in Patients With Influenza
Official title: Prevalence and Prognostic Implications of Cardiac Injury in Patients With Influenza-like Illness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Influenza, Human
Myocardial Injury
Keywords: cardiac troponin
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The clinical study will be conducted in Region Örebro County. Recruitment will start October 1st 2017 and is expected to continue for two influenza seasons until April 30, 2019. Individuals for inclusion are recruited among adult patients \> 18 years presenting with influenza-like illness at the emergency unit and who, due to strong clinical suspicion of ongoing influenza infection, are tested.

Brief summary: This study investigate the prevalence of elevated biomarkers of cardiac injury in patients with suspected influenza infection and the prognostic implication on the composite endpoint of death of any cause, hospitalization due to myocardial infarction, unstable angina, heart failure and stroke.

Detailed description: The relationship between influenza and cardiovascular events was described in an early study of influenza epidemics from 1915 to 1929 including the 1918-1920 pandemic. Retrospective studies have shown increased risk for acute myocardial infarction (AMI) during the first week following an infection with influenza.

Biochemical markers of cardiac injury such as high sensitive cardiac troponins may be increased during infection with influenza. Increased levels of cardiac troponins are associated with adverse outcome in many different populations.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) presenting with influenza-like illness.
* Written informed consent.

Exclusion Criteria:

* Inability to provide informed consent.
* Age \<18 years.
* Symptoms indicating an acute coronary syndrome, acute heart failure, rapid atrial fibrillation or acute stroke.

Primary outcomes:
measure: Level of biochemical markers
timeFrame: One year
measure: Level of biochemical markers
timeFrame: One year
Secondary outcomes:
measure: Prognostic implication
timeFrame: One year
measure: Prognostic implication
timeFrame: One year
measure: Prognostic implication
timeFrame: One year
measure: Prognostic implication
timeFrame: One year
measure: Prognostic implication
timeFrame: One year
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
References:
Clinical trial NCT03184480: Arnuity® Ellipta® Drug Use Investigation
Official title: Arnuity Ellipta Drug Use Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Drug Use Investigation
GW685698
asthma
Post-marketing surveillance
ARNUITY ELLIPTA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-06-12
Enrollment: 336
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 investigation will assess the information about safety and effectiveness of Arnuity in approximately 300 subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.

Brief summary: The aim of this post-marketing investigation is to collect and assess the information about safety and effectiveness of ARNUITY® ELLIPTA® (hereinafter referred to as "Arnuity") in daily clinical practice. The investigation will include subjects with a diagnosis of asthma bronchial who are naïve to ARNUITY. The investigator will monitor the information about safety and effectiveness of ARNUITY for one year from the start date of ARNUITY administration and Pneumonia will be considered as the priority investigation matter. 300 subjects, from approximately 150 medical institutions, will be included in this analysis. ARNUITY ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.


Eligibility criteria: Inclusion Criteria:

* The investigation will include subjects with a diagnosis of asthma bronchial, for which Arnuity is indicated and who are naïve to Arnuity.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Number of subjects with adverse events (AEs), serious AEs (SAEs), severe AEs and drug related AEs
timeFrame: One year from the start of Arnuity administration
measure: Number of subjects with pneumonia
timeFrame: One year from the start of Arnuity administration
measure: Response rate based on global assessment of effectiveness
timeFrame: One year from the start of Arnuity administration
measure: Total ACT score
timeFrame: One year from the start of Arnuity administration
Secondary outcomes:
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Nagasaki
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00371280: Prosthetic Motility and Complications in Pegged Versus Unpegged Hydroxyapatite Orbital Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anophthalmos
Orbital Implants
Keywords: hydroxyapatite
peg
prosthetic motility
orbital implant
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pegging the hydroxyapatite for increasing prosthetic motility sometimes leads to some complications for the patient. These complications ranging from discharge, granuloma formation, exposure, implant infection to socket discomfort and etc. We are going to compare prosthetic motility, objectively and subjectively (patients satisfaction) before and after pegging the hydroxy- apatite, and evaluate the complications after pegging.


Eligibility criteria: Inclusion Criteria:

* orbital hydroxyapatite implants

Exclusion Criteria:

* history of systemic disease
* history of radio therapy
* secondary hydroxapatite implant
* complications lead to re-surgery

Primary outcomes:
measure: Changing movement in up gaze: 0.58 mm
measure: Changing movement in down gaze: 0.83 mm
measure: Changing movement in medial gaze: 0.75 mm
measure: Changing movement in lateral gaze: 1.2 mm
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Babak Babsharif, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Babak Babsharif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627480: Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Official title: Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Insomnia
Insomnia Chronic
Sleep
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Fisher Wallace
First posted: 2020-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.


Eligibility criteria: Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Read/write English Insomnia Severity Index Score Greater than 14 Diagnosis of insomnia by a medical physician Subjects with a Generalized Anxiety Diagnosis will be excluded Have not contemplated suicide in the past year Not been institutionalized for mental health issues. Not currently being treated for or suspect a mental health issue Not currently experiencing problems with alcohol or drug abuse Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study Not taking medications affecting the nervous system (e.g. psychiatric medications) Not taking hypnotics or any sleep aid or marijuana (in any form) Can commit to one (1) 20 minute session per day for 8 weeks Has not used a brain stimulation treatment in one year No suspected or known history of heart disease No pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc.

Not under medical supervision for other serious medical condition Not taking opioids No pain or headaches that interrupt sleep Not participating in any other sleep study Not experiencing restless leg syndrome No Nickel Allergy No Sleep Apena as measured by STOP-Bang Assessment

Primary outcomes:
measure: Change in total sleep per night at week 4 between active and sham arm
timeFrame: baseline versus week 4
Secondary outcomes:
measure: Device Tolerance and Safety measured by SAFTEE
timeFrame: 4 weeks from baseline
measure: Change in WASO (wake after sleep onset) between sham versus active arms
timeFrame: baseline versus week 4
measure: Change in Insomnia Severity between Sham versus active arms
timeFrame: baseline versus week 4
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Remote Virtual Trial)
state: New York
Study officials:
References:
Clinical trial NCT03999762: Automated Sperm Sample Preparation Protocol
Official title: Sperm Sample Preparation Protocol for Intrauterine Insemination (IUI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Nanonc Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Utah
First posted: 2019-06-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical trial would be directed at determining the effectiveness of an innovative sperm sample preparation protocol for intrauterine insemination (IUI). The goal of the protocol would be to enable clinics not performing IUI to be able to perform IUI without requiring specialized training in sperm sample preparation.

Detailed description: Nanonc proposes an automated system for sperm sample preparation that will take in raw ejaculate and output a purified sperm population in an IUI syringe in less than 15 minutes. The IUI syringe will be detachable from the rest of the system. During the 15 minutes, the clinician will not need to perform any actions; as the system will run all of the sample processing steps in an automated fashion. Furthermore, the system will have a footprint of a small desktop printer that is portable to be conveniently placed on a bench in clinical setting. A portable system that performs automated isolation of sperm from ejaculate will revolutionize sperm processing and increase access to sperm sample preparation. Additionally, the system will decrease cost, time and skill required to process sperm, and potentially improve outcomes for patients with low sperm counts. By increasing the yield and precision of sperm isolation and concentration techniques, the investigator's approach has the potential to offer this exact benefit by specifically providing the opportunity for some patients to try less invasive and less expensive procedures.

Eligibility criteria: Inclusion Criteria:

* Any couple with doctor's order for IUI with density gradient centrifugation

Exclusion Criteria:

* Azoospermia

Primary outcomes:
measure: Total motile sperm count
timeFrame: At the time of sperm preparation
measure: Percentage of patients with positive chemical pregnancy in each study group following IUI
timeFrame: 2 weeks after IUI
measure: Percentage of patients with positive clinical pregnancy in each study group following IUI
timeFrame: 6 to 7 weeks after IUI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Nanonc Inc.
name: Raheel Samuel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113462: Triglyceride/High-density Lipoprotein Cholesterol Ratio in Chronic Kidney Disease
Official title: The Prospective Cohort Study to Investigate the Role of Plasma Triglyceride/High-Density Lipoprotein Cholesterol Ratio To Predict Cardiovascular Outcomes in Chronic Kidney Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Endothelial dysfunction
Inflammation
Insulin resistance
Tg/hdl ratio
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 197
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: renal unit

Brief summary: The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. The investigators aimed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Detailed description: Cardiovascular disease (CVD) risk is substantially increased in subjects with chronic kidney disease (CKD).The reasons for the elevated risk of CVD in patients with CKD are not fully elucidated. There is not a good prognostic tool for the prediction of increased cardiovascular risk in CKD. A simple, widely available, relatively inexpensive, and generally reproducible marker to predict the CVD risk in subjects with CKD is needed.

The Triglycerides (TG) to High Density Lipoprotein Cholesterol (HDL-C) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. No study has been performed so far, to evaluate the role of TG/HDL ratio to predict the CVD risk in patients with CKD.

This study is designed to evaluate the relationship between TG/HDL-C ratio and the endothelial functions in patients with CKD.

Eligibility criteria: Inclusion Criteria:

* patients with chronic kidney disease

Exclusion Criteria:

* taking drugs that may influence endothelial function
* acute infections

Primary outcomes:
measure: All cause mortality
timeFrame: 30 months
measure: Endothelial functions assessed by flow mediated dilatation and serum ADMA measurement
timeFrame: Once in recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
Study officials:
References:
citation: Sonmez A, Yilmaz MI, Saglam M, Unal HU, Gok M, Cetinkaya H, Karaman M, Haymana C, Eyileten T, Oguz Y, Vural A, Rizzo M, Toth PP. The role of plasma triglyceride/high-density lipoprotein cholesterol ratio to predict cardiovascular outcomes in chronic kidney disease. Lipids Health Dis. 2015 Apr 16;14:29. doi: 10.1186/s12944-015-0031-4.
Clinical trial NCT02837562: Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff
Official title: Risk of Radiation-induced Cataracts Among Interventional Cardiology Staff- CATaracts Attributed to Radiation in the CaTh Lab: The IC-CATARACT Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cataract
Keywords: Radiation exposure
Cardiac catheterization
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Dallas VA Research Corporation
First posted: 2016-07-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants of the Society of Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, 2016

Brief summary: The goal of the present study is to evaluate the prevalence of radiation-associated lens opacities among interventional cardiology staff members (such as physicians, technicians, and nurses) and determine its association with occupational history.

The hypothesis of the study is that interventional cardiology staff will have high prevalence of radiation-induced lens opacities, which will be higher than non-interventional cardiology staff and will correlate with the estimated cumulative lifetime dose.

Detailed description: This is an observational, cross-sectional study to evaluate the prevalence of posterior subcapsular cataract (PSC) and its association with prior occupational history of radiation exposure. Participants of the Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions to be held in Orlando, FL May 4th to May 7th, will be invited to participate. Both interventional cardiology and non-interventional cardiology staff and non-clinical participants will be assessed. Written informed consent will be obtained from all participants. They will subsequently be asked to complete a questionnaire on occupational radiation exposure, workplace practices and medical history followed by dilated slit lamp examination using a modified Merriam-Focht scoring system.

Eligibility criteria: Inclusion Criteria:

* Willing to undergo eye examination
* Participant at Society of Cardiovascular Angiography and Interventions 2016 Scientific Sessions

Exclusion Criteria:

* Known pre-existing severe eye disease, such as glaucoma
* Prior lens surgery
* Known hypersensitivity to the mydriatic agents
* Any other conditions that may preclude participation/ performance of slit lamp eye examination/ use of mydriatics, in the opinion of the investigator

Primary outcomes:
measure: Radiation associated lens opacities
timeFrame: At study completion, approximately 30 minutes after administration of mydriatic eye drops
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Emmanouil S Brilakis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: