louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00649467: Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg
Official title: Single-Dose Fasting Bioequivalence Study of Topiramate Sprinkle Capsules (25 mg; Mylan) and Topamax® Sprinkle Capsules (25 mg; Ortho-McNeil Neurologics) in Healthy Volunteers Dosed With Applesauce
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 144 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Dorian Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02383667: Clinical Comparison of Electrocardiograms Collected Using an Ambulatory Holter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Electrocardiography
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients within the hospital either for a procedure or for admission

Brief summary: The objective of the study is to compare electrocardiograms using ambulatory holter monitor with dry electrodes in a harness versus using an ambulatory holter with standard sticky electrodes (Red Dot) on monitored patients within the hospital. Patients will be simultaneously be hooked up to two ambulatory Holter monitors for the period of time to be not less than one hour. One holter will use standard electrodes in a standard electrode distribution. The second holter will use dry electrodes in a derived.


Eligibility criteria: Inclusion Criteria:

* Any patient within the hospital either for procedure or for admission

Exclusion Criteria:

* Patients who cannot wear a Holter monitor
* Patients undergoing an MRI or have other contraindications for wearing an ambulatory Holter monitor.

Primary outcomes:
measure: Arrythmia
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: The University of Toledo
name: Jennifer Cummings, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05959967: Vestibular Rehabilitation Exercises vs. General Fitness Training on Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction
Official title: The Efficacy of Vestibular Rehabilitation Exercises and General Fitness Training pn Dizziness, Balance Confidence, and Mobility in Individuals With Bilateral Vestibular Hypofunction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of two groups: the VRE group or the GFT group.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness of Vestibular Rehabilitation Exercises (VRE) and General Fitness Training (GFT) in adults diagnosed with vestibular disorders. The main questions it aims to answer are:

Does VRE lead to better improvements in gaze stabilization, balance, and gait than GFT? Does GFT lead to more improvements in overall fitness than VRE? Participants will be randomly assigned to either the VRE or GFT group and will participate in 60-minute exercise sessions twice weekly for 8 weeks. Researchers will compare the improvements in the two groups to see which intervention is more effective.


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 - 60 years.
* Diagnosis of a vestibular disorder confirmed by a healthcare professional.
* Able to walk unassisted for at least 10 meters.
* Able to understand and comply with the procedures of this study.
* Willing to provide informed consent.

Exclusion Criteria:

* Severe cardiovascular, respiratory, or metabolic disease that contraindicates physical exercise.
* Neuromuscular disorders that may affect balance and mobility other than the diagnosed vestibular disorder.
* History of orthopedic surgery within the past 6 months.
* Currently participating in another interventional clinical trial.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: Change in Vertigo Symptom Scale (VSS) Scores from Baseline to 8 Weeks
timeFrame: Changes between Baseline and 8 weeks
measure: Change in Biodex Balance System Scores from Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Six-Minute Walk Test (6MWT) Distance from Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
measure: Change in Flexibility Test Scores from Baseline to 8 Weeks
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT01569867: Genetic Influences on Statin Blood Concentrations in African Americans
Official title: An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adult African American Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemia
Hypercholesterolemia
Dyslipidemia
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-04-03
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals will be recruited from various hospitals, ancillary clinics, and primary-care offices affiliated with the Ohio State University Medical Center (OSUMC).

Brief summary: This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.


Eligibility criteria: Inclusion Criteria:

* African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin)

Exclusion Criteria:

* Age less than 18 years

Primary outcomes:
measure: 24-hour area under the time-concentration curve of statin concentrations in plasma
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of statin-associated muscle symptoms (SAMS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Joseph P Kitzmiller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang J, Luzum JA, Phelps MA, Kitzmiller JP. Liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of simvastatin, lovastatin, atorvastatin, and their major metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci. 2015 Mar 1;983-984:18-25. doi: 10.1016/j.jchromb.2014.12.029. Epub 2015 Jan 13.
Clinical trial NCT01040767: Comparison of Web- Versus Classroom-based Basic Ultrasound and Extended Focused Assessment With Sonography for Trauma (EFAST) Training in Two European Hospitals
Official title: Comparison of Web- Versus Classroom-based Basic Ultrasound and EFAST Training in Two European Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Learning
Keywords: Ultrasound education
Blended learning
Distance education
Trauma ultrasound
FAST
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Klinikum Nürnberg
name: Institut fuer Notfallmedizin Kempten e.V., Germany
First posted: 2009-12-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Study Objective: Training physicians in new skills via classroom-based teaching has inherent costs and time constraints. We sought to evaluate whether web-based didactics result in similar knowledge improvement and retention of basic ultrasound principles and the EFAST (Extended Focused Assessment with Sonography for Trauma) compared with the traditional method.

Methods: Physicians from two German emergency departments were randomized into a classroom group with traditional lectures and a web group that watched narrated lectures online. All participants completed a pre- and post-test, and a second post-test eight weeks later. Both groups underwent hands-on training after the first post-test. A control group completed the two initial tests without didactic intervention.


Eligibility criteria: Inclusion Criteria:

* Physicians currently practicing in a German emergency department
* Age ≥ 18 years

Exclusion Criteria:

* Inability to participate in all aspects of the study prior to study begin
* Control group: Subjects who did not complete the pre-test

Primary outcomes:
measure: Mean test scores by didactic group for three consecutive multiple choice tests
timeFrame: November 2008 - February 2009
Secondary outcomes:
measure: Participant satisfaction with training and reported comfort with ultrasound use after training
timeFrame: December 2008 - February 2009
Other outcomes:
Locations:
city: Kempten
country: Germany
facility: Institut fuer Notfallmedizin e.V.
state: Bavaria
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg
state: Bavaria
Study officials:
affiliation: Brigham and Women's Hospital, Boston USA
name: Elke Platz, MD, RDMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02687867: Real-world Comparative Effectiveness of Dabigatran Versus Vitamin K Antagonist
Official title: Real-world Comparative Effectiveness of Dabigatran Versus VKA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Non-valvular atrial fibrillation (NVAF)
Prevention
Stroke
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 56039
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 non-valvular atrial fibrillation (NVAF).

Brief summary: To obtain a better understanding on the comparative effectiveness of dabigatran versus Vitamin K antagonist (VKA) for stroke prevention in patients with Non-valvular atrial fibrillation (NVAF) in a real-life setting.


Eligibility criteria: Inclusion Criteria:

* Non-valvular atrial fibrillation will be defined as the occurrence of 2 or more inpatient or outpatient claims with ICD-9 427.31 (International Classification of Disease, Ninth Revision, Clinical Modification) as the diagnosis code at any time in the patient's data history prior to inclusion
* Patients will be required to have 180 days of enrollment for the assessment of baseline characteristics
* CHA2DS2-Vasc (Diabetes mellitus; S2: prior Stroke or TIA or Thromboembolism; V: Vascular disease; A: Age 65-74 years; Sc: Sex category ) score ≥2 during the 180 days prior to index dabigatran use baseline period

Exclusion Criteria:

* Patients \<18 years of age
* Patients with valvular Atrial fibrillation
* Pregnancy
* Malignant cancers
* Transient cause of Atrial fibrillation
* Patients with Venous thromboembolism (pulmonary embolism or Deep Vein Thrombosis)
* Patients with major surgery defined as hip or knee replacement
* Prescriptions of Oral anticoagulants (OACs) {apixaban, warfarin, dabigatran, rivaroxaban} before index date
* Prescription of more than one OAC on the index date
* Patient with any of the events defined in the composite endpoint

Primary outcomes:
measure: Incidence of Hospitalization Events (composite endpoint)
timeFrame: Within 2 years of starting treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
state: New York
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00845767: The Cardiovascular Effects of Air Pollution: the Role of Nitric Oxide
Official title: The Cardiovascular Effects of Air Pollution: the Role of Nitric Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endothelial Dysfunction
Keywords: Nitric Oxide
Nitric Oxide Synthase
Air Pollution
Endothelial Dysfunction
Diesel Exhaust
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2009-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Exposure to air pollution has been linked to increased cardiorespiratory morbidity and mortality. The exact component of air pollution that mediates this effect is unknown, but the link is strongest for fine combustion derived particulate matter derived from traffic sources. Recently, it has been demonstrated that inhalation of diesel exhaust impairs vascular vasomotor tone and endogenous fibrinolysis. The mechanism underlying these detrimental vascular is unclear, but is thought to be via oxidative stress and altered bioavailability of endogenous nitric oxide. In these studies we plan to elucidate the role of endogenous nitric oxide (NO) in the adverse vascular responses observed following exposure to diesel exhaust.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Use of regular medication (except oral contraceptive pill)
* Current smokers
* Significant occupational exposure to air pollution
* Intercurrent illness

Primary outcomes:
measure: Forearm blood flow as measured by venous occlusion plethysmography during infusion of NOS inhibitors and vasodilators
timeFrame: 2-4 hours after exposure
Secondary outcomes:
measure: Plasma nitrite concentrations
timeFrame: During forearm study
measure: Plasma concentrations of t-PA and PAI
timeFrame: After infusion of bradykinin during forearm study
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Anders Blomberg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Edinburgh
name: David E Newby, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mills NL, Tornqvist H, Robinson SD, Gonzalez M, Darnley K, MacNee W, Boon NA, Donaldson K, Blomberg A, Sandstrom T, Newby DE. Diesel exhaust inhalation causes vascular dysfunction and impaired endogenous fibrinolysis. Circulation. 2005 Dec 20;112(25):3930-6. doi: 10.1161/CIRCULATIONAHA.105.588962.
citation: Langrish JP, Unosson J, Bosson J, Barath S, Muala A, Blackwell S, Soderberg S, Pourazar J, Megson IL, Treweeke A, Sandstrom T, Newby DE, Blomberg A, Mills NL. Altered nitric oxide bioavailability contributes to diesel exhaust inhalation-induced cardiovascular dysfunction in man. J Am Heart Assoc. 2013 Feb 19;2(1):e004309. doi: 10.1161/JAHA.112.004309.
Clinical trial NCT03380767: Use of Viscoelastic Tests in the Treatment of Traumatic Induced Coagulopathy: a Pragmatic Randomized Clinical Trial.
Official title: Use of Viscoelastic Tests in the Treatment of Trauma-induced Coagulopathy: a Pragmatic Randomized Clinical Trial Comparing Viscoelastic Tests With Conventional Assays.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma, Multiple
Coagulopathy
Massive Hemorrhage
Keywords: trauma-induced coagulopathy
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Trauma is the leading cause of death in young people. Trauma-induced coagulopathy (TIC) encompasses several aspects of traumatic bleeding. Monitoring of coagulopathy comprises use of Point-of-Care (POC) methods, such as thromboelastography (TEG) or Thromboelastometry (ROTEM) and conventional laboratory assays (platelet count, fibrinogen level, and PT or INR).

POC tests are thought to have a better performance on mortality and bleeding control than conventional tests. The aim of this study is to compare POC and conventional assays with plasma consumption as a primary outcome and 28 days mortality as a secondary one.


Eligibility criteria: Inclusion Criteria: all adult (\> 18 years old) trauma patients treated in our Emergency Department with a TASH score \> 18

Exclusion Criteria:

* dead on arrival
* no blood product administered after randomization

Primary outcomes:
measure: Fresh frozen plasma consumption
timeFrame: 3 years
Secondary outcomes:
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Ospedale Papa Giovanni XXIII
state: BG
Study officials:
References:
citation: Gonzalez E, Moore EE, Moore HB. Management of Trauma-Induced Coagulopathy with Thrombelastography. Crit Care Clin. 2017 Jan;33(1):119-134. doi: 10.1016/j.ccc.2016.09.002.
citation: Gonzalez E, Moore EE, Moore HB, Chapman MP, Chin TL, Ghasabyan A, Wohlauer MV, Barnett CC, Bensard DD, Biffl WL, Burlew CC, Johnson JL, Pieracci FM, Jurkovich GJ, Banerjee A, Silliman CC, Sauaia A. Goal-directed Hemostatic Resuscitation of Trauma-induced Coagulopathy: A Pragmatic Randomized Clinical Trial Comparing a Viscoelastic Assay to Conventional Coagulation Assays. Ann Surg. 2016 Jun;263(6):1051-9. doi: 10.1097/SLA.0000000000001608.
citation: Hunt H, Stanworth S, Curry N, Woolley T, Cooper C, Ukoumunne O, Zhelev Z, Hyde C. Thromboelastography (TEG) and rotational thromboelastometry (ROTEM) for trauma induced coagulopathy in adult trauma patients with bleeding. Cochrane Database Syst Rev. 2015 Feb 16;2015(2):CD010438. doi: 10.1002/14651858.CD010438.pub2.
Clinical trial NCT01815567: DETECT and Retinal Outcomes in Hypertension
Official title: The Effects of Blood Pressure on Cognitive Function: Examining the Use of Bedside Neuropsychological Testing During Acute Hypertensive Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Retinal Disorder
Cognitive Impairment
Keywords: Hypertension
Retinal Disorder
Cognitive impairment
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2013-03-21
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency department patients that meet the inclusion/exclusion criteria.

Brief summary: The purpose of this study is to study the impact of blood pressure on cognitive performance.

Detailed description: Four groups will be evaluated for possible impact of blood pressure on cognitive performance and retinal damage.

Eligibility criteria: Inclusion Criteria:

1. Patients triaged to the Grady Memorial Hospital Emergency Department or Marcus Trauma Unit
2. Age \>18 and \<65
3. Documented history of hypertension plus one or more of the following:

   * current antihypertensive use with controlled blood pressure
   * elevated Emergency Department systolic blood pressure or diastolic blood pressure
   * OR -
4. Acutely elevated Emergency Department systolic blood pressure or diastolic blood pressure on 2 separate Emergency Department measurements in the absence of a history of hypertension

   * OR -
5. Normal systolic blood pressure or diastolic blood pressure in the absence of hypertension.

Exclusion Criteria:

1. Non-English speaking
2. Pre-visit cognitive impairment
3. Physical or psychological impairments that would prohibit comprehension and completion of DETECT testing
4. Inability to obtain adequate fundoscopic photos
5. Acute intoxication, altered mental status, or head injury within the last 6 months
6. Opiate or benzodiazepine administration by treating providers
7. Clinical condition not allowing testing.

Primary outcomes:
measure: DETECT neurocognitive outcome scores (Z-scores) in association with blood pressure measures and retinal pathology (isolated retinal hemorrhage, grade III/IV hemorrhagic retinopathy)
timeFrame: 12 months
Secondary outcomes:
measure: Variance of DETECT scores (Z-score) attributed to reading level
timeFrame: One year study periord (12 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Tamara Espinoza, MD
role: PRINCIPAL_INVESTIGATOR
References: