louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05389228: Health Consequences of the Burden of Atrial Fibrillation
Official title: Health Consequences of the Burden of Atrial Fibrillation - The Swiss-AF-BURDEN Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Burden
Keywords: Atrial Fibrillation
Burden
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Clinical Trial Unit, University Hospital Basel, Switzerland
name: Swiss Heart Foundation
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Geneva
First posted: 2022-05-25
Enrollment: 325
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients from the ongoing Swiss-AF cohort study with paroxysmal or persistent AF

Brief summary: The Swiss-AF-BURDEN study will be embedded in the follow-up visits of the Swiss-AF cohort study. The research question of the current atrial fibrillation burden will be answered by using 7-day Holter-ECG recordings and continuous implanted loop recorder recording, whereas cardiac MRI examination will give results about cardiac dimensions and function. The 7-day Holter ECG will be repeated after one year. The cMRI will be performed separately or directly after the brain MRI to minimize the additional burden for the patients. Only a subsample of 100 patients will additionally receive ILR for 2 years.


Eligibility criteria: Inclusion Criteria:

* Swiss-AF study patient
* Paroxysmal or persistent AF

Exclusion Criteria:

* Permanent AF
* Swiss-AF patients not willing or able to undergo 7-day Holter monitoring
* Specifically for cMRI: Pregnant women or women of child-bearing age without a prior negative pregnancy test

Primary outcomes:
measure: AF-burden
timeFrame: Baseline to Follow-up year 2
Secondary outcomes:
measure: Incidence of overt and covert stroke
timeFrame: Baseline to Follow-up year 2
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Michael Kuehne, MD Prof, exec MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Insel, Bern, Switzerland
name: Laurent Roten, MD Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpitaux Universitaires de Genève, Switzerland
name: Dipen Shah, MD Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279928: Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Official title: Detection of Vascular Injury in Diabetes Through Eye and Nailfold Data (DIVIDEND) - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: paediatric and adolescent population
nailfold capillaroscopy
laser Doppler flowmetry
retinal vessel calibre
retinal vessel fractal analysis
24 hour Ambulatory Blood Pressure Monitoring
Lead sponsor: John Hunter Hospital
Sponsor class: OTHER_GOV
First posted: 2011-01-20
Enrollment: 26
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were recruited from the John Hunter Children's Hospital paediatric diabetes clinic. They were between the ages of 8-18 years old.

Brief summary: This project aimed to explore novel methods of detecting small blood vessel disease in a paediatric population with type 1 diabetes mellitus. To do this the techniques of Nailfold capillaroscopy, laser Doppler flowmetry, retinal (eye) vessel analysis and 24-hr Ambulatory Blood Pressure Monitoring were used. Each of these techniques investigated different areas of small blood vessels around the body.

It was hypothesized that in a paediatric population with type 1 diabetes mellitus the novel investigations would be associated with small blood vessel disease and that widespread changes to these blood vessels would be detected through associations between the different novel investigations.


Eligibility criteria: Inclusion Criteria:

* 8-18 years old
* Have a diagnosis of type 1 diabetes mellitus

Exclusion Criteria:

* \< 8 years or \> 18 years old
* Significant autoimmune rheumatological disease (e.g. lupus or dermatomyositis)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Lambton
country: Australia
facility: John Hunter Children's Hospital
state: New South Wales
Study officials:
affiliation: John Hunter Children's Hospital
name: Rani Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hosking SP, Bhatia R, Crock PA, Wright I, Squance ML, Reeves G. Non-invasive detection of microvascular changes in a paediatric and adolescent population with type 1 diabetes: a pilot cross-sectional study. BMC Endocr Disord. 2013 Oct 5;13:41. doi: 10.1186/1472-6823-13-41.
Clinical trial NCT00748228: Dopamine in Orthostatic Tolerance
Official title: Dopamine in Orthostatic Tolerance
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Postural Tachycardia Syndrome
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: One goal of this study is to determine whether people with different amounts of dopamine-beta-hydroxylase (DBH) have different responses to events that affect blood pressure and heart rate. We will also study whether increasing dietary salt improves symptoms during upright posture. Finally, we will examine whether the dietary sodium level influences serum DBH activity and whether DBH level influences the response to sodium. DBH levels and the function of the sympathetic or involuntary nervous system will be assessed in normal volunteers and in patients with postural tachycardia syndrome (POTS).


Eligibility criteria: Inclusion Criteria:

* Upright plasma norepinephrine \> 600 pg/ml, or
* An increase in heart rate of \> 30 beats per minute upon standing, and
* Withdrawal of all medications for at least 3 days, and
* No associated medical illness, and
* Age 18 - 60 years old.

Exclusion Criteria:

* Older than 60 years of age
* Routinely taking medications affecting the autonomic nervous system
* Any chronic illness (cardiac, pulmonary, endocrine, gastrointestinal, rheumatologic) other than POTS
* Anemia (Hct \< 30)
* Women of childbearing age who are pregnant or nursing
* Unable to give informed consent

Primary outcomes:
measure: plasma dopamine-beta-hydroxylase
timeFrame: at enrollment and after tests
measure: plasma dopamine
timeFrame: after tests
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Emily M Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00704028: Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
Official title: A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-24
Enrollment: 161
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 objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.


Eligibility criteria: Inclusion Criteria:

* Subjects ≥18 years of age and able to give informed consent
* Iron deficiency is the primary etiology of anemia
* History of intolerance or an unsatisfactory response to oral iron
* Screening Visit central laboratory Hgb ≤11 g/dL
* Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion Criteria:

* Previous participation in a FCM trial
* Known hypersensitivity reaction to FCM or iron dextran
* Requires dialysis for treatment of chronic kidney disease
* Current anemia not attributed to iron deficiency
* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
* Anticipated need for surgery during the 30 day period prior to screening or during the study period
* AST or ALT greater than 1.5 times the upper limit of normal
* Received an investigational drug within 30 days of screening
* Women who are breastfeeding
* Pregnant or sexually-active females who are not willing to use an effective form of birth control

Primary outcomes:
measure: The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)
timeFrame: Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00345228: Myopic Macular Haemorrhages
Official title: Myopic Macular Haemorrhages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopic Macular Haemorrhages
Keywords: High myopia
Choroidal neovascularisation
Lacquer crack
Fundus fluorescein angiography
Indocyanine green angiography
Axial length
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2006-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: 1. To identify the underlying causes of macular haemorrhages in patients with high myopia
2. In the eyes found to have macular haemorrhages secondary to choroidal neovascularisation, we hope to identify the risk factors for the development of choroidal neovascularisation in high myopia
3. To study the functional outcome of these eyes as assessed by visual acuity
4. To study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography

Detailed description: Primary Aims

* To identify the underlying aetiologies of macular haemorrhages in myopic eyes
* To study the functional and morphological outcome of these eyes with macular haemorrhages 6 months later Secondary Aims
* To study the subgroup of eyes with myopic choroidal neovascularisation (CNV), in particular the risk factors for CNV in myopes
* To study the subgroup of eyes with macular haemorrhages in the absence of CNV

Plan of investigation:

1. Patient with myopia (\>-6.00DS) presents with loss of central vision
2. Examination reveals a macular haemorrhage
3. Investigations

   * Refraction
   * Axial length\*
   * Fundus fluorescein angiography
   * Indocyanine green angiography\*
4. Determine if a myopic CNV is present or absent
5. Management of patient: Treatment vs No treatment

   * Treatment being

     1. Conventional laser
     2. PDT
6. Review at 6 months

   * BCVA
   * Clinical appearance (fundal photo)
   * FFA
7. Review at 12 months

   * BCVA
   * Clinical appearance

Eligibility criteria: Inclusion Criteria:

* High myopia (greater than -6.00DS)
* Macular haemorrhage

Exclusion Criteria:

* Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy
* Allergy to fluorescein or indocyanine green dyes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Shu-Yen Lee, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Chong-Lye Ang, FRCOphth
role: STUDY_CHAIR
References:
Clinical trial NCT04487028: Dysphagia in Thoracic Surgical Patients
Official title: Dysphagia in Thoracic Surgical Patients: Incidence, Risk-factors, and Health Related Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Diseases
Keywords: Dysphagia
Extubation
Vocal Fold Mobility Impairment
Peak Cough Flow (PCF)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 240 individuals undergoing thoracic surgery will be enrolled in this study.

Brief summary: The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

Detailed description: Swallowing impairment and VFMI are common, yet often overlooked, complications of thoracic surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing thoracic surgery. The study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status

Eligibility criteria: Inclusion Criteria:

* adults aged 18 - 90 years old
* undergoing planned or emergent thoracic surgery via clamshell and/or extended thoracotomy
* confirmed negative COVID-19 test
* willing to participate in postoperative swallowing evaluation testing.

Exclusion Criteria:

* individuals under the age of 18.
* pregnant
* or those testing positive for COVID-19
* Additionally, the inability to demonstrate appropriate alertness and cognitive status following the procedure will exclude a participant from participating in this study to ensure protection of vulnerable individuals.

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Baseline
Secondary outcomes:
measure: Yale Residue Severity Rating Scale
timeFrame: Baseline
Other outcomes:
measure: Vocal Fold Mobility Impairment
timeFrame: Baseline
Locations:
city: Gainesville
country: United States
facility: Cardiovascular Clinic at UF Health UF
state: Florida
city: Gainesville
country: United States
facility: Thoracic and Cardiovasscular Surgery at UF Health
state: Florida
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily K Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03977428: Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
Official title: Central China Congenital Heart Disease Associated Pulmonary Arterial Hypertension Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with diagnosis of CHD-PAH

Brief summary: The study will recruit and follow up patients for five years patients newly diagnosed with congenital heart disease associated pulmonary arterial hypertension(CHD-PAH) from the investigator's hospital. The main aim of the study is to describe the aetiology, natural history and management practices of CHD-PAH in central China.

Detailed description: baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.

Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.

Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests

main outcome measure include:

death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Eligibility criteria: Inclusion Criteria:

-Clinical diagnosis of CHD-PAH (by RHC)

Exclusion Criteria:

* PAH due to other criteria;
* unable to participate

Primary outcomes:
measure: survival
timeFrame: 5 years
Secondary outcomes:
measure: clinical worsening
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asian Heart Hospital
Study officials:
affiliation: Wuhan Asian Heart Hospital
name: Qiu Qiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05077228: Efficiency of the Imaging Strategy for the Management of Suspected Covid-19
Official title: Efficiency of the Imaging Strategy for the Management of Suspected Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Dyspnea
Cough
Sputum
Diarrhea
Confusion
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever\> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020

Brief summary: Emergency departments have been placed at the heart of the patient triage strategy during the COVID-19 epidemic. In the absence of scientific knowledge on the most efficient strategy to put in place in emergency structures, the centers have proposed very heterogeneous protocols resulting from collaboration with local radiology and virology teams. While the pandemic in France appears to be currently under control, it is important to assess the sorting strategies put in place to deal with a new epidemic.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years old)
* Subject treated in the emergency rooms of participating centers for suspicion of COVID-19 presenting with fever\> 38 ° and / or respiratory signs (dyspnea, cough, sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and / or people over 85 or living in an institution during the study period from March 9 to May 8, 2020
* Subject affiliated to a social health insurance protection scheme
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: A retrospective study of the imaging strategy for the management of suspected Covid-19
timeFrame: Files analysed retrospectively from March 09, 2020 to May 08, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg
name: Sabrina GARNIER KEPKA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01265628: Validation of the GATE Software
Official title: Validation of the GATE Software for Static Visual Field Examinations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Field Defects
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Haag-Streit AG
First posted: 2010-12-23
Enrollment: 30
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: selected from the eye hospital's database

Brief summary: Comparison of the differential luminance sensitivity (DLS) values at each test point


Eligibility criteria: Inclusion Criteria:

* physical, intellectual and linguistic abilities, in order to understand the test requirements
* spherical ametropia max. ± 8 dpt, cylindrical ametropia max. ± 3 dpt
* distant visual acuity \> 10/20
* isocoria, pupil diameter \> 3 mm

Exclusion Criteria:

* pregnancy, nursing
* diabetic retinopathy
* asthma
* HIV+ or AIDS
* history of epilepsy or significant psychiatric disease
* medications known to effect visual field sensitivity
* acute ocular infections (e.g. keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drugs
* amblyopia
* squint
* nystagmus
* albinism
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or presence of macular disease and / or macular edema
* relevant opacities of central refractive media (cornea, lens, vitreous body)
* ocular trauma

Primary outcomes:
measure: Validation of visual field data and comparison of the differential luminance sensitivity (DLS) values at each test point by applying two perimetric software versions.
timeFrame: up to 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Centre for Ophthalmology, Institute for Ophthalmic Research
Study officials:
affiliation: University of Tuebingen, Centre for Ophthalmology
name: Ulrich Schiefer, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luithardt AF, Meisner C, Monhart M, Krapp E, Mast A, Schiefer U. Validation of a new static perimetric thresholding strategy (GATE). Br J Ophthalmol. 2015 Jan;99(1):11-5. doi: 10.1136/bjophthalmol-2013-304535. Epub 2014 Jul 22.