louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02349165: Standard Versus Transepithelial Corneal Crosslinking
Official title: Standard Versus Transepithelial Corneal Crosslinking for Treatment of Progressive Keratoconus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Dr. F.P. Fischer Stichting
name: Stichting Nederlands Oogheelkundig Onderzoek
First posted: 2015-01-28
Enrollment: 61
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 gold standard corneal crosslinking (CXL) technique involves the initial step of epithelial removal, in order to achieve a sufficient treatment effect (meaning: stabilisation of progressive keratoconus (KC). Our aim is to evaluate the effects of transepithelial CXL (TE-CXL), whereby the epithelium is left intact and the cornea is instead treated by a solution composed of 0.1% riboflavin, combined with enhancers, after which standard CXL is performed. This solution seems to facilitate riboflavin penetration into the corneal stroma through the intact epithelium. The investigators expect to achieve a similar effect of TE-CXL with the advantage of a faster healing time and less risk of infections.


Eligibility criteria: Inclusion Criteria:

* Documented progressive KC (by Pentacam and/or corneal topography imaging).
* A clear central cornea.
* A minimal corneal thickness of ≥ 400 µm at the thinnest corneal location (Pentacam imaging).
* Minimal Snellen corrected distance visual acuity of ≥ 0.4.
* Patient age of ≥ 18 years.

For this research study, the inclusion parameters will be the same as mentioned above, with the following additional inclusion criteria:

* Documented progression of KC, as demonstrated by anterior segment imaging and/or corneal topography:

  o Defined an increase in maximal keratometry, steepest keratometry, mean keratometry or topographic cylinder value by ≥ 0.5 D over the previous 6 months and/or a decrease in thinnest pachymetry
* Documented progression of KC defined by increase in refractive cylinder of ≥ 0.5 D over the previous 6 months

Exclusion Criteria:

* Presence of corneal scars.
* History of epithelial healing problems.
* Presence of previous ocular infection (such as herpes keratitis).
* Patients who are pregnant and/or breastfeeding.

Primary outcomes:
measure: Clinical stabilisation of keratoconus one year after CXL
timeFrame: 1 year
Secondary outcomes:
measure: Complications, defined as epithelial healing problems and/or keratitis.
timeFrame: 1 year
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.
Clinical trial NCT03246165: Predictive Factors and Complications of Delirium
Official title: Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Surgery--Complications
Age Problem
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Hospital de Messejana
First posted: 2017-08-11
Enrollment: 173
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital de Messejana in Fortaleza, Ceara.

Brief summary: The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Detailed description: Delirium is a transient and fluctuating course syndrome of acute onset that is characterized by reduced level of consciousness, global cognitive dysfunction, and disorder in the sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that affects 2-57% of the patients, reaching as high as 73% in older subjects.

The identification of patients at high risk for delirium is important to deliver proper care and avoid the consequences of this complication. However, previous studies published on the subject have not delivered definitive results in the cardiac surgery setting. Low educational level has also been studied as a risk factor for delirium after surgery but never in a group of cardiac surgery patients that includes a significant rate of illiteracy.

The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Eligibility criteria: Inclusion Criteria:

* Elective cardiovascular surgery

Exclusion Criteria:

* Blindness,
* deafness,
* previous stroke
* dementia
* delirium at inclusion, preoperatively
* creatinine clearance \< 30 ml/min
* emergency surgery

Primary outcomes:
measure: Delirium
timeFrame: Until hospital discharge or 30 days after surgery, and for up to 18 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04855565: ALY688-SR in Generally Healthy Overweight or Obese Adults
Official title: Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of ALY688-SR in Generally Healthy Overweight or Obese Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Overweight and Obesity
Lead sponsor: Allysta Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: INC Research Australia Pty Ltd
First posted: 2021-04-22
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single dose escalation study
Primary purpose: TREATMENT

Brief summary: First in human study of ALY688-SR administered as a subcutaneous injection

Detailed description: The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ALY688-SR compared to placebo administered as a subcutaneous injection.

Eligibility criteria: Inclusion Criteria:

* Body mass index 24 to 35 kg/m2 Body weight 60 to 120 kg,

Exclusion Criteria:

* Confirmed diabetes on treatment Inadequately managed hypertension Poorly controlled hypercholesterolemia

Primary outcomes:
measure: Change between pre- and post-intervention safety and tolerability assessments
timeFrame: baseline, pre-intervention through study completion at 16 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Ben Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00660465: Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises
Official title: Exploring the Relationship Between Varying CO2 Levels and the Regional BOLD Signal, by Using Breathing Exercises .
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: Regional BOLD signal dependency on arterial PaCO2.
Effect of breathing exercises on brain regional O2 level.
Healthy subjects
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2008-04-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents

Brief summary: The purpose of this study is to explore how arterial PaCO2 effect regional Blood Oxygen Level Dependent (BOLD) signal, and indirectly the brain regional O2 level .

Detailed description: Among many parameters effecting cerebral blood flow(CBF), partial pressure of CO2 (PaCO2) in arterial blood has a significant effect. A small increase in arterial PaCO2 level will cause a significant increase of CBF , followed by increase of O2 level . The main objective is to explore the effect of arterial PaCO2 level on regional CBF and brain O2 level, by using breathing exercises to modulate arterial PaCO2. The regional Blood Oxygen Level Dependent (BOLD) signal produced by MRI , will indicate the regional O2 level.

Eligibility criteria: Inclusion Criteria:

* adults over 18 years old .

Exclusion Criteria:

* under 18 years old.
* Artificial pacemaker
* implantable cardioverter-defibrillator (ICD)
* Hearing aid, implantable or portable.
* artificial heart valve
* Surgical clips
* Metal fragments in eyes
* Electronic stimulators
* Implanted pumps
* Implantable Neurostimulation Device
* metal fragments of any sort
* Permanent makeup or tattoo
* transfusion pump
* pregnant or breast feeding women
* False teeth , retainer or dental crown

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Department of Diagnostic Imaging ;Soroka Univrsity Medical Center
Study officials:
affiliation: Head, Neuroradiolgy Unit ;Department of Diagnostic Imaging ;Soroka Univrsity Medical Center
name: Ilan Shelef, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03516565: Matrix Metalloproteinases's in Oral Biofluids During Pregnancy and Postpartum
Official title: Modulation of Matrix Metalloproteinases-8, -9 and Endogenous Tissue Inhibitor-1 in Oral Biofluids During Pregnancy and Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: gingivitis
saliva
gingival crevicular fluid
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-05-04
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All women were systemically healthy

Brief summary: The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels of MMP-8, MMP-9 and TIMP-1 during 2/3 trimester of pregnancy and after delivery

Detailed description: MMP-8 and MMP-9 have been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. The balance between tissue inhibitors of metalloproteinases (TIMPs) and MMPs play an important role in maintaining the integrity of healthy periodontium.

Eligibility criteria: Inclusion Criteria:

* Pregnant group included women, who were in their second trimester (weeks 16-24) and third trimester (weeks 25-34)

Exclusion Criteria:

* (a) any known systemic disease, (b) periodontal treatment within the last six months, (c) patients having less than 10 teeth, (d) smokers and (e) individuals with BMI \> 30 kg/m2

Primary outcomes:
measure: Changing MMP-8 levels
timeFrame: 6 months
measure: Changing MMP-9 levels
timeFrame: 6 months
measure: Changing TIMP-1 levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01727765: Inspiratory Muscle Training and Asthma
Official title: Inspiratory Muscle Training as a Novel Approach in the Treatment of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma, inspiratory muscle training
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2012-11-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study which will assess the feasibility of a follow on main study. This study will examine the impact of inspiratory muscle training on quality of life, rescue drug medication usage, and other markers of asthma in adult asthmatics in the UK.


Eligibility criteria: Inclusion Criteria:

* Asthma Control Questionnaire score of ≥ 1.5
* 10 mg or less of prednisolone (or equivalent) daily
* Aged 18 to 59 years inclusive
* Able to provide written informed consent

Exclusion Criteria:

* Any significant heart or lung disease other than asthma including any previous history of pneumothorax
* Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease) not controlled with treatment, making implementation of the protocol or interpretation of the study results difficult
* Women who are pregnant
* Forced expiratory volume in one second of less than 50% best or predicted
* A history of smoking 20 cigarettes a day for 20 years or more (or an equivalent amount)
* Undertaken a structured program of inspiratory muscle training within the past three months
* Currently a participant in another interventional study

Primary outcomes:
measure: Maximal Inspiratory Mouth Pressure (MIP)
timeFrame: pre (after the 4 week run-in) and post 6 weeks of IMT
Secondary outcomes:
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Respiratory Centre, Queen Alexandra Hospital, Cosham
state: Hampshire
city: Portsmouth
country: United Kingdom
facility: University of Portsmouth
state: Hampshire
Study officials:
References:
Clinical trial NCT00513565: A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers
Official title: A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder and Anxiety Disorders
Keywords: GSK561679,
single,
dose,
lorazepam,
fMRI,
BOLD,
healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.


Eligibility criteria: Inclusion Criteria:

* Healthy males
* Non-smokers
* Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
* Normal ECG.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* History or current diagnosis of acute narrow angle glaucoma.
* Left handed

Primary outcomes:
measure: Differences in fMRI brain activation (BOLD) response in specific brain regions
timeFrame: conducted the duration of the study
Secondary outcomes:
measure: Physiologic changes
timeFrame: during & after fMRI session
measure: Visual Analogue Scale measurement of physical reactions
timeFrame: duration of study
measure: Blood level of GSK561679
timeFrame: collected during fMRI session
measure: Vital signs & ECG recording
timeFrame: duration of the study
measure: Lab tests for blood & urine
timeFrame: throughout the study
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: GSK Investigational Site
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04498065: MYocardial DOmmages Related to COVID-19
Official title: MYocardial DOmmages Related to COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Non Ischemic Myocardial Injury
Myocardial Infarction
Myocarditis
Troponin Elevation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 273
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: Patients admitted to CHU Dijon Bourgogne for COVID-19

Brief summary: Myocardial injury, as assessed by elevation of cardiac troponins (Tnc), is frequent among patients with COVID-19. Although rare autopsy cases reported COVID-19 related myocardial inflammation, the origin of Tnc elevation is unknown to date. Several cardiac causes, such as myocarditis, non-ischemic myocardial injury (NIMI), or myocardial infarction (MI) may lead to Tnc kinetic. Our work will test the hypothesis that during SARS-Cov2 infection, the elevation of cardiac biomarkers could be linked to the occurrence of myocarditis.


Eligibility criteria: Inclusion Criteria:

* COVID-19 positive patient hospitalized \< 72 h after symptoms onset with troponin assessement.

Exclusion Criteria:

* patients hospitalized \> 72h after symptom onset

Primary outcomes:
measure: characterize the myocardial damage associated with CoV-2 SARS infection
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05345665: Comparison of Three Methods of Anesthesia to Achieve a Nerve Block Anesthesia.
Official title: Comparison of Three Methods of Anesthesia to Achieve a Nerve Block Anesthesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of three methods for the realization of a neuronal blockade.

Detailed description: Evaluation of three methods during the realization of a neuronal blockade. The three stimulations were: 1) echography, 2) echography and neurostimulation, and 3) echography, neurostimulation, and active mobilization by the patient.

Eligibility criteria: Inclusion Criteria:

* 216 consecutive adult patients scheduled for an elective hand surgery

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Time
timeFrame: Measurements was performed during 20 minutes after the completion of the neuronal blockade.
Secondary outcomes:
Other outcomes:
Locations:
city: Namur
country: Belgium
facility: Clinique Saint-Luc Bouge
Study officials:
affiliation: Astes
name: Eric P Deflandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04191265: Cardiotoxicity of Aluminum Phosphide Poisoning; Tropinin and CKmb as Early Biomarkers
Official title: Cardiotoxicity of Aluminum Phosphide Poisoning; Biochemical and Electrophysiological Studies and the Utility of Tropinin and CKmb as Early Biomarkers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Aluminum Phosphid Poisoning
Keywords: tropinin
CKmb
cardiotoxicity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Assiut governorate

Brief summary: Aluminum phosphide (AlP) or rice tablet is a cheap pesticide. When it comes in contact with acid (gastric acid) or moisture, it releases phosphine (PH3) gas. The heart,lungs, liver are the main targets in acute Aluminum phosphide (AlP) poisoning. Most deaths occur due to cardiovascular toxicity.

Detailed description: Aluminium phosphide is a potent respiratory chain enzyme inhibitor. Its most important effect is the inhibition of cytochrome c oxidase. The inhibition of cytochrome c oxidase and other enzymes leads to the generation of superoxide radicals and cellular peroxides , and subsequent cellular injury through lipid peroxidation and other oxidant mechanisms. It stimulates the production of hydrogen peroxide and reactive oxygen species, malonyldialdehyde (MAD), increases superoxide dismutase and inhibits catalase, peroxidase and glutathione . Oxidative stress is one of the main mechanisms of action of aluminium phosphide toxicity

Eligibility criteria: Inclusion Criteria: ALP poisoned cases

* admitted with free ECG

Exclusion Criteria:

concomitant ingesion of other drugs or toxins

-

Primary outcomes:
measure: assess serum tropinin and CKmb as biomarkers for early detection of ALP induced myocardial injury
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Doaa
Study officials:
References:
Clinical trial NCT02641665: Plasma Biomarkers in Cardiac Valve Surgery
Official title: Measurement of Four Plasma Biomarkers for Risk Stratification and Determination of Functional Recovery After Cardiac Valve Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elective Valvular Cardiac Surgery
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 250
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: Adult patients undergoing elective or urgent cardiac valve surgery in isolation of in combination with CABG.

Brief summary: The level of four biomarkers will be measured in the patients' plasma after induction of anaesthesia. There biomarkers are NT-ProBNP, ST2, Galectin-3 and GDF-15. The level of these marker will then be correlated with early (30 days) and late (one year) patients' prognosis and with functional recovery (MLHFQ score).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Elective/urgent aortic or mitral valve surgery in isolation or combined with CABG

Exclusion Criteria:

* Emergency or salvage surgery
* Inability to consent
* Previous cardiac surgery
* Stage IV or V CDK (GFR ≤ 30 ml/min) or dialysis
* Active Endocarditis
* Liver cirrhosis
* Chronic atrial fibrillation
* Pacemaker

Primary outcomes:
measure: Composite primary outcome
timeFrame: 30 days
Secondary outcomes:
measure: ICU readmission
timeFrame: 30 days
measure: Post-operative AKI
timeFrame: 48 hours
measure: Ejection fraction
timeFrame: 1 year
measure: NYHA
timeFrame: 1 year
measure: MLHFQ
timeFrame: 1 year
measure: reshopitalisation
timeFrame: 1 year
measure: one year mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHU of Liege
Study officials:
References: