louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04280653: An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Official title: An Open-Label, Multi-Center, Clinical Study Evaluating the Effect of the NDE L68 StableFit® Punctal Plug on the Tear Lake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-21
Enrollment: 15
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: To evaluate the effect of the NDE L68 StableFit® punctal plug on the tear lake.

Detailed description: This is a Non-Significant Risk (NSR) medical device, multi-center, open-label clinical study. Each study subject that qualifies at the baseline visit will receive an NDE L68 StableFit® punctal plug in the lower punctum in one of their eyes. All study plugs will remain in the study subject's lower punctum for a period of 28 + 4 days after insertion.

Eligibility criteria: Inclusion Criteria:

1. A male or female subject, 18 years of age or older, in good general health at the time of the baseline examination, who may or may not have a mild to moderate dry eye condition
2. A subject must be able to read, comprehend and be willing to give HIPAA authorization and informed consent
3. A subject must be willing to have a punctal plug inserted in the lower punctum of one of their eyes
4. A subject must be willing to comply with all study instructions, agree to make all office appointments, and complete the entire course of the study

Exclusion Criteria:

1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in the planned study eye
2. A subject with a history of intolerance to punctal plugs
3. A subject with structural lid abnormalities (e.g., ectropion, entropion) in the planned study eye
4. A subject with any clinically significant lid, conjunctival or corneal findings in the planned study eye at the baseline visit
5. A subject with a severe dry eye condition
6. A subject experiencing epiphora in the planned study eye
7. A subject experiencing any clinically significant ocular pain or discomfort in or around either eye at the baseline visit

Primary outcomes:
measure: Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 7 Days
timeFrame: 7 days
measure: Investigators' Evaluation of the Tear Lake; Comparison of Baseline Result to 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Investigator's Evaluation \ of the Subject's Acceptance of the NDE L68 StableFit® Punctal Plug, Comparison of Baseline Result to 28 Days
timeFrame: 28 days
Other outcomes:
Locations:
city: Edgewood
country: United States
facility: Cincinnati Eye Institute-Edgewood
state: Kentucky
city: Garden City
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
References:
Clinical trial NCT01861353: Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
Official title: Randomized Controlled Trial of the Effect of Cranberry-lingonberry Juice on the Occurrence of Urinary Tract Infections, the Gut Microbiota, and the Uropathogenic Escherichia Coli
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Pyelonephritis
Cystitis
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2013-05-23
Enrollment: 113
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cranberry and cranberry-lingonberry juice prevented urinary tract infections in children and in adults in our earlier clinical trials. The preventive effect was, however, observed late in the follow-up and the next recurrence was not prevented in children. The investigators hypothesize that cranberry-lingonberry juice should be started already during the antimicrobial treatment of acute urinary tract infection in order to maximize the preventive efficacy of the juice. In addition, the investigators aim to find the explanation for the efficacy of cranberry-lingonberry juice by analyzing the concomitant changes in the chemical composition of urine and feces as well as the changes of gut microbiota.


Eligibility criteria: Inclusion Criteria:

* Recent confirmed urinary tract infection, diagnosed in Oulu University Hospital or Oulu Health Care Center
* Age 1-16 years

Exclusion Criteria:

* Continuous antimicrobial prophylaxis
* Age \< 12 months or \> 16 years
* Severe congenital kidney or other urinary tract anomaly in ultrasound

Primary outcomes:
measure: Change of the intestinal and urinary microbiome
timeFrame: 3 months to 12 months
Secondary outcomes:
measure: The occurrence of urinary tract infections (infection episodes/person years at risk)
timeFrame: 12 months
measure: Time to the first recurrence
timeFrame: 6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Pediatrics, University of Oulu
Study officials:
References:
Clinical trial NCT05557253: Effects of Remimazolam on the Intraoperative Hemodynamics in Bypass Surgery
Official title: Effects of Remimazolam on the Intraoperative Hemodynamic Parameters in Patients Undergoing Extracranial-intracranial Bypass Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraoperative Hypotension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled trial. A total of 72 patients will be randomized to receive remimazolam anesthesia or balanced anesthesia (propofol + desflurane) during extracranial-intracranial bypass surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo elective extracranial-intracranial bypass surgery
* American Society of Anesthesiologists grade 1,2,3
* Age \> 18 years old

Exclusion Criteria:

* Refuse to participate to the study
* American Society of Anesthesiologists grade 4
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* Allergic history of benzodiazepine
* Pregnant
* Acute narrow-angle glaucoma
* Shock or Coma
* Acute alcohol addicted
* Obstructive sleep apnea
* dependency on alcohol or drug
* Severe acute respiratory insufficiency
* Hypersensitivity to Dextran 40

Primary outcomes:
measure: Intraoperative hypotension
timeFrame: During surgery
Secondary outcomes:
measure: Inotropic requirements
timeFrame: During surgery
measure: Incidence of bradycardia
timeFrame: During surgery
measure: Incidence of tachycardia
timeFrame: During surgery
measure: Maximum systolic blood pressure
timeFrame: During surgery
measure: Minimum systolic blood pressure
timeFrame: During surgery
measure: Brain relaxation score
timeFrame: Immediately after dura opening
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04881253: COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)
Official title: COVID-19 Patient Cohort: Retinal Damage in Non-invasive Retinal Imaging (OCTA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Retina Injury
Keywords: OCT-A
OCT
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 100
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: Inpatients with COVID-19, patients who were hospitalised for COVID-19 and patients with COVID-19 who did not require hospitalisation

Brief summary: The objective of this research is to build a collection of non-invasive retinal imaging (OCT and OCTA) in order to investigate the incidence and impact of retinal damage in patients who have or have had COVID-19.

Detailed description: This monocentric study is aimed at 3 types of patients:

* Those who have been hospitalized for Covid-19 during the epidemic
* Newly infected and diagnosed patients Covid-19
* Those with paucisymptomatic Covid-19 who did not require hospitalisation

At the patient's inclusion, an ophthalmologic assessment will be performed including :

* visual acuity,
* SD-OCT + multicolor,
* OCT-A,
* color retinography,

Fundus examination, optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) in all COVID-19 patients may detect retinal lesions. In addition, if a correlation is demonstrated between clinical and paraclinical parameters and between disease severity and retinal vascular damage in non-invasive imaging (OCT and OCTA), this would allow a better understanding of the pathophysiology of the disease, as well as factors that may influence disease severity and the mechanisms potentially responsible for the observed disorders.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Diagnosis of COVID-19 proven on RT-PCR, antigenic test or chest CT scan
* Affiliation to the general social security system
* A consent signed by the patient

Exclusion Criteria:

- Refusal of patient participation

Primary outcomes:
measure: Retinal damage at inclusion after Covid-19 infection
timeFrame: Up to one week after inclusion
Secondary outcomes:
measure: Change of retinal vascular density at inclusion after Covid-19 infection
timeFrame: Up to one week after inclusion
measure: Impact of retinal vascular density changes on visual acuity at inclusion
timeFrame: Up to one week after inclusion
measure: Presence of Retinal toxicity (atrophy) on multimodal retinal imagery
timeFrame: Up to one week after inclusion
Other outcomes:
Locations:
city: Créteil
country: France
facility: Centre Hospitalier Intercommunal de Créteil
state: IDF
Study officials:
References:
Clinical trial NCT01891253: Inert Gas Rebreathing in Ventilated Patients
Official title: Feasibility of the Non-invasive Determination of Cardiac Output Using Inert Gas Rebreathing in Ventilated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Respiratory Failure
Heart Failure
Renal Failure
Keywords: cardiac output
mechanical ventilation
inert gas rebreathing
pulse contour analysis
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ventilated ICU patients

Brief summary: Measuring hemodynamic parameters in ventilated patients is important yet still complicated to perform. Inert gas rebreathing (IGR) showed promising results when being compared to other invasive as well as non-invasive techniques for the measurement of cardiac output. The aim of our study is to evaluate the feasibility of IGR in ventilated patients.


Eligibility criteria: Inclusion Criteria:

* age 18 - 80 years
* mechanically ventilated patient
* existing PiCCO arterial line

Exclusion Criteria:

* FiO2 \> 60% (fraction of inspired oxygen)
* PEEP \> 10 mmHg (positive end-expiratory pressure)
* SO2 \< 90% (oxygen saturation )
* Systolic blood pressure \< 90 mmHg
* Heart rate \> 150 bpm
* APRV (airway pressure release ventilation)
* ICD (implantable cardioverter defibrillator) / pace maker
* \[ Anaesthetic Conserving Device (Anaconda) \]

Primary outcomes:
measure: cardiac output
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Manheim
country: Germany
facility: Universitätsmedizin Mannheim
state: Baden-Württemberg
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Joachim Saur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05987553: The Influence of an E-learning Program on Recognition of Actinic Keratosis
Official title: The Influence of an E-learning Program on Recognition of Actinic Keratosis by General Practitioners). Implementation of Actinic Keratosis Guidelines Among General Practitioners.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Actinic Keratoses
E-learning
Dermatology
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data from general practitioners who

Brief summary: The evaluation on the diagnostic accuracy of actinic keratosis recognition by general practitioners before and after participation on an e-learning program.

Detailed description: Actinic keratosis is defined as the most frequent common intra-epithelial neoplasm in the Caucasian population, with an increasing prevalence. If left untreated, actinic keratosis has the potency to develop into a cutaneous squamous-cell carcinoma. Treatment of actinic keratosis is aimed at both lesion reduction and to prevent malignant transformation. To achieve treatment adherence for patients, it is necessary to raise physician awareness about actinic keratosis.

This study primarily aimed to investigate whether the sensitivity of establishing a correct actinic keratosis diagnosis by general practitioners (in training) would increase after participating in an e-learning program about the recognition of actinic keratosis. This was achieved by comparing the results of a pre- and post-test completed by general practitioners which was incorporated in the e-learning program.

Eligibility criteria: Inclusion Criteria:

* general practitioner in the Netherlands
* access to e-learning module via phone/computer/tablet
* knowledge of the Dutch language

Exclusion Criteria:

* no knowledge of the Dutch language
* different specialists than general practitioner

Primary outcomes:
measure: Difference in sensitivity
timeFrame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
measure: Difference in specificity
timeFrame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
Secondary outcomes:
measure: Difference in area under the receiver operating characteristic (ROC) curve
timeFrame: Measurement by baseline and after finalising the e-learning program (same day up until 30 days)
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Ellen Oyen
Study officials:
affiliation: Maastricht UMC+
name: Klara Mosterd, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02962453: Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway in Patients After Knee Arthroplasty
Official title: Multi-Modalities Evaluation of Gait Rehabilitation Robot of an End-Effector on Neuro-Muscular Pathway of the Proximal Muscles in Patients After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2016-11-11
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the clinical efficacy of gait rehabilitation robot through cortico-spinal-muscular pathway activation of the muscles remotely located from the end-effecter in patients after total knee arthroplasty.

Detailed description: pre-interventional evaluation; within 1 day of intervention start primary end point; 3 days after intervention start secondary end point; 5 days after intervention start

Eligibility criteria: Inclusion Criteria:

* Patients after Unilateral Total Knee Arthroplasty

Exclusion Criteria:

* brain disease, spinal cord injury, peripheral neuropathy, myopathy
* Inability to ambulate fully due to muscukoskeletal disorders
* MMSE\<23
* history of arthroplasty surgery on either of legs
* Cardiac pacemaker
* Refusal of participation

Primary outcomes:
measure: Change of Isometric muscle strength
timeFrame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Secondary outcomes:
measure: Change of Cortico-motor Excitability
timeFrame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
measure: Change of Spinal Motor-neuron Excitability
timeFrame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
measure: Change of Cross-sectional area and volume of thigh muscle
timeFrame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
measure: Change of Muscle work
timeFrame: 0 day( within 6 hours before the treatment start) and 5 day(within 6 hours after treatment stop)
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
Clinical trial NCT05692453: Pulse Oximetry Accuracy by Skin Color
Official title: Pulse Oximetry Accuracy by Skin Color
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 540
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing surgery at Nationwide Children's Hospital.

Brief summary: This is a prospective, non-randomized, non-blinded comparative study to evaluate the accuracy of pulse oximetry compared to co-oximetry in dark-skinned (Black) compared to lighter-skinned (White) children undergoing anesthesia, using standard FDA performance statistics as measured by mean bias and accuracy root mean squared to evaluate device performance.

Detailed description: This is a prospective, non-randomized, non-blinded comparative study.

There will be no changes to the anesthetic or surgical plan to accommodate this study. Patients undergoing anesthesia will be induced per their anesthetic team. Following endotracheal intubation, the patient will be placed on air (FiO2 21%) at 4 liters per minute fresh gas flow. After a minimum of 3 minutes has elapsed, the anesthesia team will obtain an arterial blood sample of approximately 1 mL. This can be obtained from an arterial line if one is planned for the procedure or already in place by accessing the line per standard procedure. If an arterial line is not placed, the arterial sample will be obtained by percutaneous arterial puncture using ultrasound guidance and a 25-gauge blood gas syringe. The patient's SpO2 will be noted using a pulse oximetry probe placed on the right index finger when the arterial sample is drawn, along with the date/time of sample acquisition. Once the sample is drawn, the patient's anesthetic and surgery will proceed as per his anesthesia team. The arterial sample will be immediately delivered to the Nationwide Children's Hospital laboratory for simultaneous ABG and ABG-CoOx analysis to obtain SaO2S and SaO2C, respectively.

Eligibility criteria: Inclusion Criteria:

* Children aged 2-9 years undergoing general anesthesia with or without arterial line placement.

Exclusion Criteria:

* Patients with cyanotic congenital heart disease.
* Patients with bleeding disorders.
* Patients taking blood thinners.

Primary outcomes:
measure: Accuracy of Pulse Oximetry
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Brittany Willer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02291653: Pediatric Endotracheal Intubation
Official title: Comparing the Novel McGrath MAC EMS Videolaryngoscope With Conventional Direct Laryngoscopy During Child Resuscitation: a Randomized Crossover Mannequin Study of Paramedic Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Intubation, Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We hypothesized that the McGrath MAC EMS is beneficial for intubation of pediatric manikins while performing CPR. In the current study, we compared effectiveness of the McGrath MAC EMS and MIL laryngoscopes in child resuscitation with and without CC.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* paramedic student

Exclusion Criteria:

* Not meet the above criteria
* Wrist or Low back diseases

Primary outcomes:
measure: Success of intubation
timeFrame: 1 day
Secondary outcomes:
measure: Intubation time
timeFrame: 1 day
measure: Cormack-Lehane grading
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References: