louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03214497: Protector™ Versus Supreme® Laryngeal Mask Airway
Official title: Prospective Randomised Trial of the Protector™ Versus the Supreme® Laryngeal Mask Airway
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: laryngeal mask
Supreme
Protector
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare the oropharyngeal leak pressure of the Protector Laryngeal mask with the Supreme laryngeal mask. Other secondary parameters will be studied.

Detailed description: The OLP as the primary outcome measurement will be evaluated after insertion of the LMA in each group. We hypothesize that there will be a difference of 4 cm H2O between the 2 masks, because of the different material and slightly different form of the masks. Secondary outcomes will be measured after insertion of the LMA as by protocol. Finally postoperative airway morbidity will be evaluated 3 hours after removal of the LMA.

Eligibility criteria: Inclusion Criteria:

* Age between 18-75
* ASA 1-3
* Operation on limbs
* written informed consent

Exclusion Criteria:

* known difficult airway
* anatomical abnormalities on airway, Larynx, oesophagus, stomach
* not fastened
* high aspiration risk
* patients with contraindication of laryngeal mask
* BMI \>35 kg/m2
* patients with disease which impairs accurate Investigation of patient
* cardiovascular risk factors
* COPD
* acute disease where anaesthesia is in doubt
* no written consent

Primary outcomes:
measure: OLP
timeFrame: 5 minutes
Secondary outcomes:
measure: insertion
timeFrame: 5 minutes
measure: time of insertion
timeFrame: 5 minutes
measure: Brimacombe score
timeFrame: 5 minutes
measure: respiratory pressure
timeFrame: 5 minutes
measure: suctioning catheter
timeFrame: 5 minutes
measure: suctioning fluids
timeFrame: 5 minutes
measure: CO2
timeFrame: 5 minutes
measure: blood staining
timeFrame: 5 minutes
measure: airway morbidity
timeFrame: 3 hours
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Christian Keller
Study officials:
affiliation: Schulthess Klinik
name: Berthold Moser, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05645497: Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
Official title: Evaluation of the Efficacy and Safety of the FACET FIXation Implant Compared With Pedicle Screw Fixation in Patients With Degenerative Lumbar Spinal Stenosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Degenerative Lumbar Spinal Stenosis
Lead sponsor: SC Medica
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of adult patients diagnosed with degenerative lumbar spinal stenosis who underwent their first spinal operation for lumbar decompression with pedicle screws fixation or FACET FIXation implant from 2015 to 2020 (2015-2016 with Pedicle Screw and starting November 2017 with more than 2 years postop at the date of the visit with FACET FIXation implant).

Brief summary: This is a single center, hybrid retrospective and prospective (ambispective) study to evaluate the safety and efficacy of the Facet Fixation implant.

The main objective is to evaluate the efficacy of the Facet Fixation implant compared with pedicle screw fixation to determine successful fusion in radiographic assessment at more than two years. Fusion is mainly defined as any sign of bony fusion between the facet joints or transverse processes when viewing the postoperative CT-scan at over 2 years.

Detailed description: The primary endpoint is the successful fusion rate in radiographic assessment at more than 2 years.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the surgery
* The first back operation in the patient's life was for degenerative lumbar spinal stenosis
* Surgical treatment of degenerative lumbar spinal stenosis by lumbar decompression with Pedicle Screw fixation or FACET FIXation implant.
* Patient is able to understand the information related to the study
* Patient consents to participate to the clinical investigation and agrees (non-objection) on the use of his/her personal data.

Exclusion Criteria:

* Patient received FACET FIXation implant or Pedicle Screw fixation with supplemental interbody cages.
* Unilateral Pedicle Screw or FACET FIXation implant.
* Preoperative grade ≥II spondylolisthesis
* Preoperative scoliotic deviations \>25°.
* Protected patient (under legal protection, deprived of liberty by judicial or administrative decision).
* Patient not covered by a social security scheme.

Primary outcomes:
measure: The rate of fusion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
Study officials:
References:
Clinical trial NCT01402297: Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
Official title: Hydrogen Peroxide and Nitrite Reduction in Exhaled Breath Condensate of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: apocynin
COPD
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Higher Education, Poland
First posted: 2011-07-26
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of inhaled apocynin on ROS (reactive oxygen species) and NOS (reactive nitrogen species) synthesis in 13 COPD patients. Effects of nebulized apocynin (0.5 mg/ml, 6 ml) were assessed in exhaled breath condensate (EBC) after 30, 60 and 120 minutes.

Detailed description: Apocynin reduced hydrogen peroxide concentration in exhaled breath condensate 60 and 120 minutes after apocynin nebulization comparing to placebo (0.43 μM vs. 0.59 μM and 0.41 μM vs. 0.58 μM respectively, p\<0.05). Interestingly, apocynin caused decrease of NO2- concentration 30, 60 and 120 minutes after apocynin inhalation (3.9 μM vs. 4.5 μM, 3.8 μM vs. 4.5 μM and 3.7 μM vs. 4,4 μM respectively, p\<0.05) comparing to placebo, but did not cause any significant changes in concentration of NO3- in any timepoint (p\>0.05). No influence of apocynin on safety parameters, and no adverse effects has been observed.

Eligibility criteria: Inclusion Criteria:

* patients suffering from bronchial COPD (II and III stage)
* patients free of any medication few days before research
* patients had not suffered from any infectious diseases including upper respiratory tract infections for at least 3 months prior to the study

Exclusion Criteria:

* Patients suffering from GOLD I stage
* patients taking medications few days before the study
* infectious diseases that had occurred 3 months or less before the study

Primary outcomes:
measure: Blood Pressure
timeFrame: 3 months
measure: Peripheral Blood Differential Count
timeFrame: 3 months
measure: Lung function tests (spirometry)
timeFrame: 3 months
measure: Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
timeFrame: 3 months
Secondary outcomes:
measure: Determination of H2O2
timeFrame: 3 months
measure: Determination of NO3- concentration in Exhaled Breath Condensate
timeFrame: 3 months
measure: Determination of NO2- concentration in Exhaled Breath Condensate
timeFrame: 3 months
measure: Determination of NO2- Concentration in Serum
timeFrame: 3 months
measure: Blood Pressure
timeFrame: 3 months
measure: Peripheral Blood Differential Count
timeFrame: 3 months
measure: Lung Functional Tests
timeFrame: 3 months
measure: Single Breath Carbon Monoxide Diffusing Capacity (DLCO)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Lodz
name: Rafal Pawliczak, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01372397: Reversal of Obesity Cardiomyopathy
Official title: Reversal of Obesity Cardiomyopathy After Gastric Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-13
Enrollment: 27
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are obese with heart failure and will undergo gastric bypass surgery or who have already had gastric bypass surgery.

Brief summary: The overall purpose of this study is to determine if weight loss is beneficial for obese patients with diastolic heart failure.


Eligibility criteria: Inclusion Criteria:

* All subjects will have obesity and have a BMI \> 35kg/m2.
* Subjects must be between the ages of 35 and 65 years, in order to limit the confounding affect of age on our endpoints.

To determine if potential subjects meet these criteria, they will:

1. be interviewed,
2. their clinical charts reviewed, by the research study coordinator and/or the PI, and
3. undergo a history and physical by a physician (Study Day 2). Subjects who are to undergo gastric bypass surgery will be in the intervention arm. They will be matched with control subjects. We will attempt to have no more than one control subject for each gastric surgery subject.

Exclusion Criteria:

* Subjects who have a condition that may masquerade as diastolic heart failure will be excluded (see Research and Design).
* Subjects who are \< 35 or \> 65 years, \> 400lbs (the weight limit of the MRI table) not obese, unstable, not able to lie flat for the imaging studies, not ambulatory, unable to give informed consent, pregnant, lactating, with atrial flutter or fibrillation, current smokers, or who will undergo a different type of bariatric surgery (not Roux-en-Y gastric bypass) will be excluded from participation.
* Those who have evidence of other major systemic diseases (e.g., cancer, significant lung disease, creatinine \> 2.0mg/dL, hemoglobin \< 10g/dL, and liver function tests twice the normal range) will be excluded.
* Subjects who have \> class I hypertension will be excluded. The investigators will exclude patients with an LV ejection fraction \< 45% and those with significant pulmonary hypertension (peak artery pressure \> 55mmHg).

Primary outcomes:
measure: Cardiac function, myocardial fat deposition
timeFrame: the time frame of the study
Secondary outcomes:
measure: liver fat metabolism, plasma lipidomics
timeFrame: the time frame of the study
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Linda R Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02278497: Assessment of Coronary Flow Reserve by PET-H215O and FFR. Comparison With Dynamic Acquisition Using CZT Camera
Official title: Assessment of Coronary Flow Reserve by PET-H215O and FFR in Patients Suspected of Coroanry Artery Disease. a Comparative Study With Dynamic Acquisition Using CZT Camera and 99mcTc-mibi.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
Collaborators: name: Spectrum Dynamics
First posted: 2014-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will assess coronary flow reserve by PET-H215O and FFR in patients suspected of coroanry artery disease. This a comparative study with dynamic acquisition using CZT camera and 99mcTc-mibi. 20 patients will have those measurements.


Eligibility criteria: Inclusion Criteria:

* Patient between 18 and 80 years
* Suspected coronary disease and / or coronary syndrome patient ST-
* Patient who has been informed of the study and has given his informed consent
* Patient affiliated to a social security system.

Exclusion Criteria:

* Patient having no coronary disease at coronary angiography with FFR on the 3 main epicardial arteries (absence of ≥ 50% stenosis of at least one artery)
* Delay of Care grater than 30 days between the PET and SPECT imaging and the diagnostic coronary angiography
* Patient with a recent history of myocardial infarction and STEMI, unstable angina
* Patient with extra-cardiac disease whose prognosis can interfere with the treatment decision
* Pregnant or lactating women
* Patient allergic to contrast products during coronary angiography
* Patient with MDRD clearance les than 60 ml / min
* Patient Under guardianship, or unable to understand the purpose of the study

Primary outcomes:
measure: Assess myocardial coronary reserve by cardiac CZT camera and Tcmibi comparing with the PET and the water marked during coronary FFR (Flow Fraction Reserve)
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Medecine Nucleaire
Study officials:
References:
Clinical trial NCT02595697: Communication Intervention for Toddlers With Autism
Official title: An Efficacy Trail of Enhanced Milieu Teaching Language Intervention Plus Joint Attention, Engagement, Regulation Intervention for Toddlers With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2015-11-03
Enrollment: 120
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to conduct an efficacy trial to determine whether an early communication intervention which blends two evidence-based interventions, Enhanced Milieu Teaching (EMT) and Joint Attention, Symbolic Play and Regulation Intervention (JASPER), improves social communication in toddlers with Autism Spectrum Disorder (ASD).

Detailed description: This study tests the blended intervention (J-EMT) in a parent-plus-therapist-implementation model that has been demonstrated to be effective with other populations.

The J-EMT communication intervention is tailored to the specific social communication characteristics of children with ASD and is delivered during a critical period in early communication development for these children.

In this study, the investigators compare this blended intervention (J-EMT) to a business as usual (BAU) comparison group. Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.

The investigators will examine social communication and child vocalizations, expressive and receptive language, symbolic play, and symbol-infused joint engagement to determine whether J-EMT changes both a primary functional outcome and the underlying specific skills that contribute to effective social communication in children with ASD.

Results from this study will indicate the efficacy of this variation of parent-plus-therapist-implemented EMT (i.e., J-EMT) specifically tailored to the characteristics of young children with ASD.

Eligibility criteria: Inclusion Criteria:

* Between 24 and 36 months of age
* A diagnosis of ASD as confirmed by the ADOS-2 (module 1)
* Signed informed consent
* Parent willing to be trained

Exclusion Criteria:

* Other diagnosis or disability
* Abnormal hearing and/or vision
* Language other than English is the primary language spoken at home

Primary outcomes:
measure: Number of spontaneous social communication attempts made as assessed by a 20 minute lanugage sample.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ann P Kaiser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04631497: Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
Official title: Assessment of Stress, Depression and Anxiety in Healthcare Caring for Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Keywords: Healthcare Workers
COVID-19
Mental Health Outcomes
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University Hospital in Cracow ICU depratment

Brief summary: Medical personnel working in the Intensive Care Unit will be examined by means of tests. Their aim is to check how work-related stress in a potentially lethal threat affects the occurrence of depression, stress, anxiety and sleep disorders. We also want to check whether people working in such extremely difficult conditions show no greater interest in death.

Detailed description: Every day medical staff working in very difficult conditions of intensive care. The COVID-19 virus outbreak has set another difficult task for doctors and nurses who have previously had a lot of contact with the death of their patients. The appearance of the COVID-19 virus and, above all, the inability to effectively treat the infection causes an additional psychological stimulus in medical personnel.

The aim of the study is to assess the occurrence of psychiatric disorders in medical personnel dealing with patients suffering from COVID-19 using various psychological tests.

Eligibility criteria: Inclusion Criteria:

adult employees of the Intensive Care Unit, agreeing to undergo the tests.

Exclusion Criteria:

* patient's refusal to participate in the study
* not understanding the test questions

Primary outcomes:
measure: Depression
timeFrame: 1 month
measure: Stress
timeFrame: 1 month
measure: Deal with Stress
timeFrame: 1 month
Secondary outcomes:
measure: Stress 2
timeFrame: 1 month
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University Hospital in Cracow
Study officials:
affiliation: Jagiellonian University
name: Tomasz Skladzien, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04985097: Home-based Visual Training in Patients Implanted With Trifocal Diffractive Intraocular Lenses
Official title: Preliminary Evaluation of the Clinical Benefit of a Novel Visual Rehabilitation System in Patients Implanted With Trifocal Diffractive Intraocular Lenses: A Blinded Randomized Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Disturbances and Blindness
Visual Acuity Reduced Transiently
Lead sponsor: Increase-Tech
Sponsor class: OTHER
Collaborators: name: University of Alicante
name: Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
name: Ministerio de Economía y Competitividad, Spain
First posted: 2021-08-02
Enrollment: 60
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: Experimental group vs control group
Primary purpose: TREATMENT

Brief summary: This multicentre randomised controlled trial aimed to reduce the visual discomfort that patients implanted with trifocal diffractive intraocular lenses may experience after surgery. To this end, a visual training software (Optictrain) was developed in which Gabor patches were presented to the patient on a hand-held electronic device. Patients who met all inclusion criteria and consented to participate underwent half an hour of visual training per day for a period of 20 consecutive days remotely on a colourimetrically characterised Samsung Galaxy Tab A device on which the Optictrain software (n=30) or a placebo software (n=30), respectively, was pre-installed. Corrected and uncorrected near, intermediate and distance visual acuity (VA) and mesopic near and distance contrast sensitivity (CS) were measured monocularly and binocularly at two visits: during the first postoperative week (V0) and after 20 days of visual training with the assigned software (V1). The statistical analysis of the results obtained in the study has not yet been carried out.


Eligibility criteria: Inclusion Criteria:

* Age between 18 an 90 years
* Patients implanted with trifocal diffractive intraocular lenses
* Availability and motivation to perform the visual training assigned

Exclusion Criteria:

* Age under 18 or over 90 years
* Presence of irregular cornea, illiteracy or cognitive impairment
* History of eye surgery or presence of any active ocular disease
* Intraoperative complications leading to significant visual sequelae
* Patients implanted with monofocal, extended depth of focus or refractive multifocal IOLs

Primary outcomes:
measure: Visual acuity
timeFrame: During the first post-operative week and after 20 days of vision training with the randomly assigned software
measure: Contrast sensitivity
timeFrame: During the first post-operative week and after 20 days of vision training with the randomly assigned software
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Faculty of Medicine, University of Valladolid
Study officials:
References: