louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04667442: Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
Official title: An Investigational Performance Evaluation of the Nanomix eLab® COVID-19 Rapid Antigen Panel With Samples From COVID-19 Positive and Negative Human Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Nanomix
Sponsor class: INDUSTRY
First posted: 2020-12-14
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include both symptomatic and asymptomatic subjects. Although to enrich for COVID-19 positive subjects, the study will preferentially identify and enrolled subjects who have been or will be tested by EUA RT-PCR including those who are symptomatic or hospitalized with symptoms, specifically those within 7-days of symptom onset that meet the study enrollment inclusion and exclusion criteria.

Brief summary: Prospective samples will be collected to evaluate the agreement between a EUA RT-PCR test as the comparator method against the Nanomix eLab® system.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Male or Female
* Willing and able to provide informed consent
* Symptomatic or asymptomatic
* The EUA RT-PCR sample must be collected within one (1) day of the sample collected for testing by the Nanomix eLab® COVID-19 Rapid Antigen Panel.

Exclusion Criteria:

* Subjects without both a valid EUA RT-PCR test result and a valid Nanomix eLab® COVID-19 Rapid Antigen results will be excluded
* Subjects not being able to provide consent

Primary outcomes:
measure: Demonstrate clinical agreement between an EUA RT-PCR methodology and the Nanomix eLab® COVID-19 Rapid Antigen Panel
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Emeryville
country: United States
facility: Nanomix
state: California
Study officials:
affiliation: Nanomix
name: Tina Landess
role: STUDY_DIRECTOR
References:
Clinical trial NCT06869642: MultiCPR: The Influence of Chest Compressions on Mental Arithmetics
Official title: MultiCPR: The Influence of Chest Compressions on Mental Arithmetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multitasking Behavior
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this clinical study is to investigate how performing chest compressions affects the ability to perform mental tasks. In particular, the effect on the participant's ability to perform mental arithmetic will be investigated. The aim is to draw conclusions about the effects of chest compressions on other mental tasks.

2 How does the clinical trial work? This clinical trial will be conducted in several locations and will involve a total of approximately 76 people in two sub-studies (38 people each). The study will be conducted by the Department of Anesthesiology of the Medical University of Vienna.

Participation in this clinical study is expected to last 30 minutes.

The following measures will be carried out exclusively for study reasons:

Depending on the sub-study you are participating in, different tasks will be performed:

Adult sub-study:

During this study, participants will be asked to perform mental arithmetic: Participants will be read a number every 2 seconds and have to add the last two in each case. The numbers are predetermined and randomly generated. At the end, we will evaluate how many results were correct.


Eligibility criteria: Inclusion:

* Healthy medical professionals trained in CPR (paramedics, prehospital emergency physicians, anesthesiologists, internal medicine doctors, nurses, midwifery students)
* CPR Training in the last four years
* Fit and rested.

Exclusion:

- Pregnant probands

Primary outcomes:
measure: PASAT Test
timeFrame: during the test, 2 minutes each
Secondary outcomes:
measure: Depth of chest compressions
timeFrame: during the pasat test, approx. 3 minutes in total
measure: Frequency of chest compressions
timeFrame: during the pasat test, approx. 3 minutes in total
measure: Leaning of chest compressions
timeFrame: during the pasat test, approx. 3 minutes in total
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Academic Simulation Center
Study officials:
References:
Clinical trial NCT06323642: Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia
Official title: Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pneumonia
Probiotics
Keywords: pneumonia treatment
probiotics
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial
Primary purpose: TREATMENT

Brief summary: Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia.

Detailed description: After getting written informed consent from parents/attendants, all patients aged 6 month-2yrs admitted with severe pneumonia in pediatric wards of children hospital, during the study time of 6 month will be recruited.After applying exclusion criteria remaining participants will be included in the study. The study population will be randomized in to two groups, Group A will be given probiotic sachet and group B will be given simple milk as placebo.The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo The probiotic and placebo mixture will be given daily for three days.The patients in both the groups will be followed for the duration of illness until they are either discharged or show any adverse outcomes of pneumonia.Total days of admission will be recoded for patients discharged from hospital.Parents will be asked questions regarding improvement in symptoms like fever on discharge. Duration for Improvement in tachypnea andcough will be noted for all patients. Outcomes will be duration of hospital admission, improvement in fever, tachypnea and cough.All the data collected will be entered and analyzed using SPSS latest version and analysed.

Eligibility criteria: Inclusion criteria Patient aged 2month-24months. Both male and female children

Exclusion Criteria:

Patients with severe acute malnutrition Patients with very severe pneumonia Patients with Other concurrent infections Patients having any chronic debilitating condition Children who took probiotics in past 6 months Patient requiring mechanical ventilation

Primary outcomes:
measure: Number of days in hospital
timeFrame: 6 month
Secondary outcomes:
measure: Number of days with cough, fever
timeFrame: 6 month
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pakistan Institute of Medical Sciences
state: Punjab
Study officials:
affiliation: SZABMU
name: Nighat Haider
role: STUDY_CHAIR
References:
Clinical trial NCT02348242: Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches
Official title: Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Diseases
Keywords: Intensive care
corneal damage
prevention
nursing protocol
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-01-28
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.

This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.


Eligibility criteria: Inclusion Criteria:

* adult patient
* hospitalized in an intensive care unit
* tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h

Exclusion Criteria:

* Patient currently treated by eyedrops for glaucoma
* antecedent of corneal transplant
* ocular prosthesis

Primary outcomes:
measure: Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
timeFrame: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation ophtalmologique Adolphe de Rothschild
state: Ile-de-France
Study officials:
affiliation: Fondation Ophtalomologique Adolphe de Rothschild
name: Jean-Michel DEVYS, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488042: Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue
Official title: Stapler-less Burst Pressure in a Ex-vivo Human Gastric Tissue: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Suture, Complication
Suture Rupture
Keywords: Sleeve gastrectomy
stapler-less
burst pressure
leaks
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 40
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: the gastric specimen were immediately randomly allocated to the two groups
Primary purpose: TREATMENT

Brief summary: Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.

Detailed description: Stapler-less laparoscopic sleeve gastrectomy (LSG) is emerging as a new potential affordable cost-effective alternative procedure. However, no pre-clinical data are currently available on human tissue. We aimed to evaluate whether traditionally suturing without the use of surgical stapling may produces a comparable bursting pressure on human gastric tissue.

A prospective cohort of consecutive patients underwent LSG was divided in two groups to compare a barbed extramucosal running suture (stapler-less) versus a standard stapler line. A burst pressure test was applied to the gastric specimen employing high-resolution manometric catheter. Type, location and features of the leak were described.

In human ex-vivo model, traditional surgical suture (i.e. running hand-sewn) produced an effective temporary closure, with superior resistance to increasing volume and pressure. How this may impact on clinical LSG outcomes needs further evaluations and was not the object of this study.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity according to IFSO guidelines

Exclusion Criteria:

* Gastric specimen with injury and/or electrocoagulation signs at serosa
* Presence of comorbidities capable of affecting specimen tissue resistance (i.e. type II diabetes, gastric ulcer, connective tissue disease, systemic sclerosis, polymyositis)

Primary outcomes:
measure: Gastric specimen tissue resistance
timeFrame: During procedure
measure: Gastric specimen volume resistance
timeFrame: During procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Claudio Gambardella
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Gianmattia del Genio, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811042: Ambu AuraOnce Versus Ambu AuraGain LM in Children
Official title: Laryngeal Mask Ambu AuraOnce Versus Laryngeal Mask Ambu AuraGain in Non-paralysed, Anesthetized Children: A Randomized, Crossover Study Assessing Oropharyngeal Leak Pressure and Fiberoptic Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Management
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: University of Salzburg
First posted: 2016-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* age 1 - 16 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<12 months, \>16 years)
* weight (\<12 kg, \>50 kg)
* a known difficult airway
* risk of aspiration

Primary outcomes:
measure: oropharyngeal leak pressure
timeFrame: 5 min
Secondary outcomes:
measure: fiberoptic position
timeFrame: 5 min
Other outcomes:
Locations:
city: Bozen
country: Italy
facility: Zentralkrankenhaus Bozen
city: Zürich
country: Switzerland
facility: Christian Keller MD, M.Sc.
Study officials:
References:
citation: Stogermuller B, Ofner S, Ziegler B, Keller C, Moser B, Gasteiger L. Ambu(R) Aura Gain versus Ambu(R) Aura Once in children: a randomized, crossover study assessing oropharyngeal leak pressure and fibreoptic position. Can J Anaesth. 2019 Jan;66(1):57-62. doi: 10.1007/s12630-018-1235-7. Epub 2018 Oct 12.
Clinical trial NCT04894942: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children
Official title: Evaluation of Clinical Features and Surgical Outcomes of the Too Long Anterior Process in Children: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Calcaneonavicular Coalition
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child \<16 years with calcaneonavicular coalition with Magnetic resonance imaging diagnosis and already treated orthopedically in the initial treatment of the coalition

Brief summary: Calcaneonavicular coalition represents approximately 1% of the population between 8 and 12 years. They are manifested by repeated ankle sprains or by pain. - The diagnosis is radiological on an X-ray of the foot in oblique-3/4 incidence as well as magnetic resonance imaging. Treatment is second-line surgery after failure of orthopedic treatment. This surgery is either by direct approach or by arthroscopy, by performing a bone resection to recreate sufficient space in the joint in question. The patients in this study will only be operated on openly.


Eligibility criteria: Inclusion Criteria:

* Child \<16 years
* Child with calcaneonavicular coalition
* Magnetic resonance imaging diagnosis
* Patient already treated orthopedically in the initial treatment of the coalition

Exclusion Criteria:

* Child \>=16 years

Primary outcomes:
measure: Comparison of scores before surgery and after surgery at 1 month, for all the operated patients
timeFrame: 1 month
measure: Comparison of scores before surgery and after surgery at 3 months for all the operated patients
timeFrame: 3 months
measure: Comparison of scores before surgery and after surgery at 1 12 months for all the operated patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Pediatric emergency department
Study officials:
References:
Clinical trial NCT03505242: Application of Bronchial Blocker in Minimally Invasive Cardiac Surgery
Official title: Bronchial Blocker in Blocking the Right Middle Lower Lobe Versus Double-Lumen Endotracheal Tube for One-Lung Ventilation in Minimally Invasive Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimally Invasive Cardiac Surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-04-23
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both left single lung ventilation by left double lumen tube and bilateral ventilation with selective blockage of right middle lower lobe by bronchial blocker can provide suitable surgical field for minimally invasive cardiac surgery. The current study was designed to compare the impact of these two different methods on oxygenation, degree of pulmonary collapse and postoperative complications.


Eligibility criteria: Inclusion Criteria:

* ASA II-III
* BMI 18-31
* elective minimally invasive cardiac surgery by right thoracotomy

Exclusion Criteria:

* asthma
* COPD
* previous lung surgery
* previous cardiac surgery

Primary outcomes:
measure: oxygenation
timeFrame: intraoperative
Secondary outcomes:
measure: degree of pulmonary collapse
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00451542: Divalproex vs. Lamotrigine for Bipolar Disorder
Official title: Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Relapse
Retrospective
Lead sponsor: Tuscaloosa Research & Education Advancement Corporation
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Bipolar Disorder I or II who had a prescription of divalproex or lamotrigine.

Brief summary: This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

Detailed description: The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Bipolar I or Bipolar II disorder
* Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile.
* Age 19 or older
* Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex).
* Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine.

Exclusion Criteria:

* Primary diagnosis of schizoaffective or schizophrenia during the evaluation period.
* Prescription of divalproex and lamotrigine given concurrently during the observation period.
* History of Dementia or cognitive disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tuscaloosa Reseach and Education Advancement Corporation
name: Lori L Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vieta E, Rosa AR. Evolving trends in the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2007;8(1):4-11. doi: 10.1080/15622970601083280.
Clinical trial NCT00643942: Staining in a Healthy, Non-Dry Eye Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Healthy Eyes
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with normal healthy eyes

Brief summary: The clinical objective of this study is to quantify the levels of corneal and conjunctival staining in a healthy, non-dry eye population. This is a descriptive study without test article administered.


Eligibility criteria: Inclusion Criteria:

* Healthy eyes

Exclusion Criteria:

* Age related

Primary outcomes:
measure: Corneal fluorescein staining scores
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio
state: Texas
Study officials:
References: