louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01888679: Influence of Head Positioning on the Movement of the Endotracheal Tube
Official title: Influence of Head Positioning on the Movement of the Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Conditions That May Be A Focus of Clinical Attention
Keywords: Airway
Endotracheal intubation
selective intubation
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate and measure the movement of the endotracheal tube depending on the type and the amount of movement of the head of the patient intubated using a flexible fiberoptic.

Detailed description: We performed a maximal head-neck movement trial on 50 adult patients, American Society of Anaesthesiologists 1 or 2. Patients with body mass index N35 kg · m-2, height b150 cm, airway malformations, pulmonary diseases, difficulties in neck flexion or extension, previous ENT surgery or radiotherapy, gastroesophageal reflux, or dental instability were excluded from the study.

We measured the change in distance between the ETT tip and the carina, using a fiberscope through the ETT.

Eligibility criteria: Inclusion Criteria:

* Patients older than 16 years
* ASA 1-2
* Elective surgery

Exclusion Criteria:

* Pathological changes of the trachea.
* Less than BMI 35 kg/m2.
* Patients with rheumatoid arthritis or other limitation to cervical mobility.
* Emergency surgery.
* Individuals measuring less than 150 cm.

Primary outcomes:
measure: Displacement of the endotracheal tube.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne Hospitals
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Patrick Schoettker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tailleur R, Bathory I, Dolci M, Frascarolo P, Kern C, Schoettker P. Endotracheal tube displacement during head and neck movements. Observational clinical trial. J Clin Anesth. 2016 Aug;32:54-8. doi: 10.1016/j.jclinane.2015.12.043. Epub 2016 Mar 22.
Clinical trial NCT05918679: The Brain Processes Underlying Speech Motor Learning and Speech Production
Official title: Improving Speech Motor Learning Processes Using Augmented Behavioral Interventions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2023-06-26
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this research is to develop protocols that selectively target and improve speech-motor learning processes. Participants will be asked to name pictures, read words/sentences, and listen to sounds while their speech signals will be collected during the study.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* native speaker of American English
* normal (age-appropriate) binaural pure-tone hearing threshold
* not taking medications affecting sensorimotor functioning
* no current or history of communication, neurological, or psychological disorders

Exclusion Criteria:

Primary outcomes:
measure: Change in speech output in response to previously experienced auditory errors
timeFrame: within each session of the study that may last up to 2 hours
measure: Change In Speech Output Immidiately After Hearing Auditory Errors
timeFrame: within each session of the study that may last up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
Clinical trial NCT02892279: Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure
Official title: Sympathetic Nerve Activation Evoked by Diesel Exhaust Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Microneurography
Air pollution
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The adverse effects of air pollution on cardiovascular and respiratory health have been demonstrated in an extensive series of epidemiological, observational and experimental studies. In the current project the investigators aim to determine whether an acute exposure to diesel exhaust causes impacts on sympathetic nervous system activation in healthy volunteers.

Detailed description: Brief as well as chronic exposures to air pollution have been linked with increases in cardiovascular morbidity and mortality. Evidence suggests that the strongest associations between air pollution exposure and adverse cardiovascular effects are found for combustion-derived particulate matter, especially in the fine and ultrafine ranges such as is found in diesel engine emissions. Despite a greater understanding of the cardiovascular effects of air pollution, the underlying mechanism through which exposure to fine particulate air pollution alters vascular function has yet to be determined. Microneurography is a method that records nerve impulse traffic in human peripheral nerves, allowing for the assessment of sympathetic nervous activity. The current study will employed microneurography techniques to evaluate autonomic function in association with inhaled air pollution exposure in healthy human volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy (normal ECG, lung function, blood sample, clinical examination)

Exclusion Criteria:

* Metabolic disease
* Cardiovascular disease
* Respiratory disease
* BMI ≥ 30
* Use of psychoactive medication
* Infection within 2 weeks of the study
* Smokers or regular snus usage

Primary outcomes:
measure: Microneurography
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Dept of Medicine, Lung and Allergy section, University Hospital
Study officials:
affiliation: Umeå University
name: Jenny Bosson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rankin GD, Kabele M, Brown R, Macefield VG, Sandstrom T, Bosson JA. Acute Exposure to Diesel Exhaust Increases Muscle Sympathetic Nerve Activity in Humans. J Am Heart Assoc. 2021 May 18;10(10):e018448. doi: 10.1161/JAHA.120.018448. Epub 2021 May 4.
Clinical trial NCT05823779: A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects
Official title: A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Disease
Herpes Simplex 1
Herpes Simplex 2
Keywords: HIV, Herpes Simplex 1, Herpes Simplex 2
Lead sponsor: Global Research Institute
Sponsor class: INDUSTRY
Collaborators: name: Rational Vaccines Inc
First posted: 2023-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are positive for HIV antibodies and IgG or IgM antibodies to Herpes Simplex Virus 1 or Herpes Simplex Virus 2

Brief summary: This study is an observational, cohort, prospective study looking at the frequency of Herpes Simplex Virus (HSV) 1 and or 2 outbreaks in HIV positive patients who's HIV virus is controlled on highly active anti-retroviral therapy. We will be enrolling fifty (50) patients.

Detailed description: We will be confirming that the patients are HIV positive and has antibodies to either HSV 1 or HSV 2 as part of the screening process. If so, we will then obtain patient baseline HIV-PCR, CD4, medial history including medications on day one. Whether the patient is on any or no herpes controlling medication. If the patient has what they feel is a flare up of HSV, they will come into clinic where the lesion will be culture and the patient's HIV-PCR and CD4 will also be obtained. Otherwise, the patient will receive phone follow ups every three months to see if there has been and change in their health or medications. The main endpoint is to see if there is a correlation between outbreaks in HIV patients and their CD4 cells and/or HIV and/or Herpes medication.

Eligibility criteria: Inclusion Criteria:

1. Subject must be 18 years or older at the time of screening
2. Males, Females, Transgender Male and Transgender Females
3. HIV positive
4. Positive antibody to HSV- 1/and or HSV-2
5. If Female of child baring potential, documented negative pregnancy test at the time of screening.

Exclusion Criteria:

1. Active opportunistic infection
2. Current chemotherapy
3. Unable to give informed consent

Primary outcomes:
measure: Epidemiology
timeFrame: 48 weeks
Secondary outcomes:
measure: Co Morbidity
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Global Research Institute
state: California
Study officials:
References:
Clinical trial NCT01130779: The Continuation of Erlotinib
Official title: The Continuation of Erlotinib Treatment in Non-small Cell Lung Cancer Patients Whose Brain Lesion is the Only Site of Progression : Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Erlotinib
brain metastasis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Newly developed or progressive brain metastasis during erlotinib treatment is considered progressive disease requiring change of treatment regimens despite no progression in extracranial lesions. Given that there is a dissociation in terms of response to erlotinib between brain and extracranial sites, we intend to conduct this pilot study to determine whether the continuation of erlotinib treatment can prolong the progression free interval of extracranial lesions as long as cranial lesion is controlled separately by conventional treatment modalities such as surgical resection, stereotactic radiosurgery, and whole brain radiotherapy.


Eligibility criteria: Inclusion Criteria:

1. Histologically or cytologically proven non small cell lung cancer
2. New developed or progression of brain lesions among patients with good control of extracranial lesions to erlotinib
3. patients who are receiving erlotinib as salvage therapy
4. At least one unidimensionally measurable lesion with a diameter \> 10mm using brain MRI
5. at least on unidimensionally measurable or evaluable lesion
6. male or female patients aged \>18 years
7. ECOG performance status 0-2
8. Adequate hematologic function
9. adequate renal function
10. adequate hepatic function

Exclusion criteria

1. leptomeningeal metastases
2. acute severe infection requiring antibiotic therapy
3. significant cardiovascular disease
4. uncontrolled DM
5. severe ophthalmologic disease

Primary outcomes:
measure: progression free survival
timeFrame: 6 months
Secondary outcomes:
measure: overall survival
timeFrame: 6 months
measure: response rate
timeFrame: 6 months
measure: time to treatment failure
timeFrame: 6 months
measure: toxicity profiles
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Myungju Ahn, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02645279: Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Official title: Comparison of Oral 30 % Dextrose and iv Midazolam Sedation During MRI in Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy
Trauma
Metabolic Disease
Keywords: newborn
MRI
oral 30% glucose
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 112
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the effectiveness of oral glucose administration during MRI for imaging of newborns and compare with midazolam sedation.

Detailed description: Motion artefacts affect the quality of MRI and in order to overcome this problem procedures are performed under sedation or general anaesthesia. The safety profile of these methods for newborns is unclear. Alternative non-pharmacological interventions are changeable and might be time consuming. Oral glucose/sucrose administration has been the most frequently studied non-pharmacologic intervention in term and preterm neonates during painful procedures. In this study investigators aimed to compare oral 30% glucose and intravenous midazolam their efficiency on sedation during MRI.

Eligibility criteria: Inclusion Criteria:

* Neonates requiring MR imaging for diagnosis

Exclusion Criteria:

* Patients with fever, cold symptoms, suspicion of difficult airway, hypovolemia, cardiac, renal, lung disease, malformations

Primary outcomes:
measure: Success rate of the procedures to keep the neonates quietened, motionless and slept during the procedure and to consider all images qualitatively appropriate for interpretation
timeFrame: Approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Baskent University Department of Anesthesiology
name: Anis Aribogan, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02468479: Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients With Liver Cirrhosis
Official title: Prognostic Values of Chest/Abdominal Wall Varices and Spider Nevi in Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: Liver cirrhosis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2015-06-10
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of liver cirrhosis who are consecutively admitted to our department.

Brief summary: Chest/abdominal wall varices and spider nevi are two common presenting signs of liver cirrhosis. Their prognostic values remain unclear.


Eligibility criteria: Inclusion Criteria:

1. Liver cirrhosis.
2. Consecutive admission.
3. Permitted to physical examinations.
4. Informed consents.

Exclusion Criteria:

1. Non-cirrhotic portal hypertension.
2. Malignancy.
3. Uncontrolled infection.
4. Severe chronic diseases.
5. Poor patient compliance.

Primary outcomes:
measure: Prevalence and type of chest/abdominal wall varices and spider nevi
timeFrame: 1.5 years
measure: Association between etiology of liver cirrhosis and type of chest/abdominal wall varices and spider nevi
timeFrame: 1.5 years
measure: Association between degree of liver function and type of chest/abdominal wall varices and spider nevi
timeFrame: 1.5 years
measure: Effect of chest/abdominal wall varices and spider nevi on survival
timeFrame: 2.5 years or more
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Shenyang Military Area
state: Liaoning
Study officials:
affiliation: Department of Gastroenterology, General Hospital of Shenyang Military Area
name: Xiaozhong Guo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li H, Wang R, Mendez-Sanchez N, Peng Y, Guo X, Qi X. Impact of spider nevus and subcutaneous collateral vessel of chest/abdominal wall on outcomes of liver cirrhosis. Arch Med Sci. 2019 Mar;15(2):434-448. doi: 10.5114/aoms.2018.74788. Epub 2018 Mar 28.
Clinical trial NCT04909879: Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome
Official title: Treatment of Non-COVID-19 Acute Respiratory Distress Syndrome: A Phase 2 Study of the Efficacy and Safety of Intravenous Allogeneic Adipose-Derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Ards
Keywords: ARDS
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-02
Enrollment: 0
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: This is a Phase 2 randomized study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Detailed description: This is a Phase 2, randomized controlled, multicenter study to assess the safety and efficacy of COVI-MSC in the setting of current standard of care treatments for subjects hospitalized subjects with acute respiratory distress syndrome not related to COVID-19 infection.

Subjects will be randomized 2:1 to receive COVI-MSC or placebo. COVI-MSC or placebo will be administered intravenously on Day 0, Day 2, and Day 4.

Eligibility criteria: Inclusion Criteria:

* Negative for SARS-CoV-2 infection as determined by an approved polymerase chain reaction (PCR) or an approved antigen test of any specimen
* Hospitalized with non-COVID-19-induced ARDS (any severity) with a PaO2/FiO2 (PF ratio) ≤ 300
* Requires oxygen supplementation at Screening
* Willing to follow contraception guidelines

Exclusion Criteria:

* Current standard of care treatments for ARDS appear to be working and the subject is clinically improving
* A previous stem cell infusion unrelated to this trial
* Pregnant or breast feeding or planning for either during the study
* Suspected uncontrolled active bacterial, fungal, viral, or other infection
* History of a splenectomy, lung transplant or lung lobectomy
* Concurrent participation in another clinical trial involving therapeutic interventions (observational study participation is acceptable)
* Expected survival or time to withdrawal of life-sustaining treatments expected to be \< 7 days

Primary outcomes:
measure: All-cause mortality rate at Day 28
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: All-cause mortality rate at Days 60 and 90
timeFrame: Baseline to Day 60 and Day 90
measure: Number of ventilator-free days through Day 28
timeFrame: Baseline through Day 28
measure: Number of ICU days through Day 28
timeFrame: Baseline through Day 28
measure: Clinical status at Day 28
timeFrame: Baseline to Day 28
measure: Change in oxygenation
timeFrame: Baseline to Day 2, Day 4, Day 6, Day 14, Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01988779: Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations
Official title: Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 33
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 purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

1. Adults (age ≥ 18).
2. Diagnosis of CRS.
3. Worsening sinonasal symptoms.
4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
5. English speaking.
6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).
7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.

Exclusion Criteria:

1. Patients \< 18 years of age.
2. Treatment with systemic or topical antibiotics within the last 1 month.
3. Pregnant women.
4. Non-English speaking persons.
5. Systemically ill at initial visit necessitating treatment prior to culture data.
6. Allergies to chosen susceptible antibiotics.
7. Sinonasal culture with less than 1+ growth.
8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.
9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
10. Patients with immunodeficiencies.

Primary outcomes:
measure: Change in Rhinosinusitis Disability Index (RSDI) Score
timeFrame: Baseline and 14 days after treatment
Secondary outcomes:
measure: Change in Sino-nasal Outcome Test (SNOT-22) Score
timeFrame: Baseline and 14 days after treatment
measure: Change in Bilateral Endoscopy Findings Using POSE Score
timeFrame: Baseline and 14 days after treatment
measure: Number of Participants With Post-treatment Culture Negativity
timeFrame: 14 days after treatment
measure: Mean Change in the Total Bacterial Community
timeFrame: Baseline and 14 days after treatment
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Department of Otolaryngology Head and Neck Surgery
state: New York
Study officials:
affiliation: University of Rochester
name: Li-Xing Man, MD, MPA, Msc
role: PRINCIPAL_INVESTIGATOR
References: