louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05058677: Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
Official title: Aerosolized Endotracheal Lidocaine to Avoid Intracranial Pressure Spikes in Patients With Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Traumatic Brain Injury
Keywords: lidocaine
brain injury
intracranial pressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 12
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of nebulized lidocaine before Endotracheal suctioning (ETS) compared to instilled lidocaine and the effectiveness of aerosolized lidocaine versus instilled normal saline before ETS in attenuating the increase of intracranial pressure (ICP) in severe head injured children and to evaluate the feasibility of a trial involving instilled lidocaine and aerosolized lidocaine for the management of ETS and to evaluate the safety of nebulized lidocaine in traumatic brain injury (TBI) compared to instilled lidocaine and instilled sodium chloride (NS).


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the PICU of Memorial Hermann Children's Hospital
* Severe TBI with a Glasgow Coma Scale score 4-8
* Intubated and mechanically ventilated with an ICP monitor in place.
* Continuous invasive monitoring of arterial pressure
* Hemodynamically Stable, defined by normal blood pressure for age before the ETS. We will not exclude patients with norepinephrine to maintain goal blood pressures to maintain Cerebral perfusion pressure(CPP).

Exclusion Criteria:

* Patients with sustained ICP \> 25 for more than 30 minutes mm Hg despite medical or neurosurgical intervention
* Moderate/Severe Acute respiratory distress syndrome (ARDS) with an oxygenation index \> 8
* Pulmonary hemorrhage
* Patients receiving neuromuscular blockade
* Use of other vasopressors for other causes of shock (cardiogenic, hypovolemic and septic)

Primary outcomes:
measure: Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in instilled lidocaine versus nebulized lidocaine
timeFrame: from baseline to upto 15 minutes after ETS
Secondary outcomes:
measure: Maximum difference between baseline ICP and highest ICP levels as measured by the ICP monitor in nebulized lidocaine and normal saline
timeFrame: from baseline to up to 15 minutes after ETS
measure: Number of patients with worsening respiratory dynamics
timeFrame: from baseline to up to 15 minutes after ETS
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Thao L Nguyen, DO, FAAP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373277: KF2019#1-trial: Effects of a Thrombocyte Inhibitor on a Cholesterol-lowering Drug
Official title: KF2019#1-tutkimus: Verihiutaleiden estäjän Vaikutus kolesterolilääkkeeseen
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pharmacokinetics
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
First posted: 2022-05-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The cholesterol-lowering drug rosuvastatin is a substrate of the breast cancer resistance protein (BCRP). BCRP is an efflux transporter expressed e.g. in the small intestine. It limits the oral bioavailability of rosuvastatin by transporting rosuvastatin from enterocytes back to the gut lumen. Inhibition of BCRP can increase rosuvastatin bioavailability and systemic concentrations. Ticagrelor is a platelet aggregation inhibitor used in treatment and prevention of atherothrombotic events. Ticagrelor may inhibit BCRP in humans. This study is aimed to investigate the possible interaction of rosuvastatin with ticagrelor. Ten healthy male or female non-smoking volunteers aged 18-40 years are taken into the study. Primary endpoint is area under the plasma concentration-time curve of rosuvastatin.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Age 18-40
* Healthy
* Systolic blood pressure ≥100 mmHg
* Accepted results from laboratory tests (blood haemoglobin, basic blood count and blood platelets, alanine aminotransferase, alkaline phosphatase, glutamyl transferase, creatinine, plasma potassium and sodium). Negative pregnancy test result (serum human chorionic gonadotropin) for women.
* Fully vaccinated against COVID-19.

Exclusion Criteria:

* Significant disease
* Abnormal result from the Helsinki University Hospital bleeding questionnaire
* Smoking
* Using oral contraception pills or other regular medication
* Pregnancy (current or planned) or nursing
* Participation in any other studies involving investigational or marketed drug products within three months prior to the entry into this study
* Donation of blood within three months prior to the entry into this study
* Significant overweight / small or hard-to-find veins
* Weight \< 45 kg
* BMI \< 18.5 kg/m2
* Insufficient Finnish language skills

Primary outcomes:
measure: Area under the plasma concentration - time curve of rosuvastatin
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
Secondary outcomes:
measure: Peak plasma concentration, half-life, time to peak plasma concentration, amount excreted, and renal clearance of rosuvastatin
timeFrame: Prior to and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 23, and 47 hours after administration of rosuvastatin
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Clinical Pharmacology
Study officials:
References:
Clinical trial NCT05472077: Lollipop COVID-19 Testing Study
Official title: Saliva Testing for SARS-CoV-2 With Lollipop Swab
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
SARS CoV 2 Infection
COVID-19 Pandemic
Keywords: saliva collection
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with PCR testing. The study will be open to enrollment for both children and adults in the Madison community who have at least one COVID-19 symptom that has presented in the last 5 days and who have not had a positive COVID-19 test for a previous illness within the past 3 months. Participants can expect to be in the study for the duration of the swabbing, approximately 10 minutes.

Detailed description: This study will test the hypothesis that lollipop swabs are more acceptable to individuals and PCR testing is non-inferior to performing PCR on nasal swabs. To test this hypothesis, the study team will work with local community testing sites to incorporate a lollipop swab for PCR at the time a symptomatic individual receives a nasal swab for PCR that is part of the DHS program. The study will address the following two key questions:

1. Are lollipop swabs more acceptable to individuals when compared to nasal swabs?
2. Will lollipop swabs perform as well as nasal swabs with PCR-based testing?

Participants with at least one COVID-19 symptom will be asked to suck on a swab for 20 seconds, like sucking on a lollipop. They then will be asked which COVID-19 PCR testing they would prefer if they had to do the testing again, nasal PCR versus lollipop PCR.

Eligibility criteria: Inclusion Criteria:

* Age 4 years or above
* Have at least one COVID-19 symptom that has presented in the last 5 days and will undergo a nasal PCR test at a local community testing site

Exclusion Criteria:

* Positive COVID-19 test in the past 3 months for a previous illness

Primary outcomes:
measure: Participant Sample Collection Preference
timeFrame: Day 1 (up to 10 minutes)
measure: Number of Positive COVID-19 Diagnoses
timeFrame: Day 1 (up to 10 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen Wald, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Shelby O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05072977: Photorefractive Keratectomy (PRK) : Comparison of Corneal Haze Between Two Modes of De-epithelialisation (Laser Versus Manual Alcohol)
Official title: Prospective Randomised Controlled Study in 2 Parallel Arms Comparing Corneal Haze, Visual and Refractive Outcomes and Postoperative Pain According to the Mode of De-epithelialisation (Laser Versus Manual Alcohol) During Photorefractive Keratectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Astigmatism
Keywords: Myopia
Astigmatism
Corneal haze
Trans Photorefractive Keratectomy
Alcohol Photorefractive Keratectomy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-10-11
Enrollment: 71
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: surgical correction of ametropia. A number of improvements have been introduced to overcome the side effects and complications such as corneal haze, epithelial irregularities induced by wound healing, pain and delayed visual acuity recovery associated with PRK surgery. During traditional PRK, the corneal epithelium is mechanically debrided before stromal ablation is performed. Alcohol PRK is frequently used as an alternative to mechanical epithelial debridement and is considered simpler and faster. Transepithelial PRK (TransPRK) is a new method in which the corneal epithelium is photoablated by the laser in one step using a specific ablation profile.

This study attempts to establish a means of quantitatively and objectively measuring corneal haze, using patented software based on optical coherence tomography (OCT) of the cornea. This will confirm or refute the hypothesis of a lower occurrence of corneal haze after TransPRK (experimental group) versus PRK with alcohol (control group). Each patient will have one eye randomised to one of the two groups being compared.


Eligibility criteria: Inclusion Criteria:

* Planned Photorefractive Keratectomy in both eyes
* Simple myopia or myopic astigmatism, refractive spherical equivalent between -0.50 and -9.0 diopters in both eyes with regular corneal topography

Exclusion Criteria:

* Only one eye operated on
* At least one contraindication to refractive surgery, namely : keratoconus, minimum corneal thickness \< 400 µm, severe dry syndrome, progressive corneal infection
* Personal history of corneal surgery
* Personal history of ocular pathology other than simple myopia or myopic astigmatism
* Pregnant or breastfeeding woman

Primary outcomes:
measure: Corneal haze assessed with the the software analysing the corneal OCT images
timeFrame: 1 month after refractive surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation A. de Rothschuld
Study officials:
affiliation: Hôpital Fondation A. de Rothschild
name: Alain SAAD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02337777: The Study of Functional Magnetic Resonance Imaging in Abdominal and Pelvic Diseases
Official title: The Study of Functional Magnetic Resonance Imaging in Abdominal and Pelvic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Diseases
Abdominal Diseases
Keywords: Magnetic Resonance Imaging
Magnetic Resonance Angiography
Diffusion Tensor Imaging
IDEAL
T2* mapping
Magnetic ResonanceCine
BOLD
phase contrast
diffusion-weighted imaging
Functional Magnetic Resonance Imaging
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2015-01-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with abdominal or pelvic diseases who provide informed consent Healthy Volunteers

Brief summary: The purpose of this study is to study the diagnostic efficiency of functional magnetic resonance imaging in Abdominal and Pelvic Diseases.


Eligibility criteria: Inclusion Criteria:

* All patients with abdominal or pelvic diseases who provide informed consent
* Healthy Volunteers

Exclusion Criteria:

* claustrophobic
* pregnancy

Primary outcomes:
measure: all cause mortality
timeFrame: 10years
Secondary outcomes:
Other outcomes:
Locations:
city: WuHan
country: China
facility: Tongji Hospital affiliated to Tongji Medical college of Huazhong Universitity of Science and Technology
state: Hubei
Study officials:
References:
citation: Tang H, Wang Z, Wang L, Hu X, Wang Q, Li Z, Li J, Meng X, Wang Y, Hu D. Depiction of transplant renal vascular anatomy and complications: unenhanced MR angiography by using spatial labeling with multiple inversion pulses. Radiology. 2014 Jun;271(3):879-87. doi: 10.1148/radiol.14131800. Epub 2014 Mar 3.
citation: Wang YC, Hu DY, Hu XM, Shen YQ, Meng XY, Tang H, Li Z. Assessing the Early Response of Advanced Cervical Cancer to Neoadjuvant Chemotherapy Using Intravoxel Incoherent Motion Diffusion-weighted Magnetic Resonance Imaging: A Pilot Study. Chin Med J (Engl). 2016 Mar 20;129(6):665-71. doi: 10.4103/0366-6999.177995.
citation: Wang Y, Li Z, Meng X, Hu X, Shen Y, Morelli J, Lin H, Zhang Z, Hu D. Nonmuscle-invasive and Muscle-invasive Urinary Bladder Cancer: Image Quality and Clinical Value of Reduced Field-of-view Versus Conventional Single-shot Echo-planar Imaging DWI. Medicine (Baltimore). 2016 Mar;95(10):e2951. doi: 10.1097/MD.0000000000002951.
Clinical trial NCT02354677: Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients
Official title: Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heathy Volunteers
Smokers
COPD
Keywords: Bronchial epithelium
COPD
Repair
Remodelling
Club Cells
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: COPD is characterized by exagerated decline FEV1 related to obstructive non reversible airflow. This could be the consequence of structural changes and inflammatory pattern of the bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD including a decrease in Club cells number and function.There is no treatment actually available targeted to a normal repair of the epithelium. The objective of this work is to identify potential targets for reprograming bronchial epithelial cells I order to achieve a good repair.


Eligibility criteria: Inclusion Criteria:

COPD - Smokers or ex smokers \> 30p/yr

* FEV1/FVC \< 0.7
* With a fibroscopy prescription

Smokers - Smokers or ex smokers \> 30p/yr

* FEV1/FVC \> 0.7
* With a fibroscopy prescription

Controls - age superior or equal to 18

* no smoker (for 5 years)
* with a fibroscopy prescription

Exclusion Criteria:

* Xylocaine hypersensibility
* Porphyria
* severe hepatic failure
* Epilepsy
* Severe cardiac failure

Primary outcomes:
measure: Full recovery one day after injury (yes / no) proportion of cells showing the repair, remodeling or regeneration of the epithelium (ciliated cells, mucus cells, Clara cells) in culture in air-liquid interface in the three groups
timeFrame: 1 day
Secondary outcomes:
measure: Measurement of apoptosis and inflammation (IL8)
timeFrame: 24 months
measure: Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.
timeFrame: 24 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pneumology Department
Study officials:
affiliation: University Hospital, Montpellier
name: BOURDIN Aranud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01117077: The Immune Tolerance Mechanism Induced by IL-17-producing Regulatory T Cells in the Orthotopic Liver Transplant Recipients With Aspergillosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplantation
Aspergillus
Interleukin-17
Treg Cell
Immune Tolerance
Keywords: liver transplantation
aspergillus infection
interleukin-17
Treg cell
immune tolerance
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2010-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: liver transplantation patients with aspergillus infection or without aspergillus infection

Brief summary: Infection accounted for the first cause of death in patients after liver transplantation, and 2 / 3 of the cause of death was fungal infections. The investigators group early found that T cell subsets playing a role of inducing immune tolerance were significantly increased in vivo of liver transplantation patients with aspergillus infection, which may be a kind of Treg cells expressing IL-17. To explore the immune tolerance mechanism induced by the immune balance cells is important to liver transplantation patients for improving efficacy and reducing the mortality. Therefore, the investigators are going to get the blood sample and liver tissue of the liver transplantation patients before and after treatment of aspergillus infection, flow cytometry analysis of blood T cell subsets, Cytometric Bead Array to detect changes in blood cytokines, laser capture microdissection to obtain liver biopsies of inflammatory cells in portal area and further for analysis of T cell subsets and protein. And the investigators are also to investigate the characteristics of CCR6 + CD4 + FOXP3 + Treg cell clones secreting IL-17 and the capacity of which suppressing conventional T cell proliferation. This study may find new methods, such as certain types of T cell subsets or cytokines for the treatment of liver transplant patients, which not only to anti-rejection but also to reduce fungal infection.


Eligibility criteria: Inclusion Criteria:

Liver transplantation patients

Exclusion Criteria:

Psychopath

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00586677: Evaluation of Parenting Interventions to Decrease Family Risk for Child Maltreatment
Official title: Evaluation of Parenting Interventions to Decrease Family Risk for Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Abuse
Keywords: child abuse
child neglect
PCIT
Lutzker
attachment
parenting
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: The Duke Endowment
First posted: 2008-01-04
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to evaluate specific parenting programs that aim to improve the family's ability to keep children physically safe and emotionally secure. We would like to learn more about how the treatments actually help families and to find out how an intervention that focuses on child health and safety compares with one that focuses on the parent and child relationship. We also want to determine whether participating in one program type versus the other results in further reports for child maltreatment.


Eligibility criteria: Inclusion Criteria:

* resident of Durham, NC
* a child between the ages of 0-7 was the focus of the Department of Social Services report
* child's caregiver was the focus of the report
* Child Protective Services report occurred on or after June 1, 2004
* family is English speaking
* Sexual abuse was not "confirmed" or "highly suspicious" during an evaluation

Exclusion Criteria:

* Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious"

Primary outcomes:
measure: Durham County, North Carolina Department of Social Services accepted reports of child maltreatment
timeFrame: 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Center for Child and Family Health
state: North Carolina
Study officials:
affiliation: Duke University
name: Kenneth Dodge, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Karen O'Donnell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01348477: Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia
Official title: Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal
hernia
pain
inguinodynia
mesh
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2011-05-05
Enrollment: 168
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 investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.

Detailed description: The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:

Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.

The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.

Eligibility criteria: Inclusion Criteria:

* adult patients diagnosed with uncomplicated primary inguinal hernia
* mentally healthy patients
* patients without preoperative groin pain
* patients eligible for outpatient surgery

Exclusion Criteria:

* patients with different surgical diagnosis

Primary outcomes:
measure: pain one month after surgery
timeFrame: one month
measure: pain three months after surgery
timeFrame: three months
measure: pain six months after surgery
timeFrame: six months
Secondary outcomes:
measure: dysesthesia one month after surgery
timeFrame: one month
measure: dysesthesia three months after surgery
timeFrame: three months
measure: dysesthesia six months after surgery
timeFrame: six months
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Ambulatory care medical unit number 55 (UMAA 55)
state: Guanajuato
Study officials:
affiliation: IMSS
name: Rafal L Smolinski, surgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: IMSS
name: Martha A Hernandez, researcher
role: STUDY_DIRECTOR
affiliation: IMSS
name: Sergio E Solorio, researcher
role: STUDY_CHAIR
References: