louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04352127: Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve
Official title: Comparison of Visual and Electromyography Assessments in Response to Train-of-Four Stimulation of the Ulnar Nerve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Residual Neuromuscular Blockade
Keywords: Neuromuscular Blockade
Tetragraph
AMG
EMG
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Researchers are comparing the accuracy of measuring muscle relaxation during and after surgery with a device that provides numeric value versus visual observation to count of muscle twitches or absence of them by a medical provider monitoring your anesthesia during surgery.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective surgical procedure that requires use of NMBA agents administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field

Primary outcomes:
measure: Subjective Evaluation to Neurostimulation
timeFrame: up to 1 hour postoperatively
Secondary outcomes:
measure: Incidence of Residual Neuromuscular Blockade
timeFrame: Up to 1 hour postoperatively
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J.Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04371627: Viaskin® Peanut (DBV712) Expanded Access Protocol
Official title: Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Peanut Allergy
Keywords: Peanut allergy
EPIT
Epicutaneous
Immunotherapy
Viaskin®
Lead sponsor: DBV Technologies
Sponsor class: INDUSTRY
First posted: 2020-05-01
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD

Brief summary: This is an open label expanded access program for male and female patients ≥ 4 years old.

Detailed description: This study is an open-label Intermediate-size EAP designed to provide treatment access for eligible Peanut-Allergic Children. This EAP entails visits every three months to assess patient status, safety, and to provide drug supply. Viaskin® Peanut treatment will continue until, in the clinical judgment of the Investigator, the patient is no longer benefiting from continuation of the treatment, the drug becomes approved and available by prescription, or the study is terminated.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 4 years of age
* Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients

Exclusion Criteria:

* Pregnancy or lactation or planning a pregnancy.
* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back with no intact zones to apply the Viaskin® patches.
* Patients who developed hypersensitivity to excipients of the Viaskin® patches.
* Received or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
* Receiving or planning to receive any other type of immunotherapy to any food (for example, EPIT, OIT, or SLIT or specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study.
* Use of cyclosporine or other immunosuppressive agents within 3 months before entering the study. Topical calcineurin inhibitors are permitted.
* A history of important non-compliance during the REALISE or PEOPLE studies. Important non-compliance includes patients not applying the patches for 60 or more days in total and/or for 30 or more consecutive days during the REALISE or PEOPLE studies.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03595527: Universal HIV Screening and Targeted HCV Screening in Emergency Department
Official title: Universal HIV Screening and Targeted HCV Screening in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Hiv
Keywords: Screening
Linkage to care
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: Ministere de la Sante et des Services Sociaux
name: Gilead Sciences
name: Merck Sharp & Dohme LLC
First posted: 2018-07-23
Enrollment: 6350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cross-sectional study of patients consulting in the emergency room of the Centre hospitalier de l'Université de Montréal (CHUM), to assess the implementation of an "opt-out" screening program for HIV and HCV and prospective follow-up for 3 months of positive cases.

Detailed description: The purpose of this study is to evaluate the feasibility of routine HIV and HCV screening using an "opt-out" approach at the emergency room of the CHUM and to determine the rate of new positive HIV and HCV cases. A sub-analysis will focus more specifically on HCV in the Quebec equivalent of "baby boomers" (1945-1975) since this is the group that was targeted in the United States. The second phase of this study will evaluate the effectiveness of the linkage to the healthcare system for people diagnosed with HIV or HCV and how fast these people are taken care of and put on treatment.

Eligibility criteria: Inclusion Criteria:

* Individuals attending the emergency room of the Centre hospitalier de l'Université de Montréal

Exclusion Criteria:

* Individuals unable to opt-out due to their psychological or physical condition

Primary outcomes:
measure: Prevalence
timeFrame: 10 months
Secondary outcomes:
measure: Prevalence Among Baby-boomers
timeFrame: 10 months
measure: Opt-out
timeFrame: 10 months
measure: Initial Workup
timeFrame: 1 month
measure: Cascade of Care
timeFrame: 3 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
Study officials:
References:
citation: Martel-Laferriere V, Baril JG, Alarie I, Leblanc J, Cote J, Jourdenais E, Horth D, Lambert G, Tremblay C. Opt-out universal HCV and HIV screening in a Canadian emergency room: a cross-sectional study. BMJ Open. 2022 Jan 18;12(1):e048748. doi: 10.1136/bmjopen-2021-048748.
Clinical trial NCT04725227: Determine the Effect of Prone Positioning in Adults With ARDS by Electrical Impedance Tomography
Official title: Determine the Effect of Prone Positioning on Lung Ventilation and Perfusion Distribution in Adults With Acute Respiratory Distress Syndrome by Electrical Impedance Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
Prone Position
Electrical Impedance Tomography
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring mechanical ventilation are recieved prone position ventilation who admitted to the surgical ICU.

Brief summary: determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography

Detailed description: By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.

Eligibility criteria: Inclusion Criteria:

* patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio \< 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition

Exclusion Criteria:

* contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)

Primary outcomes:
measure: Assess regional distribution of pulmonary perfusion
timeFrame: within 24 hours
measure: Assess regional distribution of pulmonary ventilation
timeFrame: within 24 hours
measure: Assess oxygenation status
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ming Zhong, MD, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang YX, Zhong M, Dong MH, Song JQ, Zheng YJ, Wu W, Tao JL, Zhu L, Zheng X. Prone positioning improves ventilation-perfusion matching assessed by electrical impedance tomography in patients with ARDS: a prospective physiological study. Crit Care. 2022 May 27;26(1):154. doi: 10.1186/s13054-022-04021-0.
Clinical trial NCT06135727: Screening Protocol
Official title: Data Collection for Development of Topcon Health Score
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Topcon Corporation
Sponsor class: INDUSTRY
First posted: 2023-11-18
Enrollment: 26
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to collect data for the development and validation a screening process using aggregate data.

In this study, data collection will encompass both retrospective and prospective approaches across multiple sites in the United States.


Eligibility criteria: Inclusion Criteria:

* Subjects 22 years of age or older on the date of data collection (retrospective) or informed consent (prospective).
* For prospective data collection or missing retrospective data collection, subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent.
* BCVA 20/40 or better (each eye).

Exclusion Criteria:

* For prospective or missing retrospective data collection, subjects unable to tolerate ophthalmic testing.
* Concomitant diseases known to affect the visual field: history of leukemia, dementia, Parkinson's disease, Alzheimer's disease, stroke, or autoimmune diseases.
* History of intraocular surgery (uncomplicated cataract or glaucoma surgeries are accepted)
* Ocular findings or history of co-morbidities, including, but not limited to: uveitis, non-glaucomatous optic neuropathy, trauma, retinal detachment, vein or artery occlusions, wet age-related macular degeneration, geographic atrophy, proliferative diabetic retinopathy, vitreous hemorrhage, severe cataract, severe non-proliferative diabetic retinopathy. Controlled diabetes and hypertension participants can be included.
* Unreliable VF testing and/or poor-quality OCT scans.
* Poor fixation.

Primary outcomes:
measure: RNFL and GCL thickness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Topcon
state: California
Study officials:
affiliation: Topcon Corporation
name: Mary Durbin, PhD
role: STUDY_CHAIR
affiliation: Topcon Corporation
name: Nevin W. El-Nimri, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707927: Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: EOA
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients operated elektively for aortic valve disease with the need of a biological valve

Brief summary: Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.


Eligibility criteria: Inclusion Criteria:

* Aortic valve disease

Exclusion Criteria:

1. Pregnant
2. Breast feeding
3. Aortic valve bigger than 23 mm
4. Endocarditis
5. EF \< 50%

Primary outcomes:
measure: Pressure gradients
timeFrame: 240 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital, Thoracic departement
Study officials:
affiliation: OUS Thoraxkirurgisk avdeling Ullevål
name: Bjørn Braathen, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: OUS thoraxkirurgisk avdeling Ullevål
name: Theis Tønnessen, MD Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00491127: Cisplatin With Gemcitabine With Dexamethasone in Patients With Aggressive Non-Hodgkin's Lymphoma
Official title: Phase II Study of Cisplatin With Gemcitabine in Fixed Dose Rate Infusion and Dexamethasone in Second-Line in Patients With Aggressive Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study it to evaluate efficacy of gemcitabine with cisplatin and dexamethasone in patients with aggressive non-Hodgkin's lymphoma who have previously progressed on first line of chemotherapy with anthracyclines.


Eligibility criteria: Inclusion Criteria:

* The patients must have a histological diagnosis of aggressive non-Hodgkin's lymphoma including the following sub-categories of the WHO classification:

  * Diffuse large B-cell lymphoma and its variants (immunoblastic, Burkitt-like, sclerosis of mediastinum, large B-cell MALT, rich in T-cells and anaplastic B-cell lymphoma)
  * Peripheral T-cell lymphoma
  * Anaplastic lymphoma of large T-cells /null cells
* Patients are eligible if they have documented evidence of progression after prior first-line chemotherapy containing anthracyclines associated or not with Rituximab. Patients with refractory disease to first line of treatment are also eligible.
* ECOG PS (performance status) less than or equal to 2
* Presence of bidimensionally measurable disease in accordance with WHO criteria.

Exclusion Criteria:

* Involvement of the CNS.
* Any medical condition which contraindicates the degree of hydration required for the safe use of cisplatin.
* Intermediate degree lymphoma derived from the malignant transformation of a previous low-grade lymphoma.
* Active infection (in the opinion of the investigator).

Primary outcomes:
measure: To evaluate response rate
Secondary outcomes:
measure: To assess toxicity
measure: Overall survival
measure: Event-free survival
measure: Progression - free survival
measure: Disease - free survival
measure: Duration of response
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03733327: BUCYE Conditioning Regimen for PCNSL Undergoing Auto-HSCT
Official title: Busulfan+ Cyclophosphamide+ Etoposide Conditioning Regimen for Primary Central Nervous System Lymphoma Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Primary Central Nervous System Lymphoma
Autologous Hematopoietic Stem Cell Transplantation
Conditioning
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
name: Guangzhou First People's Hospital
name: Zhujiang Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Third Affiliated Hospital, Sun Yat-Sen University
First posted: 2018-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of BUCYE conditioning regimens in primary central nervous system lymphoma undergoing autologous hematopoietic stem cell transplantation.

Detailed description: The prognosis of patients with primary central nervous system lymphoma (PCNSL) is poor. Recent studies have demonstrated that autologous hematopoietic stem cell transplantation (auto-HSCT) could improve the prognosis of these patients. However, the optimal conditioning regimen of auto-HSCT remains unclear. In this study, the investigators evaluated the safety and efficacy of BUCYE conditioning regimens in PCNSL undergoing auto-HSCT.

Eligibility criteria: Inclusion Criteria:

* Primary central nervous system lymphoma patients
* Achieving CR or PR, then mobilizing and collecting of peripheral blood stem cells

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: OS
timeFrame: 2 year
Secondary outcomes:
measure: DFS
timeFrame: 2 year
measure: relapse rate
timeFrame: 2 year
measure: TRM
timeFrame: 2 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hematology,Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02819427: Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures
Official title: Concomitant High-resolution Recording of Haemodynamic and Electrical Activities of Children With Typical or Atypical Absence Seizures: Near-infrared Spectroscopy (NIRS) Coupled to Electroencephalography (EEG)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Keywords: Spectroscopy, Near-Infrared
Electroencephalography
children
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with absence epilepsy presenting either typical or atypical seizures

Brief summary: This study, conducted in children with typical or atypical "absence" epilepsy, will consist of noninvasive recording of the metabolic activity of the brain concomitantly with electroencephalographic recording during seizures without the need for any additional examination. This examination will be performed by combining near-infrared spectroscopy (NIRS) optical imaging and Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.

Surface electroencephalography (EEG) is a valuable tool to assess neuronal dysfunction from a functional point of view and is used in the routine follow-up of epileptic children. Optical imaging is a recent and promising medical imaging technique, which uses near-infrared light. This rapid, noninvasive and harmless quantitative technique can be easily used at the child's bedside or in the ward and provides metabolic information on brain functioning.


Eligibility criteria: Inclusion Criteria:

* Children aged 3 to 14 years
* Featuring absence epilepsy with typical or atypical seizures characterized by the presence of spontaneous spike-wave flashes with standard EEG

Exclusion Criteria:

* All children with severe congenital malformation
* Any refusal of a parent or child
* Any child with a serious deterioration in the general condition and vital functions
* Any child with dermatitis of the face or scalp
* Children under 3 years old or over 14 years

Primary outcomes:
measure: haemodynamic changes
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Fabrice WALLOIS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06796127: A Multicenter Study of Artificial Intelligence Model for Fetal Congenital Heart Disease
Official title: Beijing Anzhen Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Congenital Heart Disease (CHD)
Artificial Intelligence (AI)
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 10000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population was from 20 multi-center medical institutions in China, and pregnant women who underwent fetal echocardiography between 16 and 40 weeks of gestation.

Brief summary: This study addresses congenital heart disease in fetuses, a specific birth defect, by collaborating with multicenter medical institutions across China. It prospectively collects echocardiographic screening, diagnostic images, and structured parameter data from both normal and abnormal fetuses. Cases are followed up, and artificial intelligence (AI) models are developed to extract fetal heart echocardiographic image features and analyze the data. This process allows for the analysis of the AI models' accuracy, sensitivity, and specificity, and verifies the application value of AI models in fetal heart echocardiographic screening and diagnosis.


Eligibility criteria: Inclusion Criteria:

* Single or multiple pregnancy;
* Gestational age 16-40 weeks;
* Fetal echocardiographic images are clear and complete;
* Clinical data are complete and detailed;
* Sign informed consent and be able to cooperate with follow-up

Exclusion Criteria:

* Fetal echocardiographic images are incomplete or of poor quality that cannot be used for research;
* Refusal or loss of follow-up

Primary outcomes:
measure: Diagnostic efficiency of AI model for fetal CHD
timeFrame: From enrollment to diagnostic verification, the evaluation period should not exceed 12 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital affiliated to Capital Medical University
state: Beijing
Study officials:
References: