louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03690908: Infraorbital Nerve Involvement on Magnetic Resonance Imaging in IgG4-related Ophthalmic Disease
Official title: Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IgG4-related Disease
Orbital Infections, Inflammations and Irritations
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-10-01
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients suffering from non-thyroid, non-lymphoma related orbital inflammation treated in Fondation Rothschild (tertiary ophtalmology facility, Paris, France) from January 2006 through April 2015.

Brief summary: Infraorbital nerve enlargement (IONE) on magnetic resonance imaging is known to be a possible consequence of IgG4-related ophthalmic disease. However this imaging sign can also be found in other conditions causing orbital inflammation. This study aims at comparing the frequency of IONE in patients suffering from IgG4-related ophthalmic disease (IgG4-ROD) versus patients suffering from non-IgG4-related ophthalmic disease (non-IgG4-ROD)


Eligibility criteria: Inclusion criteria :

* Patient aged 18 and older treated in Fondation Rothschild (tertiary ophthalmology facility, Paris, France) from January 2006 through April 2015
* Presence of a clinical orbital inflammation: mass/swelling, pain, exophthalmos, visual loss, ptosis, or diplopia.
* The presence of at least one pretherapeutic MRI confirming the inflammation of one or more orbital structures: the lacrimal gland, fat, muscles, or infraorbital nerve. The mandatory minimal MRI protocol include the following sequences: T1- and T2-weighted MRI image, in the transverse and coronal plane, and a fat-suppressed T1-weighted image in the coronal plane obtained after intravenous administration of a gadolinium chelate.
* Completion of at least one orbital biopsy with a pathologic examination and an immunohistochemical screen for IgG4.

Exclusion criteria :

* Clinical and biological signs of thyroid-associated orbitopathy
* Histologically proven lymphoma
* Pretherapeutic MRI that is insufficient for an adequate interpretation
* Absence of IgG4 testing in the pathology examination

Primary outcomes:
measure: Proportion of patients with infraorbital nerve involvement in magnetic resonance imaging
timeFrame: Within 2 weeks after the first consultation for orbital inflammation
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rotchschild
Study officials:
References:
Clinical trial NCT03661008: Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt
Official title: Paternal Involvement in Psychiatric Care of Adolescents Managed for Depression or Suicide Attempt
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Disorder
Depression
Suicide, Attempted
Child Mental Disorder
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Teenagers consulting in the adolescents psychiatric unit of the University Hospital of Reunion Island

Brief summary: Parental involvement, both quantitative and qualitative, is fundamental for a good psycho-emotional development of the child. The lack of parental involvement and especially paternal involvement significantly promotes the occurrence of behavioral disorders in children and later, in adolescence, the onset of depressive symptomatology. On the other hand, parental involvement has a protective role in the occurrence of behavioral disorders and decreases the risk of suicide attempts in adolescence. The authors of these cohort studies agree on the need for research on the identification of factors determining paternal involvement in order to organize specific prevention actions and targeted interventions to promote the involvement of fathers in psychiatric care of their adolescents.

The prevention of adolescent suicide attempts appears to be a real public health issue in Reunion Island with a suicide rate among under-35s twice as high as in Reunion than in metropolitan France.

This work is a continuation of the guidelines of good practice of the High Authority of Health (HAS) which insist on the importance of "supporting the parental function by health and public action".


Eligibility criteria: Inclusion Criteria:

Teenagers aged 13 to 17

* managed for a depressive episode (ADRS score\> 3) or for a suicide attempt
* speaking and understanding French and / or Creole language

Exclusion Criteria:

* fathers without legal responsibility for the child
* absence of consent of the adolescent or those responsible for parental authority

Primary outcomes:
measure: Proportion in the most incident factors influencing paternal involvement in psychiatric care of adolescents
timeFrame: One hour after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: France
facility: CHU Réunion
state: Reunion Island
Study officials:
References:
Clinical trial NCT05345808: Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
Official title: Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Vein Occlusion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after diabetic retinopathy. Patients with RVO are at risk of the development of macular edema. Different treatment modalities for macular edema include LASER therapy, antivascular endothelial growth factor (VEGF), and triamcinolone.

Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either central or branch.


Eligibility criteria: Inclusion Criteria:

* Diminution of vision due to macular edema secondary to non-ischemic retinal vein occlusions, either central or branch
* CMT ≥ 250 µ,
* Willing to participate in the study.

Exclusion Criteria:

* Unwilling to participate in the study
* Ischemic RVO
* previous laser treatment
* Glaucoma, macular ischemia, cataract, vitreous hemorrhage, and neovascularization of the iris
* patients with previous anti VEGFs or steroid injections or any eye surgery three months before the inclusion
* Cardiac co-morbidities result in significant hemodynamic changes
* Respiratory diseases need treatment with antibiotics
* Suffering from other chronic diseases as diabetes
* Patient with allergy from triamcinolone acetonide.

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: at the base line
measure: Best corrected visual acuity
timeFrame: at 1st month
measure: Best corrected visual acuity
timeFrame: at 3rd month
measure: Best corrected visual acuity
timeFrame: at 6th month
measure: Central macular thickness
timeFrame: at 1st month
measure: Central macular thickness
timeFrame: at 3rd month
measure: Central macular thickness
timeFrame: at 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Akram Fekry Elgazzar
Study officials:
References:
Clinical trial NCT01644838: Effect of Hyoscine and Promethazine on Labor Pain
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Labor Pain
Keywords: Hyoscine,
Promethazine,
The first stage of labor,
Labor pain
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is always considered to shorten the duration of delivery without compromising the mother and fetus by obstetrics. Hyoscine and Promethazine are used widely in hospital and research is very limited, with conflicting results regarding the efficacy of these two drugs. So the investigators decided to compare of effect of hyoscine N-butyl bromide and Promethazine on length of active phase of the first stage of labor.


Eligibility criteria: Inclusion Criteria:

* 18-35 yrs,
* primiparous,
* having single fetus with cephalic presentation, gestational age 37-42 weeks,
* having no medical diseases,
* having no history of hospitalization due to psychological diseases,
* having no addiction to cigarette,
* having no complications during pregnancy such as hypertension,
* BMI\< 26

Exclusion Criteria:

* bleeding
* CPD
* use of PG or Oxytocin
* fetus distress

Primary outcomes:
measure: Effect of Hyoscine and Promethazine on labor pain
timeFrame: up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02666638: Technical Development of up to 7T Magnetic Field Strength
Official title: Technical Development of up to 7T Magnetic Field Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Magnetic Resonance Imaging (MRI)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 69
Sex: ALL
Minimum age (years): 18
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 determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 200 Control volunteers will be scanned for approximately one hour, without contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly developed imaging software or hardware that conforms to applicable FDA standards and recommendations. The data (images) for the Control and Experimental Group will be de-identified by the scan technologist and downloaded to a workstation within the Radiology Department for offline processing. These images will be reviewed by a trained Radiologist after the subject has departed.


Eligibility criteria: Inclusion Criteria:

* Healthy control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)

Exclusion Criteria:

* Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)

Primary outcomes:
measure: Change in signal to noise ratio using statistical analysis
timeFrame: 25 minutes
measure: Change in spatial resolution using statistical analysis
timeFrame: 25 minutes
measure: Change in Temporal Resolution using statistical analysis
timeFrame: 25 minutes
measure: Change in Image Contrast using statistical analysis
timeFrame: 25 Minutes
measure: Change in image homogeneity using statistical analysis
timeFrame: 25 minutes
measure: Change in artifact reduction using statistical analysis
timeFrame: 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Yongxian Qian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04506138: Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Official title: Camrelizumab in Combination With Neoadjuvant Chemotherapy for Resectable Thoracic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of thoracic Esophageal squamous cell carcinoma
* ECOG performance status 0-1
* Age 18-75 years
* Resectable disease, cT2-4aNanyM0 or cT1-3N+M0
* Life expectancy more than 6 months
* Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

* Not suitable for surgery
* Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC
* Prior esophageal, gastric, or gastro-esophageal junction surgery
* Esophageal ulcer, esophageal perforation，chest pain（≥middle level）
* Pregnant or lactating women

Primary outcomes:
measure: Pathologic complete remission (PCR)
timeFrame: 12 weeks
measure: Major Pathologic Response (MPR)
timeFrame: 12 weeks
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Event Free Survival（EFS）
timeFrame: 5 years
Other outcomes:
measure: EQ-5D-3L questionnaire
timeFrame: 5 years
measure: FACT-E questionnaire
timeFrame: 5 years
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04368338: Lung Ultrasound to Diagnose COVID-19
Official title: Use of Lung Ultrasound in Patients Suspected of COVID-19 Infection in the Emergency Room
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Lung Ultrasound
Respiratory Complication
Keywords: Covid-19
lung ultrasound
Respiratory Complication
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Emergency Room (ER) for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound as part of the BLUE protocol.

Brief summary: Covid-19 (English acronym meaning coronavirus disease 2019) is an emerging infectious disease caused by a strain of coronavirus called SARS-CoV-2. The current pandemic has resulted in a significant number of admissions in the emergency room (ER) due to suspicion of COVID-19 infection. Use of lung ultrasound is standard practice to diagnose acute respiratory failure in ER. Recently, typical lung ultrasonographic characteristics of COVID-19 disease has been described. During the COVID-19 pandemic, the use of this tool could be of interest in order to allow an early, simple and reliable triage in patients with suspected COVID-19 infection admitted in ER. In addition, the visualization of early signs in specific areas could be a predictive marker of the severity of the disease. The objective of this project will be to study the association between the signs on lung ultrasound and the result of RT-PCR in patients with suspected COVID-19 infection in the ER.


Eligibility criteria: Inclusion Criteria:

* patients admitted to Emergency Room for suspicion of COVID-19 infection with has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound

Exclusion Criteria:

* patients \< 18 years of age or under guardianship or curators,
* pregnancy
* poor echogenicity due to the presence of an acoustic barrier (pneumothorax, subcutaneous emphysema, etc.)
* patients with a suspected or proven acute lung disease (pneumonitis, acute respiratory distress syndrome (ARDS))
* chronic interstitial lung disease
* patients who will refuse to give their consent.

Primary outcomes:
measure: Lung ultrasound/biological correlation research modulating the severity of Covid-19 disease
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: BAR
Study officials:
affiliation: CHU Amiens
name: Stéphane Bar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bar S, Lecourtois A, Diouf M, Goldberg E, Bourbon C, Arnaud E, Domisse L, Dupont H, Gosset P. The association of lung ultrasound images with COVID-19 infection in an emergency room cohort. Anaesthesia. 2020 Dec;75(12):1620-1625. doi: 10.1111/anae.15175. Epub 2020 Jul 1.
Clinical trial NCT04360538: Long Term Outcomes of Patients With COVID-19
Official title: Long Term Outcomes of Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Corona Virus Infection
Respiratory Failure
Covid-19
Keywords: long term outcomes
mechanical ventilation
noninvasive ventilation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 500
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: adult patients admitted to the intensive care unit

Brief summary: The investigators hypothesize that those with respiratory failure due to COVID-19 will have different burdens of mental and physical disability than those with respiratory failure who do not have COVID-19. Detecting these potential differences will lay an important foundation for treating long term sequelae of respiratory failure in these two cohorts.

Detailed description: The aim of this proposal to is to understand the extent and degree of physical disability, psychological sequelae, and cognitive dysfunction survivors of COVID-19 related critical illness will have upon hospital discharge, 6 months, and up to one year post discharge. These outcomes of interest will be evaluated prospectively. The investigators will perform these measures in Covid-19 patients with respiratory failure and compare them to non-Covid-19 patients with respiratory failure. The investigators also seek to determine the risk factors of these long-term complications in order to guide providers as to which patients should be screened for these deficits. Finally, the investigators will examine the association of various critical care interventions such as invasive versus noninvasive mechanical ventilation or use of sedatives and their effects on disability and cognitive dysfunction.

Eligibility criteria: Inclusion Criteria:

* adult patients admitted to the ICU

Exclusion Criteria:

* none

Primary outcomes:
measure: Quality of Life score
timeFrame: up to 12 months after discharge
Secondary outcomes:
measure: cognitive dysfunction
timeFrame: up to 12 months after discharge
measure: Functional Status Score
timeFrame: up to 12 months after discharge
measure: Physical Disability
timeFrame: up to 12 months after discharge
measure: Psychological Sequelae
timeFrame: up to 12 months after discharge
Other outcomes:
measure: hospital anxiety and depression
timeFrame: up to 12 months after discharge
measure: ICU related complications
timeFrame: hospitalization up to 6 weeks
measure: hospital discharge location
timeFrame: hospital discharge up to 6 weeks
measure: lCU length of stay
timeFrame: hospitalization up to 6 weeks
measure: hospital length of stay
timeFrame: hospitalization up to 6 weeks
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT04333238: Notation Optimization Through Template Engineering
Official title: Notation Optimization Through Template Engineering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Documentation
Keywords: Progress note
Note template
Electronic medical record
Note quality
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a randomized non-blinded controlled trial of a standard note template versus a redesigned note template using a simulated patient encounter and the electronic medical record.

Detailed description: Residents documented the simulated patient encounter using one of two templates. The standard template was based on the usual outpatient progress note. The new template placed the assessment and plan section in the beginning, grouped subjective data into the assessment section, and deemphasized elements not related to the current presentation.

Eligibility criteria: Inclusion Criteria:

* Residents who had open visit slots during their outpatient clinic time

Exclusion Criteria:

* None

Primary outcomes:
measure: Note length
timeFrame: Duration of note entry, up to 2 hours
measure: Time to note completion
timeFrame: Duration of note entry, up to 2 hours
measure: Note evaluation by authors using a likert scale
timeFrame: Immediately after note entry, up to 1 hour
measure: Note evaluation by reviewers using the Physician Documentation Quality Instrument
timeFrame: Within 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Jeremy A Epstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Epstein JA, Cofrancesco J Jr, Beach MC, Bertram A, Hedian HF, Mixter S, Yeh HC, Berkenblit G. Effect of Outpatient Note Templates on Note Quality: NOTE (Notation Optimization through Template Engineering) Randomized Clinical Trial. J Gen Intern Med. 2021 Mar;36(3):580-584. doi: 10.1007/s11606-020-06188-0. Epub 2020 Sep 8.