louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03843619: Electronic and Lab Pre-screening of New Rheumatology Patients With Rheumatoid Arthritis
Official title: Electronic and Lab Pre-screening of New Rheumatology Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Inflammatory Arthritis
Lead sponsor: Arthritis Northwest PLLC
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
name: Discus Analytics LLC
First posted: 2019-02-18
Enrollment: 200
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: All patients referred to a rheumatologist for inflammatory arthritis.

Brief summary: By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Importantly, it strives to fill an unmet need, the rapid evaluation by Primary Care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (RA) with tight control. Given the call for improved quality, value, and demonstration of results\[1\], this initiative uses the tenets of National Center for Quality Assurance's Patient Centered Specialty Program\[1\] (PCSP) and it successfully masters and streamlines coordination of care.


Eligibility criteria: Inclusion Criteria:

* First ever referral to a rheumatologist.

Exclusion Criteria:

-

Primary outcomes:
measure: To increase referral efficiencies through an electronic system to decrease the timeline prior
timeFrame: One year enrollment period
Secondary outcomes:
measure: To assess difference in disease activity progression using Clinical Disease Activity Index (CDAI) at both 12 and 24 months.
timeFrame: One year enrollment period with two year follow-up period.
measure: To assess difference in disease activity progression using Routine Assessment of Patient Index Data (RAPID3) at both 12 and 24 months.
timeFrame: One year enrollment period with two year follow-up period.
measure: To assess radiographic progression using sharp scores in the electronically referred cohorts versus the traditional cohort.
timeFrame: One year enrollment period with two year follow-up period.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04344119: Assessment of Chilbains Occuring During Covid-19 Infection
Official title: Assessment of Skin Manifestations Occuring During Covid-19 Infection With a Special Focus on Chilbains
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Manifestations
COVID
Chilblains
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 30
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with covid infection presenting with skin manifestations

Brief summary: Some patients infected by covid-19 develop skin manifestations. These manifestations are still not well known and there pathophysiology remain unclear. Among them, acral manifestation resembling to chilblains appears frequent and quite specific. The aim of this project is to better characterize the cutaneous manifestations occurring during Covid-19 infection with a special focus on chilblains. These acral manifestation could be due to a direct viral effect, but also to microthrombosis or vascularitis. Understanding the pathomechanisms involved could provide interesting clue for understanding not only the skin manifestations but also some of the other systemic symptoms associated to covid-19 infection. This study plan to characterize these acral manifestations by analyzing the clinical and dermoscopic patterns and to correlate them with the non-invasive vascular explorations but also immune and coagulopathy explorations that are done in the CHU of Nice in covid-19 patients.


Eligibility criteria: Inclusion Criteria:

* All patients with proven covid infection (using PCR, serum antibody or lung TDM) and presenting at least one cutaneous lesions that occurred during the infection.

Primary outcomes:
measure: Clinical skin manifestations
timeFrame: 3 months
Secondary outcomes:
measure: Histology and biological data
timeFrame: 3 months
measure: Non invasive vascular examination
timeFrame: 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References:
citation: Hubiche T, Cardot-Leccia N, Le Duff F, Seitz-Polski B, Giordana P, Chiaverini C, Giordanengo V, Gonfrier G, Raimondi V, Bausset O, Adjtoutah Z, Garnier M, Burel-Vandenbos F, Dadone-Montaudie B, Fassbender V, Palladini A, Courjon J, Mondain V, Contenti J, Dellamonica J, Leftheriotis G, Passeron T. Clinical, Laboratory, and Interferon-Alpha Response Characteristics of Patients With Chilblain-like Lesions During the COVID-19 Pandemic. JAMA Dermatol. 2021 Feb 1;157(2):202-206. doi: 10.1001/jamadermatol.2020.4324.
Clinical trial NCT01042119: Intravesical Injection of Botox for Treating Therapy Refractory Overactive Bladder in Females
Official title: Short- and Longterm Results After Intravesical Injection of Botulinum Neurotoxin Type A for Treating Therapy Refractory Overactive Bladder in Females - a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder Syndrome
Keywords: botulinum neurotoxin type A
BoNT/A
Botox
overactive bladder syndrome
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received at our clinic treatment with intravesical injection of Botox for idiopathic overactive bladder syndrome

Brief summary: The neurotoxin Botox (botulinum neurotoxin type A) is shown to be effective in the treatment of therapy refractory overactive bladder syndrome. Our data suggests a longer during efficacy than known from the use in striated muscle.

The aim of our study is to analyze short- and longterm efficacy after Botox treatment and to evaluate risk factors for non-responders and side effects such as urinary retention.


Eligibility criteria: Inclusion Criteria:

* intravesical treatment with Botox at our clinic

Primary outcomes:
measure: duration of effect of Botox
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Clinic for Gynaecology
Study officials:
affiliation: University Hospital of Zurich, Clinic for Gynaecology
name: David A Scheiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04413318: Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children
Official title: A Cross-over Study to Compare Two Different Tracheal Cuff Pressure Monitoring Devices in a Pediatric Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cuff Overinflation
Cuff Underinflation
Keywords: tracheal cuff pressure
pediatric critical care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 44
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.

Detailed description: In this study, the investigators will compare the duration of the period of under-inflation and over-inflation between electronic (VBM©) and pneumatic (Nosten©) devices (continuous monitoring of tracheal cuff pressure), in critically intubated children. This study aims to determine the effectiveness of the electronic device in the continuous monitoring of tracheal cuff pressure.

Eligibility criteria: Inclusion Criteria:

* Infants and children more than 2 days after birth at term and less than 5 years of age
* Patient intubated in the PICU with a cuffed endotracheal tube
* Predicted duration of mechanical ventilation \> or = 24-hours
* Signed informed consent

Exclusion Criteria:

* Intubated with an uncuffed endotracheal tube
* Children admitted to the PICU with a previous tracheostomy
* Preterm children or infants less than 2 days post-term
* Patient under block neuromuscular treatment
* Patient enrolled in another trial that might influence this study results

Primary outcomes:
measure: Percentage of time spend with over or under-inflation of the tracheal cuff
timeFrame: 12 hours
Secondary outcomes:
measure: The response time to a significant variation in cuff pressure
timeFrame: 12 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Boris LACARRA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stephane DAUGER, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06000618: Effects of Intrapulmonary Percussive Ventilator on Respiratory Function
Official title: Effects of Intrapulmonary Percussive Ventilator on Respiratory Function: an Experiment in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Clearance Impairment
Keywords: Intrapulmonary percussive
Healthy volunteer
pulmonary function
Electrical Impedance Tomography
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to prove the benefit of intrapulmonary percussive ventilator in healthy volunteers. The main questions are:

* How can intrapulmonary percussive improve lung function？
* What is the subjective feeling through intrapulmonary percussive?

Participants will be undergoing treatment of intrapulmonary percussive. Then they will be assessed for lung function and EIT before and after intrapulmonary percussive.


Eligibility criteria: Inclusion Criteria:

* No respiratory system, heart disease
* Well cooperate with the MateNeb

Exclusion Criteria:

* No respiratory illness such as influenza, pneumonia, asthma, bronchitis within the last month
* Couldn't finish three times pulmonary function test

Primary outcomes:
measure: Pulmonary function test
timeFrame: through study completion, an average one hour
measure: Electrical Impedance Tomography of Pulmonary(EIT)
timeFrame: through study completion, an average one hour
Secondary outcomes:
measure: The safety and comfort
timeFrame: The treatment was scored once after the participants completed both low and high frequency intrapulmonary percussive.Up to one week.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Sheng Wang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hassan A, Milross M, Lai W, Shetty D, Alison J, Huang S. Feasibility and safety of intrapulmonary percussive ventilation in spontaneously breathing, non-ventilated patients in critical care: A retrospective pilot study. J Intensive Care Soc. 2021 May;22(2):111-119. doi: 10.1177/1751143720909704. Epub 2020 Mar 12.
citation: Nyland BA, Spilman SK, Halub ME, Lamb KD, Jackson JA, Oetting TW, Sahr SM. A Preventative Respiratory Protocol to Identify Trauma Subjects at Risk for Respiratory Compromise on a General In-Patient Ward. Respir Care. 2016 Dec;61(12):1580-1587. doi: 10.4187/respcare.04729. Epub 2016 Nov 8.
Clinical trial NCT05072418: Postural Control Among Children with and Without Dyslexia
Official title: The Influence of Visual Information on Postural Control Among Children with and Without Dyslexia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Disorder
Keywords: child with dyslexia, postural sway
visual perception
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be 80 Chinese-speaking children between 8 and 12 years of age recruited from elementary schools in Taiwan. Half of the participants will be formally identified as dyslexia by specialists in the field of special education (Table 1), based on formal psycho-educational assessments (Chinese Character Recognition Test (Huang, 2001), Chinese reading diagnostic evaluation, and Wechsler Intelligence Scale for Children 4th Edition-Chinese version.

Brief summary: As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language.


Eligibility criteria: Inclusion Criteria:

* 1.Normal IQ(\>85, WISC-III)
* 2.Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education

Exclusion Criteria:

* 1.Attention deficit hyperactivity disorder(ADHD)
* 2.Neurological or psychiatric abnormalities
* 3.Developmental coordination disorder(DCD)

Primary outcomes:
measure: Postural sway analysis
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Stabilogram diffusion analysis of central of pressure
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Chen Kong University Hospital
Study officials:
References:
Clinical trial NCT00226018: Performance of Acceleromyography With and Without Preload
Official title: Performance of Acceleromyography With and Without Preload During Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 examine the precision, bias and limits of agreement when monitoring the neuromuscular block with acceleromyography with and without preload and compare the method to the gold standard, mechanomyography.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* General anesthesia \> 1 hour
* Surgery under supine position with possibility of monitoring the neuromuscular block in both arms (thumbs)
* Written informed content

Exclusion Criteria:

* Neuromuscular disorders, hepatic and renal dysfunction
* Medication expected to interfere with the neuromuscular blocking agent
* Allergy to any medication used during anesthesia
* Body weight less or exceeding 20% of the ideal body weight
* Pregnancy or breastfeeding

Primary outcomes:
measure: The precision of acceleromyography with and without preload during recovery
Secondary outcomes:
measure: Bias and limits of agreement for acceleromyography (AMG) with and without preload compared to mechanomyography (MMG) during recovery
measure: All the following outcomes obtained with AMG with and without preload are compared to MMG. Furthermore the responses are compared when the AMG-values are "normalized":
measure: Bias og limits of agreement between control TOF
measure: Onset time
measure: Time to reappearance of T1, T2, T3 and T4
measure: Twitch height of T1 at reappearance of T1, T2, T3 and T4
measure: Time to T1=25%
measure: Interval 25-75%
measure: Time to TOF-ratio = 0.9 and 1.0
measure: Time to final T1
measure: Time to final TOF ratio
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of anesthesia, HOC, Rigshospitalet
state: Copenhagen Ø
Study officials:
affiliation: Rigshospitalet, Denmark
name: Casper C Kjaer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06631118: Pericapsular Nerve Block Versus Propofol During Hip Fractures Surgery
Official title: Pericapsular Nerve Group (PENG) Block Versus Low Dose Propofol to Achieve Painless Sitting Position Before Spinal Anesthesia in Patients With Hip Fractures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Difference in Reduction in Visual Analogue Score at 30 Minutes
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will compare the efficacy of Pericapsular nerve group block (PENG) versus low dose Propofol for the achievement of painless sitting position before spinal anesthesia in patients undergoing repair of Hip fractures.


Eligibility criteria: Inclusion Criteria:

* All patients in the age group ranging 40-70, both genders, belonging to physical status American Society of Anaesthesiologists (ASA) I and II

Exclusion Criteria:

* Patients with old fractures (more than 7 days), polytrauma, bleeding disorders or coagulopathy, local site infection, difficulty expressing pain scores such as hearing disability, mentally challenged, dementia or psychiatric illness and who refused to take part

Primary outcomes:
measure: The difference in VAS scale
timeFrame: 30 min after giving propofol and the PENG block.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01165918: Derivation of New Human Embryonic Stem Cell Lines: Identification of Instructive Factors for Germ Cells Development
Official title: Basic Research. Unveiling Factors That Contribute to Germ Cell Differentiation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Normal Healthy Embryos
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2010-07-20
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any donated embryo

Brief summary: The purpose of this study is

1. To generate human embryonic stem cells lines (hESC) lines
2. Study of the factors that contribute to differentiation towards germ cell.


Eligibility criteria: Inclusion Criteria:

* any donated embryos

Exclusion Criteria:

* not relevant

Primary outcomes:
measure: New hESC
timeFrame: 1 year
Secondary outcomes:
measure: Factors that contribute to germ cells differentiation
timeFrame: 4 years
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka medical center
Study officials:
References:
Clinical trial NCT04943718: Personalized Vaccine for Patients With Recurrent Malignant Glioma
Official title: Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Glioma
Recurrent Glioma
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Neoantigen Biotechnology Company
First posted: 2021-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.


Eligibility criteria: Inclusion Criteria:

* age 18-70;
* signed inform consent;
* patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;
* patients' tumor tissue should have a high mutation load(\>10 TMB); be genetically unstable; at least have 10 neoantigens;
* should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;
* at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;
* have not received any immune therapy;
* at least have one measurable lesion;
* KPS \>60;
* estimated survival \> 3 months
* patients should have adequate organ and bone marrow function;

Exclusion Criteria:

* female patient is breastfeeding or pregnant;
* known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);
* known history of Graft-Versus-Host Disease (GVHD);
* participation in gene therapy;
* other malignancy;
* systemic disease: i.e., severe infection; HIV;
* other conditions upon investigator's judgement;

Primary outcomes:
measure: incidences of advent events and severe advent events
timeFrame: from initiation of study treatment to 28 weeks post-vaccination
Secondary outcomes:
measure: object response rate (ORR) according to iRANO criteria
timeFrame: from initiation of study treatment to 24 weeks post-vaccination (last shot)
measure: progression free survival (PFS)
timeFrame: up to 48 weeks post-vaccination(last shot)
measure: overall survival (OS)
timeFrame: up to 48 weeks post-vaccination(last shot)
measure: immune response based on the criteria encoded by GRT-C903 and GRT-R904
timeFrame: Baseline to end of treatment (up to approximately 12 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
Study officials:
References: