louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04844593: A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Official title: Use of Natural Language Processing (NLP) and Machine Learning (ML) for the Identification of Patients With Crohn's Disease (CD) and Complex Perianal Fistulas (CPF) and Their Characterization in Terms of Clinical and Demographic Characteristics. A Multicentre, Retrospective, NLP Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Rectal Fistula
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with CD diagnosed with or without CPF during the study period.

Brief summary: Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical records.

Detailed description: This is a non-interventional, retrospective study of participants with CD and CPF in a clinical practice setting.

The study will enroll approximately 100 participants.

The study will have a retrospective data collection to select and analyze information from EMRs processed by an AI based analytics framework that uses machine learning and NLP methodologies.

All participants will be enrolled in one observational group.

• Participants with CD

This multi-center trial will be conducted in Spain. The overall duration of the study is approximately 36 months.

Eligibility criteria: Inclusion Criteria:

1. CD participant diagnosed or not with CPF between January 1st 2015 and December 31st 2021.

Exclusion Criteria:

Not applicable.

Primary outcomes:
measure: Percentage of Participants With CD and CPF Accurately Identified With the use of NLP and Medical Language (MEL)
timeFrame: Up to Month 36
Secondary outcomes:
measure: Number of Participants With CD and CPF Characterized Using NLP and Machine Learning Techniques
timeFrame: Up to Month 36
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluna
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Comunidad De Madrid
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04500093: Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
Official title: Does Capsulectomy, Performed in Total Hip Arthroplasty With a Direct Anterior Approach Cause Knee Extension Strength Loss?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coxarthrosis
Muscle Weakness
Keywords: Hip
Arthroplasty
Quadriceps strenght
Muscle Weakness
Knee
Flexion
Extension
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total hip arthroplasty (THA) has been successful in relieving pain and restoring function in patients with advanced arthritis of the hip joint. Increased focus on earlier recovery and decreased postoperative pain has improved overall satisfaction. However, there is still a gap between the clinical scores in objective surveys and patient satisfaction. Direct anterior approach total hip arthroplasty has a low dislocation rate, abductor strength restoration, acceleration, and cosmetic advantages. In this method, capsulotomy with repair or capsulectomy is applied as the preferences of surgeons. Therefore, this can cause both a decrease in hip flexion strength and a loss in knee extension strength. Our aim in this study is to reveal how much muscle loss was caused by comparing both methods with the intact side.

Detailed description: Published data assessing biomechanical performance after THR are sparse. The majority of studies assessing post-THR hip function using robotic dynamometry have focused on evaluating surgical outcomes and prosthetic selection. These studies provide insight regarding the strength deficits of older adults after THR. However, the data are not consistent, making it difficult to assess the nature of the deficit.

Eligibility criteria: Inclusion Criteria:

* All primary THA

Exclusion Criteria:

* Secondary THA

Primary outcomes:
measure: Muscle Weakness
timeFrame: 1 year
Secondary outcomes:
measure: Harris Hip Score
timeFrame: 1 year
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
state: Fatih
Study officials:
References:
Clinical trial NCT00496093: Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
Official title: Safety, Tolerability and Immunogenicity of Pneumovax 23 (V110) in Healthy Adults in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 133
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.

Detailed description: This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.

Eligibility criteria: Inclusion Criteria:

* Healthy indian adults of 50 years of age
* In good health; any underlying chronic illness must be documented to be in stable condition
* Signed and dated informed consent prior to receipt of the study vaccine

Exclusion Criteria:

* Functional or anatomic asplenia
* History of auto immune disease
* Hypersensitivity to any of the components of the study vaccine,including phenol
* Known or suspected immune dysfunction, including persons with congenital immunodeficiency
* Prior vaccination with any pneumococcal vaccine

Primary outcomes:
measure: Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b
timeFrame: post-vaccination
Secondary outcomes:
measure: Any AE within 15 days after vaccination, with particular attention to injection site AE and fever
timeFrame: 15 days after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03359993: Umbilical Vein Needle Catheterization for Endotracheal Intubation.
Official title: Umbilical Vein Needle Catheterization for Endotracheal Intubation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Respiratory Distress Syndrome
Keywords: Endotracheal intubation
Neonatal premedication
Delivery room
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 5
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS)

Brief summary: The investigators describe a simple and efficient method to give a premedication in the delivery room, using the umbilical vein, directly punctured through Wharton's jelly.

Detailed description: The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. The investigators used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. The investigators report 5 cases of intubations in the delivery room using this method to administer the premedication.

Eligibility criteria: Inclusion Criteria:

* All the patients were preterm neonates intubated in the delivery room for infant respiratory distress syndrome (IRDS).

Exclusion Criteria:

* Refusal of legal owners

Primary outcomes:
measure: Conditions of intubation
timeFrame: Seven months
Secondary outcomes:
measure: Duration of intubation
timeFrame: Seven months
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Centre Hospitalier René Dubos
Study officials:
affiliation: Hôpital NOVO
name: Suzanne BORRHOMEE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00420693: Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Official title: Interest of Using the Sevoflurane in the Prevention of Newborns Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain Measurement
Newborn
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.


Eligibility criteria: Inclusion Criteria:

* Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit
* Patient requiring a mechanical ventilation or CPAP
* Patient requiring a KTEC
* Given consent

Exclusion Criteria:

* Contraindication to sévoflurane
* Patient already sedated with morphin and/or hypnotics
* Patient presenting neurologic troubles
* Patient enrolled in other study\*
* Infant without legacy representant

Primary outcomes:
measure: Lasted realization of the gesture defined by delay between the first draining and the end of the bandage
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille CHU Nord
state: BdR
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: fabrice michel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michel F, Vialet R, Hassid S, Nicaise C, Garbi A, Thomachot L, DI Marco JN, Lagier P, Martin C. Sevoflurane for central catheter placement in neonatal intensive care: a randomized trial. Paediatr Anaesth. 2010 Aug;20(8):712-9. doi: 10.1111/j.1460-9592.2010.03334.x.
Clinical trial NCT00307593: RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Official title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wegener's Granulomatosis
Churg-Strauss Syndrome
Microscopic Polyangiitis
Keywords: Systemic ANCA+ vascularizes
Relapse
Corticosteroids
Immunosuppressant
Infliximab/rituximab
Patients with relapsing or refractory forms of ANCA
associated vasculitides Microscopic polyangiitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.

Detailed description: The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).

Eligibility criteria: Inclusion Criteria:

* Systemic ANCA positive (+) vasculitides
* Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
* Age \>18 years old
* Written informed consent

Exclusion Criteria:

* Newly diagnosed patient
* Patient that had never received an immunosuppressant before to treat his/her vasculitis
* Malignancy
* Pregnancy

Primary outcomes:
measure: Partial or complete remission of the vasculitides
timeFrame: one year
Secondary outcomes:
measure: To study the safety and adverse effects of both regimens
timeFrame: one year
measure: Microscopic polyangiitis
timeFrame: one year
measure: Wegener's granulomatosis
timeFrame: one year
measure: Churg-Strauss syndrome
timeFrame: one year
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Loïc GUILLEVIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901693: An Evaluation of the Efficacy and Safety of AL-46383A Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adenoviral Conjunctivitis
Keywords: pink eye
eye infection
conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 452
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of AL-46383A Ophthalmic Solution for the treatment of adenoviral conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* At least one eye must have EITHER a positive adenovirus test (using the Adeno Detector™ for Adenoviral Conjunctivitis, Rapid Pathogen Screening, Inc.) OR a positive clinical diagnosis assessed by the Adenoviral Clinical Diagnostic Checklist.
* Onset and development of ocular symptoms and/or signs of conjunctivitis ≤ 7 days prior to enrollment (Day 1) in either eye.
* Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/ Independent Ethics Committee (IRB/IEC).
* Must agree to comply with the visit schedule and other requirements of the study.
* Females who are not pregnant and are not lactating. All females of childbearing potential (those who are not pre-menarcheal, not postmenopausal or surgically sterile) may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Sub-epithelial infiltrates at the Day 1 visit in either eye.
* Corneal opacity or any corneal abnormality at the Day 1 visit in either eye.
* Contact lens wear during the course of the study. Participants requiring correction must have spectacles with appropriate correction.
* Only one sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
* Abnormal findings in the posterior pole of the retina or any media opacity found in a dilated fundus examination at the Day 1 (Screening/ Baseline) visit.
* Suspected fungal, herpes, Chlamydia or Acanthamoeba infection, based on clinical observation.
* History of active uveitis or iritis in either eye.
* History of corneal transplant in either eye.
* Presence of nasolacrimal duct obstruction at Day 1.
* Use of specified prohibited medications.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Sustained microbiological success at Day 5 or Day 7
timeFrame: Up to Day 18
Secondary outcomes:
measure: Time to sustained microbiological success
timeFrame: Up to Day 18
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Sally Scheib
role: STUDY_DIRECTOR
References:
Clinical trial NCT00436293: Taxotere + Cisplatin in Nasopharyngeal Carcinoma
Official title: A Randomized Phase II Study of Concurrent Cisplatin-radiotherapy With or Without Neoadjuvant Chemotherapy Using Taxotere and Cisplatin in Advanced Nasopharyngeal Carcinoma (NPC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasopharyngeal Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 61
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: Primary objective:

To assess and compare the toxicities of patients with advanced NPC treated with concurrent cisplatin-radiotherapy with or without neoadjuvant Taxotere (docetaxel) and cisplatin.

Secondary objective:

To assess tumor control and survival


Eligibility criteria: Inclusion Criteria:

* International Union against Cancer stages III and IV newly diagnosed NPC

Exclusion Criteria:

* Inadequate bone marrow reserve
* Inadequate renal function
* Other primary malignancy
* Evidence of distant metastases

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Treatment response is evaluated by correlating findings on clinical examination, endoscopy, biopsy, Computed tomography or Magnetic resonance imaging as appropriate.
timeFrame: From administration of drug to end of study
Secondary outcomes:
measure: Adverse Events
timeFrame: From administration of drug to end of study
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Iris Chan
role: STUDY_DIRECTOR
References:
Clinical trial NCT03057093: TIII Over TI in Subjects With Myocardial Infarction
Official title: Assessment of T Wave Changes of Patients With Acute Non-ST-elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: NSTEMI - Non-ST Segment Elevation MI
Keywords: NSTEMI, ECG
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 903
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with acute myocardial infarction without ST segment elevation

Brief summary: Study was performed to identify ECG criteria for unmasking of subjects with NSTEMI at elevated risk.

Detailed description: In the present study the investigators assessed the value of T wave changes in subjects with NSTEMI (TIII\>TI).

Eligibility criteria: Inclusion Criteria:

* NSTEMI and PCI

Exclusion Criteria:

* NSTEMI without percutaneous intervention

Primary outcomes:
measure: Myocardial infarction size
timeFrame: 5 Days
Secondary outcomes:
measure: Correlation with coronary artery
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05991193: A Study With Central Nervous System Metastatic EGFR Mutation Positive Non-small Cell Lung Cancer
Official title: A Non-interventional Study and Its Clinical Relevance With Central Nervous System Metastatic Epidermal Growth Factor Receptor Mutation Positive Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
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: Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically.

Brief summary: This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.

Detailed description: This is a descriptive observational study, in which data are collected in an EGFR mutant NSCLC. Our research plan aims to use multi-omics approaches to predict the likelihood of patients developing brain metastases, assess the prognosis of brain metastasis treatment, and identify potential biomarkers.

Eligibility criteria: Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Patient with EGFR 19Del or L858R mutation diagnosed histologically or cytologically. The mutations above may exist alone or together.
* Patients must have untreated advanced Non-Small Cell Lung Cancer (NSCLC).
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None

Primary outcomes:
measure: Progression-free survival
timeFrame: 2 years
Secondary outcomes:
measure: Central nervous system (CNS) progression-free survival
timeFrame: 2 years
measure: Objective Response Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References: