louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06241365: The Predictive Role of C-reactive Protein to Albumin Ratio (CAR) in the Treatment of Septic Arthritis in Young Chlidren
Official title: The Predictive Role of C-reactive Protein to Albumin Ratio (CAR) in the Treatment of Septic Arthritis in Young Chlidren
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Arthritis
Lead sponsor: Children's Hospital of Soochow University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators reviewed the clinical records of patients under 4 years old with SA who were admitted to the Department of Orthopedics at the Children's Hospital of Soochow University for SA treatment between January 2016 and December 2022.

Brief summary: Purpose: C-reactive protein to albumin ratio (CAR) has emerged as a novel marker of inflammation. However, almost no research has evaluated the role of CAR in septic arthritis (SA). There is currently controversy over the timing of surgery. Our aim is to explore the application of the CAR in predicting the treatment choice for SA in children under 4 years of age.

Methods: Retrospective analysis of the clinical data from children under four years of age admitted to the Department of Orthopedics at Children's Hospital of Soochow University between January 2016 and December 2022 due to SA. Patients were divided into surgery group and conservative group based on whether the patients underwent surgery. The clinical data of the two groups were compared. Multivariate logistic regression analysis was performed to determine the independent predictors for SA requiring surgical intervention. Receiver operating characteristic (ROC) curves were plotted for the independent predictive indicators, and the area under curve (AUC) was determined. The cut-off value was determined using Youden index, and diagnostic accuracy indicators such as sensitivity (SEN), specificity (SPE), positive predictive value (PPV) and negative predictive value (NPV) were calculated.


Eligibility criteria: Inclusion Criteria:

* (1) Meeting the aforementioned SA diagnostic criteria, regardless of the affected joint; (2) Completing routine blood and biochemical tests within 24 hours of admission; (3) No surgery or antibiotics administered prior to admission.

Exclusion Criteria:

* (1) Cases of transient synovitis, rheumatism-related diseases (JIA, etc.), simple acute hematogenous osteomyelitis, or acute exacerbation of chronic hematogenous osteomyelitis after revision of the diagnosis; (2) Postoperative iatrogenic infection; (3) Incomplete clinical data.

Primary outcomes:
measure: CAR
timeFrame: December 2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02216565: Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase
Official title: Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke, Acute
Keywords: Stroke
Endovascular treatment
Tandem carotid occlusions
Fibrinolysis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2014-08-15
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.

The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.

The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone


Eligibility criteria: Inclusion Criteria:

* Radiologically proven acute proximal occlusion of middle cerebral artery

AND one of the three following :

1. tandem internal carotid / middle cerebral artery occlusion
2. intravenous thrombolysis contraindicated because of high risk of haemorrhage
3. intravenous thrombolysis not possible because of delay \> 4.5 hours

Exclusion Criteria:

* Impossibility to perform endovascular recanalization within 6h
* Clinically minor stroke (NIHSS score below 5 at baseline)
* Extended cerebral infarction
* Severe comorbidity
* Life expectancy below 3 months before stroke
* Pregnancy or breastfeeding
* modified Rankin Score superior to 2 before stroke

Primary outcomes:
measure: Improvement in NIHSS score after 24h
timeFrame: 24 hours
Secondary outcomes:
measure: Improvement in NIHSS score after 7 days
timeFrame: 7 days
measure: Functional recovery after 3 months
timeFrame: 3 months
measure: Fatality within 7 days
timeFrame: 7 days
measure: Fatality within 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
affiliation: Hopital Lariboisiere, Paris
name: Marc-Antoine Labeyrie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondation Ophtalmologique Adolphe de Rothschild, Paris
name: Michel Piotin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02002065: The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children
Official title: The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis A
Keywords: hepatitis A
inactivated hepatitis A vaccine
attenuated alive hepatitis A vaccine
immune persistence
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-12-05
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Chinese children aged 18 to 35 months old

Brief summary: The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.

Detailed description: In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008.

This study is the fifth-year follow-up research for the previous clinical trial.

Eligibility criteria: Inclusion Criteria:

* All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial

Exclusion Criteria:

* Subjects who refused to continue in the follow-up study

Primary outcomes:
measure: The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination
timeFrame: 60 months after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin center for disease prevention and control
Study officials:
affiliation: Tianjin Center for Diseases Control and Prevention
name: Zhi-Lun Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Z, Zhu X, Hu Y, Liang M, Sun J, Song Y, Yang Q, Ji H, Zeng G, Song L, Chen J. Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine. Hum Vaccin Immunother. 2017 Jun 3;13(6):1-6. doi: 10.1080/21645515.2016.1278329. Epub 2017 Feb 14.
Clinical trial NCT00568165: EMEPIC : Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure
Official title: Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Congestive Edema
Cardiac Disease
Keywords: Heart failure, congestive
Echocardiography
Patient care team
Lead sponsor: University Paris 7 - Denis Diderot
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. The hypothesis is that a mobile team will lead to shorter hospitalization.

Detailed description: Randomized, controlled, monocentric study comparing Standard care with the care provided by a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward on the duration of hospitalization, re-hospitalization rate à 30 days, emergency visit within 30 days, treatment at discharge, mortality within hospital stay and at 30 days.

Eligibility criteria: Inclusion Criteria:

* Hospitalized for suspected heart failure
* \> or = 18 years

Exclusion Criteria:

* Refuses to participate

Primary outcomes:
measure: Duration of hospitalization.
timeFrame: 30 days
Secondary outcomes:
measure: Re-hospitalization rate à 30 days Emergency visit within 30 days Treatment at discharge Mortality within hospital stay Mortality at 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Paris
country: France
facility: JONDEAU
Study officials:
affiliation: UNIVERSITY PARIS 7
name: Guillaume JONDEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01335165: Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Official title: A Phase 1, Single Ascending Dose Study of the Safety and Pharmacokinetics of TT30 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)
Keywords: PNH
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to understand the safety, pharmacokinetics and pharmacodynamics of a single dose of TT30 (ALXN1102 and ALXN1103 formulations) when given IV (through a vein) or SC (under the skin) to patients with PNH.

Detailed description: This is an open-label, single-dose, dose-escalation study to assess the safety, tolerability, PK, PD, and immunogenicity of TT30 given as an IV infusion and as a SC injection in subjects with PNH or evidence of circulating PNH cells.

Eligible subjects with PNH will be vaccinated with meningococcal vaccine at least two weeks prior to dosing (if not previously vaccinated or if revaccination is required).

On study day 1, the subject will receive the single dose of TT30 as an IV infusion over 60 minutes or as a SC injection, and be followed with additional study evaluations over the next 59 days.

Eligibility criteria: Inclusion Criteria:

* Individuals at least 18 years of age with a diagnosis of PNH \& vaccination against meningococcus.

Exclusion Criteria:

* Abnormal renal or liver function
* History of meningococcal disease
* History of Guillain-Barre syndrome
* Known infection with HIV or Hepatitis B or C
* History of thrombotic events

Primary outcomes:
measure: Assess the safety and tolerability of a single dose of TT30.
timeFrame: 60 days
Secondary outcomes:
measure: Characterize PK, PD and immunogenicity of a single dose of TT30.
timeFrame: 60 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: U nemocnice 1
country: Czech Republic
facility: Institute of Hematology and Blood Transfusion / Institut Hematologie a krevní transfuze
state: Prague 2
city: Via Pansini 5
country: Italy
facility: Federico II University of Naples
state: Naples
city: Dębinki 7
country: Poland
facility: University Clinical Centre
state: Gdańsk
city: Denmark Hill
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: London
Study officials:
affiliation: Alexion Pharmaceuticals, Inc.
name: Bill Lundberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06925165: Ultrasound Measured Hyomental Distance to Tongue Thickness Ratio as a Predictor of Difficult Intubation in Infants
Official title: Ultrasound Measured Hyomental Distance to Tongue Thickness Ratio as a Predictor of Difficult Intubation in Infants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ultrasound
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants aged 1 to 12 months

Brief summary: Evaluation the role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants

Detailed description: Sonographic assessment of the airway after induction of anesthesia and Master Degree Thesis / MFA/ISRO/ Faculty Of Medicine/ASU Page 6 intubation: All infants will be placed in a supine position with their heads slightly extended. Then, the low-frequency probe (curved) will be first placed under the chin in the midsagittal plane and adjusted to show a clear view of the entire tongue outline and the border of the mandible and hyoid bone on the screen. The image will be frozen and stored. On the image the tongue thickness will be measured, which is the maximum vertical distance from the sub mental skin to the tongue surface (Yao W, Wang B 2017). After that, the HMDE will be measured, which is the distance from the lower border of the mentum of the mandible to the upper border of the hyoid bone.

Eligibility criteria: Inclusion Criteria:

* Infants aged 1 to 12 months

Both sexes.

Physical status ASA I or II

Exclusion Criteria:

* Restricted mobility of temporomandibular joint
* Absent anesthesia or surgical consent
* Maxillofacial trauma or tumors
* A large mass or scar under the chin

Primary outcomes:
measure: role of ultrasound measured hyomental distance to tongue thickness ratio in predicting difficult intubation in infants.
timeFrame: 2 to 3 minutes after induction of anaesthesia and intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Anesthesia resident Ain Shams University
name: Shaimaa Reda Ahmed, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03929965: Anlotinib in Advanced Solid Tumors With FGFR Alteration
Official title: Anlotinib in Advanced Solid Tumors With FGFR Alteration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Solid Tumor
Keywords: Anlotinib
FGFR
solid tumors
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 30
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 clinical trial aims to evaluate the efficacy, safety of Anlotinib in advanced solid tumors with FGFR alteration.


Eligibility criteria: Inclusion Criteria:

Patients should be histologically diagnosed with advanced solid tumors; Patients with FGFR mutation(including mutation, fusion, rearrangements ); Patients have measurable lesions; Patients are not available for targeted therapy or patients refuse to receive targeted therapy afer second-line treatment; Over 3 weeks after radiotherapy and the radiotherapy focus was not be measured; Age should be 18-25 years; Performance status should be 0-2; Life expectancy should be more than 12 weeks;

Exclusion Criteria:

Patients underwented major surgery or severe trauma within 4 weeks; Patients allergiced to experimental drugs; Patient ready to give birth or who is pregnant; Patients with brain metastases; Patients with chemotherapy contraindication; Patients could not tolerate chemotherapy; Patients have secondary primary tumor.

Primary outcomes:
measure: Objective Response Rate(ORR)
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01055665: Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain
Official title: Cognitive Behavioral Therapy, Self-Efficacy, and Depression in Persons With Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-25
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with chronic pain and depressive symptoms in a pain rehabilitation program.

Brief summary: The investigators are exploring the role of Cognitive Behavioral Therapy (CBT), a treatment for depression, on self-efficacy (feeling empowered to accomplish a given task) and depression in persons with chronic pain and depression. Past research has shown that persons with chronic pain show improvement in self-efficacy and depression scores when they are using CBT. The Pain rehabilitation Center (PRC) at Mayo Clinic is adding CBT focused groups to better understand the role of CBT on self-efficacy and depression in persons with chronic pain and depression.

Detailed description: Subjects will need to complete two questionnaires on admission and on discharge from the PRC program to measure self-efficacy and depression. The first is the Pain Self-Efficacy Scale (PSEQ) which is a measure of self-efficacy in persons with chronic pain. The second questionnaire is the Center for Epidemiologic Studies Depression Scale (CES-D) which is a measure of depressive symptoms in persons with chronic pain. Both scales will also be used for clinical information. Persons who score 27 or higher on the CES-D will be approached for potential consent to this evidence based project. Each patient in the PRC will participate in up to 6 CBT sessions but only persons who, upon admission, score 27 or greater on the CES-D will be studied for any changes in scores from admission to discharge.

Eligibility criteria: Inclusion Criteria:

* 18 and over with chronic pain and
* score of 27 or higher on CES-D scale

Exclusion Criteria:

* 17 or younger, no chronic pain,
* cognitively unable to participate in programming

Primary outcomes:
measure: Change on a depression and self-efficacy scale
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Virginia R Nash, RN, MS, CNS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00595465: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51
Official title: Comparison of Three Commercial Batches of the Japanese Encephalitis Vaccine IC51. Double Blind, Randomized, Controlled Phase 3 Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Japanese Encephalitis
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 389
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to demonstrate equivalence of three commercial IC51 batches in terms of geometric mean titers for anti-JEV neutralizing antibody


Eligibility criteria: Main Inclusion Criteria:

* Male and female healthy adults aged at least 18 years, with written informed consent and either no childbearing potential or negative pregnancy test

Main Exclusion Criteria:

* History of immunodeficiency or immunosuppressive therapy,
* Known Human Immunodeficiency Virus (HIV); OR
* Drug addiction including alcohol dependence

Primary outcomes:
measure: Geometric Mean Titer (GMT) for Anti-JEV Neutralizing Antibody
timeFrame: Day 56
Secondary outcomes:
measure: Seroconversion Rate
timeFrame: Day 56
measure: Safety and Adverse Events
timeFrame: Day 56
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universität Wien, Universitätsklinik für Klinische Pharmakologie
city: Berlin
country: Germany
facility: Berliner Zentrum Reise- und Tropenmedizin
city: Munich
country: Germany
facility: Klinikum der Universität München, Abteilung für Infektions- und Tropenmedizin
city: Rostock
country: Germany
facility: Klinik und Poliklinik für Innere Medizin der Universität Rostock
Study officials:
affiliation: Valneva Austria GmbH
name: Nicole Haas
role: STUDY_DIRECTOR
References: