louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04884542: Multigen Plus H Study and AMF TT Cones
Official title: A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H Alone or Involving AMF TT Cones.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthroplasty, Replacement, Knee
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
Collaborators: name: North American Science Associates Ltd.
First posted: 2021-05-13
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subject population for this study includes adult subjects in whom the decision to perform a Total Knee Arthroplasty with Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to include the subject into the study.

Brief summary: The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age ≥ 18 years old
* Given written informed consent approved by the reference Ethics Committee (EC)
* Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
* Subject is able to comply with the protocol

Exclusion Criteria:

* Age \&amp;lt; 18 years old
* Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
* Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
* Female subjects who are pregnant, nursing, or planning a pregnancy
* Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS \&lt; 70 points.

Primary outcomes:
measure: Functional Knee Society Score (KSS)
timeFrame: Month 24
Secondary outcomes:
measure: KOOS-ADL (Function in Daily Living subdomain)
timeFrame: Month 24
measure: VAS Pain score
timeFrame: Month 24
measure: Survivorship of the implant
timeFrame: Month 24
measure: Radiographic implant evaluation and stability assessment
timeFrame: Month 24
measure: Safety evaluation
timeFrame: Intra-operatively, Month 3, Month 12, and Month 24
Other outcomes:
Locations:
city: Gand
country: Belgium
facility: AZ Jan Palfijn Gent
city: Bratislava
country: Slovakia
facility: Nemocnica Bory - Penta Hospital
Study officials:
References:
Clinical trial NCT06206642: Comparing 18F-FAPI-04 and 18F-FDG PET/CT in Cancer Detection
Official title: Evaluation of a Novel Targeted Molecular Probe 18F-FAPI-04 PET/CT for Various Malignant Tumors: Comparison With 18F-FDG PET/CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Keywords: 18F-FDG
18F-FAPI
PET/CT
Lead sponsor: Lanzhou University Second Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Evaluating fluoro-18-fibroblast activation protein inhibitor-04 positron emission computed tomography's diagnostic efficacy for primary malignancies versus 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose.

Detailed description: In recent years, radionuclide labeled fibroblast activating protein inhibitors (FAPIs) have gradually become a new strategy for targeted diagnosis and therapy. In this study, radionuclide 18F was used to label FAPI, and the imaging value of FAPI was compared with that of common developer 18F-FDG. To evaluate the diagnostic value of 18F-FAPI-04 PET/CT in various malignant tumors.

Eligibility criteria: Inclusion Criteria:

Adult (≥18 years old); PET/CT examination is required after evaluation by oncologist. Healthy persons who volunteer for PET/CT scans; Can cooperate to complete the inspection process; I or family members, legal representatives agree to participate in the study and can sign the informed consent in person.

Exclusion Criteria:

The patient has a serious underlying disease or mental illness and is unable to cooperate with the PET/CT examination; Have received systematic chemotherapy; Previous history of primary tumor; Pregnancy; I or family members, legal representatives are unable or unwilling to provide written informed consent.

Primary outcomes:
measure: Sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 18F-FAPI-04 PET/CT
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
Study officials:
affiliation: Lanzhou University Second Hospital
name: Liu Jiangyan
role: STUDY_DIRECTOR
References:
Clinical trial NCT06843642: The Development of Diagnosis and Prognosis Predictive Model for Peripheral Nerve Disease
Official title: The Development of Diagnosis and Prognosis Predictive Model for Peripheral Nerve Disease Using Big Data From Magnetic Resonance Neurography: A Multicenter Cohort Study（MRN-PND）
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Nerve Disease
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Wuhan No.1 Hospital
name: University Hospital Heidelberg
name: West China Hospital
First posted: 2025-02-25
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy People and Patients with Peripheral Nerve Disease

Brief summary: This is a retrospective observational cohort study (MRN-PND), aiming to explore the utility of contrast-enhanced MRN (ceMRN) compared to plain MRN in diagnosing peripheral nerve diseases and predicting the prognosis of patients with these conditions. Additionally, artificial intelligence (AI) methods are employed to enhance the diagnostic accuracy of MRN for peripheral nerve diseases and to precisely predict disease outcomes.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent MRN scanning at Wuhan Union Hospital between January 2015 and January 2025;
2. Age \> 18 years;
3. Definitive clinical diagnosis (either healthy individuals or patients with a specific condition).

Exclusion criteria：

1. Poor quality of imaging;
2. Incomplete clinical data or loss to follow-up;
3. Unclear clinical diagnosis.

Primary outcomes:
measure: Correlation analysis of MR information and diagnosis outcome
timeFrame: 0.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital，Tongji Medical College，Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT06257342: Physical Abilities of Teenagers With Familial Mediterranean Fever
Official title: Physical Abilities of Teenagers With Familial Mediterranean Fever
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Familial Mediterranean Fever
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Teenagers with familian mediteranean fever

Brief summary: Physical abilities of teenagers with familial Mediterranean fever

Detailed description: Physical abilities of teenagers with familial Mediterranean fever by describing the maximum oxygen consumption (VO2max) estimated from a 6-minute walk test

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of FMF according to the Tel-Hashomer criteria for whom a sports evaluation was offered during their bridging program
* Age \>12
* Followed or having been followed in the pediatric department of the CH of Versailles
* No opposition of the patient and his/her parent/legal guardian in case of a minor patient

Exclusion Criteria:

Expressed refusal of the patient and his/her parent/legal guardian to participate in the study and/or to use genetic data for research purposes

Primary outcomes:
measure: the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test
timeFrame: 6 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CH de Versailles
Study officials:
References:
Clinical trial NCT03214042: Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases
Official title: Efficacy and Safety of K-rod Dynamic Stabilization System in the Repair of Lumbar Degenerative Diseases: Study Protocol for a Prospective, Self-controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intervertebral Disk Degeneration
Lead sponsor: Shenyang Orthopedic Hospital
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 67
Sex: ALL
Minimum age (years): 32
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To conduct a prospective, single-center, self-controlled, clinical trial to verify the efficacy and safety of K-Rod dynamic stability system in the repair of lumbar degenerative diseases following 2 years follow-up, aiming to provide references for clinical treatment of lumbar degenerative diseases.

Detailed description: Posterior internal fixation and fusion systems are still one of the main methods for the treatment of chronic back pain due to intervertebral disc degeneration, but adverse reactions, such as accelerated regression of adjacent segments, are often inevitable during the treatment.

At present, various pedicle screw-based posterior dynamic stability systems of the lumbar spine have become an alternative fusion therapy for lumbar degenerative diseases. Dynamic stability is defined to reduce the loading on the intervertebral disc/articular surfaces, to maintain movement under mechanical load, to limit the abnormal movement of the spinal segment, and to reduce the stress on the bone-screw interface dynamically and stably. An ideal fixation system will be stable enough to maximize the fusion rate without the need for excessive rigidity, as well as to maintain maximum load and physiological posture of the vertebral segment, thereby reducing the horizontal stress of the adjacent segment.

Eligibility criteria: Inclusion Criteria:

* Degenerative lumbar spondylolisthesis (degree I)
* Nerve root canal or central spinal canal stenosis
* Accompanying nerve root pain and/or chronic back pain
* 32-76 years old
* Regardless of gender
* All patients or family members signed the informed consent

Exclusion Criteria:

* Systemic infection;
* Poor compliance and inability to complete the trial

Primary outcomes:
measure: Oswestry dysfunction index scores
timeFrame: at month 24 after surgery
Secondary outcomes:
measure: Lumbar lordosis angle
timeFrame: at month 24 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shenyang Orthopedic Hospital
name: Shuyi Gong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140642: Safety and Efficacy Study of AI LVEF
Official title: Blinded Randomized Controlled Trial of Artificial Intelligence Guided Assessment of Cardiac Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Systolic
Heart Failure, Diastolic
Keywords: Echocardiogram
Artificial Intelligence
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 3495
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Studies will be randomized 1:1 to either sonographer preliminary report finding or AI preliminary report finding with final adjudication by the cardiologist. With AI preliminary report, the preliminary interpretations will be generated by AI (artificial intelligence) technology \[a semantic segmentation model\] and the PACS system's native EF calculation workflow will be used to calculate LVEF. The study team will assess how much cardiologists edit and change this preliminary interpretation is from the final interpretation.
Primary purpose: DIAGNOSTIC

Brief summary: To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of left ventricular ejection fraction compared to sonographer measurements in preliminary readings of echocardiograms.


Eligibility criteria: Inclusion Criteria:

* The study imaging studies will include patients who underwent imaging (limited or comprehensive transthoracic echocardiogram studies) and a LVEF was adjudicated in the echocardiography/non-invasive cardiac imaging laboratory.
* The study participants are cardiologists reading in the echocardiography/non-invasive cardiac imaging laboratory.

Exclusion Criteria:

* The study imaging studies will exclude transesophageal echocardiogram imaging.
* The study will exclude cardiologists who decline to participate

Primary outcomes:
measure: Frequency of >5% change in LVEF between preliminary and final report
timeFrame: 10 Minutes
measure: Average change in LVEF between preliminary and final report
timeFrame: 10 Minutes
Secondary outcomes:
measure: Frequency cardiologist adjusts preliminary annotation
timeFrame: 10 Minutes
measure: Average change in LVEF between prior clinical report and final report
timeFrame: 10 Minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
References:
citation: Ouyang D, He B, Ghorbani A, Yuan N, Ebinger J, Langlotz CP, Heidenreich PA, Harrington RA, Liang DH, Ashley EA, Zou JY. Video-based AI for beat-to-beat assessment of cardiac function. Nature. 2020 Apr;580(7802):252-256. doi: 10.1038/s41586-020-2145-8. Epub 2020 Mar 25.
Clinical trial NCT00261742: Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Streptococcal Dermatitis
Official title: Comparative Trial of Oral Penicillin Versus Cefuroxim for Treatment of Perianal Dermatitis - an Open, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Streptococcal Infections
Keywords: perianal
dermatitis
streptococcus pyogenes
Lead sponsor: University Children's Hospital Basel
Sponsor class: OTHER
First posted: 2005-12-05
Enrollment: 194
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci.

Detailed description: The goal of the study is to investigate, which of two antibiotic treatments - oral penicillin for 10 days or oral cefuroxim for 7 days - is more successful for patients (1-16 years of age) with perianal dermatitis caused by group A beta-hemolytic streptococci (GABHS). Diagnosis is based on positive perianal culture for GABHS. Informed consent will be obtained.

The study will be performed in the region of Basel, Switzerland, in private practices of pediatricians, general practitioners, and selected pediatric dermatologists as well as in the out-patient departments of the University Children's Hospital Basel and the department for dermatology of the University of Basel.

Patients (or their parents) will fill in a daily diary on signs and symptoms of disease; furthermore, clinical investigations (inspection of the site of infection) will be performed on enrollment (Day 1), Day 3, and at the end of treatment (Day 10).

Eligibility criteria: Inclusion Criteria:

* informed consent
* age 1-16 years
* typical clinical symptoms for perianal dermatitis
* positive perianal culture for GABHS

Exclusion Criteria:

* antibiotic treatment in previous 14 days
* immunodeficiency
* penicillin allergy
* cephalosporin allergy
* further bacterial infections

Primary outcomes:
measure: Resolving signs and symptoms of perianal dermatitis
Secondary outcomes:
measure: microbiological cure (= negative culture for GABHS) at end of treatment
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital Basel
name: Ulrich Heininger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Children's Hospital Basel
name: Urs B Schaad, MD
role: STUDY_DIRECTOR
References:
citation: Landolt M, Heininger U. [Prevalence of perianal streptococcal dermatitis in children and adolescents]. Praxis (Bern 1994). 2005 Sep 21;94(38):1467-71. doi: 10.1024/0369-8394.94.38.1467. German.
Clinical trial NCT01821742: Echocardiography in Kids Intensive Care Decision Support
Official title: Echocardiography in Kids Intensive Care Decision Support - is Focused Echocardiography Superior to Pressure Derived Measurements at Predicting Fluid Responsiveness in Critically Ill Children?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Cardiac Output
Keywords: Shock
Fluid bolus
Cardiac output
Children in intensive care
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 25
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Shocked children on PICU

Brief summary: A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU.

Detailed description: A study to determine if echocardiographically derived parameters, plethysmographic variability index and pulse pressure variation predict fluid responsiveness in children on PICU. These parameters will be measured pre and post fluid bolus in children prescribed fluid bolus therapy for clinical indications on the PICU. Children will be classified as responders (\>10% increase in cardiac output) and non responders (\<10% increase). Appropriate statistical tests will be performed to determine the most useful predictor of an increase in cardiac output following a fluid bolus.

Eligibility criteria: Inclusion Criteria:

* Any ventilated child requiring fluid bolus therapy on the PICU for clinical indications

Exclusion Criteria:

* Arrythmia
* Intracardiac shunt

Primary outcomes:
measure: Fluid responsiveness
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: David Inwald, MB BChir
role: PRINCIPAL_INVESTIGATOR
References:
citation: McLean JRL, Inwald DP. The utility of stroke volume variability as a predictor of fluid responsiveness in critically ill children: a pilot study. Intensive Care Med. 2014 Feb;40(2):288-289. doi: 10.1007/s00134-013-3171-x. Epub 2013 Dec 5. No abstract available.
Clinical trial NCT04642742: Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
Official title: Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hyperlipidemia
Lead sponsor: Piper Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2020-11-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Purchasers of OTC plant sterol product who have used the plant sterol product for at least 10 weeks

Brief summary: The purpose of this study is to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in reducing LDL-C cholesterol in a real word setting.

Detailed description: While the safety and benefits of plant sterol supplements have been established and are incorporated into many lipid lowering guidelines, there have been few prior studies of plant sterol chewables in gummy format among real world subjects. In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation in a real world setting.

Eligibility criteria: Inclusion Criteria:

1. Subject is an adult ≥18 years of age who continuously used the sponsor's product for at least 10 weeks prior to the Follow-on Lipid Test
2. Baseline Lipid Test conducted within past 2 years
3. If smoker, smoking status or frequency has not changed between two lipid test dates
4. Subject understands the study procedures and signs forms documenting informed consent

Exclusion Criteria:

1. Subject was taking a prescription cholesterol-lowering medication or taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin or omega-3 fatty acid supplements at the time of either lipid test
2. Subject does not read English

Primary outcomes:
measure: % change in LDL-C from baseline
timeFrame: >10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Piper Biosciences, Inc.
state: California
Study officials:
References: