louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06762119: A Study of CAR-T Cells in Subjects with Autoimmune Diseases
Official title: A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects with Autoimmune Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Autoimmune Diseases
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.

Detailed description: This study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of CAR-T Cells to treating Subjects with Autoimmune Diseases.

Eligibility criteria: Key Inclusion Criteria:

1. Male or female, between 18 and 65 years old;
2. Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia；
3. Good organ functions;
4. Voluntary participates this trial and can comprehend and sign ICF.

Key Exclusion Criteria:

1. Had or has active malignancy;
2. Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
3. Combined with other autoimmune disease that needs treatment;
4. Pregnant or lactating women;
5. Has other factors that deemed not suitable by investigator.

Primary outcomes:
measure: Dose Limiting Toxicity
timeFrame: 0~28 day after treatment
measure: Frequency of AEs, SAEs
timeFrame: 0 day to 24 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
Study officials:
References:
Clinical trial NCT05055219: Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
Official title: Conventional and Metabolomic Predictors of Prediabetes & Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PreDiabetes
Obesity, Childhood
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-09-24
Enrollment: 772
Sex: ALL
Minimum age (years): 8
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of normal weight, overweight or obese individuals aged 8 to 17 years at visits #1 and #2, and can be as old as 22 years for follow-up visits #3 and #4. Participants will be recruited from a variety of sites including University Michigan clinical sites, non-University of Michigan clinical sites, schools in the local area, and the University Michigan medical school campus. Participants from Group 2 (visits #3-4) completed visits #1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes.

Brief summary: The purpose of this study is to evaluate the longitudinal test performance of an array of conventional biomarkers of glycemia, including Hemoglobin A1c (HbA1c), and novel metabolomic biomarkers for identifying progression of glucose tolerance (normal to prediabetes or prediabetes to diabetes) in an overweight and obese pediatric cohort.


Eligibility criteria: Inclusion Criteria:

* Groups 1 and 2 (overweight and obese groups):
* Age 8-17 years for the visits #1 and #2, individuals can be as old as 22 years for follow-up visits #3 and 4
* Overweight or obese, as defined by a BMI ≥ 85th% \& \<95th% or BMI ≥ 95th%, respectively by age and sex, and for those 16 years and older, BMI ≥25 and \<30 and BMI ≥30
* For Group 2 only: previously completed visits 1-2 in 2007-2013 and formally agreed to be re-contacted for study purposes
* Group 3 (Normal weight controls):
* Age 8-17 years
* Healthy weight, as defined by a BMI ≥ 5th percentile \& \< 85th percentile, respectively by age and sex

Exclusion Criteria:

* Previous diagnosis of type 1 diabetes
* Use of concurrent medications known to affect glucose metabolism (metformin, oral steroids, sulfonylureas, insulin)
* Verbal report of Pregnancy

Primary outcomes:
measure: Progression of glucose tolerance
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Joyce Lee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06979219: Streamlining Radioembolization for Small HCC
Official title: Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 138
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hepatocellular carcinoma who are scheduled for radioembolization

Brief summary: In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size \< 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.


Eligibility criteria: Inclusion Criteria:

* HCC can be diagnosed by AASLD guideline
* hepatocellular carcinoma 5cm or smaller
* dysmorphic intratumoral vessels 3mm or smaller
* Child-Pugh class A
* ECOG 0 or 1
* the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine)

Exclusion Criteria:

* hepatic vein invasion on CT/MRI
* hepatic vein enhancement on arterial phase of CT/MRI
* TIPS
* dysmorphic intratumoral vessels \> 3mm
* main portal vein invasion
* significant COPD or interstitial lung disease

Primary outcomes:
measure: complete response rate by mRECIST
timeFrame: up to 1 year
Secondary outcomes:
measure: objective response rate
timeFrame: up to 1 year
measure: local progression-free survival
timeFrame: From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months
measure: Progression-free survival
timeFrame: From date of radioembolization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: overall survival
timeFrame: From date of radioembolization until the date of death from any cause, assessed up to 60 months
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
References:
Clinical trial NCT00860119: Bioequivalence of Alprazolam Sublingual vs Oral Tablets
Official title: Open-Label, Randomized, Single-Dose, 2-Way Crossover Pivotal Bioequivalence Study Comparing Alprazolam Immediate Release (IR) Tablets (Administered Orally) And Alprazolam Sublingual (SL) Tablets (Administered Sublingually)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-11
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects
* BMI 17.5 - 30.5
* Must provide informed consent

Exclusion Criteria:

* Clinically significant disease
* Narrow angle glaucoma
* Positive drug screen

Primary outcomes:
measure: Alprazolam bioavailability assessed as area under the concentration-time curve (AUC) and maximum concentration (Cmax)
timeFrame: 11 days
Secondary outcomes:
measure: Alprazolam time of maximum concentration (Tmax) and half life
timeFrame: 11 days
measure: Adverse events, clinical laboratory tests, vital signs
timeFrame: 11 days
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02698319: The Copenhagen Triage Algorithm
Official title: The Copenhagen Triage Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triage
Keywords: Triage
Systematic Triage
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 50000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Crowding in the emergency department (ED) is a well documented problem putting patients at risk of adverse outcomes. To combat this, most ED's use some form of triage. In the last two decades systematic triage or process triage has become the norm in most countries but this approach is supported by limited evidence. Our aim is to develop a faster triage model of only a few vital parameters, based on a data from a large cohort of unselected ED patients and evaluate if such a model combined with a clinical assessment by the ED nurse is inferior to existing triage models in a prospective cluster-randomized trial


Eligibility criteria: Inclusion Criteria:

* Patients presenting acutely to the Acute ward/Emergency department in two hospitals in the Capital of Denmark

Exclusion Criteria:

* Patients presenting in Pediatric, Gynecological or Obstetric units

Primary outcomes:
measure: All cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: Number of patients with an admission to the intensive care unit
timeFrame: 30 days
measure: Length of stay during admission
timeFrame: 30 days
measure: Waiting time for treatment
timeFrame: 8 hours
measure: Number of readmissions
timeFrame: 30 and 90 days
measure: All cause mortality
timeFrame: 48 hours
measure: All cause mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
state: Region Hovedstaden
city: København NV
country: Denmark
facility: Bispebjerg Hospital
state: Region Hovedstaden
Study officials:
affiliation: kasper.karmark.iversen@regionh.dk
name: Kasper Iversen, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hasselbalch RB, Pries-Heje M, Schultz M, Plesner LL, Ravn L, Lind M, Greibe R, Jensen BN, Hoi-Hansen T, Carlson N, Torp-Pedersen C, Rasmussen LS, Iversen K. The Copenhagen Triage Algorithm is non-inferior to a traditional triage algorithm: A cluster-randomized study. PLoS One. 2019 Feb 4;14(2):e0211769. doi: 10.1371/journal.pone.0211769. eCollection 2019.
citation: Hasselbalch RB, Plesner LL, Pries-Heje M, Ravn L, Lind M, Greibe R, Jensen BN, Rasmussen LS, Iversen K. The Copenhagen Triage Algorithm: a randomized controlled trial. Scand J Trauma Resusc Emerg Med. 2016 Oct 10;24(1):123. doi: 10.1186/s13049-016-0312-6.
Clinical trial NCT00093119: Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Official title: A Phase II Trial of ABI-007 in Previously Treated Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Metastases
Keywords: Metastatic Melanoma
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2004-10-04
Enrollment: 75
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: This trial will treat patients previously treated for advanced (metastatic) melanoma (skin cancer) with a new chemotherapeutic medicine. The new chemotherapy will be administered weekly in cycles of three weekly doses followed by one week rest. A minimum of three cycles of therapy will be given to determine the anti-tumor response of the new chemotherapy. Patients may continue to stay on therapy a maximum of 9-12 cycles if treatment shows continuing benefit.


Eligibility criteria: Inclusion Criteria:

* Confirmed Metastatic Melanoma
* At least 18 years old
* No other active malignancy
* Hemoglobin at least 9
* Platelet Count at least 100,000 cells/mm3
* ANC at least 1500 cells/mm3
* AST \& ALT less than 2.5X upper limit of normal
* Total bilirubin less than 1.5mg/dL
* Creatine less than 1.5 mg/dL
* Alkaline phosphatase less than 2.5X upper limit of normal
* Life expectancy of at least 12 weeks
* ECOG performance status of 0-1
* Patient must provide informed consent
* Patient must provide authorization to disclose

Exclusion Criteria:

* Evidence of active brain metastases
* The only evidence of metastasis is lytic or blastic bone metastases
* Pre-existing peripheral neuropathy of NCI Toxicity Criteria Scale of grade greater than 2
* Received radiotherapy in last 4wks, except if to a non-target lesion only
* Clinically significant concurrent illness
* Investigator's opinion that patient unlikely to complete study
* Cytotoxic chemotherapeutic agent treatment or investigational drug within previous 4wks
* History of allergy/hypersensitivity to study drug
* Serious Medical Risk Factors determine by the investigator

Primary outcomes:
measure: Determine anti-tumor activity of ABI-007 in patients with metastatic melanoma.
Secondary outcomes:
measure: Evaluate number of cycles required before patients achieve maximum response
Other outcomes:
Locations:
city: Durham
country: United States
facility: Abraxis BioScience Inc.
state: North Carolina
Study officials:
affiliation: Celgene Corporation
name: Michael Hawkins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02139319: Dose-Escalation of Botulinum Toxin in Subjects With Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Knee Osteoarthritis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and tolerability of the drug product at each dose level.


Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee
* Fully weight bearing in the index knee with or without the need for assistive/orthopaedic devices
* Pain score ≥40 mm of the index knee
* Committing to continue using their assistive/orthopaedic device throughout the study using the same regimen

Exclusion Criteria:

* Any infection in the index knee or inflammatory skin disease or other inflammatory diseases at the index knee or the anticipated injection site
* Surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
* Any painful orthopaedic disorder of the back or hip which is likely to interfere with the safety or efficacy assessments
* A joint disorder other than osteoarthritis in the index knee which could potentially interfere with the safety or efficacy assessments

Primary outcomes:
measure: Incidence and severity of adverse events
timeFrame: Up to 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
Study officials:
affiliation: Galderma R&D
name: Q-Med AB
role: STUDY_DIRECTOR
References:
Clinical trial NCT01025219: A Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction : a Case Control Study
Official title: A Case Control Study on Contribution to the Analysis of the Phenotypic Heterogeneity in Crack/Cocaine Addiction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dependence, Cocaine
Keywords: Diagnosis of dependence on cocaine according to DSM-IV-TR criteria
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 600
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the phenotypic candidates symptoms, in patients with crack/cocaine addiction, in terms of clinical comorbidities, dimensions of personality, and neuropsychological evaluations apt to be associated with genetic and genotypic characterisations, notably on the polymorphisms of the genes coding or regulating dopaminergic, norepinephrine and serotoninergic systems.

Detailed description: Genetic studies show an association between drug addiction and the dopaminergic system and its modulators. Nonetheless, results are contradictory, partially due to the heterogeneity of the phenotype addiction. Placed on the trafficking route of cocaine, and homogeneously populated, Martinique is of particular interest for the study of the vulnerability of the crack/cocaine addiction. In a precedent study, supported by a grant MILDT / INSERM 2000, on 155 men dependent to crack/cocaine and characterised with three clinical dimensions -sensation seeking, impulsivity and childhood ADHD- we found an association between each dimension and polymorphisms of DRD2 and DRD4 genes.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cocaine abuse/dependence according to DSM-IV-TR criteria
* Come from French West Indies (3 grandparents are African-Caribbean)
* Sign a written informed consent

Exclusion Criteria:

* Minor
* Men with no cocaine abuse/dependence according to DSM-IV-TR criteria

For the control:

Inclusion Criteria:

* Platelets donor
* No substance abuse/dependence according to DSM-IV-TR criteria
* Come from French West Indies (3 grandparents are African-Caribbean)
* Sign a written informed consent

Exclusion Criteria:

* Minor
* Men refusing a genetic study

Primary outcomes:
measure: The specific measure that will be related to core objectives of the study is to constitute a sample collection from saliva.
timeFrame: The saliva will be collect at the end of the first visit
Secondary outcomes:
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: Service de psychiatrie et addictologie - CHU de Fort-de-France
state: Martinique
Study officials:
affiliation: CHU de Fort-de-France
name: Jérôme LACOSTE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06301919: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization
Official title: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization : a "Real-life" Retrospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Haemostasis Embolisation
Keywords: Emergency
Hemostatic agent
NBCA bleeding
Trans-arterial embolisation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Brief summary: NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.


Eligibility criteria: Inclusion Criteria:

* All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Exclusion Criteria:

* Patients lost for follow-up, patients without preoperative CT.

Primary outcomes:
measure: Evaluation of technical success
timeFrame: Month : 1
Secondary outcomes:
measure: Assessment of clinical success
timeFrame: Month : 1
measure: Assessment of clinical success
timeFrame: Month : 1
measure: Assessment of clinical success
timeFrame: Month : 1
measure: Assessment of clinical success
timeFrame: Month : 1
measure: Assessment of clinical success
timeFrame: Month : 1
Other outcomes:
Locations:
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Rémi GRANGE, MD
role: PRINCIPAL_INVESTIGATOR
References: