louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06957535: Community-led Navigation to Address Disparities in Mammography Among Native American Women
Official title: Community-led Navigation to Address Disparities in Mammography Among Native American Women
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Genentech Foundation
First posted: 2025-05-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to evaluate the effectiveness of an intervention to promote breast cancer screening mammography among women in one community on the Navajo Nation. The intervention is Tablet-based Education to improve the Acceptance of Mammography (TEAM). TEAM encompasses culturally-tailored mammography education modules that were developed using a community-based participatory research process. Women will be randomized to receive TEAM or TEAM + Navigation. Navigation involves monthly 1:1 support from a Diné peer-navigator.


Eligibility criteria: Inclusion Criteria:

* Self-identify as American Indian or Alaska Native (AIAN)
* Identify as Female
* Are 40-74 years of age
* Are a registered patient at Chinle Comprehensive HealthCare Facility (CCHFC)
* Live within 80 miles of CCHFC
* Have not received a mammogram within the prior 12 months
* Do not have a personal history of breast cancer
* Are not planning to move in the next 6 months
* Willing to be randomized

Exclusion Criteria:

* Do not self-identify as American Indian or Alaska Native (AIAN)
* Do not identify as Female
* Are not 40-74 years of age
* Are not a registered patient at CCHCF
* Do not live within 80 miles of CCHCF
* Have received a mammogram within the prior 12 months
* Have a personal history of breast cancer
* Are planning to move in the next 6 months
* Unwilling to be randomized

Primary outcomes:
measure: Number of participants with mammography
timeFrame: 3 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chinle
country: United States
facility: Navajo Nation Center for Indigenous Health
state: Arizona
Study officials:
affiliation: Johns Hopkins University
name: Katie Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03996135: Evaluation of Accuvein in Cirrhotics Patients
Official title: Study of the Effectiveness of a Venous Illumination System for Peripheral Venous Pathways in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to evaluate the effectiveness of AccuVein AV400 to facilitate placement of peripheral intravenous catheters in cirrhotic adults by comparing the success rate of the first attempt to install a peripheral venous catheter with or without AccuVein AV400®.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient presenting a liver cirrhosis
* Patient requiring the placement of a venous peripheral catheter
* Patient informed and giving free and informed consent
* Patient affiliated to a French social security scheme

Exclusion Criteria:

* Patient under 18 years old
* Patient unable to give consent
* Patient under guardianship or curatorship

Primary outcomes:
measure: First Attempt Success Rate of Cannulation
timeFrame: baseline
Secondary outcomes:
measure: change of the score A-DIVA
timeFrame: baseline and end of hospitalization (up to a month)
measure: Cost
timeFrame: baseline
measure: Life expectancy of the catheter
timeFrame: baseline
measure: Utilisation of a central venous catheter
timeFrame: baseline
measure: Pain's score
timeFrame: baseline
measure: Numbers of attempts
timeFrame: baseline
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT05354635: Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care
Official title: Therapeutic Follow-up of Antibiotics in Pediatric Intensive Care
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intensive Care Units, Pediatric
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 280
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The aim of the research is to evaluate the adequacy of antibiotic therapy in children admitted to the pediatric intensive care unit at the University Hospital of La Réunion. The study population is intended to be exhaustive and will include all subjects affiliated to the Social Security who meet the eligibility criteria.

Brief summary: Currently, recommendations for antibiotic testing (ATS) in adult intensive care have been published. The 2018 SFAR and the Abdul- Aziz et al expert conference recommend routine testing for β-lactams, aminoglycosides, linezolid, and vancomycin and provide plasma concentration goals. No recommendations have been made for the pediatric intensive care unit (PICU) population. However, several articles report suboptimal plasma concentrations for the most frequently used antibiotics in PICU. The University Hospital of Reunion is the reference center for the western region of the Indian Ocean. This region presents a large mixed population due to the migratory flow, as well as a specific bacterial ecology. This suggests that the data already collected on antibiotic dosage in other European studies may not be fully extrapolated to Reunion Island.

It is in this context that we will study the plasma concentration of antibiotics for all children who received the most commonly used antibiotics (β-lactams, linezolid, vancomycin, and aminoglycosides) during their hospitalization in PICU.


Eligibility criteria: Inclusion Criteria:

* Any child hospitalized in the pediatric intensive care unit of the CHU Nord de La Réunion,
* Age is less than 18 years,
* Having started a curative antibiotic therapy by β-lactam, linezolid, vancomycin or aminosides.
* For whom a non-opposition has been collected orally from both or one of the child's legal guardians and from the child himself (if applicable),
* Covered by Social Security.

Exclusion Criteria:

-Patients on prophylactic antibiotic therapy

Primary outcomes:
measure: The occurrence of at least one "underdosing" event of one of the Antibiotics used in a patient included during his or her hospitalization in pediatrics intensive care unit (PICU)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: Réunion
facility: CHU de la Réunion
Study officials:
References:
Clinical trial NCT00098735: Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Official title: Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Kidney,Transplantation, rejection, immunosuppression
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-08
Enrollment: 140
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: In patients who receive an organ transplant, their body considers this organ as foreign and attempts to destroy it. This is called rejection. All patients who receive an organ transplant, will take a combination of anti-rejection medications. These medications prevent the new organ from being rejected from the body. FTY720 is a new compound that helps prevent organ rejection.


Eligibility criteria: Inclusion Criteria:

* First kidney transplantation
* Male and female patients
* Between 18 and 65 years old

Exclusion Criteria:

* Patient in need of multi-organ transplant
* Patients with history of cardiac arrest
* Patients with any past or present malignancy

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 6 months post transplant
measure: Permanent resumption of dialysis within 6 months post transplant
measure: Surgical removal of graft within 6 months post transplant
measure: Death within 6 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 6 months post transplant
Secondary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 12 months post transplant
measure: Permanent resumption of dialysis within 12 months post transplant
measure: Surgical removal of graft within 12 months post transplant
measure: Death within 12 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 12 months post transplant
measure: Serum creatinine, estimated creatinine clearance, abnormalities of vital signs and laboratory variables and measurements of urine protein at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
measure: FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Day 28, Months 6 and 12
measure: Absolute lymphocyte count at Days 0, 1, 7, 14 and 28, Months 3, 6, 9 and 12.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: NOVARTIS
role: STUDY_DIRECTOR
References:
citation: Tedesco-Silva H, Mourad G, Kahan BD, Boira JG, Weimar W, Mulgaonkar S, Nashan B, Madsen S, Charpentier B, Pellet P, Vanrenterghem Y. FTY720, a novel immunomodulator: efficacy and safety results from the first phase 2A study in de novo renal transplantation. Transplantation. 2005 Jun 15;79(11):1553-60.
Clinical trial NCT01899235: The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Official title: The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stable Angina
Coronary Stenosis
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aachen Resonance GmbH
First posted: 2013-07-15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.


Eligibility criteria: Inclusion Criteria:

* Patient ≥ 18years old
* Stable angina symptoms
* Elective treatment to coronary lesion
* Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

Exclusion Criteria:

* Left main stem lesion
* Bifurcation lesions
* Acute coronary syndrome (UAP, NSTEMI, STEMI)
* Cardiogenic shock
* Chronic total occlusion
* Additional lesions requiring PCI
* Platelet count ≤ 50 x 109/mm3
* Left ventricular ejection fraction ≤ 30%
* Patient life expectancy less than 12 months
* Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
* Participation in another investigational drug or device study
* Patient unable to give informed consent

Primary outcomes:
measure: Major adverse cardiac events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
References:
Clinical trial NCT03513835: Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
Official title: Diagnostic Screening Tests and Potential Biomarkers in Mitochondrial Myopathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitochondrial Myopathies
Healthy Controls
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Genetically verified primary Mitochondrial disorder with myopathy.

Brief summary: The purpose of this study is to develop simple diagnostic screeningtests and investigate potential biomarkers for identifying patients with abnormalities of mitochondrial function, which also can be used as outcome measures in future clinical trials. The study will investigate two submaximal tests: a submaximal handgrip test and a walking test. Furthermore investigators will investigate Acyl-carnitine profiles and GDF-15 levels in patients with mitochondrial myopathy.


Eligibility criteria: Inclusion Criteria:

* age 18-75
* verified mitochondrial myopathy
* or healthy control
* or disease control (another neuromuscular disease)

Exclusion Criteria:

* Patient has any prior or current medical conditions that, in the judgment of the Investigator, would prevent the patient from safely participating in and/or completing all study requirements.
* Patient has symptoms of mitochondrial myopathy due to known secondary mitochondrial dysfunction
* Patient does not have the cognitive capacity to understand/comprehend and complete all study assessments.
* Pregnancy or breastfeeding.

Primary outcomes:
measure: Serum lactate / pyruvate ratio
timeFrame: 1 hour
measure: Serum Acyl-carnitine levels
timeFrame: 1 hour
measure: Serum GDF-15
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Neuromuscular Center, Rigshospitalet
Study officials:
References:
citation: Lokken N, Skriver SV, Khawajazada T, Storgaard JH, Vissing J. Plasma lactate responses during and after submaximal handgrip exercise are not diagnostically helpful in mitochondrial myopathy. Mitochondrion. 2021 Sep;60:21-26. doi: 10.1016/j.mito.2021.07.002. Epub 2021 Jul 15.
Clinical trial NCT01446835: Asian Clinical Evaluation of an Investigational Contact Lens for Cosmetic Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cosmetic Appearance
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 151
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to compare the cosmetic appearance of two different contact lenses on Asian eyes.

Detailed description: Participants will be asked to evaluate the cosmetic appearance of two different contact lenses worn contralaterally for 20 minutes. No vision or comfort variables will be assessed in this cosmetic appearance and lens fit non-dispensing study.

Eligibility criteria: Inclusion Criteria:

* Female between 18 and 30 years of age (inclusive).
* If under 21 years of age, subject must sign informed assent and have written consent of parent or guardian to participate.
* Sign written Informed Consent.
* Chinese, Japanese, or Korean descent.
* Brown eye color.
* Spherical equivalent refractive error of -0.50 diopter (D) and between (-1.50 to -2.50D), (-3.50 to -4.50D) and (-5.50 to -6.50D).
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical ophthalmic trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Cosmetic Appearance Preference
timeFrame: After 20 minutes of wear
Secondary outcomes:
measure: Lens Centration
timeFrame: After insertion and before 20 minutes of wear
Other outcomes:
Locations:
city: Spoc
country: Singapore
facility: Singapore Polytechnic
state: W115
Study officials:
affiliation: Singapore Polytechnic
name: Danny Sim Chek Hoo, B Optom (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04266535: TCI vs Manually Controlled Infusion of Propofol
Official title: TCI vs Manually Controlled Infusion of Propofol in Patients Sceduled for Laparoscopic Surgery; a Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia, Intravenous
Laparotomy
Airway Extubation
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anestectic records

Brief summary: Anesthesia records for patients anesthetized with target controlled infusion of propofol and remifentanil will be matched with patients anesthezied with manyally controlled infusion.

The aim of the study is to verify differences in time to extubation and amount of drugs used.

anesthetize


Eligibility criteria: Inclusion Criteria:

- Patients to laparoscopic surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Post procedural awakening
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03927235: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases
Official title: The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in Different Freezing Time in the Diffuse Parenchymal Lung Diseases: a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transbronchial Cryobiopsy
Freezing Time
Diagnostic Yield
Safety
Keywords: Transbronchial Cryobiopsy
freezing time
Diagnostic Yield
Safety
Diffuse Parenchymal Lung Disease
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety.

Detailed description: Transbronchial cryobiopsy in different freezing time is performed in patients with undefined diffuse parenchymal lung diseases, and assess the diagnostic yield and safety. This is a prospective randomized control trial.

Eligibility criteria: Inclusion Criteria:

1. The patients are admitted in the institution as DPLD, while undefined after thorough history collection, laboratory examination and radiological data.
2. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed.
3. Blood gas analysis, routine blood test, ECG examination, coagulation function, immunological examination, chest HRCT, and liver/kidney function test have been completed.

Exclusion Criteria:

1. The radiological data indicates non-DPLD
2. The clinical examinations mentioned above are not completed.
3. The patient cannot endure or does not agree the procedure.

Primary outcomes:
measure: Diagnotic yield
timeFrame: two weeks
Secondary outcomes:
measure: Complication rate
timeFrame: one week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02102035: Direct and Reversed Dorsal Digital Island Flaps: A Review of 65 Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Reconstruction
Sensory Restoration
Keywords: defect
dorsal branch of the proper digital nerve
dorsal digital island flap
sensory reconstruction.
Lead sponsor: The Second Hospital of Tangshan
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 65
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reconstruction of soft tissue defects in the fingers continues to be a challenge problem. The study reports reconstruction of small to moderate defects of the fingers with the direct and reversed dorsal digital island flaps and evaluates the results of the use of the flaps.The main outcomes are static 2-point discrimination and Semmes-Weinstein monofilament scores of the flap and joint motion.

Detailed description: At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination (2PD) test and Semmes-Weinstein monofilament (SWM) test. Active motion of the joints is measured using a standard hand goniometer. For the direct DDIF, total active motion is calculated as the sum of degrees of active flexion of the interphalangeal and the metacarpophalangeal joints subtracted from the degrees of extension deficit. For the reversed DDIF, total active motion of the donor finger is calculated as the sum of degrees of active flexion of the proximal and distal interphalangeal joints subtracted from the degrees of extension deficit.

Eligibility criteria: Inclusion Criteria:

* a defect greater than or equal to 1.5 cm in length
* the defects on the dorsal and lateral aspects of the fingers
* the defects located between the distal 1/2 of the middle phalanx and the tip of the finger
* a patient between 15 and 60 years of age.

Exclusion Criteria:

* injuries involving the donor sites or the course of the vascular pedicle
* a defect less than 1.5 cm in length.

Primary outcomes:
measure: Static 2-point discrimination test
timeFrame: 16 to 24 months
Secondary outcomes:
measure: Total active motion
timeFrame: 16-24 months
Other outcomes:
Locations:
city: Tangshan
country: China
facility: The Second Hospital of Tangshan
state: Hebei
Study officials:
References:
citation: Chen C, Tang P, Zhang L. Reconstruction of a soft tissue defect in the finger using the heterodigital neurocutaneous island flap. Injury. 2013 Nov;44(11):1607-14. doi: 10.1016/j.injury.2013.06.025. Epub 2013 Jul 18.