louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01299129: Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
Official title: Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis Related Cystoid Macular Edema
Keywords: Uveitis
Cystoid macular edema
microperimetry
functional visual acuity
intravitreal triamcinolone
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: uveitis ambulance patients of the department of ophthalmology, medical university vienna

Brief summary: Purpose:

To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing.

Methods:

28 patients with uveitis-associated CME were examined before intravitreal triamcinolone injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading speed using a standardized German-language test (Radner Reading charts), contrast sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time were compared to the respective outcome of visual function.


Eligibility criteria: Inclusion Criteria:

* intraocular inflammation
* able to read
* \> 18 years old

Exclusion Criteria:

* cataract
* amblyopia
* dyslexia
* already applicated intravitreal triamcinolone for current cystoid macular edema

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
References:
Clinical trial NCT04554329: Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection
Official title: Efficacy of Bandage Contact Lenses Versus Eye Patching in Early Postoperative Period of Müller's Muscle-conjunctival Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eyelid Diseases
Keywords: patient comfort
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 40
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: Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.

Detailed description: Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.

Eligibility criteria: Inclusion Criteria:

* Patients who had unilateral ptosis and underwent unilateral MMCR

Exclusion Criteria:

* Patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.

Primary outcomes:
measure: patient comfort
timeFrame: 1 week
measure: patient comfort
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpasa Numune Education and Research Hospital
state: Marmara
Study officials:
References:
Clinical trial NCT06880029: Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy
Official title: Circadian Rhythm Impact on Triple Negative Breast Cancer Response to Neoadjuvant Immunotherapy - a Feasibility Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Triple Negative Breast Cancer (TNBC)
Keywords: TNBC
Immunotherapy
Circadian rhythm
Lead sponsor: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CIRCADIAN is a prospective randomized clinical trial designed to evaluate the impact of pembrolizumab infusions' time-of-day on pathological complete response (pCR) rate among TNBC patients undergoing neoadjuvant treatment.

Detailed description: Patients will be randomized 1:1 to receive all neoadjuvant pembrolizumab cycles (400 mg every 6 weeks) before versus after noon. Subjects will be stratified based on clinical stage at diagnosis (St. II vs III).

Primary outcome will be pCR rate. As a secondary outcome, we will assess for treatment related toxicity.

For planned exploratory circadian rhythm evaluation, daily body temperature and salivary cortisol variation will be measured before each ICI infusion and the Munich Chronotype Questionnaire (MCTQ) will be applied. To assess for emotional stress, physical exercise habits, stimulating substances use and light exposure, patients will also be subjected to the Distress Thermometer and a lifestyle questionnaire. For planned exploratory biomarker research, tumor infiltrating lymphocytes (TILs) analysis will be performed on the initial diagnostic biopsy and after surgery, on residual tumor (in patients not achieving pCR). Cytokine quantification and bulk RNA sequencing plus flow cytometry studies for immune populations profiling will be performed on peripheral blood, at baseline and before surgery, to check for potential biomarkers of circadian modulation.

Eligibility criteria: Inclusion Criteria:

* Female sex
* Age 18 - 75 years old
* Diagnosed with Stage II or III TNBC and candidates for neoadjuvant treatment with ChT+pembrolizumab after multidisciplinary group discussion.

Exclusion Criteria:

* Patients unable to understand or consent to the study;
* Patients not completing ≥2 cycles of planned neoadjuvant pembrolizumab cycles or ≥50% of planned neoadjuvant ChT cycles;
* Patients under daily ≥10 mg of prednisolone or equivalent

Primary outcomes:
measure: Pathological complete response rate
timeFrame: At the time of definitive surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova de Gaia/Espinho
state: Região
Study officials:
References:
Clinical trial NCT04039529: Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
Official title: Novel Guidance Device for Image Fusion and Needle Guidance in Lung, Liver or Kidney Biopsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Liver Biopsy
Lung Biopsy
Kidney Biopsy
Keywords: lung biopsy
kidney biopsy
liver biopsy
image fusion
Lead sponsor: Clear Guide Medical
Sponsor class: INDUSTRY
Collaborators: name: Temple University
name: National Institutes of Health (NIH)
First posted: 2019-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: testing whether biopsies and ablations performed with the SCENERGY result in less patient radiation dose or reduced procedure time compared to biopsies performed under CT-guidance only.
Primary purpose: TREATMENT

Brief summary: This study investigates whether a new image fusion technology can reduce patient radiation dose from CTs and/or procedure time during biopsies of lung, liver or kidney.

Detailed description: This study proposes the use of a new fusion technology, Scenergy (Clear Guide Medical; FDA 510(k) K171677), which fuses CT images to real-time US images to minimize the drawbacks of each modality while enhancing their benefits. Such benefits include, the reduction of radiation dose to the patient with the fusion of initial CT imaging overlaying the live US images. The fused imaging software allows the operator to watch the needle tip advance towards the lesion on both live US and overlaid CT imaging. In such a setting, the operator would only need to perform an initial CT scan, advance the needle into position using fused US/CT images, and a final CT scan to ensure needle tip location. This eliminates interval CT scans that are usually required after each incremental needle position adjustment, and thus, reduces radiation dose to the patient and wasted procedural time during the incremental CT scans.

Eligibility criteria: Inclusion Criteria:

* all patients between the ages of 18 and 80 years old at time of procedure who are pre-scheduled for a lung, kidney, or liver biopsy.

Exclusion Criteria:

* any patient who was under the age of 18 or over the age of 80 at time of the procedure or who does not wish to volunteer for the study.

Primary outcomes:
measure: Radiation Dose during Procedure
timeFrame: 1 hour
Secondary outcomes:
measure: Time to Reach Target of Biopsy
timeFrame: 1 hour
measure: Experience Level
timeFrame: 1 hour
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04764929: Pediatric Helmet CPAP Pilot Study
Official title: Helmet CPAP for Infants and Pediatric Patients With Acute Respiratory Distress
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis, Viral
Pneumonia, Viral
Pneumonia, Bacterial
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This a research study to find out whether giving Continuous Positive Airway Pressure (CPAP) through a Helmet is the same or better than giving CPAP through a Facemask, Nasal Mask, or Nasal Prongs. CPAP can help kids with lung infections breathe easier. The machine delivers pressurized air, which may help people with lung infections breathe more easily. Doctors routinely use a Facemask, Nasal Mask or Nasal Prongs to give CPAP for kids with lung infections, but the researchers want to know whether using Helmet CPAP is the same or better.

Detailed description: Prior clinical trials have demonstrated efficacy of Helmet CPAP in adults with acute respiratory distress syndrome, superior tolerance and improved respiratory scores compared to nasal/facial CPAP in infants, and no major safety concerns were identified with the use of helmet CPAP. This is a prospective pilot study to (1) determine if infants and pediatric patients requiring CPAP in the PICU will tolerate helmet CPAP for at least four hours, and (2) measure changes in the respiratory rate, oxygen saturation, heart rate and blood pressure over four hours. If helmet CPAP is found to be well tolerated in this small cohort, a larger study comparing it directly to other CPAP interfaces will be conducted.

Eligibility criteria: Inclusion Criteria:

* One month to 5 years of age (inclusive) admitted to the PICU with community acquired pneumonia or bronchiolitis, having been stable on nasal or facemask CPAP for at least four hours but less than 48 hours, and parental informed consent.

Exclusion Criteria:

* Age less than 1 month or greater than 5 years
* Positive for COVID-19
* Need for invasive mechanical ventilation or higher levels of non-invasive ventilation such as bi-level positive airway pressure (BPAP)
* Unresponsiveness (GCS 8 or less)
* Hypotension as defined as a systolic blood pressure less than 5th percentile for age
* Existing head or neck trauma, known or suspected air leak syndrome (pneumothorax, pneumomediastinum, subcutaneous emphysema), known or suspected increased intracranial pressure
* Non-English speaking parent

Primary outcomes:
measure: Number of Participants Who Tolerated CPAP Helmet for at Least Four Hours
timeFrame: Four hours
Secondary outcomes:
measure: Respiratory Rate
timeFrame: 4 hours
measure: Heart Rate
timeFrame: 4 hours
measure: Oxygen Saturation
timeFrame: 4 hours
measure: Systolic Blood Pressure
timeFrame: 4 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References:
Clinical trial NCT02613429: Identification of Airway Structures Necessary for Airway Access Via the Skin
Official title: Identification of Airway Structures Necessary for Airway Access Via the Skin to be Used in Case of Failure to Maintain Oxygenation With Non-invasive Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Airway Obstruction
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-11-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.

The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.

Detailed description: Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation.

The researchers will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage of a healthy subject with different methods including application of ultrasonography.

Eligibility criteria: Inclusion Criteria:

* Anaesthesiologist

Exclusion Criteria:

* unvillingnes to participate

Primary outcomes:
measure: time to identify the structures necessary for percutaneous airway acess
timeFrame: two minutes after initiation of the attempt to identify the airway structures
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, department of anaesthesia
city: Copenhagen
country: Denmark
facility: Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael S Kristensen, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02110329: Simultaneaous Detection of Quantitative Somatic Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study
Official title: Simultaneous Detection of Somatic Quantitative Molecular Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Stage II and III
Keywords: colorectal cancer
stage II and III
somatic quantitative molecular alterations
Qantitative Multiplex Pcr of Short fluorescent Fragments method (QMPSF)
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.

AIMS \& METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.


Eligibility criteria: Inclusion Criteria:

* age over 18
* localized colon cancer
* proven adenocarcinoma
* surgery R0
* no metastatic disease
* stage II or III
* WHO performance status 0, 1 or 2
* availaible frozen tissue
* written consent
* no major co-morbidities

Exclusion Criteria:

* metastatic disease
* hereditary colorectal cancer
* rectal cancer

Primary outcomes:
measure: Recurence rate according to molecular results
timeFrame: 36 months
Secondary outcomes:
measure: Survival rate according to molecular results
timeFrame: 60 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon
city: Lille
country: France
facility: Chu Lille
city: Rouen
country: France
facility: Chu Hopitaux de Rouen
Study officials:
References:
Clinical trial NCT06831929: HPV Ends Here: Increasing Uptake of the HPV Vaccine
Official title: Human Papillomavirus Ends Here: A Multilevel Intervention to Increase Uptake of the HPV Vaccine Among Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV Vaccine
Keywords: HPV
Human Papillomavirus
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-02-18
Enrollment: 2232
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Develop, implement, and evaluate a culturally tailored multilevel intervention to increase uptake of the HPV vaccine among eligible patients ages 10-12 of the University of California, Davis Health Community Physician (UCDH CP) primary care practices using a randomized controlled trial design.

Detailed description: The goal of this study is to use an evidence-based approach to develop, implement and evaluate a ML intervention on increasing HPV vaccine uptake among UCDH CP patients ages 10-12.

Aim 1. Refine and finalize a parent, primary care team and clinic ML intervention to increase uptake and completion of the HPV vaccine series among adolescent patients of the UCDH CP practices. In Phase 1, semi-structured qualitative interviews with key stakeholders will be conducted to refine the content and implementation approaches.

Aim 2. Conduct and evaluate the effectiveness and sustainability of the ML intervention. In Phase 2, twelve UCDH CP practices will be recruited to participate in a 2-arm parallel group randomized controlled trial. The primary outcome age-appropriate completion of the HPV vaccine series will be assessed via Epic, the UCDHS electronic medical record (EMR) software. It is hypothesized that patients of clinics in the intervention condition will have significantly higher HPV completion rates compared to patients of clinics in the control condition (usual care).

Eligibility criteria: Inclusion Criteria:

• Clinic patients between the ages of 10-12 who are eligible for the HPV vaccine

Exclusion Criteria:

• Clinic patients who already received the HPV vaccine or with any contraindication to the HPV vaccine.

Primary outcomes:
measure: Primary Outcome: Evaluation
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
Study officials:
affiliation: University of California, Davis
name: Julie HT Dang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02292329: Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome
Official title: Cardiovascular Benefits of Acai in Volunteers at Risk of Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: flow-mediated dilation
Acai polyphenols
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2014-11-17
Enrollment: 23
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to carry out a randomized double blind controlled trial in 30 male subjects to investigate the effect of acai consumption on acute changes in vascular function, and to other cardiovascular markers. As a secondary aim the study will allow us to characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour period.


Eligibility criteria: Inclusion Criteria:

* Male, 30-65 aged, BMI 25-35 kg/m2, Cholesterol \<8 mmol/l.

Exclusion Criteria:

* Female, BMI \<25 or \>35 kg/m2, Cholesterol \>8mmol l-1, elevated fasting blood sugar \> 6.5 mmols l-1 , elevated systolic blood pressure \>150 mmHg, history of stroke or heart attack within the previous 12 months, current smoking, taking lipid lowering, blood pressure lowering or anti-blood clotting medication or taking micronutrient supplements.

Primary outcomes:
measure: Flow-mediated dilation
timeFrame: Change from baseline to 2h
Secondary outcomes:
measure: plasma polyphenol metabolites
timeFrame: Change from baseline to 24h
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: Hugh Sinclair Unit of Human Nutrition
state: Berkshire
Study officials:
affiliation: University of Reading
name: Daniel Commane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alqurashi RM, Galante LA, Rowland IR, Spencer JP, Commane DM. Consumption of a flavonoid-rich acai meal is associated with acute improvements in vascular function and a reduction in total oxidative status in healthy overweight men. Am J Clin Nutr. 2016 Nov;104(5):1227-1235. doi: 10.3945/ajcn.115.128728. Epub 2016 Sep 28.