louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06899906: Efficacy and Safety of Dalbavancin As Suppressive Therapy
Official title: Efficacy and Safety of Dalbavancin As Suppressive Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Efficacy and Safety of Dalbavancin
In Subjects Who Received SAT with DAL
For Acute or Chronic Infections Between July 2019 and December 2024
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients managed for gram-positive infection between July 2019 and December 2024 in the MIT department.

Brief summary: Dalbavancin (DAL) is a semi-synthetic antibiotic that belongs to the lipoglycopeptide family and is structurally derived from teicoplanin, respect of which it has two structural differences that enhance its anti-staphylococcal binding affinity and extend its half-life to between 149 and 250 hours. It achieves adequate tissue penetration in the skin, bones, joints, lung tissues, and peritoneal space, maintaining concentrations above the MIC for susceptible Gram-positive pathogen.

DAL is a bactericidal antimicrobial agent that binds the C-terminal D-alanyl-D-alanine on the bacterial cell wall, blocking trans-glycosylation and transpeptidation processes essential for cell wall synthesis. It seems also to be able to enhance neutrophil antibacterial activity improving PMNs' intracellular killing of MRSA. It has also a good antibiofilm activity, alone or in combination with other molecules. Like other glycopeptide molecules, DAL shares a similar spectrum of activity, with demonstrated in vitro activity against various Gram-positive bacteria, including Staphylococcus spp, Streptococcus spp and Enterococcus (faecium, and faecalis). Resistance to DAL is possible in these gram-positives bacteria, given to presence of enzymes that produce low-affinity binding precursors for the antibiotic's binding site. DAL is capable to overcome Van-B mechanism of resistance, but it results not active in producing Van-A strains.

The study objectives was to evaluate efficacy and safety of DAL treatment.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Patients received SAT with DAL for acute or chronic infections (defined as a long-standing infection due to a previously uneradicated pathogen, following unsuccessful antibiotic or surgical treatments) between July 2019 and December 2024
* Patient who was informed and did not object to participating in the study

Exclusion Criteria:

* -\< 18 years
* Subjects who received DAL not for SAT purposes

Primary outcomes:
measure: efficacy of DAL treatment, measured as the proportion of stable infection
timeFrame: Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: HCL
state: Lyon
Study officials:
References:
Clinical trial NCT00511706: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Choroidal Neovascularization
Age-Related Maculopathy
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 243
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
* Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria:

* Any intraocular surgery within 3 months
* Glaucoma
* Cataract
* High eye pressure
* Uncontrolled systemic disease

Primary outcomes:
measure: Injection Free Interval
timeFrame: Week 1 to Week 25
Secondary outcomes:
measure: Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25
timeFrame: Baseline, Week 25
measure: Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye
timeFrame: Baseline, Week 25
measure: Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye
timeFrame: Screening (-Week 28), Week 25
Other outcomes:
Locations:
city: Boynton Beach
country: United States
state: Florida
city: Parramatta
country: Australia
state: New South Wales
city: Paris
country: France
city: Tel Aviv
country: Israel
city: Milano
country: Italy
city: Seoul
country: Korea, Republic of
city: Auckland
country: New Zealand
city: Coimbra
country: Portugal
city: Southampton
country: United Kingdom
state: Hampshire
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.
Clinical trial NCT05051306: Effects of Resistance Exercise on Metabolic Responses
Official title: Effects of Volume-matched Resistance Exercise With Different Loads on Metabolic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Response
Keywords: resistance exercise
equal training volume
immune response
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Healthy young adults will complete three trials in a randomized crossover counter-balanced order, including two different loads of resistance exercise and sedentary control. During each trial, blood samples will be collected.

The investigators hypothesized that high-load and low-load resistance exercise exert similar metabolic responses.


Eligibility criteria: Inclusion Criteria:

* Age: 20-30
* Healthy male
* Without experience of resistance training

Exclusion Criteria:

* No acute or chronic musculoskeletal symptoms
* Smoking
* Alcohol or drug abuse
* Fail to conduct resistance exercise

Primary outcomes:
measure: Changes in glucose
timeFrame: 4-hour during each study intervention
measure: Changes in insulin
timeFrame: 4-hour during each study intervention
measure: Changes in TG
timeFrame: 4-hour during each study intervention
measure: Changes in uric acid
timeFrame: 4-hour during each study intervention
Secondary outcomes:
measure: Changes in biomarkers of inflammation
timeFrame: 4-hour during each study intervention
measure: Changes in cortisol
timeFrame: 4-hour during each study intervention
measure: Changes in lactate
timeFrame: 4-hour during each study intervention
measure: Changes in complete blood count
timeFrame: 4-hour during each study intervention
measure: Borgs Ratings of Perceived Exertion (RPE)
timeFrame: 1-hour during each exercise intervention
measure: Changes in ET-1
timeFrame: 4-hour during each study intervention
measure: Changes in NO
timeFrame: 4-hour during each study intervention
measure: Changes in biomarkers of muscle damage
timeFrame: 4-hour during each study intervention
measure: Heart rate (HR)
timeFrame: 6-hour during each study intervention
measure: Visual Analogue Scale (VAS) of appetite
timeFrame: 6-hour during each study intervention
measure: Changes in biomarkers of appetite
timeFrame: 4-hour during each study intervention
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
affiliation: National Taiwan Normal University
name: Hung-Wen Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01978106: Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Astigmatism
Keywords: toric calculator
toric intraocular lens power
Acrysof
Tecnis
iTrace
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 33
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who planned to undergo cataract removal by phacoemulsification between January 2013 to April 2013 at the Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea were included in this study.

Brief summary: Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.


Eligibility criteria: Inclusion Criteria:

* Subjects who planned to undergo cataract removal by phacoemulsification
* Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry

Exclusion Criteria:

* Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
* a history of intraocular or corneal surgery and ocular trauma
* biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
* contact lens wearer

Primary outcomes:
measure: Difference of toric intraocular lens power between three toric calculators
timeFrame: Immediately after measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00930306: AZD2066 Cocktail Study
Official title: A Phase I, Open Label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: Chronic Pain
AZD2066
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study-specific procedures
* Healthy volunteers with BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion Criteria:

* History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
* Clinically significant illness as judged by the Investigator, within four weeks before the first administration of investigational product.
* Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: Frequent sampling occasions during
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Södertälje, Sweden
name: Biljana Lilja
role: STUDY_DIRECTOR
affiliation: ICON Development Solutions, Manchester, UK
name: Simon Constable
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771406: CPAP and Nebivolol in Hypertensive Obstructive Sleep Apnea (OSA) Patients.
Official title: Effects of Continuous Positive Airway Pressure (CPAP) and Nebivolol Treatment on Arterial Blood Pressure and Endothelial Function in Hypertensive OSA Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Endothelial Dysfunction
Obstructive Sleep Apnea
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine how effective CPAP treatment and treatment with nebivolol are respectively on reducing blood pressure and on endothelial dysfunction in patients suffering from obstructive sleep apnea and hypertension.


Eligibility criteria: Inclusion Criteria:

* male/female ≥ 18 years old
* patient with obstructive sleep apnea (apnea-hypopnea index ≥ 20) naïve for CPAP treatment
* patient with weak or moderate hypertension (140 \<= systolic blood pressure (SBP) \< 180 mmHg and 90 \<= diastolic blood pressure (DBP) \< 110 mmHg naïve for any antihypertensive treatment
* negative pregnancy test
* ambulatory patient
* patient who have signed the informed consent form
* patient affiliated to social security

Exclusion Criteria:

* pregnant or nursing woman
* acute hepatic failure, biliary cirrhosis, cholestasis
* clearance of Cockcroft \< 30 ml/min/1.73m2
* sick sinus syndrome, including sino-atrial block
* second and third degree heart block (without a pacemaker)
* history of bronchospasm and bronchial asthma
* bradycardia (heart rate\< 60bpm prior to start therapy)
* severe peripheral circulatory disturbances
* acute hypertension (SBP\>= 180 mmHg and/or DBP \>= 110 mmHg)
* severe daytime sleepiness (Epworth rating scale \> 15)
* known cardiovascular pathologies
* contraindication to CPAP
* allergy to nebivolol
* patient treated with antihypertensive drug(s), with class I antiarrhythmics (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone)
* patient treated with CPAP
* patient kept in detention, major protected by the law, hospitalised person
* patient currently participating in another clinical trial

Primary outcomes:
measure: change in mean arterial blood pressure
timeFrame: measurement assessed at w8,w14,w22
Secondary outcomes:
measure: change in endothelial function
timeFrame: measurement assessed at w8,w14,w22
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Catharina Belge, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05516706: Dynamic Stretching Versus Plyometric Push up Training on Upper Body Performance in Cricketers
Official title: Dynamic Stretching Versus Plyometric Push up Training on Upper Body Performance in Cricketers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Keywords: plyometric, dynamic stretching, agility
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were two groups
Primary purpose: TREATMENT

Brief summary: A comparison of dynamic stretching and plyometric pushup training on upper body performance tests of cricketers was performed.

Detailed description: A Randomised control trial was performed for six weeks in which a sample size of 22 was taken participants were divided into two groups in which one group performed warm-up and dynamic stretching and the other group performed warm-up plyometric pushup.

Eligibility criteria: Inclusion Criteria:

* Active cricket players ( who are currently laying cricket on the field)
* National-level cricket players having experience of 3 to 6 months
* Age 18 to 25 years
* Male cricketers

Exclusion Criteria:

* History of recent fracture of cervicothoracic region
* Disc prolapse stage 3
* Any other comorbid condition

Primary outcomes:
measure: One Arm Hop test
timeFrame: 6th week
Secondary outcomes:
measure: Medicine Ball throw test
timeFrame: 6th week
Other outcomes:
measure: Y- Balance Test
timeFrame: 6th week
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Federal Cptial
Study officials:
affiliation: Riphah International University
name: Waqar Awan, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252106: Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
Official title: Long-term Effectiveness of Contour Augmentation in Sites With Early Implant Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Dental Implants, Single-tooth
Grafting Bone
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this prospective case series study, 20 patients with an implant-borne single crown following early implant placement with simultaneous contour augmentation will be followed for 10 years. Clinical, radiologic, and esthetic parameters will be assessed. In addition, cone beam computed tomography (CBCT) will be used at 10 years to examine the facial bone wall and compared to the 6 year data.


Eligibility criteria: Inclusion Criteria:

* Single tooth gaps post extraction in the esthetic zone
* Written informed consent

Exclusion Criteria:

* Heavy smoking (more than 10 cigarettes per day)

Primary outcomes:
measure: Effectiveness of contour augmentation
timeFrame: 10 year examination
Secondary outcomes:
measure: Esthetic examination
timeFrame: 10 year examination
measure: Peri-Implant soft tissue health
timeFrame: 10 year examination
measure: Peri-implant bone loss over time
timeFrame: 10 year examination
measure: Peri-Implant soft tissue health
timeFrame: 10 year examination
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital
Study officials:
affiliation: University of Bern
name: Daniel Buser, DMD
role: STUDY_CHAIR
References:
citation: Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.
Clinical trial NCT04939506: COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana
Official title: COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Vaccine Refusal
Vaccine Hesitancy
Keywords: Vaccine Completion
COVID19 Testing
COVID19 Education
Point of Care Testing
Healthcare Personnel Education
Healthcare Disparities
Lead sponsor: Xavier University of Louisiana.
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics using a rapid vaccine education model delivered at the point of care.

Detailed description: This project is a 2-year study to investigate vaccine hesitancy and vaccine completion among vulnerable communities in the Southeastern Louisiana region. This study will be used to track COVID-19 vaccine completion among patients who seek testing, either as in-person or purchasing at home COVID testing, from pharmacies, urgent cares and clinics. The proposal will introduce a rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel and includes monitoring for COVID-19 vaccine completion among enrolled patients. Investigators anticipate an increase in COVID-19 vaccine completion rates for those who participate in the rapid vaccination education model.

Eligibility criteria: Inclusion Criteria:

* Unvaccinated adult participants, 18-99 years of age, able to provide informed consent, and to communicate in English, Spanish or Arabic. Also, individuals with incomplete vaccination (primary series or COVID-19 booster).

Exclusion Criteria:

* Persons fully vaccinated for COVID-19 (including primary series and boosters), persons with any documented allergies to components of the COVID-19 vaccines, or contraindications to receiving a COVID-19 vaccine.

Primary outcomes:
measure: COVID-19 Vaccine Completion
timeFrame: 9 months intervention
Secondary outcomes:
measure: Vaccine Hesitancy Likelihood Scale
timeFrame: 9 months post intervention
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Xavier University of Louisiana
state: Louisiana
Study officials:
affiliation: Xavier University of Louisiana.
name: Sara Al-Dahir, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nunez Community College
name: Klaus Heyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: