louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06743256: Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
Official title: Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the Levita Magnetic Surgical System in Laparoscopic Gynecological Procedures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecological Laparoscopic Surgery
Lead sponsor: Levita Magnetics
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A study at multiple centers to evaluate the safety and practicality of the Levita Magnetic Surgical System for use in laparoscopic gynecological surgeries.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Having a BMI of at least 20 kg/m2
* Scheduled to undergo elective gynecological procedure
* Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

* Individuals with BMI higher than 60 kg/m2.
* Emergency procedures (e.g., ectopic pregnancy, severe bleeding).
* Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
* Individuals with pacemakers, defibrillators, or other electromedical implants.
* Individuals with ferromagnetic implants.
* Clinical history of impaired coagulation confirmed by abnormal blood tests.
* Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use.
* Pregnant or wishes to become pregnant during the length of study participation.
* Individual is not likely to comply with the follow-up evaluation schedule.
* Participating in a clinical trial of another investigational drug or device.

Primary outcomes:
measure: Number of Participants with Device and/or Procedure Related Adverse Events
timeFrame: From enrollment to end of follow up at 30 days.
measure: Average Number of Ports
timeFrame: During index procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Peñalolén
country: Chile
facility: Hospital Clinico San Borja Arriaran
state: Santiago
city: Peñalolén
country: Chile
facility: Hospital Santiago Oriente "Dr. Luis Tisné Brousse"
state: Santiago
Study officials:
References:
Clinical trial NCT03125356: Low-calorie Sweeteners and Adipose Signaling
Official title: Low-calorie Sweeteners and Adipose Signaling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional and Metabolic Diseases
Keywords: diet soda
low-calorie sweeteners
obesity
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether eight weeks of low-calorie sweetener (LCS) exposure exerts cardiovascular and/or metabolic effects among LCS-naïve overweight and obese adolescents and young adults. We will examine changes in gene expression in subcutaneous fat and will correlate these molecular changes with plasma biochemistry.

Detailed description: The proposed study will investigate LCS-induced changes in metabolically "at-risk" young adults, under conditions that reflect typical beverage consumption. We will first identify molecular pathways potentially affected by LCS (adipose transcriptomics via global RNAseq) and then identify links between LCS-induced gene expression changes and circulating levels of key metabolic biomarkers and clinical outcomes. We will perform subcutaneous adipose biopsies before and after consumption of 12 ounces of diet soda three times daily for eight weeks. Within-subjects changes in adipose gene expression will be evaluated using RNAseq. We will then correlate transcriptomic changes with circulating levels of key inflammatory and metabolic biomarkers, to provide mechanistic insight into which pathways drive clinically-relevant LCS-induced metabolic impairments. We will measure glucose, insulin, inflammatory markers and adipose-derived hormones before and after eight weeks of LCS exposure.

Eligibility criteria: Inclusion Criteria:

1. Female
2. 18-25 years of age
3. Overweight and mild to moderate obesity (25 ≤ body mass index (BMI) \<35 kg/m2)
4. Consumption of \<1 food/beverage with sucralose and/or acesulfame-potassium per month
5. Able and willing to comply with all study procedures for the duration of the study

Exclusion Criteria:

1. Overt diabetes
2. Renal/gastrointestinal conditions
3. Pregnant/lactating
4. Recent significant weight change
5. Acute illness (w/fever)
6. Antibiotics in past 3 months
7. Use of illegal drugs/condition limiting ability to give consent.

Primary outcomes:
measure: Transcriptomics
timeFrame: Pre/post 8 weeks of diet soda
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Milken Institute School of Public Health and GW Medical Faculty Associates
state: District of Columbia
Study officials:
References:
Clinical trial NCT05643456: Surgery for Large Angle Exotropia Two Muscles Versus Three Muscles
Official title: Comparison Between The Results Of Operating Two Muscles And Operating Three Muscles For The Treatment Of Large Angle Exotropia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exotropia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 69
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 69 Patients with exotropia of (40-55) PD who are ≥ 5 years old. The 1st group will do two muscles surgery; bilateral lateral rectus recession. The 2nd group will do three muscles surgery; bilateral lateral rectus recession and unilateral medial rectus tucking.
Primary purpose: TREATMENT

Brief summary: Comparison Between The Results Of Two Muscles Surgery And Three Muscles Surgery For The Treatment Of Large Angle Exotropia

Detailed description: Exotropia is classified as Primary which includes constant and intermittent exotropias. Secondary XT include Sensory and consecutive XT. Management for IXT consists of non-surgical and surgical treatment. There is some controversy regarding the optimal surgical method varying between bilateral lateral rectus recession (BLR), unilateral lateral rectus recession-medial rectus resection (RR) and bilateral medial rectus resection (BMR).

Eligibility criteria: Inclusion Criteria:

* Patients above age of 5 years with concomitant Exotropia of (40-55) PD of any type.

Exclusion Criteria:

1. Angle of deviation less than 40 PD or more than 55 PD.
2. History of previous surgery.
3. Inconcomitant exotropia.
4. Incomitance in any gaze.
5. Associated vertical deviation(oblique dysfunction,A or V pattern).
6. Patients with neurological deficit.

Primary outcomes:
measure: alignment in the primary position
timeFrame: 1 week to 6 months
measure: palpebral fissure height
timeFrame: 1 week to 6 months
measure: End gaze deficit
timeFrame: 1 week to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Reham fawzy elsherbiny
Study officials:
affiliation: Cairo University
name: Lobna MH Khazbm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343156: Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Official title: Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Oculis
Sponsor class: INDUSTRY
First posted: 2022-04-25
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death.

A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems.

A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.


Eligibility criteria: Key Inclusion Criteria:

1. Had DME of less than 3 years duration since diagnosis with presence of intraretinal and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator).
2. Had definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator's clinical evaluation and by SD-OCT;

   ...

Key Exclusion Criteria:

1. Had macular edema considered to be due to a cause other than DME;
2. Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).

   ...

Primary outcomes:
measure: Mean Change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA)
timeFrame: Baseline & Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Michael Larsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02414256: PECS Block in Breast Surgery: an Observational Multicenter Study
Official title: PECS Block in Breast Surgery: an Observational Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Pain
Keywords: breast surgery
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients submitted to breast surgery

Brief summary: We will enroll patients submitted to breast surgery (in and outsettings) with regional anesthesia.

The blinded observers, in the first 48 hours post-operative, will evaluate (telephone interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10 = worst possible pain) thereby recording the treatment procedures in accordance with usual clinical practice. At the same time we will evaluate the presence of intraoperative or postoperative complications related to regional anesthesia, the PONV rate (post-operative nausea and vomiting) and the analgesic/antiemetic therapy.


Eligibility criteria: Inclusion Criteria:

ASA I-II-III Patients Written Informed Consent

Exclusion Criteria:

ASA IV Active Heart Failure Coagulation Disease Chronic Pain Allergies to Local Anesthetics

Primary outcomes:
measure: Pain Intensity Misure
timeFrame: 2 days
Secondary outcomes:
measure: Complications Regional Anesthesia Related
timeFrame: 1 days
measure: PostOperative Nausea Rate
timeFrame: 2 days
measure: Intraoperative Opioids Use
timeFrame: surgical time
measure: Postoperative Analgesics
timeFrame: 2 days
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Department of Day Surgery Ospedale di Circolo Varese
state: VA
Study officials:
affiliation: University Hospital Varese
name: Andrea L Ambrosoli, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02442856: Non-invasive Measurement of Cerebral Dynamic Autoregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall objective of this study is to evaluate the use of diffuse correlation spectroscopy to non-invasively measure dynamic cerebral autoregulation in subjects with vascular risk factors. Optical cerebral blood flow measurements will be correlated with changes in arterial blood pressure to assess how CBF is maintained in response to changes in ABP, and will be compared to transcranial doppler reference measurements.


Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 50 years
* Positive history of at least one of the following vascular disk factors: hypertension, diabetes, hyperlipidemia, coronary artery disease, atrial fibrillation, prior myocardial infarct, transient ischemic attack, or history of smoking

Exclusion Criteria:

* Vascular risk factor subjects:

  1. Pregnant women
  2. Prisoners
  3. Prior neurosurgical procedure or traumatic brain injury, including hemicraniectomy or other skull defect
  4. Prior history of ischemic or hemorrhagic stroke
  5. Prior lower extremity amputation
  6. Peripheral vascular disease

Primary outcomes:
measure: dCA Measurement During Acute Changes in Mean Arterial Pressure, TCD
timeFrame: 1.5 hours
measure: dCA Measurement During Acute Changes in Mean Arterial Pressure, Optical
timeFrame: 1.5 hours
Secondary outcomes:
Other outcomes:
measure: Linear Relationship Between Rate of Regulation Measured Using TCD and Optics
timeFrame: 1.5 hours
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02389556: Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in Relation to the Development of Obesity in Korean Children
Official title: Serum ANGPTL3, ANGPTL8 and Glypican 4 Concentrations in Relation to the Development of Obesity in Korean Children: a Three Year Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 457
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in this study were selected from the Korean Metabolic disorders \& Obesity Study in Elementary School children (KMOSES).

Brief summary: ANGPTL3 and ANGPTL8 are emerging molecules involving lipid metabolism. In previous in vivo study using mice, ANGPTL8 regulated the activation of ANGPTL3 which was known to inhibit lipoprotein lipase activity and stimulate lipolysis of adipose tissue. Besides, glypican 4 was identified as a novel adipokine modulating adipocyte differentiation. Thus, the investigators postulated that different serum concentrations of ANGPTL3, ANGPTL8 and glypican 4 might affect progression of obesity in children. The investigators measure these molecules in Korean children, and investigate the association between these molecules and development of obesity.

Detailed description: Participants in this study were selected from the Korean Metabolic disorders \& Obesity Study in Elementary School children (KMOSES), the main aim of which was to comprehensively assess obesity-related metabolic risk factors and to evaluate clinical outcomes in Korean children prospectively. Korean children who were participated in a school-based health examination, were reexamined for the 3-year follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* Participants who were reexamined for the 3 year follow-up assessment

Exclusion Criteria:

* Participants who were not being available for the 3 year follow up assessment

Primary outcomes:
measure: The changes of body mass index according to serum level of ANGPTL3, ANGPTL8 and glypican 4
timeFrame: Baseline and 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Korea University College of Medicine
state: VD
Study officials:
affiliation: Department of Internal Medicine, Korea University College of Medicine
name: Kyung Mook Choi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02089256: Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
Official title: Effect of Repeated Administration of Liraglutide on Insulinogenic Indices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study investigates the effect of glucagon-like peptide receptor 1 agonist, liraglutide, on insulin secretion. Study hypothesis: the effect of liraglutide on insulin release may change after repeated administration. The effect of liraglutide on insulin release will be tested using graded glucose infusion test (GGIT) in healthy volunteers. GGIT will be performed without medication and repeated 12 hours after first dose of liraglutide and after 3 weeks of treatment with liraglutide.


Eligibility criteria: Inclusion Criteria:

* Weight 50-100 kg

Exclusion Criteria:

* Chronic disease
* Concomitant drug use
* Pregnancy or lactation
* Fasting glucose \>6 mmol/L.

Primary outcomes:
measure: Change in the glucose-sensitivity of the beta cells
timeFrame: baseline, first dose, after 3-weeks on treatment
Secondary outcomes:
measure: Effects on adrenal hormones
timeFrame: baseline, acute administration, 3 weeks
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: Tartu University
name: Vallo Volke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sedman T, Vasar E, Volke V. Tolerance Does Not Develop Toward Liraglutide's Glucose-Lowering Effect. J Clin Endocrinol Metab. 2017 Jul 1;102(7):2335-2339. doi: 10.1210/jc.2017-00199.
citation: Sedman T, Heinla K, Vasar E, Volke V. Liraglutide Treatment May Affect Renin and Aldosterone Release. Horm Metab Res. 2017 Jan;49(1):5-9. doi: 10.1055/s-0042-109065. Epub 2016 Jun 14.
Clinical trial NCT04914156: The Use of Nutrigenomics in Sports Nutrition
Official title: The Use of Nutrigenomics in Sports Nutrition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sport Nutrition
Nutrigenomics
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study's aim is to determine if nutrigenomics-based dietary advice is a greater motivator for dietary change amongst an athlete population. Specifically, the investigators will be examining whether nutrigenomics-based personalized dietary advice results in greater changes in dietary intake and body composition amongst athletes compared to personalised population-based sports nutrition advice. It is hypothesized that the Nutrigenomics in Sports Nutrition group would engage in greater dietary changes and better adhere to the dietary advice compared to the standard advice group.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Competes in representative sports team
* Has access to the internet and smart phone device
* Able to speak English

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Changes in dietary intake from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in body composition from baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: University of Auckland
Study officials:
References:
Clinical trial NCT04664556: Invasive Pneumococcal Disease Study
Official title: Population-based Nationwide Study on Invasive Pneumococcal Infections Among Children (0-18 Years) in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumococcal Infections
Pneumococcal Conjugate Vaccine
Antibiotic Treatment
Mortality
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-12-11
Enrollment: 1369
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with invasive pneumococcal disease for whom the pneumococcal strain is sent to the National reference Center for Pneumococci for serotyping

Brief summary: After 7 then 13 valent pneumococcal conjugate vaccine implementation in France in children, we will evaluate the impact of this vaccination on invasive pneumococcal disease (IPD). We will describe the clinical characteristics of IPD, pneumococcus serotyping, underlying conditions and vaccination status.


Eligibility criteria: Inclusion Criteria:

* Isolate of Streptococcus pneumoniae from at least one blood culture, or pleural fluid, or joint fluid, or cerebrospinal fluid or other normally sterile body site, or if there is a positive blood PCR.

Exclusion Criteria:

* Pneumococcal strain not transmetted to National Reference Center for Pneumococci or to Regional Pneumococci Observatory

Primary outcomes:
measure: Severity of invasive pneumococcal disease
timeFrame: before hospital discharge
Secondary outcomes:
measure: Impact of vaccines
timeFrame: before hospital discharge
Other outcomes:
Locations:
city: Creteil
country: France
facility: ACTIV
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Levy Corinne
role: STUDY_DIRECTOR
affiliation: Association Clinique Thérapeutique Infantile du val de Marne
name: Cohen Robert
role: PRINCIPAL_INVESTIGATOR
References: