louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06184789: Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure
Official title: Multiparametric Protocol for Assessment of Intraprocedural Result of MITRACLIP Procedure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Residual Mitral Regurgitation
Keywords: MitraClip
Residual Mitral Regurgitation
Mitral Insufficiency
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with either degenerative or functional, severe or moderate to severe mitral regurgitation (MR) undergoing percutaneous edge-to-edge repair at San Raffaele Hospital from April 2019.

Brief summary: Quantification of residual mitral regurgitation (MR) after MitraClip may be challenging. Quantitative methods for severity assessment may be inaccurate and recent recommendations suggest an assessment of changes in both hemodynamic and echocardiographic parameters, but an established prospectively validated approach is still lacking.


Eligibility criteria: Inclusion Criteria:

* Patients with either degenerative or functional, severe or moderate to severe mitral regurgitation (MR) undergoing percutaneous edge-to-edge repair at San Raffaele Hospital from April 2019.

Exclusion Criteria:

* None

Primary outcomes:
measure: Efficacy of multiparametric assessment of mitral regurgitation ofter Mitraclip
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCSS San Raffaele
Study officials:
References:
Clinical trial NCT01834989: Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I
Official title: Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tendinopathy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2013-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.

Detailed description: Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up

Eligibility criteria: Inclusion Criteria:

* chronic patellar tendinopathy (\> 3 months)
* anterior-posterior thickening of the tendon (1 mm compared to mid-tendon)
* hypo-echoic area with enhanced vascularization

Exclusion Criteria: injection

* corticosteroid injection within the last 12 months
* Knee operation
* Knee osteoarthritis
* Diabetes
* Smoking
* Body mass index \>30

Primary outcomes:
measure: Tendon structure
timeFrame: After 12 weeks intervention (tendon biopsy)
Secondary outcomes:
measure: Tendon Pain
timeFrame: 1 year (before and after 12 weeks intervention and 1 year after intervention start)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine, Copenhagen
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenhagen, Denmark
name: Michael Kjaer, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Section of Sport Science, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000 Aarhus C, Denmark
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Sports Medicine, Copenhagen, Bispebjerg Hospital, 2400 Copenahagen, Denmark
name: Jens Olesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olesen JL, Hansen M, Turtumoygard IF, Hoffner R, Schjerling P, Christensen J, Mendias CL, Magnusson PS, Kjaer M. No Treatment Benefits of Local Administration of Insulin-like Growth Factor-1 in Addition to Heavy Slow Resistance Training in Tendinopathic Human Patellar Tendons: A Randomized, Double-Blind, Placebo-Controlled Trial With 1-Year Follow-up. Am J Sports Med. 2021 Jul;49(9):2361-2370. doi: 10.1177/03635465211021056. Epub 2021 Jun 17.
Clinical trial NCT06824389: Evaluate the Performance of Large Language Models in Ophthalmologic Patient Consultation
Official title: Evaluate the Performance of Large Language Models in Ophthalmologic Patient Consultation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-emergency Ocular Diseases
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The intelligent image models lack an understanding of diagnostic and treatment logic, and have not considered textual information such as symptoms and signs. Large language models like ChatGPT, can learn medical knowledge, understand, and generate human natural language, offering new technologies for medical knowledge-based intelligent question answering and the creation of smart medical documents. Therefore, our team plan to verify large language models' feasibility and effectiveness in ophthalmology clinics for medical history collection and examination recommendations during consultations, comparing its performance with traditional methods.


Eligibility criteria: Inclusion Criteria:

* No age or gender restrictions for patients.
* Non-emergency ocular diseases including corneal diseases, lens disorders, and vitreoretinal diseases.
* Voluntary participation with signed informed consent.

Exclusion Criteria:

* Top 10 Ocular Emergencies: globe perforation, ocular chemical injury, corneal ulcer perforation, Pseudomonas aeruginosa keratitis, acute angle-closure glaucoma, acute panophthalmitis, central retinal artery occlusion, acute optic neuritis, endophthalmitis, and orbital cellulitis.

Primary outcomes:
measure: Medical History Collection Scoring
timeFrame: through study completion, up to 1 week.
Secondary outcomes:
measure: Accuracy of Recommended Tests
timeFrame: through study completion, up to 1 week.
measure: Duration of Medical History Collection
timeFrame: through study completion, up to 1 week.
measure: Patient satisfaction
timeFrame: through study completion, up to 1 week.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03813589: Congestive Heart Failure and Atrial Tachyarrhythmias in Pmk Patients
Official title: State of congEstive heArt Failure Before the onSet of atrIal Tachyarrhythmias Detected by Implanted devicE in Pacemaker Patients (SEASIDE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure，Congestive
Atrial Arrhythmia
Lead sponsor: San Leonardo Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients implanted with dual chamber pacemaker able to automatically detect congestive heart failure and atrial tachyarrhythmias events.

Brief summary: The aim is to correlate relationship between congestive heart failure and onset of atrial tachyarrhythmias in pacemaker patients. Both atrial events and state of congestive heart failure are collected automatically by implanted device.


Eligibility criteria: Inclusion Criteria:

* Recent implant of DR pacemaker according to current guidelines
* Sinus Rhythm at enrollment

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Evaluate relationship between atrial tachyarrhythmias and congestive heart failure
timeFrame: twelve months
Secondary outcomes:
measure: Detect optimal device programming
timeFrame: twelve months
Other outcomes:
Locations:
city: Castellammare Di Stabia
country: Italy
facility: San Leonardo Hospital
state: Napoli
Study officials:
affiliation: San Leonardo Hospital
name: Giovanni Russo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01638689: A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
Official title: A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Mechanism of Action of escitalopram
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Healthy males were examined with positron emission tomography (PET) and the radioligand 11C-AZ10419369, before and after administration of a single dose escitalopram. A change in the binding potential of 11C-AZ10419369 between the baseline and the post-dose condition was hypothesized to reflect a change in serotonin concentration.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent
2. Male gender
3. Age 20 to 30 years
4. Healthy according to physical examination, ECG, MRI and blood chemistry

Exclusion Criteria:

1. Past or present psychiatric disease
2. Past or present brain disorder or injury, including loss of consciousness for more than five minutes
3. Past or present drug or alcohol abuse
4. Past or present use of antidepressant or antipsychotic medications
5. Regular use of medications (including herbals), that could interfere with the pharmacodynamics or pharmacokinetics of escitalopram
6. Significant abnormality on ECG
7. Structural abnormality in the brain confirmed by MR examination
8. Claustrophobia
9. Any metal devises or implants in the body
10. Intolerance to escitalopram or any of the components of the formula
11. Predisposition to motion sickness
12. Inability to understand and comply with the study requirements
13. Any medical condition that, in the opinion of the investigator, make the subject unsuitable for the study or put the subject at additional risk

Primary outcomes:
measure: Change in binding potential of 11C-AZ10419369 between baseline and post-dose condition
timeFrame: One day (PET measurement before and after escitalopram administration on the same day)
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: PET center, Department of Clinical neuroscience, Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Magdalena Nord, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nord M, Finnema SJ, Halldin C, Farde L. Effect of a single dose of escitalopram on serotonin concentration in the non-human and human primate brain. Int J Neuropsychopharmacol. 2013 Aug;16(7):1577-86. doi: 10.1017/S1461145712001617. Epub 2013 Jan 25.
Clinical trial NCT00572689: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Official title: Pilot Study of Exenatide Pharmacokinetics and Pharmacodynamics in Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gestational Diabetes
Keywords: Exenatide
TCF7L2 polymorphism
Pharmacodynamics
Pharmacokinetics
Lead sponsor: Georgetown University
Sponsor class: OTHER
Collaborators: name: Medstar Health Research Institute
First posted: 2007-12-13
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study is being done to study how exenatide, an FDA-approved drug that lowers blood sugar in non-pregnant patients with type II diabetes, works in pregnant women. To do this, we will study the drug's pharmacokinetics (what the body does to the drug; specifically, how quickly your body breaks down and excretes exenatide) and pharmacodynamics (what the drug does to the body; specifically, how effectively exenatide helps your pancreas secrete insulin and how well it controls blood sugar after a meal). There are only two main drug therapies (insulin injections and glyburide pills) currently used for gestational diabetes and not all women achieve good enough blood sugar control without side effects. Therefore, we hope to find out if exenatide might also be helpful in gestational diabetes.


Eligibility criteria: Inclusion Criteria:

* Pregnant women (singleton)
* Gestational diabetes not requiring medical therapy
* Between 18 and 50 years of age
* Able to give written informed consent

Exclusion Criteria:

* Women in the first trimester of pregnancy
* Hematocrit less than 30%
* Current or past treatment with any hypoglycemic agent
* Women with gastrointestinal disease or symptoms consistent with nausea, vomiting, abdominal pain or reflux requiring medical treatment.
* Women with high triglyceride levels, history of gallbladder or pancreatic disease.
* Clinical diagnosis or history of any renal insufficiency (or decreased creatinine clearance)

Primary outcomes:
measure: glycemic control through insulin, glucose, c-peptide and glucagon assays
timeFrame: duing testing days
Secondary outcomes:
measure: TCF7L2 polymorphism
timeFrame: During subject testing days
measure: Exenatide Pharmacodynamics and Pharmacokinetics
timeFrame: During testing days
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Georgetown University Medical Center, Medstar Health Research Institute
name: Jason G Umans, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medstar Health Research Institute
name: Maisa N Feghali, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04499989: Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
Official title: Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery: a Randomized Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUCD Complication
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized trial
Primary purpose: PREVENTION

Brief summary: To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

Detailed description: Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.

Eligibility criteria: Inclusion Criteria:

* Non-pregnant women
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section

Exclusion Criteria:

* Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids.
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to isonicotinic acid hydrazide .
* Women refuse to participate in the study

Primary outcomes:
measure: the difference in the pain intensity scores between the study groups
timeFrame: 10 minutes
Secondary outcomes:
measure: Provider ease of insertion
timeFrame: 10 minutes
measure: insertion time
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan universirty
name: nahla w Shady, md
role: STUDY_CHAIR
References:
Clinical trial NCT00549289: Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-006)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: Sirion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-25
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this phase III, open-label study is to determine the safety and tolerability of cyclosporine in the treatment of dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dry eye syndrome

Exclusion Criteria:

* Intraocular or refractive surgery in the study eye within 3 months prior to study start
* Unwilling to discontinue use of contact lenses during the study
* Pregnancy or lactation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
Study officials:
affiliation: Sirion Therapeutics
name: Roger Vogel
role: STUDY_CHAIR
References:
Clinical trial NCT04252989: Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children
Official title: Atropine 0.01% Eyedrops for Evolutive Myopia Treatment in Children. MYOPSTOP
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myopia
Children
Keywords: atropine
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 50
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with active myopia treated with ATROPINE 0.01% eye drops

Brief summary: Prevalence of myopia and its complications has been increasing over the past decades, especially among children and adolescents. It reaches record levels in Asia: nearly 80% of the population in some regions in 2012 where the investigators speak in terms of epidemic.

ATROPINE 0.01% eyedrops one drop per day is today an evolutive myopia treatment, whose results are promising.

The investigators use this eye drops in our clinical practice at hospital of Saint-Etienne since 2017.

Few clinical data have been published so far concerning the French population.

The investigators would like to build a database so that the investigators can publish our results and share our experience.


Eligibility criteria: Inclusion Criteria:

* Children with active myopia treated with ATROPINE 0.01% eye drops
* patient affiliated with a social security organization
* agreement of both parents

Exclusion Criteria:

* non compliance with treatment

Primary outcomes:
measure: previous refractions
timeFrame: every 6 months up to age 18 years
measure: refraction of parents
timeFrame: every 6 months up to age 18 years
measure: intra-ocular pression
timeFrame: every 6 months up to age 18 years
measure: objective refraction after "fog"
timeFrame: every 6 months up to age 18 years
measure: cycloplegia with SKIACOL
timeFrame: every 6 months up to age 18 years
measure: slit lamp
timeFrame: every 6 months up to age 18 years
measure: dilated eye exam
timeFrame: every 6 months up to age 18 years
measure: biometrics
timeFrame: every 6 months up to age 18 years
Secondary outcomes:
measure: undesirable events collection
timeFrame: every 6 months up to age 18 years
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: CHU de Saint Etienne
Study officials:
affiliation: CHU de Saint Etienne
name: Marie Caroline TRONE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05055089: Short- and Medium-term Results of New Generation Aortic
Official title: Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Echocardiography
Aortic Valve
Cardiac Surgery
Mortality
Keywords: Echocardiography
Aortic valve
New-generation bioprosthesis
Conventional bioprosthesis
Rapid-deployment bioprosthesis
Sutureless valves
Function prostheses
Cardiac Surgery
Mortality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from the Cardiac Surgery Department of the University Hospital of Amiens of Picardy, France, short- and medium-term survival of patients undergoing surgical aortic valve replacement with new-generation bioprostheses compared with patients who received a traditional bioprosthesis.

Brief summary: Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.


Eligibility criteria: Inclusion Criteria:

* Retrospectively included all patients examined since 2010.
* Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.

Exclusion Criteria:

* Refusal to participate in the patient.
* Patients who have previously had aortic valve surgery.

Primary outcomes:
measure: Variation of mortality rate between both groups
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Nord
Study officials:
References: