louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04880928: Comparison Mydriasis by Mydrane With Topical Drop Application
Official title: Prospective Intraindividual Comparison of the Mydriasis of a Standardized Intracameral Anaesthetics With the Topical Preoperative Drop Application in the Uncomplicated Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-05-11
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to compare the effectiveness of the intracameral application of Mydrane® (standardized combination of Tropicamide 0.02%, Phenylephrine 0.31% and Lidocaine 1%) with the preoperative topical application (Tropicamide 0.5% and Phenylephrine 10%). To evaluate the steadiness of the dilating effect on the pupil, the ratio of eyes without necessity for further pupil dilating procedures to perform the capsulorhexis is assessed.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between the age of 50 to 100 years
* Day-hospital and inpatient care
* Clinically significant opacity of the lens with indication for cataract surgery on both eyes
* Lack of previous ophthalmic surgeries
* Lack of relevant ophthalmic conditions: Pseudoexfoliation syndrome, eye injuries, present inflammation (in terms of uveitis, endophthalmitis and iridocyclitis), restricted mydriasis (pupil diameter below 7mm after application of tropicamide 0.38% and phenylephrine HCL 2.5% - at preoperative examination), elevated intraocular pressure, alpha-receptor inhibitor intake (e.g. tamsulosin) due to impeded mydriasis

Exclusion Criteria:

* Allergic to phenylephrine, tropicamide, sodium metabisulfite, disodium edetate, sodium hydroxide, hydrochloric acid, lidocaine hydrochloride, sodium chloride, disodium phosphate dodecahydrate, disodium phosphate dihydrate
* Allergic to anesthesia (amide type)
* Allergic to atropine derivates
* Heart disease, tachycardia, hypertensive crises
* Aneurism of big vessels
* Untreated hyperthyroidism
* Untreated closed angle glaucoma and narrow angles with tendencies to glaucoma by intake of mydriatic drugs
* Pregnancy, breast feeding and premenopausal women

Primary outcomes:
measure: pupil dilating
timeFrame: during first and second surgery: a maximum of four weeks between first and second surgery
Secondary outcomes:
measure: subjective highest intraoperative pain
timeFrame: after first and second surgery: a maximum of four weeks between first and second surgery
measure: subjective perception of anesthetic procedures
timeFrame: after first and second surgery: a maximum of four weeks between first and second surgery
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
Study officials:
References:
Clinical trial NCT01112228: Clinical Staging Tools for the Impacts of Obesity on Individuals
Official title: Assessing Clinical Staging Tools for Tracking the Impacts of Obesity on Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with BMI \> 40 or \>35 and a obesity-related medical condition

Brief summary: This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment.

Detailed description: This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment

Eligibility criteria: Inclusion Criteria:

* Morbid obesity
* At least 1 year follow-up after bariatric surgery

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Changes in Obesity Scores After Weight Loss Treatment
timeFrame: Minimum of 1 year follow-up
Secondary outcomes:
measure: Changes in Obesity Scores in Various Subgroups
timeFrame: Minimum of 1 year follow-up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Weight Centre, Imperial College London
Study officials:
affiliation: Imperial College London
name: Carek le Roux, MD PhD
role: STUDY_CHAIR
References:
citation: Aasheim ET, Aylwin SJ, Radhakrishnan ST, Sood AS, Jovanovic A, Olbers T, le Roux CW. Assessment of obesity beyond body mass index to determine benefit of treatment. Clin Obes. 2011 Apr;1(2-3):77-84. doi: 10.1111/j.1758-8111.2011.00017.x. Epub 2011 Jul 5.
Clinical trial NCT05209828: Post-market Clinical Follow-up of Pfmmedical Ports
Official title: Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access Port
Patient Satisfaction
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 149
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: 150 patients requiring repeated vascular access

Brief summary: Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The focus is on patient reported satisfaction, clinical application, and complication rates.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18 years.
* Medical indication for port catheter implantation.
* The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study.
* Patient information has been provided and written consent exists.

Exclusion Criteria:

* Contraindications according to the manufacturer´s instructions for use (IFU).
* The patient is institutionalised by court or official order (MPDG §27).
* Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study.
* Patients who currently already have a port implanted.

Primary outcomes:
measure: Patients satisfaction
timeFrame: 6 months after port implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University Hospital
state: Baden-Württemberg
Study officials:
affiliation: University Hospital Heidelberg
name: Phillip Knebel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagel SN, Teichgraber UK, Kausche S, Lehmann A. Satisfaction and quality of life: a survey-based assessment in patients with a totally implantable venous port system. Eur J Cancer Care (Engl). 2012 Mar;21(2):197-204. doi: 10.1111/j.1365-2354.2011.01275.x. Epub 2011 Aug 18.
Clinical trial NCT01133028: Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention Deficit Hyperactivity Disorder (ADHD)
Official title: Classroom-Level Intervention to Promote Peers' Acceptance of Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2010-05-28
Enrollment: 102
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Children with Attention-Deficit/Hyperactivity Disorder (ADHD) comprise about 5-10% of the elementary school-age population. One place where children with ADHD have great difficulty is in being accepted by peers and in making friends. It has unfortunately been very difficult for the field to find good treatments for peer relationship problems for this population. Even when children with ADHD do improve their behavior, it is common that peers do not seem to like the child with ADHD any better. This may happen because children often have negative reputations with their classmates that are hard to change. That is, once a class of children get the impression that one child is disliked or the social outcast, even if that child's ADHD symptoms get better, the peer group may not notice any of these improvements. It is hypothesized that the elementary school teacher may be able to help peers notice positive behavior changes in children with ADHD when they do occur. This clinical trial will design and pilot-test an intervention that would train teachers in classroom practices to reduce the peer rejection of students with ADHD. The pilot test will be conducted in a summer program created to be similar to a regular school classroom in structure. If the treatment seems to succeed in the summer program, then it will be tried in regular classrooms in a future study.


Eligibility criteria: Inclusion Criteria:

* Children ages 6-8
* Primary diagnosis of ADHD

Exclusion Criteria:

* Pervasive Developmental Disorder
* Verbal IQ below 75

Primary outcomes:
measure: Child Peer Relationships
timeFrame: The first day of the treatment and the last day of the treatment (two weeks later)
Secondary outcomes:
measure: Child Behavior Problems
timeFrame: The first day of the treatment and the last day of the treatment (two weeks later)
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Amori Y Mikami, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01464528: Safety Study of Use of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
Official title: Use Of Hyaluronic Acid Gel To Prevent Intrauterine Adhesions In Hysteroscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Tissue Adhesions
Keywords: hysteroscopy
postoperative complications
adhesions
hyaluronic gel
prevention
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Operations in the uterus are currently possible using a hysteroscope. One serious though rare complication of such procedures is the development of intra-uterine adhesions. There currently are no methods to prevent this. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery.

Detailed description: Operations in the uterus are currently possible using a hysteroscopic approach. Intrauterine procedures include; polypectomy, myomectomy, removal of lost IUD,removal of a septum and more. One serious though rare complication of operative hysteroscopy is the development of intra-uterine adhesions. Such adhesions, also known as asherman's syndrome, can cause serious consequences such as infertility and miscarriage. The hypothesis is that the removal of the endometrium and the exposure of ra uterine wall to each other can cause attachment and adhesions. the treatment is to mechanically break the adhesion. recurrence is however common. There currently are no methods to prevent adhesions following curettage or hysteroscopy. The aim of this study is to evaluate the safety of using hyaluronic gel after hysteroscopic surgery. At a later research, the efficacy of barrier gel will be measures.

Eligibility criteria: Inclusion Criteria:

* age 18 year old and over
* need of hysteroscopic surgery

Exclusion Criteria:

* preoperative fever or infection
* malignancy
* previous PID
* contraindications for anesthesia
* pregnancy
* under 18 year old
* not able to read and/or understand informed consent
* taking any medicine other than oral contraceptives

Primary outcomes:
measure: Patient satisfaction following gel application
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah
name: Ariel Revel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02017028: Correlation Between Endothelial Function and Trans Radial-procedural Events
Official title: Correlation Between Endothelial Function and Trans Radial-procedural Events
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Injury; Blood Vessel, Wrist, Radial Artery
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients planned for elective trans-radial cath

Brief summary: The aim of this study is to investigate the relation between the previous presence of endothelial dysfunction and the development of radial artery vasospasm during the trans-radial coronary evaluation.

Detailed description: All patient will undergo pre procedural endoPAT assessment for endothelial dysfunction

Eligibility criteria: Inclusion Criteria:

Patients without angiographic proof of coronary disease, with scheduled elective coronary angiographic evaluation by radial approach.

Exclusion Criteria:

Impossibility to perform radial approach; abnormal Barbeau test result (type C and D); previous important trauma of the upper limbs; presence of fistule for renal dialysis; lymphedema; acute myocardial infarction, severe valvular heart disease; patients with NYHA class III and IV heart failure; malignancy; active myocarditis; HIV infection or immunodeficiency state; chronic viral infection; acute systemic infection requiring antibiotics; systemic inflammatory disease; Raynaud's syndrome; refusal to sign the informed consent form. All participants must give a written informed consent

Primary outcomes:
measure: To assess relation between the presence of previous endothelial dysfunction and radial artery vasospasm
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical center
Study officials:
affiliation: Sheba MC
name: Amit Segev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02551328: Preconditioning With Sevoflurane and Propofol in Patients Undergoing Minimally Invasive Mitral Valve Surgery
Official title: A Single-center Observational Study Investigating the Effect of Volatile Conditioning (VC) With Sevoflurane on Myocardial Biomarkers and Platelets Function in Patients Having Minimally Invasive Mitral Valve Surgery (MIMV)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Ischemia
Lead sponsor: Fondazione Toscana Gabriele Monasterio
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age\>=18 Pt undergoing elective (or urgent) first-time minimal invasive mitral valve surgery Pt will have to sign informed consent

Brief summary: The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes (sevo \\propofol)

Detailed description: The main aim of this study is to compare markers of cardiac injury (Troponin I), inflammatory response and platelets function during minimally invasive mitral valve repair or replacement (MIMV) via right mini-thoracotomy in two standard anaesthetic regimes:

* Volatile conditioning (sevoflurane) used during induction (preconditioning) and during the operation as maintenance (perconditioning) and no propofol.
* Propofol induction and maintenance (TIVA) and no volatile anaesthetics.

Outlet/residual blood samples coming from routine check will be collected at different time points.

Study will be powered on Troponin I (primary statistical outcome). Original secondary outcome will be considered: platelets activation, left ventricle function, clinical figures (length of stay, inotrops requirements, ventilation times and other relevant).

Eligibility criteria: Inclusion Criteria:

1. Age ≥18
2. Patients undergoing elective (or urgent) first-time minimal invasive mitral valve surgery.

Exclusion Criteria:

1. Cardiogenic shock or cardiac arrest, emergent CABG
2. Renal failure (with a GFR \< 30 ml/min/1.73m2),
3. Glibenclamide or nicorandil (as these medications may interfere with VC)
4. Pregnancy
5. Known intolerance/allergy to sevoflurane or propofol

Primary outcomes:
measure: Myocardial Injury assessed by changes in Troponin values
timeFrame: properatively-6, 12, 24, 48 and 72 hours after the end of ischaemic cardioplegic arrest
Secondary outcomes:
Other outcomes:
Locations:
city: Massa
country: Italy
facility: Ospedale del cuore, Pasquinucci Hospital, Fondazione Monasterio
Study officials:
affiliation: Fondazione Toscana Gabriele Monasterio
name: Paolo Del Sarto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06294028: International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
Official title: International Multicenter Project Comparing Radiofrequency Ablation Versus Implantable Defibrillator After Well-tolerated Ventricular Tachycardia in Ischemic Heart Disease with Minimally Impaired Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Heart Disease
Ventricular Tachycardia
Keywords: Ablation
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evidence for the usefulness of the defibrillator in cases of preserved left ventricular ejection fraction and well-tolerated ventricular tachycardia (without cardiocirculatory arrest or syncope) is lacking, as no previous trials have included such patients. Additionally, sudden death in this particular population is low compared to other subgroups of patients with malignant ventricular arrhythmias.

On the other hand, numerous recent retrospective data show that ablation of ventricular tachycardia can reduce mortality, and also clearly reduces the number of recurrences in prospective studies.

Finally, a very low rate of sudden death was observed in a multicenter European retrospective study that we conducted, including patients with well-tolerated ventricular tachycardia in structural heart disease with minimally impaired ejection fraction and benefiting from ablation without implantation of defibrillator.


Eligibility criteria: Inclusion Criteria:

* ischemic heart disease with history of infarction - LVEF\> 35% (measured by MRI)
* sustained monomorphic ventricular tachycardia - without history of syncope or cardiac arrest -
* having signed informed consent
* affiliated to a social security system

Exclusion Criteria:

* transient regressive cause of ventricular tachycardia
* recent myocardial infarction (\<2 months)
* ventricular tachycardia by reentry from branch to branch
* serious conduction disturbances (with indication of stimulation)
* contraindication to the implantation of a defibrillator or to the performance of an ablation (life expectancy \<1 year, relevant comorbidities)
* pregnancy
* age \<18 years
* Patient under legal protection, guardianship or curatorship

Primary outcomes:
measure: Monitoring for the occurrence of at least one serious event during the 36 months of follow-up
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Rangueil Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Philippe MAURY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05438628: Preoperative Frailty Assessment With Ultrasound in Elderly Patients
Official title: Preoperative Frailty Assessment With Point-of-care Ultrasound in Elderly Patients Scheduled for Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 60 years old or older scheduled for total knee arthroplasty

Brief summary: In this study, the investigators aim to evaluate the prediction accuracy of the thickness measured with point-of-care ultrasound of the rectus abdominis, biceps brachii muscles of frailty.


Eligibility criteria: Inclusion Criteria:

* Patients 60 years old or older scheduled for total knee arthroplasty

Exclusion Criteria:

* Unable to communicate with the patient or the patient's guardian
* Myopathy
* History of injury of rectus abdominis, biceps brachii or quadriceps femoris muscle.
* History of total knee arthroplasty in the recent 3 months prior to surgery

Primary outcomes:
measure: Prediction accuracy of the thickness of rectus abdominis, biceps brachii muscles measured with point of care ultrasound
timeFrame: Preoperative evaluation
Secondary outcomes:
measure: Thickness of quadratus femoris muscle measured with point-of care ultrasound
timeFrame: Preoperative evaluation
measure: Circumference of thigh
timeFrame: Preoperative evaluation
measure: Difference between thickness of left and right rectus abdominis muscles
timeFrame: Preoperative evaluation
measure: Difference between thickness of left and right biceps brachii muscles
timeFrame: Preoperative evaluation
measure: Difference between thickness of left and right quadriceps femoris muscles
timeFrame: Preoperative evaluation
measure: Unplanned ICU admission
timeFrame: First 30 days post surgery
measure: Unplanned discharge to nursing facility
timeFrame: First 30 days post surgery
measure: Incidence of postoperative delirium
timeFrame: First 30 days post surgery
measure: ICU stay duration
timeFrame: First 30 days post surgery
measure: Total length of stay
timeFrame: First 30 days post surgery
measure: Number of falls
timeFrame: First 30 days post surgery
measure: Readmission in the 30-day postoperative period
timeFrame: First 30 days post surgery
measure: Mortality
timeFrame: First 30 days post surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: