louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06209034: Intraoperative Optic Nerve Sheath Diameter Changes After Laparoscopic Surgery
Official title: Ultrasonographic Evaluation of Intraoperative Optic Nerve Sheath Diameter Changes in Patients Undergoing Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Optic Nerve Sheath Diameter
Intracranial Pressure Increase
Keywords: Ultrasonography
Optic nerve sheath diameter
Laparoscopic surgery
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Laparoscopic surgery is a widely used alternative to open surgery; Advantages include reduced bleeding and pain intensity, shorter hospital stay, and improved cosmetic results.

Laparoscopic surgery involves the creation of a carbon dioxide (CO2) pneumoperitoneum to facilitate a clear surgical view, which can result in increased intracranial pressure (ICP).

Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment.Ultrasonographic assessment of optic nerve sheath diameter (ONSD) has been proposed as a non-invasive measurement of intracranial pressure.

Detailed description: Ultrasonographic measurement of optic nerve sheath diameter (ONSD) is a simple, non-invasive, yet reliable technique for ICP assessment. Previous studies have demonstrated that ultrasonographic measurement of ONSD correlates with the degree of ICP and can detect intracranial hypertension in a variety of clinical settings.

It was planned to measure the optic nerve sheath throughout the surgery with the help of a linear ultrasound probe.

Ultrasonographically, in each measurement, the optic nerve sheath diameter (ONSD) was detected 3 mm behind the entry point of the optic nerve into the globe in both eyes. ONSD will be measured bilaterally 3 mm behind the papilla. It will be evaluated by transverse measurement for each optic nerve.

Eligibility criteria: Inclusion Criteria:

* 18-75 aged patients
* American Society of Anesthesiologists Classification (ASA) I-II-III patients
* Patients undergoing laparoscopic surgery

Exclusion Criteria:

* American Society of Anesthesiologists Classification (ASA) IV-V patients
* Those with known ophthalmic disease
* Those with a history of ophthalmic surgery
* Those with any known neurological disorder
* History of intracranial hypertension
* Patients who will undergo open abdominal surgery

Primary outcomes:
measure: Evaluation of optic nerve sheath diameter
timeFrame: During the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
city: Kocaeli
country: Turkey
facility: Sevim Cesur
Study officials:
affiliation: Kocaeli University
name: Sevim Cesur
role: STUDY_DIRECTOR
References:
Clinical trial NCT00919334: Myopia Control With Simultaneous Vision Approach
Official title: Control of Myopia Progression in Myopic Children Using Simultaneous Vision Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myopia
Keywords: Myopia progression
Myopia control
Simultaneous vision
Myopic defocus
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if the 'Defocus Incorporated Soft Contact' (DISC) lens slows myopia progression in Hong Kong schoolchildren using simultaneous vision approach.

Detailed description: The investigators hypothesize that the natural process of emmetropization in human is regulated by the equilibrium between the opposite hyperopic and myopic defocus. A sharp focus of retinal image (foveal fixation) is fundamental for co-ordination of the equilibrium. The DISC lens is a custom-made multi-zone bifocal soft contact lens which is based on simultaneously provides clear vision and defocus at all viewing distances. It comprises of correcting zones for correcting distant prescription(correction of refractive error, and defocusing zones to incorporate constant myopic defocus for slowing down myopia progression.

Eligibility criteria: Inclusion Criteria:

* Age 8-13 years
* Myopia (SE) between -1D to -5D
* Astigmatism less than or equal to -1D
* Anisometropia: less than or equal to 1.25D
* aided VA (monocular): 0.00 log MAR or better
* willingness to wear contact lens constantly
* availability for follow-up for at least 2.5 years
* parents' understanding and acceptance
* willing to provide refractive status of grandparents

Exclusion Criteria:

* Severe ocular or systemic allergies
* Taking any medication that might have an impact on contact lens wear or that might influence the outcome of the clinical trial
* Ocular or systemic condition that might affect refractive development
* Strabismus at distance or near
* Prior use of bifocal or progressive lenses
* Prior use of rigid gas permeable lenses and Ortho-K lenses

Primary outcomes:
measure: The changes of cycloplegic refractive errors
timeFrame: every 6 months for 2 years
Secondary outcomes:
measure: The changes of axial length
timeFrame: every 6 months for 2 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Optometry Clinic, School of Optometry, The Hong Kong PolyU
Study officials:
affiliation: School of Optometry, The Hong Kong PolyU
name: Carly SY Lam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam CS, Tang WC, Tse DY, Tang YY, To CH. Defocus Incorporated Soft Contact (DISC) lens slows myopia progression in Hong Kong Chinese schoolchildren: a 2-year randomised clinical trial. Br J Ophthalmol. 2014 Jan;98(1):40-5. doi: 10.1136/bjophthalmol-2013-303914. Epub 2013 Oct 29.
Clinical trial NCT01461434: Graz Study on the Risk of Atrial Fibrillation
Official title: Randomized Controlled Trial to Evaluate Implanted Event Recorders for the First Diagnosis of Atrial Fibrillation in High-risk Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Hypertension
Diabetes
Chronic Heart Failure
Vascular Disease
Keywords: atrial fibrillation
biomarkers
stroke prevention
implantable loop recorder
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2011-10-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation (AF) is the most common clinical arrhythmia. AF is associated with increased risk for stroke due to blood clots formed in the fibrillating atria. Some patient characteristics increase the likelyhood of AF and at the same time the risk of stroke when AF has developed. To reduce the risk of stroke, anticoagulation therapy is recommended in patients with AF and risk factors (such as high blood pressure, diabetes, vessel disease). However, occasional (paroxysmal) AF may occur without symptoms and remain undetected, leaving patients at risk.

Aim of the prospective randomized study is to compare two management strategies for patients at increased risk for AF but without a known history of AF. Patients are seen regularly (monthly, then quarterly) for follow-up (incl. ECG recording and blood sample). One group of patients additionally receives a subcutaneous implantation of a loop recorder for continuous rhythm monitoring, while the control group remains on standard follow-up. Observation period is one year (optional extension for 3 years). The time to first diagnosis of AF is compared between groups, blood samples are analyzed for potential biomarkers of AF.


Eligibility criteria: Inclusion Criteria:

* CHA2DS2-VASc risk score \>= 4\*
* 18 years or older

Exclusion Criteria:

* known history of atrial fibrillation
* implanted rhythm device
* pre-existing indication for oral anticoagulation

(\*)CHA2DS2-VASc: C - chronic heart failure (1 point); H - hypertension (1 point); A - age \>= 75 years (2 points); D - diabetes (1 point); S - stroke (2 points); V - vascular disease (1 point); A - age \>=65 and \< 75 years (1 point); Sc - sex category (female) (1 point) ;

Primary outcomes:
measure: Time to first diagnosis of atrial fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Time to change in therapy based on the diagnosis of atrial fibrillation
timeFrame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
measure: Hospitalizations
timeFrame: 12 months
measure: Change in NTproBNP serum level associated with occurrence of atrial fibrillation
timeFrame: Baseline (0 months), 1,2,3,4,5,6,9 and 12 months
measure: Death
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH/Uniklinikum - Klinische Abteilung für Kardiologie
Study officials:
References:
Clinical trial NCT00368134: To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes
Official title: A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Vildagliptin
HbA1c
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 370
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.


Eligibility criteria: Inclusion Criteria:

* Diagnosis as Type 2 Diabetes
* Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
* Outpatients

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
* Significant heart diseases
* Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in HbA1c after 12 weeks
Secondary outcomes:
measure: Change in FPG after 12 weeks
measure: Change in Fasting Lipids after 12 weeks
measure: Change in HOMA-IR after 12 weeks
measure: Change in HOMA-B after 12 weeks
measure: Safety Profile after 12 weeks treatment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02528617: The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher Disease
Official title: The Effect of Velaglucerase Alfa (Vpriv) on Skeletal Development in Pediatric Gaucher Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Gaucher Disease Type 1
Gaucher Disease Type 3
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Texas Scottish Rite Hospital for Children
First posted: 2015-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the effect of Velaglucerase Alfa on skeletal bone development of children with Type 1 or Type 3 Gaucher Disease. In addition, the natural history and neurological status of children with Type 3 Gaucher Disease will be studied.


Eligibility criteria: Inclusion Criteria:

* Enzyme Replacement Therapy naive,
* confirmed diagnosis of Gaucher disease type 1 or 3,
* able to travel to Dallas, Texas 1x per year for baseline plus 3 consecutive years,
* able to tolerate all study procedures,
* skeleton not fully formed as confirmed by DXA and MRI),
* and willing to receive velaglucerase alfa infusions every other week for the duration of the study.

Exclusion Criteria:

* Clinically unstable,
* taking or have taken bisphosphonates,
* Gaucher type 2,
* pregnant female,
* or deemed inappropriate for participation by the principal investigator.

Primary outcomes:
measure: Change in Z-scores from baseline in Skeletal Bone Mineral Density by Duel-energy X-ray absorptiometry (DXA) in children with Gaucher Disease type 1 and 3 receiving velaglucerase alfa.
timeFrame: Baseline pre-intervention and yearly thereafter for 3 years
Secondary outcomes:
measure: Change in degrees/second from baseline in saccadic eye movements in children with Gaucher type 3 receiving velaglucerase alfa.
timeFrame: Baseline pre intervention and yearly thereafter for 3 years
measure: Change from baseline neurodevelopmental testing normalized scores in children with Gaucher Disease type 3 receiving velaglucerase alfa.
timeFrame: Baseline pre intervention and yearly thereafter for 3 years
measure: Change from baseline brainstem auditory evoked potential results measured in microvolts in children with Gaucher Disease type 3 receiving velaglucerase alfa.
timeFrame: Baseline pre-intervention and yearly thereafter for 3 years
measure: Change from baseline EEG (electroencephalogram) results measured in Hertz in children with Gaucher Disease type 3 receiving velaglucerase alfa.
timeFrame: Baseline pre-intervention and yearly thereafter for 3 years.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
Study officials:
affiliation: Baylor Research Institute/Institute of Metabolic Disease
name: Raphael Schiffmann, M.D.,M.H.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02246517: The Effect of N2O on Chronic Neuropathic Pain Patients
Official title: The Effect of N2O on Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neuropathic Pain
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.).

Detailed description: Important pharmacological agents for treatment of chronic neuropathic pain such as ketamine block NMDA receptors. Nitrous oxide, an inhalant agent used extensively In anesthesia, also have antagonist property of NMDA receptors. The investigators hypothesize that prolonged treatment with N2O can alleviate chronic neuropathic pain of different causes (e.g. diabetic neuropathy, post herpetic neuralgia etc.). In order to examine our theory we Will recruit 40 patients aged 18-65 that suffer from chronic neuropathic pain. The patients will be divided to two groups of which half will receive treatment with N2O and half with placebo (pure O2) as a repeated weekly treatment for 4 weeks. At the beginning of the each session the patient will be asked to fill questionnaires regarding their pain quality and severity

Eligibility criteria: Inclusion Criteria:

* men and women at the age 18-65
* patient that suffer from chronic neuropathic pain
* VAS\>40
* DN4 score \>4
* takes pain medication on a regular basis
* Didn't get epidural injection for the pas month
* signed an informed consent form

Exclusion Criteria:

* patients that suffer from chronic lung disease.
* patients with cancer
* patients with heart disease
* pregnant and lactate woman
* patients that suffer from depression

Primary outcomes:
measure: change in adult pain as measured by visual Analog Scale for Pain (VAS Pain)
timeFrame: baseline and average of week for 4 weeks
Secondary outcomes:
measure: change in adult pain as measured by Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: baseline and average of week for 4 weeks
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pain Medicine Unit
Study officials:
References:
Clinical trial NCT05843617: Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
Official title: Comparison of Bioavailability of Liposomal and Traditional Formulation of Vitamin C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability of Vitamin C
Keywords: Ascorbic Acid
Liposomal Vitamin C
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Warsaw
name: Medical University of Gdansk
First posted: 2023-05-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim of the study was to compare the profiles of vitamin C serum concentration in healthy volunteers after the single oral administration either in a liposomal or traditional formulation.

Detailed description: The randomized, double-blind, cross-over study was conducted under the supervision of physician on a group of 10 healthy subjects. The volunteers received 1g of vitamin C in a traditional formulation (powder in capsules), and after 14 days of a washout period 1 gram of liposomal formulation (powder in capsules). Venous blood was collected from each participant of the study immediately before the administration of a studied substance and 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 24 hours post the administration.

Eligibility criteria: Inclusion Criteria:

* Women and men, 18-65 years old.
* Signed informed consent.
* No injuries or hospitalizations within the last 3 months.
* Refraining from consuming any vitamin C supplements or foods enriched with vitamin C for a period of 72 hours. Limiting excessive consumption of red peppers, parsley (stalks), Brussels sprouts, broccoli, turnip, tomatoes, cabbage, spinach, watercress, citrus fruits, and citrus juices. Not taking acetylsalicylic acid (aspirin, polopiryna, etopiryna) during the study.
* Participants should fast for at least 8-12 hours prior to the administration of the preparations.

Exclusion Criteria:

* Unwilling to give consent.
* Injuries within the last 3 months.
* Cancer (current or past).
* Renal dysfunction (eGFR \< 60 ml/min).
* Gastrointestinal disorders (including use of antacids).
* Tobacco use in any form.
* Pregnancy/breastfeeding.
* Patient after organ transplantation, after a stroke, use of anticoagulants, use of immunosuppressants.
* Female patient receiving hormonal therapy (contraception).

Primary outcomes:
measure: Total amount of ascorbic acid that has been absorbed, defined as AUC
timeFrame: baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
measure: Maximum concentration of ascorbic acid (Cmax)
timeFrame: baseline, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 24 hours post the administration
Secondary outcomes:
measure: Concentration of ascorbic acid after 24 hours (C24h)
timeFrame: 24 hours post the administration
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
References:
Clinical trial NCT00270517: Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia
Official title: A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Community Acquired Pneumonia
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2005-12-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia


Eligibility criteria: Inclusion Criteria:

* Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.
* Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact
* If female, must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

* Other infections
* Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy
* History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins
* Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality
* Requirement of parenteral antimicrobial therapy for treatment of pneumonia
* Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism
* Immunocompromised subjects

Primary outcomes:
measure: Clinical Cure 7-14 days after end of therapy
Secondary outcomes:
measure: Bacteriological response
measure: Radiographic response
measure: Change in signs and symptoms
measure: Safety
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Enanta Pharmaceuticals, Inc.
state: Massachusetts
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Study Director
role: STUDY_DIRECTOR
References: