louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03352492: Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
Official title: Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Angle-Closure
Lead sponsor: University of the Incarnate Word
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Paired eye
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.


Eligibility criteria: Inclusion Criteria:

* Angle-closure glaucoma
* Angle-closure glaucoma suspect

Exclusion Criteria:

* Monocular status
* Previous intraocular surgery
* Visual acuity worse than 20/40
* Prior episode of acute angle-closure glaucoma
* Pregnancy

Primary outcomes:
measure: Change in visual acuity
timeFrame: 30 days post-operative
Secondary outcomes:
measure: Change in Peli-Robson contrast sensitivity
timeFrame: 30 days post-operative
measure: Change in CSV-1000 contrast sensitivity
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of the Incarnate Word
state: Texas
Study officials:
affiliation: University of the Incarnate Word
name: Richard Trevino, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02721992: Graves' Orbitopathy and Hypercholesterolemia
Official title: A Prospective Study on the Association Between Graves' Orbitopathy and Hypercholesterolemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graves' Ophthalmopathy
Hypercholesterolemia
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off methimazole since two days to perform radioiodine treatment

Brief summary: The investigators have recently observed retrospectively that the occurrence of Graves' Orbitopathy in patients with Graves' disease is less frequent in patients with normal cholesterol levels, in line with another recent observation suggesting that statins play a protective role in Graves' patients from developing Graves' Orbitopathy. The present study is designed in order to investigate the possible association between Graves' Orbitopathy and high cholesterol level as well as the relation between Graves' Orbitopathy degree and high cholesterol level


Eligibility criteria: Inclusion Criteria:

1. Graves' disease with Graves' Orbitopathy
2. Graves' disease without Graves' Orbitopathy

Exclusion Criteria:

1. Previous treatment with radioiodine
2. Previous treatment with thyroidectomy

Primary outcomes:
measure: Relationship between LDL cholesterol levels and Graves' Orbitopathy
timeFrame: Baseline
Secondary outcomes:
measure: Relationship between LDL cholesterol levels and the activity of Graves' Orbitopathy
timeFrame: Baseline
measure: Relationship between LDL cholesterol levels and the severity of Graves' Orbitopathy
timeFrame: Baseline
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Ospedale Cisanello-Endocrinology I and II
Study officials:
References:
Clinical trial NCT02031692: Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in BPPV
Official title: Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Benign paroxysmal positional vertigo
Vitamin D
Calcium
Prevention
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2014-01-09
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the supplementation of vitamin D and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin D deficiency/insufficiency.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* brief episodes of vertigo induced by head motion
* a typical positioning nystagmus characteristic of BPPV
* no supplementation of vitamin D or calcium at the time of recruitment
* informed consent to participate in this study
* subject treated by repositioning maneuver

Exclusion Criteria:

* other identifiable disorders of the central nervous system
* supplementation of vitamin D or calcium at the time of recruitment
* pregnancy
* a history of an allergic reaction, or a medically significant adverse reaction to the investigational product
* contraindication to cholecalciferol and calcium carbonate

Primary outcomes:
measure: Recurrence frequency of benign paroxysmal positional vertigo
timeFrame: Up to 1 year
Secondary outcomes:
measure: Changes in serum 25-hydroxy vitamin D level
timeFrame: Up to 1 year
measure: Falling frequency
timeFrame: Up to year
measure: Fracture frequency
timeFrame: Up to 1 year
measure: Quality of life
timeFrame: Up to 1 year
measure: Recurrence rate of benign paroxysmal positional vertigo
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National Universtiy Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Ji-Soo Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong SH, Kim JS, Shin JW, Kim S, Lee H, Lee AY, Kim JM, Jo H, Song J, Ghim Y. Decreased serum vitamin D in idiopathic benign paroxysmal positional vertigo. J Neurol. 2013 Mar;260(3):832-8. doi: 10.1007/s00415-012-6712-2. Epub 2012 Oct 25.
citation: Jeong SH, Choi SH, Kim JY, Koo JW, Kim HJ, Kim JS. Osteopenia and osteoporosis in idiopathic benign positional vertigo. Neurology. 2009 Mar 24;72(12):1069-76. doi: 10.1212/01.wnl.0000345016.33983.e0.
citation: Jeong SH, Kim JS. Impaired Calcium Metabolism in Benign Paroxysmal Positional Vertigo: A Topical Review. J Neurol Phys Ther. 2019 Apr;43 Suppl 2:S37-S41. doi: 10.1097/NPT.0000000000000273.
Clinical trial NCT00231192: Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Official title: Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Adolescents
Cystic Fibrosis
Insulin
Repaglinide
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2005-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD in adolescents. In addition, successful treatment of CFRD with repaglinide will improve nutritional status, ameliorate declines in pulmonary function, and will not have a negative impact upon quality of life.

Detailed description: This study will test the hypothesis that oral repaglinide is equivalent to insulin in the treatment of new-onset CFRD. This hypothesis will be tested using the following aims:

Specific Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon blood glucose (BG) and insulin excursion during an oral glucose tolerance test.

Specific Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon BG as measured by continuous glucose monitoring, fasting BG, 2-hour post-prandial BG, hemoglobin A1C, and serum fructosamine.

Secondary Aim 1: To determine the effect of three months of repaglinide and insulin treatment upon weight, body mass index, and lean body mass in adolescents with new-onset CFRD.

Secondary Aim 2: To determine the effect of three months of repaglinide and insulin treatment upon pulmonary function in adolescents with new-onset CFRD.

Secondary Aim 3: To determine the effect of three months of repaglinide and insulin treatment upon quality of life in new-onset CFRD.

Eligibility criteria: Inclusion Criteria:

Cystic Fibrosis, Blood glucose concerning for diabetes -

Exclusion Criteria:

Known Cystic Fibrosis-Related Diabetes, Liver Disease, FEV1\<40%

-

Primary outcomes:
measure: blood glucose
measure: insulin excursion during oral glucose tolerance test
measure: fasting blood glucose
measure: 2-hour post-prandial blood glucose
measure: hemoglobin A1C
measure: serum fructosamine
Secondary outcomes:
measure: weight
measure: body mass index
measure: lean body mass
measure: pulmonary function
measure: quality of life
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Andrea Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06538792: Proprioception, Muscle Strength and Kinesiophobia After Anterior Cruciate Ligament Reconstruction
Official title: Effect of Proprioception and Muscle Strength on Kinesiophobia After Anterior Cruciate Ligament Reconstruction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone ACL reconstruction surgery will be recruited from the Department of the Orthopaedics and Traumatology, Bezmialem Vakıf University Hospital.

Brief summary: Fear of re-injury after anterior cruciate ligament reconstruction surgery (ACLR) affects individuals' return to sports and physical activity negatively. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Detailed description: Factors such as graft type, patient age, activity level and athletic experience, as well as psychological factors such as psychological readiness for return to sports, fear of re-injury, and motivation during the rehabilitation process, affect returning to sports after ACLR. Fear is a psychological reaction that occurs after injury and is clearly seen during the period when athletes continue to actively participate in sports. Individuals' confidence in their knees and pain after surgery affect their fear of movement.

While kinesiophobia provides benefits in protecting injured body parts in the acute phase of pain, it can lead to inactivity, emotional stress and risk of re-injury in the long term. Kinesiophobia changes the biomechanics of movements and pain perception. Insufficient muscle strength and instability in the knee negatively affect confidence in the knee. The aim of this study is to evaluate the effects of proprioception and muscle strength on kinesiophobia in patients who have undergone anterior cruciate ligament reconstruction surgery.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-35
* History of ACL reconstruction surgery at least 6 months ago

Exclusion Criteria:

* History of previous lower extremity surgery
* History of lower extremity injury within the last 6 months
* Having a vestibular or neurologic pathology that would affect balance

Primary outcomes:
measure: Kinesiophobia
timeFrame: Baseline
measure: Joint position sense
timeFrame: Baseline
measure: Muscle strength
timeFrame: Baseline
measure: Dynamic stability
timeFrame: Baseline
Secondary outcomes:
measure: Return to sports after ACL injury
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Kubra Alpay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277092: Near Infrared Light in Paediatric Blood Drawing Centre
Official title: Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Drawing Procedure
Keywords: Child, blood drawing procedure, near Infrared light
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2017-09-08
Enrollment: 115
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.

The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.


Eligibility criteria: Inclusion Criteria:

* subjects accessing the outpatient blood-drawing service

Exclusion Criteria:

* application of topical anaesthetic cream

Primary outcomes:
measure: Time to perform the procedure
timeFrame: Intraprocedural
Secondary outcomes:
measure: Success at first attempt
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: IRCCS Burlo Garofolo
Study officials:
affiliation: IRCCS Burlo Garofolo
name: Egidio Barbi, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Conversano E, Cozzi G, Pavan M, Minute M, Gortan E, Montico M, Vecchi Brumatti L, Ronfani L, Barbi E. Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure. Ital J Pediatr. 2018 May 25;44(1):60. doi: 10.1186/s13052-018-0501-1.
Clinical trial NCT04685044: Testing a 32-channel Transmit/Receive MRI Head Array
Official title: Testing the IH 1Tx32Rx Head Array, a 32-channel Transmit/Receive Radiofrequency (RF) Array
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Magnetic resonance imaging (MRI) is a diagnostic tool in medicine that generates high quality images of the human body without the use of x-rays. Volunteers will be asked to participate in a study to evaluate improved MRI hardware that can be used to enhance the ability of MRI as a diagnostic tool. Specifically, this hardware is designed to acquire high quality images of the brain. This MRI hardware will eventually be integrated into a positron emission tomography (PET) system, which will be able to detect trace amounts of brain disease and/or brain function simultaneously with MRI. The combined system is known as a PET/MRI. For the purposes of this test, the investigators are just evaluating the MRI hardware, which will be installed in a plastic mockup of the PET system.


Eligibility criteria: Inclusion Criteria:

* 18-75 years old
* Must be able to give consent
* Must complete the MRI screening questionnaire

Exclusion Criteria:

* Contraindications to MRI procedure

Primary outcomes:
measure: Quantitative equivalence or improvement of MRI image quality relative to the current mMR Array
timeFrame: 1 year
Secondary outcomes:
measure: Qualitative equivalence or improvement of MRI image quality relative to the current mMR
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care, London
state: Ontario
Study officials:
References:
Clinical trial NCT01355744: Swiss Study on Spider Bites
Official title: Swiss Study on Spider Bites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spider Bite
Keywords: humans
insect bites
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2011-05-18
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every person with a suspected spider and treated by a Swiss Physician.

Brief summary: About spider bites in Middle Europe, there are published only a dozen cases. The investigators suspect that they may be much more frequent than reflected by the literature analysis (but much less dangerous than thought by people). From June 1st 2011 to November 30st 2012 the investigators collect clinical data on patients treated for spider bites in Switzerland.

Detailed description: Inclusion criteria: Every human treated for suspected spider bite in Switzerland willing to participate this study.

Eligibility criteria: Inclusion Criteria:

* adult or child treated for a suspected spider bite in Switzerland

Exclusion Criteria:

* unwillingness to participate to the study

Primary outcomes:
measure: Clinical follow up of bite lesions.
timeFrame: 14 days (or more if necessary)
Secondary outcomes:
measure: Time spread of spider bites
timeFrame: 18 months
measure: Causative animals
timeFrame: 18 months
Other outcomes:
Locations:
city: Steinach
country: Switzerland
facility: Praxis Dr. med. Markus Gnaedinger
state: SG
Study officials:
affiliation: Department of General Practice University Hospital Zurich
name: Markus P. Gnädinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gnadinger M, Nentwig W, Fuchs J, Ceschi A. Swiss prospective study on spider bites. Swiss Med Wkly. 2013 Sep 4;143:w13877. doi: 10.4414/smw.2013.13877. eCollection 2013.
Clinical trial NCT01403844: Carotenoid Response to the Intake of Vegetables and Fruits
Official title: Skin Carotenoid Response to Intake of Vegetables and Fruits Recommended by the Dietary Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resonance Raman Spectroscopy for Dietary Carotenoid Intake
Keywords: resonance Raman spectroscopy
Dietary Guidelines
fruits
biomarkers
carotenoids
MyPlate
vegetables
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2011-07-27
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.

Detailed description: This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 - 65 years
* Weight stable (±5 lbs) for at least 2 months prior to the start of the study
* Body mass index (BMI) between 19-30 kg/m2
* Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
* Willing to maintain baseline weight and physical activity levels

Exclusion Criteria:

1. BMI greater than 30.
2. Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
3. Current smoker
4. Allergies or intolerances to foods to be utilized in the study
5. Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
6. Pregnancy or lactating

Primary outcomes:
measure: Serum and skin levels of carotenoids in adults fed a high carotenoid diet
timeFrame: 28 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: James Roemmich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jahns L, Johnson LK, Mayne ST, Cartmel B, Picklo MJ Sr, Ermakov IV, Gellermann W, Whigham LD. Skin and plasma carotenoid response to a provided intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. 2014 Sep;100(3):930-7. doi: 10.3945/ajcn.114.086900. Epub 2014 Jul 9.