louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01493609: A Clinical Trial of a New Computer Based Intervention for Children With Autism.
Official title: Computer Learning in Children - the Edinburgh Autism Social-attention Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Autism Spectrum Disorder
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
name: Newcastle University
First posted: 2011-12-16
Enrollment: 54
Sex: ALL
Minimum age (years): 15
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The CLICK-EAST research project is an investigation of the efficacy of a computer based learning programme which aims to teach the fundamental components of social attention to young children with autism spectrum disorder (ASD). "Social attention" describes the process of choosing to look at or listen to social information in the world, normally in preference to any other available information. Social information normally refers to people: for example, we notice human voices more than birdsong or traffic noise, even if the latter is louder. As a rule, children with ASD are less likely to prioritise this kind of social information. This is thought to have a significant effect on their development and behaviour. For example, a child who doesn't listen to what his parents say may be very slow to learn language, and may also fail to follow important instructions. Our goal is to create a new learning programme, in the form of an enjoyable computer game, which encourages children to practise the skills of looking at and listening to people, despite the presence of distracting information. The investigators will develop the game with the input of an advisory group of parents and teachers of children with ASD as well as some young adults with an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers with ASD and their families, in order to determine whether the game is having a positive effect on the children's abilities.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of core autism
* aged between 15 months and 5 years, 11 months.
* minimum nonverbal age equivalent of 15 months.

Exclusion Criteria:

* Children with epilepsy whose developmental progress may be impeded
* families with little knowledge of the English language such that their understanding of the information sheets and instructions accompanying the trial is limited. Unfortunately funding is not available for the provision of translators or translated materials.

Primary outcomes:
measure: Autism Diagnostic Observation Schedule - Change (ADOS-C)
timeFrame: approx 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Midlothian
city: Edinburgh
country: United Kingdom
facility: Clinical Research Facility, Royal Hospital for Sick Children
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Sue Fletcher-Watson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00935909: Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
Official title: Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IV Cannulation
Keywords: IV cannulation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Luminex Corporation
name: Outcomes Research Consortium
First posted: 2009-07-09
Enrollment: 603
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The floor patients meeting the inclusion/exclusion criteria that need an IV

Brief summary: The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.

Detailed description: A single initial data page will be filled out by one of the study team members present with the IV Team at the time of the cannulation. The data from these forms will be entered by the investigator or research assistant into a database maintained only for this study. There will be two groups in this randomized study. One group will receive IV cannulation with the VV and the second group will receive standard cannulation without the VV. The chance of receiving either treatment is based on randomly generated computer codes, unknown by the IV team. We want to evaluate successful IV cannulation on first attempt as well as the time taken for cannulation. All documents will be de-identified of data that contains HIPAA protected health information (PHI) at the end of the study. We estimate approximate enrollment to be 790 children. The study is expected to last 12 months and will only be conducted at Children's Medical Center Dallas.

Eligibility criteria: Inclusion Criteria:

* Patients age 0-18 requiring IV cannula (ASA 1-4) with a modified DIVA score ≥ 2 at the time of assessment

Exclusion Criteria:

* Patients with visible veins will be excluded from the study as well as patients with known difficult IV access which are scheduled for PICC line placement.

Primary outcomes:
measure: Successful IV cannulation on the first attempt
timeFrame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
Secondary outcomes:
measure: Total time to successful IV cannulation
timeFrame: Time of cannulation will be measured from the application of the tourniquet until successful IV cannulation.
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
Study officials:
affiliation: UT Southwestern
name: Peter Szmuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01032109: Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration
Official title: Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Lead sponsor: Kumamoto University
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 45
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 12-month results of two single initial treatments-photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab-for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

* choroidal neovascularization caused by age-related macula degeneration
* no previous treatment
* a follow-up at least 12 months
* a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

* choroidal neovascularization caused by other eye diseases
* ocular surgery within the past 3 mouths
* history of uveitis
* intraocular pressure higher than 25 mmHg, or glaucoma
* history of systemic or ocular thromboembolic events.

Primary outcomes:
measure: Visual acuity
timeFrame: The comparison between baseline and 12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Kumamoto
country: Japan
facility: Department of Ophthalmology and Visual Science, Graduate School of Medical Sciences, Kumamoto University
Study officials:
affiliation: Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
name: Takahiro Kawaji, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.
Clinical trial NCT02778009: Fit Physicians: Use of Activity Monitors and Activity Integration Program in First Year Medical Students
Official title: Fit Physicians: A Novel Physical Activity Integration Program to Improve Fitness and Activity in Medical Students: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Activity
Body Weight Changes
Keywords: Medical student
Activity Monitor
Medical school
Fitness
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using FitBit activity monitors, physical activity levels will be monitored in first year medical students. Body Composition will be measured as well.

Detailed description: Using fitness trackers and exercise testing, it will determine if participating in a novel program that incorporates wellness into the academic term will improve fitness.

An estimate, 120 students will enroll in this study. Men and women aged 18-55 years of age that are just entering medical school. Students who are currently pregnant will not be allowed to participate in this study.

Participation will involve 2 visits at the start of the academic school year, and two visits at the end of the academic school year.

These visits will entail you undergoing a body composition scan measured by an duel energy x-ray absorptiometry (iDEXA) machine. The scan takes approximately 15 minutes. Subjects may be asked to perform an exercise stress test on a treadmill. The exercise test is approximately 40 minutes. Subjects may be asked to participate in a fitness program 2x a week, and may be asked to wear a Fitbit Flex™ activity tracker on the wrist for the duration of the school year. Investigators will be accessing academic grades to use for statistical purposes only. Subject names will never be given to any other party other than the investigators involved.

Eligibility criteria: Inclusion Criteria:

* First year medical students
* Must have smartphone

Exclusion Criteria:

* Medical conditions that prohibit exercise
* pregnancy

Primary outcomes:
measure: Steps per day measured daily by FitBit Flex
timeFrame: 10 months
Secondary outcomes:
measure: Body Mass Composition assessed by iDEXA scan
timeFrame: 10 months
measure: Academic Performance assessed by numeric grade point average
timeFrame: 10 months
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: NYIT College of Osteopathic Medicine
name: Brian Harper, MD
role: STUDY_CHAIR
References:
citation: DiFrancisco-Donoghue J, Jung MK, Stangle A, Werner WG, Zwibel H, Happel P, Balentine J. Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. Prev Med Rep. 2018 Sep 11;12:122-127. doi: 10.1016/j.pmedr.2018.09.004. eCollection 2018 Dec.
Clinical trial NCT01996709: Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Official title: Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: Silicone hydrogel contact lenses
Multi-purpose solution
Lid Papillae
Palpebral Roughness
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-11-27
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.


Eligibility criteria: Inclusion Criteria:

* Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
* Symptoms of contact lens discomfort as defined by the protocol.
* Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
* Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Extended (over-night) contact lens wearer.
* Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
* Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
timeFrame: Baseline (Day 0), Day 90
Secondary outcomes:
measure: Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
timeFrame: Day 90
measure: Mean Frequency Score for Symptoms of Grittiness at Day 90
timeFrame: Day 90
measure: Mean Frequency Score for Symptoms of Dryness at Day 90
timeFrame: Day 90
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Lisa Zoota, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT01527656: Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Subjects
Official title: Single-Centre, Randomised, Balanced, Double-Blind, Cross-Over Trial Investigating the Bioequivalence of Formulation 2 and Formulation 4 of Biphasic Insulin Aspart 70 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the bioequivalence of two formulations of biphasic insulin aspart 70 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination, as judged by the investigator
* Body Mass Index (BMI) between 19.0-30.0 kg/m\^2
* Glycohemoglobin (HbA1c) within laboratory normal range
* Non-smokers

Exclusion Criteria:

* Clinically significant abnormal haematology, biochemistry, urinalysis or ECG (electrocardiogram) screening tests, as judged by the investigator
* Liver enzyme values (ALAT and ASAT) exceeding 2 times the upper reference limit according to the local laboratory
* A history of any illness that, in the opinion of the Investigator and/or Sponsor, might confound the results of the trial or pose additional risk in administering the investigational product to the subject
* History of or current addiction to alcohol or drugs of abuse as determined by the investigator (positive urine drug screen and breath alcohol screen)
* HIV (human immunodeficiency virus), Hepatitis B or C positive
* Subjects with a first-degree relative with diabetes mellitus
* A history of multiple and/or severe allergies to drugs or foods or a history of anaphylactic reactions
* Known or suspected allergy to trial product or related products
* Smoking during the past three months

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-16 hours
measure: Cmax, maximum insulin aspart concentration
Secondary outcomes:
measure: tmax, time to maximum insulin aspart concentration
measure: Area under the insulin aspart curve
measure: Mean residence time (MRT)
measure: t½, terminal half-life
measure: Incidence of hypoglycaemic events
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hanefeld M, Fischer S, Julius U, Schulze J, Schwanebeck U, Schmechel H, Ziegelasch HJ, Lindner J. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up. Diabetologia. 1996 Dec;39(12):1577-83. doi: 10.1007/s001250050617.
Clinical trial NCT00894556: A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine (0462-087)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Crossover Trial to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg for the Treatment of Acute Migraine in Sumatriptan Non-Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Keywords: Treatment of acute migraine with or without aura in adults
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to provide evidence supporting the benefit of Rizatriptan in patients who have an inadequate response to sumatriptan.


Eligibility criteria: Inclusion Criteria:

* Patient has a history of migraine with or without aura for 1 year or more with 2-8 moderate or severe migraine attacks per month
* Patient generally does not respond to treatment with sumatriptan
* Patient of reproductive potential agrees to remain abstinent or use one method of highly effective birth control (i.e. IUD, condoms, hormonal contraceptive, diaphragm, vasectomy) for the duration of the study
* Patient is able to complete paper diary

Exclusion Criteria:

* Patient is pregnant or breast feeding or excepts to become pregnant during the study
* Patient has history of mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours
* Patient has basilar or hemiplegic migraines
* Patient is unable to distinguish between migraine attacks from other types of headaches
* Patient has more than 15 headache-days per month
* Patient was greater than 50 years old at age of migraine onset
* Patient has failed to respond to 3 or more triptans
* Patient has a repeated history of failing to respond to or tolerate rizatriptan
* Patient uses opioids as primary migraine therapy
* Patient uses daily opioids
* Patient has a history of Cerebrovascular Accident (CVA) or other significant cardiovascular disease
* Patient has uncontrolled hypertension
* Patient has a history of neoplastic disease
* Patient is taking a serotonin reuptake inhibitor (SSRI or SNRI) where the dose has changed 3 months prior to screening
* Patient has a history of drug or alcohol abuse

Primary outcomes:
measure: Pain Relief (PR)
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Pain Freedom (PF)
timeFrame: 2 hours post dose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Seeburger JL, Taylor FR, Friedman D, Newman L, Ge Y, Zhang Y, Hustad CM, Lasorda J, Fan X, Hewitt D, Ho T, Connor KM. Efficacy and tolerability of rizatriptan for the treatment of acute migraine in sumatriptan non-responders. Cephalalgia. 2011 May;31(7):786-96. doi: 10.1177/0333102410390399. Epub 2010 Nov 15.
Clinical trial NCT06232356: Screening for Lung Health by a Mobile Device
Official title: Respiratory Health Screening Using a Mobile Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Diseases
COPD
Keywords: Spirometry
Lead sponsor: SEPAR- EPOC
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of adult subjects (healthy or with respiratory disease - COPD) between 18 and 80 years of age, who will be enrolled in the pulmonary function laboratories of the participating hospitals, from among those listed above, who are attended to a functional respiratory examination.

Brief summary: Respiratory diseases are a common cause of mortality and disability at the worldwide and national levels. Many of them are characterized by underdiagnosis and diagnosis in advanced stages of the disease, and in most of them, forced spirometry is one of the fundamental tools to assess the diagnosis and seriousness of the disease.

To help in improving the detection of respiratory diseases and the understanding of the respiratory health of the general population, one possible solution would be to develop a mobile application that could assess respiratory health by using the sound signal of exhaled air recorded by a mobile microphone.

This project will aim to validate a mobile application (WebApp) for the detection of pulmonary function disorders. It is planned to recruit 267 subjects, with and without respiratory disease, who are attended in pulmonary function laboratories of 10 Spanish hospitals, to compare the sensitivity of this application in the diagnosis of pulmonary function disorders (either obstructive patterns or PRISm) versus the gold standard (spirometry). Ease of use and user satisfaction with the application will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Adult subjects with age range between 18 and 80 years old
* Signing the informed consent form
* Subjects scheduled for respiratory function tests at the pulmonary function laboratory for clinical reasons
* Having a cell phone and be willing to install the application

Exclusion Criteria:

* Contraindication to perform any of the protocol procedures
* Inability to answer the study questionnaires.

Primary outcomes:
measure: Main Outcome
timeFrame: At the time of assessment
Secondary outcomes:
measure: Secondary Outcome
timeFrame: At the time of assessment
measure: Secondary Outcome
timeFrame: At the time of assessment
measure: Secondary Outcome
timeFrame: At the time of assessment
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: