louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06315829: Artificial Intelligence-based Video Analysis to Detect Infantile Spasms
Official title: A Machine Learning Approach to Infantile Spasms Recognition in Video Recordings
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infantile Spasms
Keywords: Seizure
Epilepsy
Infantile Spasm
Epileptic Spasm
West Syndrome
Hypsarrhythmia
Artificial Intelligence
Video Analysis
Computer Vision
Machine Learning
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 200
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the outpatient and inpatient settings of Johns Hopkins Hospital, an academic medical center located in Baltimore, Maryland offering tertiary and quaternary care.

Brief summary: Infantile spasms are a type of seizure linked to developmental issues. Unfortunately, they are often misdiagnosed, causing delays in treatment. The purpose of this study is to develop a computer program that can reliably differentiate infantile spasms from similar, yet benign movements in videos. This computer program will learn from videos taken by parents of study participants. Quickly recognizing and treating infantile spasms is crucial for ensuring the best developmental outcomes.


Eligibility criteria: Inclusion Criteria:

* Participant age less than 24 months
* Participant evaluated in the Johns Hopkins Outpatient Center, Johns Hopkins Pediatric Emergency Department or Johns Hopkins Inpatient Units due to spells of abnormal movement or seizure
* Participant evaluated by a pediatric neurologist during the outpatient or inpatient visit at Johns Hopkins Hospital
* At least one video recording of the spell of abnormal movement produced by the parent/guardian available for provider review

Exclusion Criteria:

* Poor video recording quality
* Entire patient is not in frame

Primary outcomes:
measure: Model Sensitivity (Recall)
timeFrame: 2 years
measure: Model Specificity
timeFrame: 2 years
measure: Model Positive Predictive Value (Precision)
timeFrame: 2 years
measure: Model Negative Predictive Value
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins Neurology
name: Eric Kossoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Biomedical Engineering
name: Rama Chellappa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01007929: Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects
Official title: An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: ADME
safety
oral solution
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-05
Enrollment: 4
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\] AZD1236 in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Non-smokers

Exclusion Criteria:

* Subjects who are exposed to radiation exposure as part of their occupation
* Subjects exposed to radiation levels above background of \>5 mSv in last year, \>10 mSv over last 5 years or a cumulative total of \> 1 mSv per year of life
* A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc

Primary outcomes:
measure: Pharmacokinetic profile. Concentration of AZD1236 in plasma
timeFrame: Before and after dosing
measure: Total Radioactivity
timeFrame: Before and after dosing
Secondary outcomes:
measure: Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination
timeFrame: Before and after dosing
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CPU Medical Director
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695929: Levosimendan in Congenital Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cardiovascular Defects
Low Cardiac Output Syndrome
Keywords: cardiac surgery with cardiopulmonary bypass
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2008-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support

Exclusion Criteria:

* Patients with renal and/or hepatic dysfunction
* Patients requiring inotropic support before their surgery
* Septic patients

Primary outcomes:
measure: serum lactate
timeFrame: 12 h postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint Luc
Study officials:
References:
citation: De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.
citation: Namachivayam P, Crossland DS, Butt WW, Shekerdemian LS. Early experience with Levosimendan in children with ventricular dysfunction. Pediatr Crit Care Med. 2006 Sep;7(5):445-8. doi: 10.1097/01.PCC.0000235251.14491.75.
citation: Turanlahti M, Boldt T, Palkama T, Antila S, Lehtonen L, Pesonen E. Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery. Pediatr Crit Care Med. 2004 Sep;5(5):457-62. doi: 10.1097/01.pcc.0000137355.01277.9c.
Clinical trial NCT00958529: Gastrointestinal Toleration of Inulin Products
Official title: Effect of Two Doses of Inulin Products on Gastrointestinal Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: fiber
inulin
gastrointestinal tolerance
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Cargill
First posted: 2009-08-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The intake of inulin products has been linked to multiple health benefits which has lead to inulin fortification in food products.

The investigators hypothesis that doses of up to 10 grams of inulin products should be well tolerated and not result in a significant increase in gastrointestinal symptoms.

Detailed description: 0, 5, and 10 grams of inulin

Eligibility criteria: Inclusion Criteria:

* english speaking
* healthy men and women
* 18 and 60 years of age
* non-smoking
* non-dieting
* BMI less than 30
* standard diet consisting of no more than 15 grams fiber
* not taking medications

Exclusion Criteria:

* BMI more than 30
* CVD
* Diabetes Mellitus
* cancer in prior 5 years
* renal or hepatic disease
* bacterial infection in past 2 weeks
* more than 5 kg weight loss in past 3 months
* history of drug or alcohol abuse in past 6 months
* use of weight loss, lipid-lowering, anti-hypertensive, or anti- inflammatory medications
* concurrent or recent intervention study participation
* consumption of laxatives
* history of gastrointestinal disorders
* food allergies
* pregnant or lactating women

Primary outcomes:
measure: Gastrointestinal Tolerance Score
timeFrame: Aug 2008 thru Oct 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota: Nutrition and Food Science Department
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Joanne L Slavin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226729: Associations Between Vision and Brain Function
Official title: Quantitative Assessment of the Vison Using Structural and Functional Indicators and Associations With Brain Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Vision; Disorder, Loss
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy children aged 3 to 12 years old. Patients who have been diagnosed with nervous system diseases were excluded.

Brief summary: Case-control studies and meta-analysis have reported that several ocular features, especially the thickness of the peripapillary retinal nerve fiber layer and visual acuity, are related to the brain degeneration and cognitive impairment. In our study, we aim to quantitatively assess ocular features using structural and functional indicators and define its associations with brain development and intelligence in children.


Eligibility criteria: Inclusion Criteria:

* age from 3 to 12 years old

Exclusion Criteria:

* diagnosed with nervous system disease before

Primary outcomes:
measure: the visual information processing function
timeFrame: recorded at enrollment
measure: best corrected visual acuity
timeFrame: recorded at enrollment
Secondary outcomes:
measure: refractive status
timeFrame: recorded at enrollment
measure: intraocular pressure
timeFrame: recorded at enrollment
measure: fundus picture
timeFrame: recorded at enrollment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen Univerisity
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04545229: VR for Pain Management During Adult Burn Dressing Change
Official title: Virtual Reality Distraction to Reduce Opioid Pain Medication Use During Adult Burn Dressing Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Burns
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2020-09-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-group RCT
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial to evaluate the efficacy of the VR-based Pain Alleviation Tool (VR-PAT) in reducing opioid pain medication use during adult burn dressing changes.

Detailed description: A pilot three group gender-balanced randomized clinical trial (RCT) among adult burn patients (18 years old or above) at OSU Medical Center Inpatient Burn Program. The intervention group will receive VR-PAT as a distraction tool during the dressing change procedure (active VR group) while the comparison groups will receive either a comparable passive VR distraction tool that uses the same hardware and visual/audio features, but requires no active interaction (Control Group 1), or no distraction at all (Control Group 2).

Eligibility criteria: Inclusion Criteria:

1. Adult burn patient age 18-70
2. First admission for acute burn requiring dressing change
3. First admission for burn injury
4. Using Opioids for dressing changes
5. Burn is ≤ 4 days post burn

Exclusion Criteria:

1. Severe burn(s) on the face/head preventing utilization of VR
2. Cognitive/motor impairment preventing valid administration of study measures
3. Unable to communicate in English
4. Prisoners and patients who were pregnant
5. Patients admitted to the ICU

Primary outcomes:
measure: Patient self-reported pain
timeFrame: During burn dressing changes
Secondary outcomes:
measure: Opioid medication utilization, morphine equivalent dose per day during inpatient hospital stay.
timeFrame: Each day during inpatient hospital stays up to 7 days.
Other outcomes:
measure: Patient VR experience
timeFrame: Subjective experience during burn dressing change, on average lasting 15-45 minutes.
measure: Nurse reported feasibility of VR in clinical burn wound care
timeFrame: Subjective observation of patient's utilization of VR during burn dressing change, on average lasting 15-45 minutes.
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: The Ohio State University/Nationwide Children's Hospital
name: Henry Xiang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armstrong M, Coffey R, Luna J, Xiang H. Pilot randomized clinical trial of virtual reality pain management during adult burn dressing changes: Lessons learned. PLOS Digit Health. 2023 Sep 25;2(9):e0000231. doi: 10.1371/journal.pdig.0000231. eCollection 2023 Sep.
Clinical trial NCT01699529: Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Official title: Multi-electrode Radiofrequency Renal Denervation System Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, non-randomized and open label feasibility study. The study is intended to evaluate safety and efficacy of multi-electrode radiofrequency renal denervation in patients with uncontrolled hypertension.


Eligibility criteria: Inclusion Criteria:

* Individual is ≥ 18 and ≤ 80 years old.
* Individual has an office systolic blood pressure of 160 mmHG or greater (≥ 150 mmHg for Type 2 diabetics) based on an average of 3 office/clinic blood pressure readings
* Individual is adhering to a stable medication regimen including ≥ 3 anti-hypertensive medications(preferred that one is a diuretic) for a minimum of two weeks prior to screening.

Exclusion Criteria:

* Individual has an estimated glomerular filtration rate (eGFR) of \< 45 mL/min/1.73 m2
* Individual has type 1 diabetes mellitus
* Individual requires chronic oxygen support or mechanical ventilation (e.g., tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
* Individual has primary pulmonary hypertension.
* Individual is pregnant, nursing or planning to be pregnant.

Primary outcomes:
measure: Acute safety as measured by procedural complications
timeFrame: 1 month
Secondary outcomes:
measure: Change in Office Systolic Blood Pressure
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Melbourne
country: Australia
facility: Epworth Hospital
state: Victoria
city: Wellington
country: New Zealand
facility: Wellington Hospital
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Robert Whitbourn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitbourn R, Harding SA, Walton A. Symplicity multi-electrode radiofrequency renal denervation system feasibility study. EuroIntervention. 2015 May;11(1):104-9. doi: 10.4244/EIJV11I1A18.
Clinical trial NCT01639729: Effect of Delivery Route on PK of Sufentanil NanoTab
Official title: Effect of Delivery Route on the Pharmacokinetics of Sufentanil NanoTab® in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: pharmacokinetics
area under curve
time to maximum concentration
Lead sponsor: Talphera, Inc
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Determine whether the amount of drug absorbed is different if the tablet is placed under the tongue, placed between the cheek and gum, or swallowed.


Eligibility criteria: Inclusion Criteria:

* body mass index 18 - 30

Exclusion Criteria:

* pregnant females
* smokers
* pulmonary disease
* sleep apnea

Primary outcomes:
measure: AUC (0 - Inf)
timeFrame: 24 hours
measure: Cmax
timeFrame: 24 hours
measure: Tmax
timeFrame: 24 hours
measure: CST 1/2
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA
state: Kansas
Study officials:
affiliation: Talphera, Inc
name: Pamela Palmer, M.D.
role: STUDY_DIRECTOR
References:
citation: Willsie SK, Evashenk MA, Hamel LG, Hwang SS, Chiang YK, Palmer PP. Pharmacokinetic properties of single- and repeated-dose sufentanil sublingual tablets in healthy volunteers. Clin Ther. 2015 Jan 1;37(1):145-55. doi: 10.1016/j.clinthera.2014.11.001. Epub 2014 Dec 24.
Clinical trial NCT04385329: Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
Official title: Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Keywords: Myofascial pain syndrome
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.


Eligibility criteria: Inclusion Criteria:

* Adult age (18 to 75 years) and written informed consent;
* Unilateral heel pain of four weeks or longer duration;
* Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
* Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
* Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.

Exclusion Criteria:

* No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
* No clinical signs of lumbar radiculopathy at physical examination;
* No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
* No previous fractures or surgery in the affected ankle and foot;
* No rheumatologic diseases, no plantar fibromatosis

Primary outcomes:
measure: Change in FFI-foot function index
timeFrame: FFI was administered at baseline, at two months time point and at three months time point
Secondary outcomes:
measure: Change in PPT-pressure pain threshold
timeFrame: PPT was recorded at baseline, at two months time point and at three months time point
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03444129: Pilot Evaluation of an Interactive Health Game
Official title: Pilot Evaluation of an Interactive Health Game Designed to Promote Healthy Eating and Physical Activity on Older Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Health Attitude
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Broad, diverse, and innovative efforts are needed to address the growing dual public health challenges of obesity and diabetes, especially for those at increased risk like minority older adults. The emerging field of health games offers an innovative opportunity to reach populations to provide healthy eating and physical activity messages. Little research has focused on the use of health games specifically tailored for older adults. This study builds upon a health game designed to provide knowledge, facilitate movement, enhance motivation, and encourage healthy eating (HE) and physical activity (PA) behaviors in youth. This study will adapt, implement, and evaluate the feasibility, acceptability, adherence, and preliminary outcomes of the game among overweight/obese African American older adults.


Eligibility criteria: Inclusion Criteria:

* Age between 50 and 65 years
* Overweight or obese (25kg/m2 ≤ BMI \< 40kg/m2)
* African American/Black by self-report
* Risk factors for diabetes (based on adapted ADA risk test)

Exclusion Criteria:

* Adults with cognitive impairments, based on the adapted Mental Status Questionnaire (MSQ).
* Health conditions that preclude participation in physical activity program, based on the Exercise Assessment and Screener for You (EASY) physical activity screener.
* Already diagnosed with diabetes by self-report
* Currently engaging in vigorous physical activity
* Non-English speaking
* Does not meet inclusion criteria

Primary outcomes:
measure: Eating habits
timeFrame: 6 weeks
measure: Physical activity patterns
timeFrame: 6 weeks
measure: Motivation
timeFrame: 6 weeks
Secondary outcomes:
measure: Weight
timeFrame: 6 weeks
measure: Adherence
timeFrame: 6 weeks
measure: Short International Physical Activity Questionnaire
timeFrame: 6 weeks
measure: MPP Acceptability Survey
timeFrame: 6 weeks
measure: MPP stages of change survey
timeFrame: 6 week s
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: UIC
name: Amparo Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Delaware
name: Laurie Ruggiero, PhD
role: PRINCIPAL_INVESTIGATOR
References: