louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02673411: Ultrasonography SWE for Hepatic Fibrosis Evaluation
Official title: Diagnostic Performance of Shear Wave Elastography for Fibrosis Evaluation: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis
Keywords: elastography
ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to undergo liver resection or liver biopsy (n=138). Volunteers who agree to undergo US shear wave elastography (n=20) to determine inter-observer agreement.

Brief summary: The purpose of this study is to measure diagnostic performance of ultrasound shear wave elastography to detect advanced hepatic fibrosis.

Detailed description: Hepatic fibrosis causes liver dysfunction and HCC. Since hepatic fibrosis is reversible dynamic condition, its monitoring is important to predict long term outcome and to determine treatment plan.

The reference of standard to diagnose hepatic fibrosis is biopsy, but recently non-invasive method such as stiffness imaging has been drawing a lot of attention. In this study, ultrasound shear wave elastography will be performed and its diagnostic performance to detect advanced hepatic fibrosis (= \> F2) will be measured using histologic grade as a reference.

Eligibility criteria: Inclusion Criteria:

* volunteers who agree to undergo US shear elastography OR
* patients with chronic liver disease who are scheduled to undergo liver resection or liver parenchymal biopsy.

AND

* = or \> 18 years
* sign informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: diagnostic performance to detect advanced hepatic fibrosis
timeFrame: 1 month
Secondary outcomes:
measure: interobserver agreement of ultrasound SWE
timeFrame: 1 day
measure: agreement with MR elastography
timeFrame: 1 month
measure: Technical success rate
timeFrame: 6 months
measure: Reliable measurement rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong Min Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774211: Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.
Official title: Prospective Prevalence and Validation Study of Pediatric Intensive Care Delirium.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Delirium
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2021-03-01
Enrollment: 141
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric intensive care patients

Brief summary: Pediatric delirium (PD) is a poorly investigated clinical problem that needs to be further explored in a Danish context. Children are at risk of discomfort and suffering if they experience delirium. The condition is associated with prolonged mechanical ventilation, longer hospital stay, increased mortality, and risk of long-term cognitive impairment. Therefore, it is important to assess critically ill children with a validated tool to enable early detection and management of the condition. In this study, the investigators will determine the prevalence of pediatric intensive care delirium. To this end, the investigators will validate the Sophia Observation withdrawal Symptoms - Pediatric delirium scale (SOS-PD) for patient assessment.

Detailed description: Prospective prevalence and validation study of pediatric intensive care delirium.

Aim: To validate the SOS-PD assessment tool and determine the prevalence of delirium in children aged 3 months to 18 years in a Danish context.

Data analysis and power calculation: With 140 patients, the accuracy estimate in this study will have a 95% confidence interval of +/- 5%. Accuracy defined as (true positive + true negative) / all x 100 is expected to be 90%. The validity of the SOS-PD assessment tool is calculated from standard definitions of sensitivity, specificity, positive predictive value and negative predictive value. The prevalence is calculated in percent. All data will be entered and encoded in RedCap and exported to SPSS for statistical analysis of data.

Eligibility criteria: Inclusion Criteria:

* Pediatric intensive care patients
* Length of stay of 48 hours or more

Exclusion Criteria:

* Non Danish speaking
* Use of neuromuscular blocking agents
* sedation level at COMFORT behavior score \> 11 or Richmond Agitation Sedation Scale \> -3

Primary outcomes:
measure: Prevalence of delirium in children aged 3 months -18 years of age
timeFrame: The observation period is 24 hours
Secondary outcomes:
measure: Validation of the Sophia Observation Withdrawal Symptoms - Pediatric Delirium scale (SOS-PD) assessment tool in to a Danish context.
timeFrame: The observation period is 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Suzanne Forsyth Herling
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05703711: Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Official title: Combining mHealth and Nurse-delivered Care to Improve the Outcomes of People With Serious Mental Illness in West Africa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychosis
Mania
Depression
Keywords: mHealth
Psychosis
Mania
Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In West Africa, most people with serious mental illness receive care from traditional or faith healers at prayer camps. The stepped-wedge cluster randomized trial aims to evaluate the effectiveness of a dual-pronged intervention package comprised of a mobile health program designed to train healers to deliver evidence-based psychosocial interventions combined with pharmacotherapy delivered directly to the patients at their prayer camps via a visiting nurse in Ghana.

Detailed description: The study involves deployment of an intervention in Ghanian prayer camps where traditional and faith healers provide care for people with mental illness. The intervention has two components: a visiting nurse that provides medications to patients staying at the prayer camps combined with a smartphone app called M-Healer that is used by the staff working at the camps. The app is designed to provide them with training on how to deliver some psychosocial interventions, monitor the health and well-being of their patients, and protect human rights at the camps.

The stepped-wedge cluster randomized study design involves all participant groups beginning the trial receiving enhanced usual care with random sequential crossover of groups to the experimental condition until all groups have been exposed to the full intervention. Throughout the study, participant data will be collected at baseline, mid-treatment, and post-treatment. Following study completion, the intervention will be evaluated by comparing changes in psychiatric symptoms of participants from baseline to post-treatment.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Speaks Twi or English
* Current inpatient staying at a study prayer camp
* A diagnosis of psychosis, mania, or depression

Exclusion Criteria:

* Serious physical illness or in need of urgent medical attention

Primary outcomes:
measure: Psychiatric symptoms
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Depressive symptoms
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00883311: A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
Official title: A Clinical Usage Study to Evaluate the Safety and Efficacy of BRT-FC-83C in the Management of Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Efficacy
Lead sponsor: Biomed Research & Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether the topical application of BRT-FC-83C is effective in the treatment of mild to moderate atopic dermatitis.

Detailed description: Atopic dermatitis is a common skin disease. BRT-FC-83C is a skin cream that does not contain corticosteroids or other anti-inflammatory components. It represents a novel class of skin barrier repair therapy for chronic dermatoses. The objective of this clinical study is to determine whether BRT-FC-83C, applied twice a day to the affected area of the skin, ameliorates signs and symptoms of mild to moderate atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* Clinically verified mild to moderate atopic dermatitis. Atopy diagnosis based on clinical scores of 3-7.5 based on the Rajka and Langeland criteria
* Men or women ages 18-50 years
* At least one mild to moderate atopic lesion involving no more than 20% Body Surface Area (BSA)
* Active atopic dermatitis for at least 3 years
* Willingness to cooperate and participate by following study requirements
* Written informed consent

Exclusion Criteria:

* Individuals with actively oozing atopic lesions
* Individuals who are smokers
* Individuals with insulin-dependent diabetes mellitus
* Individuals that are known to be pregnant, nursing, or planning to become pregnant within the next six months after enrollment
* Individuals currently participating in another clinical usage study that would interfere with this study

Primary outcomes:
measure: Change in mean Atopic Dermatitis Severity Index (ADSI) in lesional skin at target site
timeFrame: Eight weeks
Secondary outcomes:
measure: Change in mean Trans Epidermal Water Loss (TEWL) in lesional skin at target site
timeFrame: Eight weeks
measure: Change in mean corneometer measurement in lesional skin at target site
timeFrame: Eight weeks
measure: Self assessment of efficacy of BRT-FC-83C on signs and symptoms of atopic dermatitis
timeFrame: Eight weeks
measure: Change in Investigator's Global Assessment (IGA) in lesional skin at target site
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Colorado
Study officials:
affiliation: Thomas J. Stephens & Associates, Inc.
name: Nathan S. Trookman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604328: Safety and Tolerability of a Prostaglandin Ocular Implant for Treatment of Open Angle Glaucoma
Official title: An Open-label Phase I Study to Evaluate the Safety, Tolerability and Biodegradation Period of PolyActiva PA5108 Ocular Implant When Administered Intracamerally to the Anterior Chamber of the Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Open-angle Glaucoma
Lead sponsor: PolyActiva Pty Ltd
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single centre, open label, study to assess the safety, tolerability and biodegradation of PA5108 ocular implant in adults who have Open Angle Glaucoma (Primary or Secondary).

Detailed description: Participants who are currently managing their Open Angle Glaucoma with combination drop therapy will be recruited. Drop therapy will cease in the treatment eye and continue in the contralateral eye. The treated eye will receive via injection, a single PA5108 ocular implant. Participants will be monitored for safety and tolerability of the ocular implant until it completely biodegrades.

Eligibility criteria: Inclusion Criteria:

* Grade 3 or 4 open angle glaucoma (Shaffer-Etienne scale)
* Visual acuity in non-study eye same or better than study eye
* Currently taking topical ocular hypotensive medication including a prostaglandin analogue

Exclusion Criteria:

* Aphakic eyes
* Only one eye
* History of, or current uveitis, Cystoid Macular Edema (CME) or cornea edema
* Intraocular surgery or cornea/refractive surgery in study eye in past 6 months or anticipate need for eye surgery (including laser) in study eye during study period
* Current retinal detachment
* Uncontrolled infection in the eye

Primary outcomes:
measure: Safety and tolerability as measured by the occurrence of adverse events
timeFrame: 4 weeks
Secondary outcomes:
measure: Timeframe to complete implant biodegradation based on implant size and location
timeFrame: 6 months
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Melbourne
country: Australia
facility: Melbourne Eye Specialists
state: Victoria
Study officials:
affiliation: The Royal Victorian Eye & Ear Hospital
name: Nathan Kerr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00546728: The Vascular Effects of Exenatide Versus Metformin in Patients With Pre-Diabetes
Official title: The Chronic and Acute Postprandial Vascular Effects of Exenatide vs. Metformin in Abdominally Obese Patients With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Impaired Glucose Tolerance
Lead sponsor: St. Paul Heart Clinic
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
name: Eli Lilly and Company
name: International Diabetes Center at Park Nicollet
First posted: 2007-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of exenatide versus metformin on vascular health with chronic (3-month) therapy and during a 2-hour period following a meal in patients with pre-diabetes. It is predicted that exenatide will improve vascular health to a greater degree compared to metformin.


Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 18 years old
* Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose \>140 mg/dL OR impaired fasting glucose: fasting glucose \> or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c \> or = 5.7%
* Abdominal obesity: waist circumference \>102 cm (men) and \>88 cm (women)
* Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria:

* Type 2 diabetes
* Current use of glycemic control medications within one month of randomization
* Fasting glucose \>126 mg/dL
* Current use of weight loss medication
* Previous weight loss surgery
* History of severe gastrointestinal disease
* Standard clinical contraindications to exenatide or metformin therapy
* Unstable angina
* Heart failure
* Stroke or coronary artery bypass graft within 3 months of screening
* Women who are currently pregnant or planning to become pregnant
* Breastfeeding women
* Clinically significant liver disease
* Creatinine \> 1.5 mg/dL
* Hepatic function greater than 3 times upper limit of normal
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent

Primary outcomes:
measure: Change in Reactive Hyperemic Index Over the 3-month Treatment Period
timeFrame: Change from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis Park
country: United States
facility: International Diabetes Center at Park Nicollet
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Heart Clinic
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Aaron S. Kelly, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kelly AS, Bergenstal RM, Gonzalez-Campoy JM, Katz H, Bank AJ. Effects of exenatide vs. metformin on endothelial function in obese patients with pre-diabetes: a randomized trial. Cardiovasc Diabetol. 2012 Jun 8;11:64. doi: 10.1186/1475-2840-11-64.
Clinical trial NCT06079528: Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women
Official title: Effect of Electromagnetic Stimulation Combined With Visceral Manipulation on Stress Urinary Incontinence In Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Postmenopausal Disorder
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the effect of electromagnetic stimulation combined with visceral manipulation on stress urinary incontinence in postmenopausal women

Detailed description: According to the authors' knowledge, no prior studies that included MS with a VMT maneuvers to improve the success rates of stress urinary incontinence (SUI) treatment. Consequently, the purpose of this study was to assess the effect of electromagnetic field stimulation with VMT and PFMT in treatment of postmenopausal women with SUI.

Eligibility criteria: Inclusion Criteria:

Fifty postmenopausal women suffering from SUI with grades mild to moderate, were referred from........Hospital after SUI diagnosis confirmation with urodynamics. They were selected from outpatient clinic of department of physical therapy for Women's Health of the faculty of Physical Therapy, Cairo university. The inclusion criteria included sedentary and medically stable postmenopausal women, with age range of 50 to 66 years old.

Exclusion Criteria:

resence of a urinary tract infection (UTI), other types of UI, previous incontinence and pelvic floor surgeries, metallic implant, contraindications for MS, cognitive alterations, collagen or muscle-related diseases, and neurological abnormalities were exclusion criteria.

Primary outcomes:
measure: Assessing the change in vaginal pressure
timeFrame: at baseline and after 12 weeks of intervention
Secondary outcomes:
measure: Assessing the change in Urinary Incontinence symptoms
timeFrame: at baseline and after 12 weeks of intervention
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic faculty of physical therapy cairo university
Study officials:
affiliation: Cairo University
name: Dina Mohamed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01614028: Total Hip Arthroplasty Using Small Direct Anterior Incision: The Role of Short Femoral Stem
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2012-06-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study aims to investigate short-term outcomes following the use of two femoral stems used during Total Hip arthoplasty: the Fitmore Femoral stem and the M/L Taper Femoral stem.


Eligibility criteria: Inclusion Criteria:

* Patient signed an IRB, study specific informed patient consent.
* Patient is a male or non-pregnant female age 18 years or older at the time of study device implantation.
* Patient has primary diagnosis of non-inflammatory degenerative joint disease.
* Patient is a candidate for primary cementless total hip replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

* Patient has a Body Mass Index (BMI) \> 40 Kg/m2.
* Patient has an active or suspected infection at the time of device implantation.
* Patient is immunologically suppressed.
* Patient requires revision surgery of a previously implanted total hip replacement.
* Patient has a known sensitivity to device materials.

Primary outcomes:
measure: Short term hip function
timeFrame: within six weeks post-operative
Secondary outcomes:
measure: Short-Term Pain Levels of direct anterior and anterolateral surgical approaches
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Institute at AtlantiCare
state: New Jersey
city: Philadelphia
country: United States
facility: Rothman Institute at Thomas Jefferson University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03603028: Mixed Reality Gaming for Chronic Low Back Pain
Official title: Mixed Reality Gaming for Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Low Back Pain
Keywords: Walking
Exercise
Exergaming
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: From The Future LLC
First posted: 2018-07-27
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mixed Reality Gaming for Chronic Low Back Pain

Detailed description: The company, From the Future and University of Alabama at Birmingham (UAB) team aimed to develop a virtual reality (VR) game that integrated with the features of a specialized self-driven treadmill to provide accessible and progressive walking challenges for individuals with chronic low back pain (LBP). The game was designed to go beyond typical VR research efforts and provide a truly immersive and engaging experience that would motivate individuals with high pain-related fear to keep moving.

Eligibility criteria: Inclusion Criteria:

History of chronic low back pain

Exclusion Criteria:

No major neurological, cardiac, pulmonary, or other orthopedic injuries

Primary outcomes:
measure: Walking Distance
timeFrame: Day 1 through Day 3 of study
Secondary outcomes:
measure: Walking Speed
timeFrame: Day 1 - Day 3 of study
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Brown, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: