louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04360369: Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Official title: Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Glaucoma
Keywords: Tonometry, Ocular
Lead sponsor: Reichert, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
Primary purpose: DIAGNOSTIC

Brief summary: Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann Applanation Tonometer (within +/- 5.0 mmHg).

Detailed description: The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera Tonometer.

Eligibility criteria: Inclusion Criteria:

* Subjects must be male or female, between the ages of 18 and 90 years old;
* Be able and willing to provide signed informed consent
* Be able to follow study instructions

Exclusion Criteria:

* Subjects with only one functional eye;
* Subjects with one eye having poor or eccentric fixation;
* Subjects with central corneal thickness greater than 600 µm or less than 500 µm (about 2 standard deviations the human mean);
* Subjects with corneal scarring or who have had corneal surgery, including corneal laser surgery;
* Subjects with concomitant ocular diseases such as: microphthalmos, buphthalmos, nystagmus, keratoconus, severe dry eye syndrome, blepharospasm, any other corneal or conjunctival pathology or infection;
* Contact lens wearers;
* Known allergy to proparacaine or fluorescein as these are used to anesthetize the eye and allow IOP measurement, respectively, when used with the GAT.

Primary outcomes:
measure: Demonstrate compliance with ANSI Z80.10-2014-Ophthalmics-Ophthalmic Instruments-Tonometers.
timeFrame: Through study completion, approximately 4 months.
Secondary outcomes:
measure: Data collection for two measurement modes.
timeFrame: Through study completion, approximately 4 months.
measure: Data collection for device calibration.
timeFrame: Through study completion, approximately 4 months.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Department of Ophthalmology, Duke University
state: North Carolina
Study officials:
affiliation: Department of Opthalmology, Duke University
name: Henry Tseng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01804569: The Effects of Self-Moxibustion Therapy on Subjective Physical Symptoms and Health-related Quality of Life of the Elderly. The Effects of Self-Moxibustion Therapy
Official title: The Effects of Self-Moxibustion Therapy on Subjective Physical Symptoms and Health-related Quality of Life of the Elderly.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Improvement of the Elderly
Lead sponsor: Pusan National University
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be significant differences between control and experimental group after the moxibustion intervention as to, subjective physical symptoms and quality of life.


Eligibility criteria: Inclusion Criteria:

* Male and female older adults age between 65-85
* Agree to participate and sign for the trail after understanding of study purpose, and method.
* Able to answer for questions by verbally or literally
* Able to participate in 2weeks after follow-up

Exclusion Criteria:

* Having physical disorder such as thyroids, severe heart disease, dietetic mellitus, severe liver disease, allergy
* Subjects who can not attend more than 3 times of intervention session
* Subjects who are eligible by the decision of investigator

Primary outcomes:
measure: subjective physiological symptoms
timeFrame: 2 weeks after the intervention
Secondary outcomes:
measure: Quality of Life
timeFrame: 2 weeks after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University
name: Jooshin Kim, MSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06233669: An Analysis of Burnout Among Surgery Residents at a Tertiary Care Hospital in Pakistan: A Prospective Cohort Study
Official title: An Analysis of Burnout Among Surgery Residents at a Tertiary Care Hospital in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Psychological
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 95
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post graduate residents working in surgery and allied.

Brief summary: To determine the scores of exhaustion, depersonalization and personal achievement according to Maslach Burnout Inventory (MBI) in surgical residents.

Detailed description: A prospective cohort study was conducted at Pakistan Institute of Medical Sciences Islamabad with a 6-month duration from June 1, 2023 to November 30, 2023 after approval from the Institutional review board, 95 surgical residents working in Departments of Surgery \& Allied of age less than 35 years (any gender) with duty of at least 60 hours per week were enrolled in study by using non-probability convenience sampling technique. Residents were informed about the study procedure and consent for inclusion was taken from them. Data analysis was done through SPSS v.26.

Eligibility criteria: Inclusion Criteria:

* Residents working in departments of surgery and allied
* Both genders
* Less than 35 years old
* Performing duty of at least 60 hours per week

Exclusion Criteria:

* Those who did not wish to participate

Primary outcomes:
measure: To determine the scores of exhaustion, depersonalization and personal achievement according to Maslach Burnout Inventory (MBI) in surgical residents.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University/PIMS
Study officials:
References:
Clinical trial NCT05987969: Efficacy and Safety of the Alena App as a Treatment for Social Anxiety Disorder
Official title: Efficacy, Tolerability and Safety of a Smartphone-delivered, Fully Automatic Cognitive Behavioural Therapy Programme for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder (Social Phobia)
Social Anxiety
Social Anxiety Disorder
Keywords: RCT
mobile applications
social anxiety
mental health
social anxiety disorder
Lead sponsor: Aya Technologies Limited
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is a randomised controlled trial that seeks to investigate the efficacy and safety of the Alena app as a treatment for social anxiety disorder.

Detailed description: This will be a 10-week web-based parallel-group unblinded randomised controlled trial with an 8-week intervention period and a 2-week follow-up post-intervention. Participants will be randomly allocated to receive access to the Alena app or to a wait list control group, in a 1:1 ratio. The Alena app primarily comprises CBT-based therapy for social anxiety based on the Clark and Wells model, as well as cognitive assessments, calming exercises and a community forum.

Eligibility criteria: Inclusion criteria:

* Scored over 30 on the SPIN (indicating at least moderate social anxiety)
* Aged 18 or over
* Fluent in English
* Has access to a smartphone (iOS or Android) and the internet
* UK resident

Exclusion criteria:

* Currently receiving therapy for their mental health
* Mental health medication has changed (dosage or presence) in the last 8 weeks
* Scores over 7 on the AUDIT-C and/or yes on either drug dependence question taken from the DUDIT (indicating drug or alcohol abuse)
* Previous experience with the Alena app through prior studies or user testing

Primary outcomes:
measure: Change in Social Phobia Inventory (SPIN)
timeFrame: Change from baseline SPIN at 8 weeks
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Change from baseline WSAS at 8 weeks
Secondary outcomes:
measure: Change in Social Phobia Inventory (SPIN)
timeFrame: Change from SPIN level at the end of the intervention period at 4 weeks later
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: At the follow-up point of 4 weeks after the end of the intervention period.
measure: Serious adverse events
timeFrame: Within the intervention period of 8 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Aya Technologies Limited
Study officials:
References:
Clinical trial NCT01755169: Ketamine in Chronic Kid's (KiCK) Pain
Official title: Ketamine in Chronic Kid's (KiCK) Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Chronic pain
Child
Pediatric
Ketamine
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2012-12-24
Enrollment: 7
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.

Detailed description: Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.

Eligibility criteria: Inclusion Criteria:

* Subject, parent, or guardian willing and able to give informed consent
* NRS for pain over the past 24 hours \>4 at baseline
* Chronic pain, which has been present for \>3 months, or persisting longer than is normal for the underlying diagnosis
* Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
* Able to tolerate and cooperate with neurocognitive assessment
* Age 8-20 years old

Exclusion Criteria:

* If they are known or suspected to have drug addiction
* Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
* Uncontrolled hypertension
* Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
* Previous intolerance or allergic reaction to ketamine
* Pregnancy
* Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
* Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Amy-Lee Bredlau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01684969: Evidence of Haloperidol Absorption After Topical Administration
Official title: Topical Haloperidol: Evidence of Absorption After Topical Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Nausea
Vomiting
Keywords: Nausea
vomiting
gastrointestinal symptoms
palliative care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2012-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be a blinded study to compare the absorption of topical haloperidol with placebo


Eligibility criteria: Inclusion Criteria

* Age: patient must be 18 years or older and less than 70 years of age.
* Provision of informed consent
* No previous adverse reaction to haloperidol
* No current use of haloperidol
* Good health
* No alcohol within 24 hours of the study
* No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.
* Normal neurologic exam

Exclusionary Criteria

* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
* Recent cerebral trauma
* Study will exclude women who are pregnant and/or nursing
* Women who are of child bearing potential must have a negative urine pregnancy test.
* History of seizures
* Taking medications that can interact with haloperidol
* Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.

Primary outcomes:
measure: To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration.
timeFrame: baseline to 240 minutes after administration.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Eric Prommer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03164369: Real Time 3D Navigation and Traditional US to Identify Epidural Space Depth in Pregnancy
Official title: Accuracy of Real Time 3D Navigation Device to Identify Lumbar Epidural Spacy in Pregnant Patients. A Comparison With Standard Ultrasound.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound
Keywords: epidural block, ultrasound
Lead sponsor: Città di Roma Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy single fetus pregnant

Brief summary: The aim of this double blinded study is to assess the abilities of the SpineNav3DTM technology (Accuro) to identify the lumbar epidural space in parturients using as comparator a standar ultrasound (US) device.

Detailed description: SpineNav3DTM technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D.

Assuming a Type I error rate of 5% (α = 0.05) and a Type II error rate of 20% (β=0.2), a minimum of 76 subjects will be required. All the subjects will have their lumbar area scanned for the measurements of the depth of the epidural space (recorded in cm) by two anesthesiologist, one expert in UD and the other a novice, previously instructed to the use of the Accuro device.

All measurements will be performed either in the sitting or in the supine position at L1/L2, L2/L3 and L3/L4 levels. The expert operator will assess the lumbar spine by using both the devices (standard US and Accuro) while the novice will use only the Accuro.

The primary end-point of the study will be the accuracy of the Accuro to determine the depth of the epidural space using a midline approach using as comparator the measurement obtained with the standard ultrasound device performed by the expert operator.

Eligibility criteria: Inclusion Criteria:

* Healthy pregnant women undergoing antenatal anesthetic consultation

Exclusion Criteria:

-

Primary outcomes:
measure: epidural space depth
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Citta di Roma Hospital
Study officials:
affiliation: Citta di Roma Hospital
name: Giorgio Capogna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04043169: Clearblue Pregnancy Test - Lay User Study
Official title: Clearblue Pregnancy Test - Lay User Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
Collaborators: name: WCCT Global
First posted: 2019-08-02
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.

Brief summary: The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

Detailed description: The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use.

This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user.

A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18 to 45
* Willing to conduct a pregnancy test to determine or confirm their pregnancy status
* Willing to reveal their pregnancy status
* Willing to provide a blood sample
* Willing to give informed consent

Exclusion Criteria:

* Significant affiliation with SPD
* Has professional experience of using lateral flow-based devices
* Beyond the first trimester of pregnancy
* Taken a hormonal preparation containing hCG in the last month.
* Has a medical condition that means that it is not appropriate to give a blood.

Primary outcomes:
measure: Accuracy of Clearblue pregnancy test
timeFrame: 3 days
Secondary outcomes:
measure: Sample method agreement
timeFrame: 1 day
measure: Coordinator agreement
timeFrame: 1 day
measure: Device usability
timeFrame: 1 day
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT
state: California
Study officials:
affiliation: SPD Development company Ltd.
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT01310569: Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome
Official title: Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS, Skinfold thickness, HOMA-IR
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2011-03-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PCOS witout any other metabolik diseases

Brief summary: This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.

Detailed description: Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.

Eligibility criteria: Inclusion Criteria:

* All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels.

Exclusion Criteria:

* Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.

Primary outcomes:
measure: Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
Study officials:
affiliation: Gulhane School of Medicine
name: Aydogan Aydogdu, MD
role: STUDY_DIRECTOR
References: