louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03832244: The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales
Official title: The Role of Sub-mental Ultrasonography in Diagnosing Obstructive Sleep Apnea and Its Correlation With Subjective Scales
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Diagnostic Imaging
Ultrasound
Keywords: sub-mental ultrasonography
obstructive sleep apnea
Lead sponsor: Bartin State Hospital
Sponsor class: OTHER_GOV
First posted: 2019-02-06
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * For study group: Patients who have been diagnosed as having obstructive sleep apnea on polysomnography
* For control group: Patients who have a negative polysomnography or normal scores from subjective scales

Brief summary: The investigators hypothesize that sub-mental ultrasonography measures are strongly correlated with the severity of Obstructive Sleep Apnea Syndrome and the related specific subjective scales.

Detailed description: Polysomnography (PSG) is the gold-standard diagnose tool for Obstructive Sleep Apnea (OSA). However, the availability of PSG is limited, particularly in developing and / or least developed countries. Sub-mental ultrasonography is stepped forward with its practical and cheap nature and its widespread use.

The investigators aimed to perform sub-mental ultrasonography to the patients who underwent to PSG by a blind-to-the-PSG-results radiologist and analyse the correlation between ultrasound measures, Apnea-Hypopnea Index (measured by Polysomnography) and subjective OSA scales.

Eligibility criteria: Inclusion Criteria:

* Patient who consented for sub-mental ultrasound

Exclusion Criteria:

* Any pharyngo laryngeal anatomic abnormality
* Previous history of Obstructive sleep apnea treatment
* Previous history of surgical intervention to the pharyngo laryngeal anatomic area

Primary outcomes:
measure: Tongue base thickness
timeFrame: Baseline
measure: Retropalatal distance
timeFrame: Baseline
measure: Distance between lingual arteries
timeFrame: Baseline
Secondary outcomes:
measure: Stop-Bang questionnaire
timeFrame: Baseline
measure: Berlin Questionnaire
timeFrame: Baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline
measure: Neck circumference
timeFrame: Baseline
measure: The thyromental distance
timeFrame: Baseline
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bartin State Hospital
Study officials:
affiliation: Coordinator of Sleep Disorders Centre of Bartin State Hospital
name: Ozge Yagcioglu Yassa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013.
Clinical trial NCT00759044: Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function
Official title: Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Maculopathy
Diabetic Macular Edema
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).

Brief summary: To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with AMD, or
* Patients diagnosed with DME
* Age over 18 years
* Inform consent

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Glaucoma
* Dilatation of the pupil \< 5 mm

Primary outcomes:
measure: Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI Clinical Trial Center
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José G Cunha-Vaz, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16. doi: 10.1109/TBME.2004.839801.
Clinical trial NCT01797744: Vestibular Rehabilitation for Strokepatients With Dizziness
Official title: Vestibular Rehabilitation for Strokepatients With Dizziness - a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Dizziness
Keywords: Stroke
Dizziness
Vestibular rehabiliation
Balance
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skåne, Primary health care, Sweden
First posted: 2013-02-22
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, the investigators has shown that dizziness is common among patients with first time stroke and that it affects self perceived health. There are indications that vestibular rehabilitation can have effect of neurological causes of dizziness and vertigo and it therefore seems important to find out if vestibular rehabilitation can affect dizziness among patients with stroke.

The aim of this study is to find out if vestibular rehabilitation can have any effect on function, balance and self-rated health among patients with first time stroke.


Eligibility criteria: Inclusion Criteria

• First time stroke with dizziness -

Exclusion Criteria

* Not first time stroke
* No dizziness

Primary outcomes:
measure: The Activities-specific Balance Confidence Scale
timeFrame: Change between baseline and three months after baseline
measure: EuroQol 5D
timeFrame: Change between baseline and three months after baseline
measure: The Berg Balance Scale
timeFrame: Change between baseline and three months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Lund University
Study officials:
References:
Clinical trial NCT01389544: A Study on the Interaction Between Danoprevir/Ritonavir and Methadone
Official title: Investigation of the Effect of Multiple Doses of Danoprevir/Ritonavir on Methadone in Subjects on Stable Methadone Maintenance Therapy (MMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This multicenter, open-label study will assess the effect of multiple doses of danoprevir/ritonavir on steady-state pharmacokinetics of methadone. Subjects on stable methadone maintenance therapy (20 - 120 mg daily as single oral morning dose) will receive danoprevir 100 mg orally twice daily and ritonavir 100 mg orally twice daily for 10 days.


Eligibility criteria: Inclusion Criteria:

* Male and female adults, 18 - 65 years of age, inclusive
* Subjects must be on a stable methadone maintenance regimen (20 to 120 mg/day) for the treatment of opiate addiction for at least 30 days prior to screening and should be on a stable dose for at least 14 days prior to Day -1
* Body weight \>/= 50 kg
* Body mass index (BMI) 18.0 - 32.0 kg/m2
* Females of childbearing potential and males with female partners of childbearing potential must agree to use 2 forms of non-hormonal contraception during the study and for 90 days after the last study drug administration

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Symptoms of methadone withdrawal at screening, on Day -2 or Day -1
* Inadequate venous access
* History or evidence of any clinically significant disease or disorder, except for drug abuse or dependence
* Positive test for alcohol or drugs of abuse at screening and up to Day -2 (with the exception of methadone)
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol); alcohol consumption will be prohibited during study confinement and for at least 48 hours before screening, dosing and each scheduled visit
* Positive for hepatitis B, hepatitis C or HIV infection

Primary outcomes:
measure: Effect of danoprevir/ritonavir on steady state pharmacokinetics (area under the concentration - time curve (AUC)) of methadone
timeFrame: 10 days
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 4 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01644344: A Prospective Trial Comparing the Cost of Post Operative X-rays for Fractures Treated With Stable Internal Fixation
Official title: Pilot Study for a Randomized Control Trial Comparing the Cost of a Simplified Post-Operative Radiographic (SPOR) Protocol for Fractures With Stable Internal Fixation Treated at Health Sciences Centre
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Simplified Postoperative Radiographs
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre Foundation, Manitoba
First posted: 2012-07-19
Enrollment: 39
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard post-operative radiographic protocol for the monitoring of fractures at HSC includes post-operative in hospital radiographs as well as radiographs at the two week follow up appointment. This is in addition to good quality intra-operative radiographs. With current operative techniques and implants, orthopaedic surgeons can achieve reliably stable internal fixation. In fact, patients are often allowed to take weight through the fractured limb immediately post-operatively. In these cases, redundant post-operative radiographs likely represent an avoidable cost to the system financially, and an avoidable cost to the patient in additional time spent in hospital and unnecessary radiation exposure.


Eligibility criteria: Inclusion Criteria:

* Femur fracture treated with intramedullary nailing
* Tibia fracture treated with intramedullary nailing
* Ankle fractures treated with standard compression technique
* Humeral shaft fractures treated with standard compression technique
* Forearm fractures treated with standard compression technique
* One or both bones fractured
* Simple fracture or presence of single butterfly fragment treated with lag screw
* Clavicle fracture treated with standard compression technique
* Olecranon fracture treated with standard compression technique

Exclusion Criteria:

* Age \< 17 years, or open growth plates
* Multiple orthopaedic fractures
* History of radiographic appearance of osteoporosis or osteopenia or poor operative bone quality
* Likely difficult with follow-up in first 6 weeks
* Same day surgery case
* Surgeon feels patient should be excluded

Primary outcomes:
measure: cost-effectiveness of a simplified post-operative radiographic protocol for selected fractures
timeFrame: post-operative day one or two in hospital, as well as in clinic at two and six weeks
Secondary outcomes:
measure: Patient satisfaction
timeFrame: At six weeks post-op
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
References:
Clinical trial NCT00004844: Randomized Study of Fetal Neurotransplantation for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Colorado, Denver
First posted: 2000-02-25
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Assess the safety and efficacy of embryonic mesencephalic dopamine cell implants into the putamen of patients with Parkinson's disease.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are stratified by age (over and under 60). Patients are randomized to receive either sham surgery or tissue implantation.

Embryonic tissue is prepared. While patients are awake, but sedated, bilateral incisions are made in the skin and burr holes drilled in the skull. A cannula is inserted into the brain to the posterior putamen. Implant patients receive embryonic neural tissue or sham patients have no needles penetrate the brain. After 1 year, patients who receive the sham operation in the first operation may receive embryonic neural tissue in a second operation.

Patients are followed every 4 months during the first year and every 6 months thereafter.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Idiopathic Parkinson's disease for at least 7 years with rest tremor or bradykinesia and one of the following cardinal signs: Rigidity Flexed posture Loss of postural reflexes Freezing (motor blocks)
* Continuing response to levodopa
* Presence of at least one of the following intractable symptoms or signs: Intractable disabling fluctuations Intractable disabling dyskinesias Intractable "on" freezing (i.e., motor blocks that interfere with walking despite being "on"
* Bilateral parkinsonism when "off" (may be asymmetry between right and left sides)
* Decreased dopa uptake in the striatum

--Prior/Concurrent Therapy--

* No prior brain surgery

--Patient Characteristics--

* Cardiovascular: No severe cardiopulmonary disease
* Neurologic: No history of strokes No neuroleptics No encephalitis No oculogyric crisis No remission No cerebellar signs No dementia (Mini-Mental state score no greater than 22) No supranuclear gaze palsy No Babinski sign No orthostatic hypotension No hydrocephalus No brain tumor No occlusive cerebrovascular disease
* Pulmonary: Absolute standing pressure at least 90/60 mmHg
* Other: No diabetes mellitus No exposure to toxins No other severe medical disease Hamilton Depression Scale score of less than 20 points

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Curt R. Freed
role: STUDY_CHAIR
References:
Clinical trial NCT06836544: Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia
Official title: Efficacy of the ALL YOU NEED is LOVE Healthcare Transition Syllabus Among Pre- and Posttransplant Adolescents in Cali, Colombia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant
Keywords: Pediatric nephrology
Educational
Healthcare transition
Kidney failure
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
Collaborators: name: International Society of Nephrology
First posted: 2025-02-20
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Background: To achieve optimal outcomes, adolescents with chronic or end-stage kidney disease must undergo healthcare transition (HCT) preparation from a pediatric- to an adult-focused setting. The pediatric nephrology group at the Fundación Valle del Líli in Cali, Colombia, collaborated with the University of North Carolina Chapel Hill STARx Program and Hospital Infantil de México Federico Gómez to start an HCT preparation program using their tools. The objective of this study was to evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus (Spanish version) and its effects on HCT readiness in young patients with kidney failure, including renal transplants.

Methods: A pre-test/post-test quasi-experimental study was conducted without control group in 11- to 21-year-old consecutive patients with kidney failure followed at the Fundación Valle de Lili. Using the TRxANSITION Index, HCT readiness skills were measured before and after implementing the "ALL YOU NEED IS LOVE" syllabus, an educational curriculum delivered in three monthly 2-hour sessions. Analysis was performed using linear mixed models in R Studio software to evaluate intervention effects while accounting for participant characteristics.


Eligibility criteria: Inclusion Criteria:

* Patients aged 11 to 21 years along with their primary caregivers
* Either renal transplant recipients or in a renal transplant protocol
* Under follow-up by the Nephrology Service at Fundación Valle del Lili.

Exclusion Criteria:

* Patients were excluded if they did not sign the informed consent and/or assent to participate in the study.
* If they lost their care agreement with Fundación Valle del Lili due to administrative reasons related to their health insurance provider

Primary outcomes:
measure: To evaluate the efficacy of the "ALL YOU NEED IS LOVE" syllabus
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Betz CL, Ferris ME, Woodward JF, Okumura MJ, Jan S, Wood DL. The health care transition research consortium health care transition model: a framework for research and practice. J Pediatr Rehabil Med. 2014;7(1):3-15. doi: 10.3233/PRM-140277.
Clinical trial NCT01594944: Fetal Orbital Measurements by 3D Ultrasound
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orbital Volume
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2012-05-09
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women 13-37w

Brief summary: The investigators will measure fetal orbital transverse and anterior-posterior diameter by 2D ultrasound and orbital volume by 3D ultrasound in women visiting our unit for other examinations during pregnancy. The investigators will examine 5-10 women in each gestational age in order to create a normal values curve throughout pregnancy.


Eligibility criteria: Inclusion Criteria:

* well dated singleton pregnancies

Exclusion Criteria:

* multiple pregnancy
* pregnancies with known malformations,
* chromosomal abnormalities or
* intrauterine infections

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01470144: Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Official title: An Open-label Extension of Study AC-066A301 Investigating the Safety and Tolerability of ACT-385781A in Patients With Pulmonary Arterial Hypertension (PAH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
Collaborators: name: Chiltern International Ltd.
name: Effi-Stat
First posted: 2011-11-11
Enrollment: 41
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, nonrandomized extension to study AC-066A301. The study will assess safety and tolerability of ACT-385781A while providing a means for continuing treatment after ending participation in study AC-066A301.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent prior to initiation of any study-mandated procedure
2. Patients who completed participation in study AC-066A301
3. Patients who have not obtained access for commercial EFI at the time of ending participation in study AC-066A301

Exclusion Criteria:

1. Patients who prematurely discontinued study drug in study AC-066A301
2. Patients for whom continued treatment with EFI is no longer considered appropriate

Primary outcomes:
measure: Treatment-emergent Adverse Events
timeFrame: On average 2.72 years
Secondary outcomes:
measure: Exposure Duration
timeFrame: On average 2.72 years
Other outcomes:
Locations:
Study officials:
References: