louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01155726: The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Official title: The Effect of Masking on Subjective Results During Daily Disposable Contact Lens Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 134
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 purpose of this study is to explore the effect of masking on subjective ratings for two daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* 17 years of age or older.
* Ocular exam within 2 years.
* Currently wearing soft contact lenses on a daily wear basis.
* Contact lens prescription between +6.00D and -10.00D.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular disease.
* Use of systemic or ocular medications that may affect ocular health.
* Unable to achieve an acceptable fit with the study lenses.
* Anisometropia \>1.00D or astigmatism \>0.75D.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Average Subjective Comfort
timeFrame: Insertion, 4 hours, 8 hours each: Day 1, Day 2, and Day 3
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research: University of Waterloo
state: Ontario
Study officials:
References:
Clinical trial NCT02705326: Evaluating the Efficacy of Opti-Speech for Speech Treatment
Official title: Evaluating the Efficacy of Opti-Speech, a 3D Visual Feedback System, for Speech Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Articulation Disorder
Dysarthria
Prelingual Deafness
Lead sponsor: Vulintus, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Callier Center for Communication Disorders
name: Cleveland Hearing and Speech Center
name: Case Western Reserve University
First posted: 2016-03-10
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 85
Standard ages: CHILD
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 determine if feedback from a three-dimensional real-time visualization of the tongue, a program called Opti-Speech, can be used to improve speech.

Detailed description: Participants will be asked to complete the Goldman Fristoe Test of Articulation along with several other assessment tests. Then speech treatment, guided by Opti-Speech, will be provided to the participant for up to 10 treatment sessions. The participant will be asked to come back after the final treatment for a 2-month follow-up assessment.

Eligibility criteria: Inclusion Criteria:

* English speaking individuals with speech errors resulting from persistent speech sound disorder, individuals with dysarthria resulting from neurological disorders and individuals with pre-lingual or congenital deafness.

Exclusion Criteria:

* Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists

Primary outcomes:
measure: Percent articulatory accuracy
timeFrame: within 30 minutes of treatment
Secondary outcomes:
measure: Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-Treatment
timeFrame: Immediately prior to first speech treatment and 2 months after final treatment.
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Hearing and Speech Center
state: Ohio
city: Richardson
country: United States
facility: Callier Center for Communication Disorders at UT Dallas
state: Texas
Study officials:
affiliation: Cleveland Hearing and Speech Center, Case Western Reserve University
name: Jennell Vick, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Callier Center for Communication Disorders at UT Dallas
name: Thomas F Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vulintus, Inc.
name: Holle L Carey, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Katz WF, Mehta S. Visual Feedback of Tongue Movement for Novel Speech Sound Learning. Front Hum Neurosci. 2015 Nov 19;9:612. doi: 10.3389/fnhum.2015.00612. eCollection 2015.
Clinical trial NCT04569526: Ultrasonography Guided Brain Lesions Resection:
Official title: Ultrasonography Guided Brain Lesions Resection: a Tool for a Real Time Intraoperative Neuronavigation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Who Are Diagnosed to Have Intracranial Lesions
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed to have brain lesion, selected based on the inclusion and exclusion criteria

Brief summary: 1. Evaluate the clinical value of intraoperative ultrasonography as a real-time guidance
2. Combination of data of MRI Tractography and intra operative ultrasonography will be useful in good localization of lesions or not .
3. Maximal safe resection .

Detailed description: Accurate pre and intraoperative localization of Brain lesions is a challenge in neurosurgery specially deep intra cerebral lesions. Stereotaxy and neuronavigator played a major role in preoperative and intraoperative evaluation of exact location of intra cerebral lesions, the main drawbacks of using steriotaxy and neuronavigator that they are time consuming, complicated and expensive.(1) Nowadays we use MRI Tractography as preoperative imaging to localize lesions and there relation to neural tracts specially in eloquent brain areas, and also intraoperative ultrasonography Which act as a real-time, unexpansive and relatively simple tool for intraoperative visualization of the lesion's location, size, extent and its relationship with the surrounding tissue, also it can reveal the lesion's blood supply, it can measure the rate and direction of arterial blood flow.(2,3,4) Intraoperative ultrasonic imaging was first applied as a real-time navigation system in neurosurgery in 1980. (5) In this research we will combine the use of preoperative MRI tractography with intra operative ultrasonography in accurate localization of brain lesions and its relation with important tracts and if this combination will be beneficial and add to the safety of excision of lesions or not.

Eligibility criteria: Inclusion Criteria:

* Patients who are diagnosed to have Intracranial lesions Patients with recurrent lesions

Exclusion Criteria:

* Patients who are unfit for surgery Patients who have multifocal lesions

Primary outcomes:
measure: Extent of resection of the lesion
timeFrame: 48 hours
Secondary outcomes:
measure: post operative complication
timeFrame: one month
Other outcomes:
Locations:
Study officials:
affiliation: assuit nuiversity hospital neurosurgery department
name: Radwan nouby mahmoud, prof
role: STUDY_DIRECTOR
affiliation: assuit nuiversity hospital neurosurgery department
name: wael mohamed ali, prof
role: STUDY_DIRECTOR
affiliation: assuit nuiversity hospital neurosurgery department
name: mohamed aly ragaee, prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT03650426: Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty
Official title: Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Onlay Patellar Resurfacing Technique
Inlay Patellar Resurfacing Technique
Patellar Resurfacing
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 235
Sex: ALL
Standard ages: CHILD
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 clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria:

* Valgus deformity
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* History of patellar instability

Primary outcomes:
measure: Change of post-operative anterior knee pain
timeFrame: Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
measure: range of motion of knee
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: Knee Society and Knee Society function score
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: New patellar score
timeFrame: Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
measure: Oxford knee score
timeFrame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
measure: Prevalence of anterior knee pain ,AKP
timeFrame: Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery
measure: Prevalence of patellar crepitus complication
timeFrame: Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok,
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02550626: Exploring the Relationship Between Alpha-synucleinopathy Related Non-motor Symptom and Post-op. Delirium in Elderly Patients With Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-operation Delirium
Alpha-synucleinopathy Related Non-motor Symptom
Keywords: delirium
alpha synucleinopathy
spine surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 106
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: spine surgery

Brief summary: Hypothesis is that the presence of a-synucleinopathy related non motor symptoms could be predictive factor for post-operative delirium. During 72hrs after spine surgery, investigator will observe occurrence of post-operative delirium, and analysis difference of a-synucleinopathy related non motor symptoms between 2 groups.

Detailed description: Postoperative delirium appear approximately 10-70% of patients older than 65 yrs undergoing surgery and it is strongly associated with poor surgical outcome. The clinical characteristics of postoperative delirium are fluctuating attention, visual hallucination, disorganized thought and alter sleep-wake cycles. This is quite similar to core features of α-synuclein-related cognitive disorders such as parkinson's disease dementia and dementia with lewy body. At that point, investigator thought that postoperative delirium is preclinical stage of a-synucleinopathy. In other words, a-synuclein related disorders and postoperative delirium may share an underlying neurochemical change in their pathogenesis.

investigator will recruit age 65 and older patients scheduled to perform spine surgery. The pre-operative evaluation include neurologic exam, baseline cognitive function and a-synucleinopathy related non motor symptoms through Questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Age 65 and older patients
2. Scheduled to perform spine surgery in severance hospital

Exclusion Criteria:

1. Previous delirium history
2. Previous chemotherapy or radiotherapy within 1yr due to underlying cancer.
3. Severe hepatic/renal dysfunction

Primary outcomes:
measure: existence of anosomia
timeFrame: A day before operation
Secondary outcomes:
measure: existence of constipation
timeFrame: A day before operation
measure: existence of orthostatic hypotension
timeFrame: A day before operation
measure: existence of insomnia
timeFrame: A day before operation
measure: existence of depression
timeFrame: A day before operation
measure: existence of anxiety
timeFrame: A day before operation
measure: existence of REM sleep behavior disorder
timeFrame: A day before operation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Neurology, Yonsei University College of Medicine
state: Seou
Study officials:
References:
Clinical trial NCT03277326: Interscalene vs Anterior and Posterior Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries
Official title: Randomised, Controlled Trial Comparing Interscalene Versus Anterior and Posterior Approaches of Suprascapular Nerve Block for Shoulder Arthroscopic Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroscopic Shoulder Surgery
Interscalene Block
Suprascapular Nerve Block
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare ISB vs anterior and posterior approaches of suprascapular block in terms of lung function and analgesia

Detailed description: Interscalene block (ISB) is commonly used to provide pain control for shoulder surgeries. However, it is associated with several side effects, in particular, a high incidence of phrenic nerve blockade.

The suprascapular nerve block (SSB) has been proposed as an alternative to the ISB as it has a lower likelihood of causing phrenic nerve blockade. There are 2 commonly used approaches for the suprascapular nerve block, anterior and posterior. The anterior approach may still result in some degree of impairment of lung function.

The primary aim is to assess the pulmonary function after performance of ISB, aSSB and pSSB. Secondary outcomes are analgesic effects and incidence of adverse effects of these blocks.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective arthroscopic shoulder surgery under general anaesthesia
* Patients 21 years old and above
* American Society of Anesthesiologists (ASA) physical status 1 to 3
* BMI 18-35 kg/m2

Exclusion Criteria:

* Patients unable to give consent or inability to communicate/ cooperate
* Patients with chronic use of strong opioids (morphine, oxycodone)
* Patients with allergy to local anaesthetics or any drugs included in the study
* Patients with contraindications for regional anaesthesia such as coagulopathy
* Patients with pre-existing neurological deficits in upper limb/ phrenic nerve palsy
* Patients with pre-existing lung disease (COPD, uncontrolled asthma)

Primary outcomes:
measure: Pulmonary function
timeFrame: 2 years
Secondary outcomes:
measure: Analgesic effects and complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: CGH
name: Yean Chin Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01580826: Pasteurization of Mother's Own Milk for Preterm Infants
Official title: Pasteurization of Mother's Own Milk for Preterm Infants : a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: pasteurization
human milk
very low birth weight infants
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 303
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesize that short term infection-related benefits of human milk feeding are decreased by the process of pasteurization. Primary objective of the study is to compare the incidence of late-onset sepsis in very low birth weight infants assigned randomly to receive either pasteurized or raw expressed mothers'own milk.

Detailed description: In this prospective, randomized, controlled trial, all patients born before 32 weeks of gestational age and/or with birth weight below 1500 g admitted to the tertiary neonatal intensive care unit(NICU) of the University Hospitals Leuven within 24 hours of birth, are eligible for inclusion in the study except for infants who died within the first 24 hours. Infants whose mothers intend to breastfeed will be randomly assigned, using a digital system, to receive either raw or pasteurized mother's own milk. The duration of the study is from birth to eight weeks of age or to discharge from the NICU, whichever occurs first. The need to ensure proper handling of the milk precludes true blinding of the caregivers. The institutional review board approved the study and written informed parental consent iss obtained before enrolment.

Eligibility criteria: Inclusion Criteria:

* all patients born before 32 weeks of gestational age and/or with BW below 1500 g admitted to the tertiary NICU of the University Hospitals Leuven within 24 hours of birth

Exclusion Criteria:

* died within 24 hours after birth
* no consent
* admitted after 24 hours of birth

Primary outcomes:
measure: incidence of late-onset sepsis
timeFrame: up to 8 weeks of age
Secondary outcomes:
measure: necrotizing enterocolitis
timeFrame: up to 8 weeks of age
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Veerle Cossey, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00648726: An Open, Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin Versus Cefuroxime Alone or With Oral Erythromycin for the Treatment of Chinese Patients Who Were Hospitalized for Pneumonia
Official title: An Open, Prospective, Randomized, Multi-Center Study of the Efficacy and Safety of Intravenous Followed by Oral Azithromycin vs. Cefuroxime Monotherapy or Plus Oral Erythromycin for the Treatment of Chinese Hospitalized Patients With Community- Acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To validate the efficacy and safety of azithromycin for the treatment of Chinese patients hospitalized with community-acquired pneumonia (CAP), compared with cefuroxime or the combination of cefuroxime plus oral erythromycin.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Patients hospitalized with a diagnosis of community acquired pneumonia (CAP) as defined by the presence of new infiltrate(s) including manifestation of consolidation, patchy, diffuse or interstitial inflammation on chest X-ray with or without pleural effusion plus at least 1 of the following: new cough and expectoration or progression of respiratory symptoms with purulent sputum with or without chest pain; fever; auscultatory findings such as rales or evidence of pulmonary consolidation; blood leukocyte count \>10×109/L or \<4×109/L with or without \>15% bands or a blood leukocyte count between 4 and 10 with neutropils greater than or equal to 75%

Exclusion Criteria:

Exclusion Criteria:

* Patients with hospital acquired pneumonia, aspiration pneumonia, severe pneumonia, history of post-obstructive pneumonia, active tuberculosis or bronchitis, bronchiectasis or chronic obstructive pulmonary disease without evidence of acute infection were not eligible for this study
* Patients treated with any systemic antibiotic within 72 hours prior to study entry were not eligible unless the medication was, in the opinion of the investigators, classified as having failed

Primary outcomes:
measure: clinical efficacy (cure or marked improvement)
timeFrame: Visit 3 (Day 9 +-1 of treatment)
Secondary outcomes:
measure: bacteriological efficacy (eradication)
timeFrame: Visit 3
measure: clinical efficacy
timeFrame: Visit 4 (8 +/-1 days after treatment)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00720226: Efficacy of Losartan in Preventing Progression of COPD
Official title: Efficacy of Losartan in Preventing Progression of COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Emphysema
Chronic Bronchitis
Smoking
Keywords: COPD
emphysema
angiotensin receptor blocker
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Merck Sharp & Dohme LLC
First posted: 2008-07-22
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).

Detailed description: Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.

Eligibility criteria: Inclusion Criteria:

* Adults with COPD who are either active or former smokers

Exclusion Criteria:

* Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.

Primary outcomes:
measure: Change in Percent Emphysema on CT Scan
timeFrame: Change between baseline and month 12.
Secondary outcomes:
measure: Change in FEV1 (L)
timeFrame: Measured at Baseline and Month 12
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Asthma and Allergy Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Robert A. Wise, MD
role: PRINCIPAL_INVESTIGATOR
References: