louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03767985: Patching or Gaming as Amblyopia Treatment?
Official title: A Randomised Clinical Trial Objectively Comparing the Effect of Patching Therapy With Video Gaming for Amblyopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amblyopia
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Lijf & Leven
name: ODAS Stichting
name: Uitzicht
name: University of Applied Sciences Utrecht
First posted: 2018-12-07
Enrollment: 124
Sex: ALL
Minimum age (years): 4
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to either the standard patching therapy or the dichoptic video game therapy.
Primary purpose: TREATMENT

Brief summary: Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. Standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular to improve visual acuity not only in children but also in adults. In this study we aim to compare the standard occlusion therapy with dichoptic video gaming.

Detailed description: Amblyopia affects 3% of the children and is caused by strabismus, anisometropia or both. The standard treatment is glasses and patching therapy. From North-America, behavioural training, i.e. dichoptic training, perceptual learning and video gaming, has become increasingly popular. The rationale behind these games is by using dichoptic stimulation, with the contrast of the stimuli presented to the good eye reduced to match the appearance of the same stimuli when shown to the amblyopic eye, suppression can be alleviated. The many studies now conducted, demonstrate improvement in visual acuity with the games, the effect however is limited, but the rate of improvement is higher. In these studies, prescribed patching-time was compared to realised game-time. We have demonstrated in multiple studies that electronically measured compliance is low: on average only 50%.

In this study we aim to compare the effect of patching therapy, using the ODM to objectively measure compliance, with the effect of a novel dichoptic action video game in children as well as in adults. In addition, the adult participants will undergo fMRI scans to document any changes in the visual cortex before and after either therapy.

Eligibility criteria: Inclusion Criteria:

* Amblyopia; an interocular difference in visual acuity of at least 2 logMAR lines.

Exclusion Criteria:

* A non-comitant or large angle constant strabismus \>30Prism Dioptres, a neurological disorder, nystagmus, other eye disorders and diminished acuity due to medication, brain damage or trauma.

Primary outcomes:
measure: Visual Acuity improvement
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: South-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Johannes R Vingerling, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03983785: The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
Official title: The Effect of Pilates and Elastic Taping on Balance and Postural Control in Early Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Pilates
Elastic Taping
Balance
Postural control
Early Parkinson's Disease
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to compare the effects of pilates training and elastic taping on balance and postural control in early Parkinson's patients.

Detailed description: The subjects were randomly divided into 3 groups as pilates, elastic taping and waiting list control group. Individuals were given 60-minute pilates training twice a week for 6 weeks. In addition to Pilates training, elastic taping was applied twice a week for postural correction of the back. Individuals were evaluated for balance and postural control before and after training. Evaluation of clinical balance with Berg Balance Scale and Trunk Impairment Scale; Stability Limits, Sits Up, Normal and Tandem Walking Tests were performed with NeuroCom Balance Master balance and performance system.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Idiopathic Parkinson Disease
* Mini Mental Test Score≥24
* Modified Hoehn and Yahr Score≤2
* Ability to stand 1 minute independently
* Ability to walk 10 meters

Exclusion Criteria:

* Other orthopaedic, neurologic or visual disease which could affect ability of balance and walking
* Unstabl cardiovasvularly disease
* History of Surgery about Parkinson disease

Primary outcomes:
measure: Balance
timeFrame: 7.5 months
measure: Postural control
timeFrame: 7.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
affiliation: Dokuz Eylul University
name: Evrim Goz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529485: Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
Official title: Research and Quantification of Factors Influencing Endothelial Damage During Phacoemulsification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Cell Loss, Corneal
Cataract
Phacoemulsification
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cataract surgery

Brief summary: The aim of this study is to determine the principal factors that influence endothelial cell loss three month post cataract surgery.

Methods: Multi center observational Cohort study, inclusion period from 12/01/2022 to 10/06/2022. One hundred and seventy-five eyes of hundred and four patients who have appointment for cataract surgical indication were included. The percentage of corneal endothelial cell loss was quantified using specular microscopy before and 3 months after the surgery.

14 variables (pre-operative and intra-operative) that could be associated to endothelial cell injury were selected.

A bivariate analysis of relationship between these factors and endothelial cell loss at 3 months was performed by simple linear regression (Wilcoxon and Fischer tests). Multivariate analysis was performed by multiple linear regression in order to identify the factors independently related to endothelial cell loss.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing cataract surgery
* Visual acuity monoyer scale \<8/10e (\> +0.2 logMar)
* Nuclear, cortical and posterior subcapsular cataract with normal density to severe in the LOCSIII classification
* Covered by the social security scheme
* Have given their oral agreement

Exclusion Criteria:

* Corneal disease: keratitis, dystrophy or corneal degeneration
* Any disease of the anterior segment
* Low preoperative endothelial cell density \<1000 c/mm²
* Pregnancy, lactation
* Risk factors for surgical per-operative complication
* Uncontrolled ocular pressure
* Combined surgery (cataract with corneal graft, cataract with glaucoma surgery, cataract with vitrectomy, ....)
* Under legal protection

Primary outcomes:
measure: The difference in central corneal endothelial cell density (cells/mm²) between the 1st preoperative measurement and the postoperative measurement at 3 months.
timeFrame: 3 months after cataract surgery
Secondary outcomes:
measure: Postoperative visual acuity
timeFrame: 3 months after cataract surgery
measure: Postoperative corneal edema
timeFrame: 3 months after cataract surgery
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital de Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Jean Marc Perone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547285: Analysis of the Biomechanics of Walking
Official title: Analysis of the Biomechanics of Walking in the Senior Under the Terms of Footwear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elderly People
Falls
Keywords: biomechanics of walking
footwear
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly people

Brief summary: The proportion of people aged 60 and over in the French population has increased from 18% in 1970 to over 22% in 2010.

One major problem in the elderly is falling. About half of these falls cause a minor injury and between 5% and 25% will cause a more serious injury such as a fracture or a sprain (Alexander et al., 1992; Nevitt et al., 1991).

It therefore seems essential to study the locomotion of seniors to limit the maximum risk of falling into a public health measure.

Two factors may be involved:

1. The first corresponds to factors related to natural aging topics
2. The second is the environment that is a real problem for seniors (Rolling showers, presence of works ....) And especially the port of inappropriate footwear.

Indeed, most of the elderly, institutionalized or not, do not wear proper shoes. It is this parameter that will be highlighted in our study.

Detailed description: The subjects will test different characteristics on the same shoe. A single parameter vary for each condition (Different insole, heel height, stem length ...) For each condition, analysis of locomotion on treadmill ADAL be performed as well as tests on postural balance platform. Kinematic measurements, accelerometer and postural will be performed for each subject.

Eligibility criteria: Inclusion Criteria:

* Topic of footwear for women 37-38-39 and 41-42-43 for men

Exclusion Criteria:

* Presence major pathology, fracture or surgery, at the musculoskeletal system, under 3 years
* Presence of prosthesis in the lower limb (hip, knee, ankle)
* Presence of hallux valgus or pronounced toe claw,
* Diabetes,
* Presence of osteoarthritis in the lower limbs
* Presence of medication or other problems affecting the balance of subjects.

Primary outcomes:
measure: Best stability shoe
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Roger OUILLON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06521385: Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
Official title: Comparison of Non-invasive Respiratory Monitoring System (RMS) to Capnography for Respiratory Rate (RR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Monitoring
Lead sponsor: Makani Science
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 32
Sex: ALL
Minimum age (years): 22
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to compare the performance of a novel non-invasive respiratory monitoring system against the gold standard methods (capnography) in human subjects. The main question it aims to answer is whether the novel monitoring system comparable to the current standards.


Eligibility criteria: Inclusion Criteria:

* Between age of 22-99
* BMI between 15 and 40 kg/m\^2

Exclusion Criteria:

* Medical history of serious symptomatic, cardiac, or pulmonary disease.
* History of serious skin irritation (severe rash or blisters) caused by medical adhesives (tape).
* Cannot lay still for one (1) hour.
* Cannot give written informed consent.
* Unable to follow instructions.

Primary outcomes:
measure: Respiratory Rate Accuracy Compared Between Experimental and Reference Devices
timeFrame: 1 hour
Secondary outcomes:
measure: Respiratory Rate Bias Compared Between Experimental and Reference Devices
timeFrame: 1 hour
measure: Makani Science System Performance after Simulated Breathing Artifacts
timeFrame: 15 minutes
measure: Makani Science System Performance after Position Change
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Illumination Foundation
state: California
Study officials:
References:
Clinical trial NCT05779085: Efficacy of a Deep Cleansing Gel Containing 2% Salicylic Acid, 0.2% Zinc Gluconate and 0.05% Lipohydroxy Acid in the Management of Mild to Moderate Facial Acne
Official title: ASSESSMENT OF CLINICAL, INSTRUMENTAL AND NOTICED EFICACY BY SUBJECTS OF A COSMETIC PRODUCT 12.0417.01.090 UNDER NORMAL CONDITIONS OF USE Study With Dermatological Follow-up Including Instrumental Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris on the Face
Lead sponsor: Cosmetique Active International
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 13
Maximum age (years): 26
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged between 13 to 25 years of age with mild to moderate acne.

Brief summary: A clinical study with 56 healthy subjects (both sexes) aged between 13 to 25 years old. Subjects enrolled had a minimum of 5 inflammatory lesions (papules, nodules and pustules) and 10 non-inflammatory lesions (open and closed comedones), determined by dermatologist. The clinical evaluation considered in oiliness, shininess and global aspect of the skin too. Instrumental assessment of oiliness and shininess was performed, respectively, by Sebumeter and Sebutape.

IThe tested cleanser was used twice daily (morning and evening) during 28 days.


Eligibility criteria: Inclusion Criteria:

* subjects aged 13-25 years
* mild to moderate acne on the face
* signed informed consent

Exclusion Criteria:

* subjects below 13 years and above 26 years
* severe acne on the face

Primary outcomes:
measure: Global lesion count
timeFrame: baseline
measure: Global lesion count
timeFrame: Day 28
measure: Closed comedones
timeFrame: baseline
measure: Closed comedones
timeFrame: Day 28
measure: papules
timeFrame: baseline
measure: papules
timeFrame: Day 28
measure: skin oiliness
timeFrame: baseline
measure: skin oiliness
timeFrame: Day 28
measure: skin sebutape
timeFrame: baseline
measure: skin sebutape
timeFrame: Day 28
measure: subject satisfaction
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Niterói
country: Brazil
facility: Carlos Tortely Hospital
Study officials:
References:
Clinical trial NCT00722956: Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin
Official title: A Phase I, Single Centre, Open-label Study to Assess the Pharmacokinetics of Both AZD5672 (Steady-state) and Atorvastatin (Single Dose) When Co Administered in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Pharmacokinetics
Keywords: atorvastatin
AZD5672
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and atorvastatin (single dose) when co administered in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Females should not be of childbearing potential
* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results

Exclusion Criteria:

* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate
* Known allergy to atorvastatin (or other statins) or previous complications to atorvastatin therapy.
* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer).

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study periods
Secondary outcomes:
measure: Safety variables (adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment periods
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D, Charnwood, UK
name: Rod Hepburn
role: STUDY_DIRECTOR
affiliation: PAREXEL Clinical Pharmacology Research Unit
name: Maura Fallon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05833256: A Prediction Model for 1-year Mortality After Valvular Heart Surgery
Official title: Inflammation-related Markers for the Prediction of Postoperative 1-year Mortality in Patients Undergoing Valvular Heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Valvular Heart Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 2046
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Tertiary care hospital

Brief summary: The investigators aimed to develop a predictive model for mortality incorporating nutritional, inflammatory, and perioperative factors in patients undergoing valvular heart surgery. In this retrospective study, the investigators aimed to establish a comprehensive prediction model to predict the risk of 1-year mortality in valvular heart surgery patients through the identification of the inflammatory index most associated with 1-year mortality and developing a prognostic nomogram model incorporating perioperative risk factors with nutritional and inflammatory indices that would be verified by validation cohorts.


Eligibility criteria: Inclusion Criteria:

1) patients who presented for surgery primarily due to valvular heart disease, including those who required concomitant coronary artery bypass surgery, aortic procedures, or other cardiac procedures.

Exclusion Criteria:

1. patients aged \<18 years
2. undergoing transcatheter valve replacement, combined congenital heart surgery, or implantation of ventricular assist device, 3) lacking data required for calculating inflammatory indices, or 4) follow-up loss.

Primary outcomes:
measure: 1-year mortality after valvular heart surgery
timeFrame: 1 year after valvular heart surgery
Secondary outcomes:
measure: neutrophil-to-lymphocyte ratio (NLR), calculated as the number of neutrophils divided by the number of lymphocytes
timeFrame: within 1 month before surgery
measure: monocyte-to-lymphocyte ratio (MLR), calculated as the number of monocytes divided by the number of lymphocytes
timeFrame: within 1 month before surgery
measure: platelet-to-lymphocyte ratio (PLR), calculated as the number of platelets divided by the number of lymphocytes
timeFrame: within 1 month before surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Jin Sun Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01669356: The Effect of Parenteral Nutrition Supplement on Esophagectomy Patients
Official title: The Effect of Parenteral Nutrition Supplement Versus Enteral Nutrition Alone on Nutrition Status After Esophagectomy: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophagus Cancer
Keywords: malnutrition
parenteral supplement
rest metabolic rate
postoperative complications
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Malnutrition is common in esophagus cancer patients, especially after surgery therapy. Whether parenteral supplement with enteral nutrtion is benificial for patients after esophagectomy is controversial, when compared with enteral nutrition alone. In this study, the investigators are to examine the effect of enteral nutrition supplemented with parenteral nutrtion on nutrition status after esophagectomy.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of esophagus cancer
* Undergo esophagectomy
* Nasoenteral tube is placed or surgical jejunostomy is performed

Exclusion Criteria:

* Contraindication for enteral nutrition or parenteral nutrition
* Malnutrition before surgery ( BMI \> 30 or \< 18.5)
* Hepatic dysfunction preoperatively
* Renal dysfunction preoperatively
* Infection before surgery
* Usage of corticosteroid before surgery

Primary outcomes:
measure: postoperative laboratory parameters changes for nutrition assessment compared to preoperation
timeFrame: from one day before surgery to the 7th postoperative day
measure: postoperative body composition change compared to preoperation measurement
timeFrame: from one day before surgery to the 7th postoperative day
Secondary outcomes:
Other outcomes:
measure: complicatons incidence after surgery
timeFrame: 28 days after surgery
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
Study officials:
References:
citation: Wu W, Zhong M, Zhu DM, Song JQ, Huang JF, Wang Q, Tan LJ. Effect of Early Full-Calorie Nutrition Support Following Esophagectomy: A Randomized Controlled Trial. JPEN J Parenter Enteral Nutr. 2017 Sep;41(7):1146-1154. doi: 10.1177/0148607116651509. Epub 2016 May 20.