louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02089191: Tear Film Stability of DAILIES® AquaComfort Plus® Contact Lenses vs. MyDay® Daily Disposable Contact Lenses
Official title: Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: DACP
DAILIES® AquaComfort Plus
Tear film stability
NIK-BUT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.


Eligibility criteria: Inclusion Criteria:

* Must sign an Informed Consent form;
* Adapted, current soft contact lens wearer;
* Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
* Cylinder ≤ -1.00 D in both eyes at Visit 1;
* Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
* Willing to wear study lenses up to 12 hours and attend all study visits;
* Able to be successfully fitted with study lenses;
* Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* Use of artificial tears and rewetting drops during the study;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Any abnormal ocular condition observed during Visit 1;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Participation in any clinical study within 30 days of Visit 1;
* Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
timeFrame: Day 1, Hour 12, each period
Secondary outcomes:
measure: Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear
timeFrame: Hour 12
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Alcon Investigative Site
Study officials:
affiliation: Alcon Research
name: Global Medical Affairs, Clinical Manager, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT04257591: Effects of Hamstrings Strengthening in Proffesional Athlets
Official title: Effects of Hamstrings Strengthening in Proffesional Athlets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise
Hamstring Injury
Keywords: exercise
therapeutics
prevention
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Athelts that meet the inclusion criteria will be randomized into two groups. The experimental group will receive an 8-week (3 days per week) specificl protocol based on hamstring strengthening (isometric, concentric and excentric exercises), and the control group will not receive any additional exercise. The aim of the study is to investigate the changes in hip and knee muscle strength, in the extensibility of cuadriceps, hamstrings and hip abductors, in the physical functions and in the final marks.


Eligibility criteria: Inclusion Criteria:

* Professional Athlet
* 3 or more trainign days
* Previous hamstring injury but without symptoms for 3 months or \>30% difference between cuadriceps and hamstrings strength (considered as a risk for hamstring injury)

Exclusion Criteria:

* Sistemic pathologies
* Any other type of musculoskeletal injuries in lower limb or lumbar spine
* To have a previous specific protocol
* To skip more than 3 training days
* General contraindications for physical activity

Primary outcomes:
measure: muscle strength
timeFrame: Baseline
measure: muscle strength
timeFrame: up to 8 weeks
measure: muscle extensibility
timeFrame: Baseline
measure: muscle extensibility
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Physical function
timeFrame: Baseline
measure: Physical function
timeFrame: up to 8 weeks
measure: Mark
timeFrame: Baseline
measure: Mark
timeFrame: up to 8 weeks
measure: Number of hamstring injuries
timeFrame: Baseline
measure: Number of hamstring injuries
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Luis Ceballos Laita
Study officials:
References:
Clinical trial NCT06653491: Immediate Effects of the HVLA Talocrural Distraction Technique in Soccer Players
Official title: Immediate Effects of the HVLA Talocrural Distraction Technique in Dorsiflexion, the Plantar Center of Pressure and the Percentage of Rearfoot Loading in Soccer Players
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ankle Injury
Plantar Pressure
Keywords: ankle
manual therapy
plantar pressure center
mobility
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the effect of a high-speed, low-amplitude physiotherapy technique at the ankle level, when performed on amateur soccer players.

Detailed description: In this randomized, single-blind, cross-sectional and prospective clinical trial, the effect on ankle mobility and changes in plantar pressure centers obtained after performing a high-velocity, low-amplitude physiotherapy technique in amateur soccers will be assessed.

Two intervention groups are used; in one of them this treatment will be applied in a real way, and in the other one a simulation will be carried out.

Eligibility criteria: Inclusion Criteria:

* Men over 18 years old
* Men that played or have played soccer as an amateur or professional on a regular basis
* No previous musculoskeletal history that would contraindicate HLVA techniques (recent fractures, osteosynthesis material placed in the joint, infections...)

Exclusion Criteria:

* Subjects under 18 years old
* Subjects who have suffered musculoskeletal pathology in the lower limb that contraindicates manipulation or who have a medical diagnosis of chronic ankle instability
* Subjects who suffer neurological or cognitive alterations that prevent the understanding of questionnaires or physical tests; and those who have not signed the informed consent documents

Primary outcomes:
measure: Ankle range of motion
timeFrame: one day
measure: plantar pressure centers
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kamali F, Sinaei E, Bahadorian S. The immediate effect of talocrural joint manipulation on functional performance of 15-40 years old athletes with chronic ankle instability: A double-blind randomized clinical trial. J Bodyw Mov Ther. 2017 Oct;21(4):830-834. doi: 10.1016/j.jbmt.2017.01.010. Epub 2017 Jan 25.
citation: Manoel LS, Xixirry MG, Soeira TP, Saad MC, Riberto M. Identification of Ankle Injury Risk Factors in Professional Soccer Players Through a Preseason Functional Assessment. Orthop J Sports Med. 2020 Jun 24;8(6):2325967120928434. doi: 10.1177/2325967120928434. eCollection 2020 Jun.
citation: Knuckles AM, Torp DM, Hubbard-Turner T, Donovan L, Thomas AC. Multi-axis destabilisation device influences plantar pressure distribution in adults with chronic ankle instability. Sports Biomech. 2022 Apr;21(4):501-516. doi: 10.1080/14763141.2021.1896773. Epub 2021 Mar 28.
Clinical trial NCT01948791: 16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients
Official title: 16 Weeks Interventional Study on Titration and Dose/Efficacy Assessment of Exelon (Rivastigmine) in Chinese Alzheimer's Disease Patients (INSTINCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
ENA713
Chinese patients
INSTINCT
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-09-24
Enrollment: 222
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration


Eligibility criteria: Key Inclusion Criteria:

* Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* MMSE score of ≥ 10 and ≤ 26
* The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks
* Be in stable medical condition
* Have signed off informed consent form by patients or his/her legal guardian

Key Exclusion Criteria:

* Severe AD
* Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition
* Attending other clinical trials or taking other clinical trial drugs
* A score of \> 4 on the Modified Hachinski Ischemic Scale (MHIS);
* Patients who is using any AChEI or memantine

Primary outcomes:
measure: Mean Change From Baseline in the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog)
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline, Week 16
measure: Mean Change From Baseline in Neuropsychiatric Inventory (NPI) Score
timeFrame: Baseline, Week 16
measure: Change From Baseline in Caregiver Burden Inventory (CBI) Score
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Department of Neurology, Xuanwu HospitalCapital Medical University, Beijing, P.R.China
name: Jianping Jia, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06814691: Effects on In-Game Decision Making Processes
Official title: Evaluation of Analytical Thinking Skills and Reaction Tests of Female Football Players on Performance: Effects on In-Game Decision Making Processes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletic Injuries
Keywords: exercise
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The footballers who will take part in the study will be selected from players between the ages of 18-30, who are actively playing in professional football teams and have at least two years of experience.

Brief summary: This study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

Detailed description: This study aims to investigate the effects of analytical thinking skills and reaction speed on performance in female football players.

Eligibility criteria: Inclusion Criteria:

* Accepting the voluntary basis
* To be between the ages of 18-35
* To take part in professional football clubs
* Not having suffered any serious injury in the last 6 months
* To be able to participate in the Tampa Kinesiophobia Scale
* To be able to actively participate in technology-based tests such as decision-making simulations and Blazepod

Exclusion Criteria:

* Not accepting the voluntary basis
* Individuals who have had a surgical procedure in the last six months
* Use of NSAIDs and similar disease modifying drugs in the last month (Diaserein, Glucosamine etc.)

Primary outcomes:
measure: Assessment of Analytical Thinking and Decision-Making Processes
timeFrame: day 1
measure: Assessment of Analytical Thinking and Decision-Making Processes-Accuracy
timeFrame: day 1
measure: Assessment of Analytical Thinking and Decision-Making Processes-Error Rates
timeFrame: day 1
measure: Tampa Scale of Kinesiophobia-Reaction Times
timeFrame: day 1
measure: Reaction Time Measurement (Using Blazepod)
timeFrame: day 1
measure: Y-Balance Test
timeFrame: day 1
measure: Push-Up Test
timeFrame: day 1
measure: Seated Ball Throw Test
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçehir University
Study officials:
References:
Clinical trial NCT02018991: Late Acquired Malaposition and Different Polymers
Official title: Incidence and Predictors for Late Acquired Stent Malaposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - a Prospective, Randomized Comparison Using Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Late Acquired Stent Malaposition
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 69
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 polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malaposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with newer-generation polymers designed to improve biocompatibility are unknown.

Detailed description: please see brief summary

Eligibility criteria: Inclusion Criteria:

* Patients who underwent an elective treatment of a coronary lesion \> 20mm with a DES

Exclusion Criteria:

* chronic renal failure (serum creatinine ≥ 2.5mg/dl)
* restenotic lesions

Primary outcomes:
measure: Number of stent struts with late acquired malaposition
timeFrame: 1 year after stent implantation
Secondary outcomes:
measure: number of stent struts with late acquired malaposition
timeFrame: 2 years after stent implantation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: PI
name: Thomas Neunteufl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06021691: Gestational Diabetes Mother-infant Cohort
Official title: A Cohort Study on the Impact of Gestational Blood Glucose Management and Postnatal Nurturing Environment on Delayed Language Development in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gestational Diabetes Mellitus in Pregnancy
Cognitive Impairment
Cohort Study
Keywords: Child cognitive impairment
Intrauterine high-glucose environment
Acquired nurture environment
Lead sponsor: Gansu Provincial Maternal and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The pregnant women with abnormal blood glucose levels and the offspring

Brief summary: The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children. The study investigated the results of blood glucose screening during pregnancy for the children's mothers, and followed up on the blood glucose management effectiveness of pregnant women with abnormal blood glucose levels before delivery. Participants will be also surveyed the "S-S method for language development assessment, "gsell Scale", and "0-6 year-old family nurturing environment evaluation scale" to evaluate the language development and family nurturing environment.

Detailed description: Glucose management during pregnancy and the postnatal nurturing environment are keys to early detection and early intervention of language delay, which is important to reduce abnormal language development in children. In this study, mothers diagnosed with gestational diabetes mellitus in the department of hospital and offspring were used as participants. The investigators take a follow-up visit to participants' offspring using the S-S method of language development assessment, gsell Infant and Toddler Development Scale, and 0-6 years old family parenting environment evaluation scale. The bi-directional dynamic cohort study is to learn about the effects of prenatal exposure to high blood glucose levels and postnatal nurturing environment factors on delayed language development in children.

Eligibility criteria: Inclusion Criteria:

* Children 1.5-2.5 years old with no serious underlying diseases and no hearing impairment.

Exclusion Criteria:

* diagnosed hearing impairment, organic dysarthria, oral disease; (ii) cerebral palsy;
* neurological and hereditary metabolic diseases; (iv) deaf father/mother.

Primary outcomes:
measure: delayed language development in children
timeFrame: 2023.1-2025.11
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: GansuPMCH
state: Gansu
Study officials:
affiliation: Gansu Provincial Maternal and Child Health Care Hospital
name: Cheng Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649891: Checklists Resuscitation Emergency Department
Official title: Clinical Use of an Emergency Manual by Resuscitation Teams and Impact on Performance in the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shortness of Breath
Chest Pain
Abdominal Pain
Altered Mental Status
Syncope
Seizures
Vertigo
Trauma
Allergic Reaction
Fever
Cardiac Arrest
Asthma Acute
COPD Exacerbation Acute
Pneumonia
Pulmonary Edema - Acute
Bradycardia
Tachycardia
Shock
Burns
Poisoning
Diabetic Ketoacidosis
Hyperglycemic Hyperosmolar Nonketotic Syndrome
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will systematically evaluate how an emergency manual-a collection of checklists and fact sheets-affects the performance of resuscitation teams during the management of priority one patients in an emergency department.

Detailed description: Simulation-based studies indicate that crisis checklist use improves management of patients with critical conditions in the emergency department (ED). This six-month-long study prospectively evaluates a digital emergency manual-a collection of crisis checklists and fact sheets-during the management of priority 1 patients in the Skåne University Hospital at Lund's ED.

Eligibility criteria: Inclusion Criteria:

* Consecutive priority 1 patients managed in the resuscitation room of Skåne University Hospital at Lund's Emergency Department

Exclusion Criteria:

* None

Primary outcomes:
measure: Degree of indication of interventions performed thanks to Do-Confirm Emergency Manual use
timeFrame: 1 hour
Secondary outcomes:
measure: Team's subjective evaluation of Emergency Manual value
timeFrame: 1 hour
measure: Degree of indication of interventions that might have been performed had the Emergency Manual been used
timeFrame: 1 hour
measure: Structured interviews
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Skane's University Hospital in Lund, Emergency Department
name: Eric Dryver, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00351780: Fractional Flow Reserve-guided Provisional Side Branch Intervention
Official title: Physiologic Evaluation of the Provisional Side Branch Intervention Strategy for Bifurcation Lesions Using Fractional Flow Reserve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: fractional flow reserve
bifurcation
stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-07-13
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study purpose: To evaluate fractional flow reserve-guided side branch intervention strategy Method: Provisional side branch intervention if jailed side branch FFR\<0.75

Detailed description: Patients with de novo, coronary bifurcation lesions with jailed side branches after successful drug-eluting stent implantation at the main branches will be prospectively and consecutively enrolled. Control group patients will be selected from the database.

Jailed side branches need to have an ostial stenosis \>50%, vessel size \>2 mm, vessel length \>40 mm and lesion length \<10 mm by visual estimation.

Study procedure Coronary stenting of the main branch should be performed with standard interventional techniques using drug-eluting stents. In the FFR group, pressure measurement would be performed using a 0.014 inch pressure guide wire (PressureWire, Radi Medical Systems, Uppsala, Sweden)Lesions with an FFR \<0.75 are considered to have functionally significant stenosis and side branch balloon dilatation is allowed only for these lesions. It is recommended to use a smaller balloon than the side branch vessel diameter. After kissing balloon inflation, FFR will be measured again at the same site and further intervention is only recommended when FFR was \<0.75 after kissing balloon dilatation. In the conventional group, the decision to treat the side branch lesion and the method of intervention are all up to the operators' discretion.

Eligibility criteria: Inclusion Criteria:

Jailed side branches with an ostial stenosis \>50%, vessel size \>2mm, vessel length \>40mm and lesion length \<10mm by visual estimation.

Exclusion Criteria:

ST elevation myocardial infarction Left main stenosis, totally occluded lesion Angiographically visible thrombus, significant lesion within the main branch proximal to the stented segment, significant distal lesion at a side branch Regional wall motion abnormalities of the stented artery and jailed side branch segments Left ventricular ejection fraction\<40% Primary myocardial disease Serum creatinine \>2mg/dl Predilatation of side branch before the main branch stent implantation Contraindications to adenosine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: