louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06115161: Development and Validation of an Instrumented Ankle-foot Orthosis
Official title: Development and Validation of an Instrumented Ankle-foot Orthosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Foot Drop
Keywords: ankle foot orthosis
validation
survey
gait analysis
biomecanics
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Turbomed Orthotics Inc.
First posted: 2023-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Trial with condition crossover
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Foot drop (weakness or paralysis of the muscles that lift the foot) refers to a condition that prevents people from properly lifting their foot and toes while walking. Foot drop has a negative impact on the balance, mobility, and confidence of people with the condition. Dragging one's toes on an uneven floor or a carpet can lead to tripping and falling.

TurboMed Orthotics Inc. has developed various orthoses for several years in order to improve the gait and quality of life for people suffering from foot drop. In order to help clinicians better monitor and assess gait parameters over time, the company wants to offer clinicians a tool for a more rigorous analysis. Thus, the objective of the proposed project is to develop a questionnaire for identifying the clinical need for the data generated by the instrumented orthosis. The instrumented orthosis will also be compared to a reference system in a validation effort.


Eligibility criteria: Inclusion Criteria for Patients questionnaire:

* Having foot drop

Inclusion Criteria for Clinician questionnaire:

* Being a clinician who treats foot drop patients

Inclusion Criteria for Gait analysis:

* Having foot drop

Exclusion Criteria for Gait analysis:

* Not being able to walk without a cane or a walker
* Having lower extremity spasticity

Primary outcomes:
measure: Gait Temporal parameters
timeFrame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
measure: Heel strike angle
timeFrame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
measure: Gait Spatial parameters
timeFrame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
measure: Gait speed
timeFrame: During the intervention, 10 walking trials will be assessed, all trials will be performed in the same session
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: TOPMED
Study officials:
References:
Clinical trial NCT01153061: Endoscopic Closure of Tracheoesophageal Fistulas With Occluder Device
Official title: Endoscopic Closure of Tracheoesophageal Fistulas With a Cardiac Septal Defect Occluder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acquired Tracheo-esophageal Fistula
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: W.L.Gore & Associates
First posted: 2010-06-29
Enrollment: 4
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic closure of tracheoesophageal fistulas with a device used for closure of cardiac septal defects.


Eligibility criteria: Inclusion Criteria:

* Patients over 14 years old
* Benign tracheoesophageal fistulas identified through bronchoscopy;

Exclusion Criteria:

* Malign neoplasia
* Current mechanical ventilation
* Immunosuppressed
* Current local inflammatory process at fistulas borders
* Other clinical risk factors

Primary outcomes:
measure: Closure of tracheoesophageal fistulas with the Gore Helex Septal Occluder
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor)-Clinics Hospital Sao Paulo University Medical School
Study officials:
affiliation: Heart Institute (InCor)-HC of the Sao Paulo University Medica School
name: Miguel L Tedde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04920461: Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Official title: Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Cerebellar Lesions
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Being able to pass initial neuropsychological tests within 10 days after stroke

Exclusion Criteria:

* Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
* Chronic alcoholism
* MRI contraindication.

Primary outcomes:
measure: Presence of Neuro-Visual Disorder
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Eloi MAGNIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00652483: Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 433
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: This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

* Uncontrolled systemic disease
* Known allergy or sensitivity to brimonidine

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: Week 2 - Month 3
Secondary outcomes:
measure: IOP
timeFrame: Month 6 - Month 12
Other outcomes:
Locations:
city: Atlanta
country: United States
state: Georgia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01516983: Icotinib Combined With WBRT For NSCLC Patients With Brain Metastases and EGFR Mutation
Official title: A Single Center, Open Label, Dose-Finding Study to Determine the Safety of Icotinib in Combination With Whole Brain Radiation Therapy For NSCLC Patients With Brain Metastases and EGFR Mutation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-small Cell Lung Cancer
Brain Metastases
Keywords: Safety
EGFR-TKI
NSCLC
Icotinib
WBRT
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: 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 evaluate the safety and tolerability of Icotinib at different dose levels in combination with whole brain radiotherapy for NSCLC patients with brain metastases and EGFR mutation.

Detailed description: The long-term control of brain metastases becomes a clinical challenge. Whole brain radiotherapy, the standard treatment for patients with multiple brain metastases, can only bring a modest survival improvement around 3-6 months. EGFR-TKIs like icotinib with its proven activity in non-small cell lung cancer may provide clinical benefits in such patients.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmation of non-small cell lung cancer (NSCLC).
* Diagnosis of brain metastases on a Gadolinium-enhanced MRI. More than 3 sites of intracranial metastases, or the longest diameter of the intracranial lesion is more than 3cm.
* Positive EGFR mutation.

Exclusion Criteria:

* Previous usage of EGFR-TKI or antibody to EGFR: gefitinib, erlotinib, herceptin, erbitux.
* CSF or MRI findings consistent with metastases of spinal cord, meninges or meningeal.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 6-12 months
Secondary outcomes:
measure: Neurological progression-free survival
timeFrame: 3-6 month
measure: Progression-free survival
timeFrame: 3-6 months
measure: Overall survival
timeFrame: 6-12 months
measure: Response rate
timeFrame: 3-6 month
measure: Quality of life measured by FACT-L/LCS 4.0
timeFrame: 1 year
measure: Neurocognitive effects
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: West China Hospital
name: You Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736783: Plyometric and Strength Training of Quadriceps and Hamstrings in Football Players
Official title: Comparative Effects of Plyometric and Strength Training of Quadriceps and Hamstrings on Sprint and Agility Performance in Football Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Football Players
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 36
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Football is a trendy sport in the world. A typical footballer runs more than 10 kilometers in an average game of 90 minutes. FIFA regulates the sport of football and the world cup is conducted every 4 years. Plyometric exercise training uses speed and different forced movements to build muscle power. Plyometrics training improves physical performance and the ability to do different activities. Strengthening exercises are designed to increase the strength of specific groups of muscles. Strengthening exercises overload the muscle until the point of muscle fatigue. By conducting the study, it will help us to make a better understanding that whether plyometrics or strength training is more effective so that we can cooperate it into the regular exercise of the football player so that their sports performance can be enhanced.

Detailed description: It will be a randomized clinical trial. It will be conducted at the Pakistan sports board and coaching center, Lahore. A sample of 40 athletes will be taken using convenient sampling. Athletes will be randomly allocated into two groups. Group A was given plyometrics and group B was given strengthening exercises. Athletes will be assessed using a 20m sprint test and an Illinois agility test before the initiation of the exercise regimen. Athletes will perform plyometrics 5 days a week and strength training twice a week for 6 weeks. Athletes will be reassessed after 6 weeks. Statistical analysis will be used to determine their effects with the help of the software SPSS 25.

Eligibility criteria: Inclusion Criteria:

* the age group of 15-30 years.
* Participants that are practicing five times a week
* Participants having experience of at least 1 year

Exclusion Criteria:

* Athletes with any musculoskeletal injuries;
* Athletes with any systemic illness;
* Novice football players
* Elite/ International players

Primary outcomes:
measure: 20 meter sprint test
timeFrame: 6 weeks
measure: Illinois Agility Test
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Sports Board
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Asrar Yousaf, Masters
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05307783: EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
Official title: A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Bleeding Hemorrhage
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are treated with EmboCube to control bleeding or hemorrhage in accordance with the current approved CE Mark indication for use (IFU) as stated in the IFU.

Brief summary: This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.

Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
3. Subject provides written informed consent to study data collection.

Exclusion Criteria:

1. Bleeding site in the neck, head, or brain.
2. Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
3. In the investigator's opinion, participation in the study may not be in the subject's best interest.

Primary outcomes:
measure: Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours
timeFrame: 24 hours
measure: Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Liverpool
country: Australia
facility: South Western Sydney Local Health District
city: Sydney
country: Australia
facility: Alfred Health
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes - Caremeau
city: Paris
country: France
facility: HEGP
Study officials:
References:
Clinical trial NCT01412983: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Official title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
* Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.

Exclusion Criteria:

* An active ocular disease, any corneal infiltrative response or are using any ocular medications.
* Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
* Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any scar or neovascularization within the central 4mm of the cornea.
* Have had any corneal surgery.
* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Currently wear monovision, multifocal, or toric contact lenses.
* Allergic to any component in the study care products.

Primary outcomes:
measure: Visual Acuity
timeFrame: One week
Secondary outcomes:
measure: Overall Comfort
timeFrame: One week
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Beverly J Barna, CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT00727883: Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
Official title: Retrospective Observational Trial on Reasons for Withdraw of Adjuvant Tamoxifen in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Adjuvant TAM
post-menopausal
women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-04
Enrollment: 190
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post menopausal women treated with adjuvant TAM for breast cancer

Brief summary: Retrospective observational trial on reasons for withdraw of Adjuvant Tamoxifen in Breast Cancer patients


Eligibility criteria: Inclusion Criteria:

* Breast Ca Patients with surgery and withdraw of adjuvant treatment with Tamoxifen for Tam related AEs
* Documented reasons for treatment withdrawal

Exclusion Criteria:

* enrollment in other studies
* treatment withdraw for other causes than Tam related AEs

Primary outcomes:
measure: incidence of withdraw from adjuvant Tamoxifen due to Tam related AEs
timeFrame: January 2003-December 2004
Secondary outcomes:
measure: Types of TAM related AE
timeFrame: January 2003-December 2004
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01553383: Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea
Official title: Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for OSA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Adverse Effects
Keywords: OSA
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve "Provent" in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.


Eligibility criteria: Inclusion Criteria:

* Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI \> 10/hr)
* Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA.
* Able to sign informed consent and use the PEEP nasal valve.
* Age between 18-65 years old.
* Willing to attend follow up.

Exclusion Criteria:

* Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve.
* Unable to sign consent or use PEEP nasal valve.
* Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority.
* Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.

Primary outcomes:
measure: Apnea Hypopnea Index (AHI)
timeFrame: 1 month
Secondary outcomes:
measure: side effects as a measure of tolerability
timeFrame: 1 month
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Study officials:
References:
Clinical trial NCT02475083: Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
Official title: Therapeutic Effect of Virtual Reality in Patients After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Virtual reality
Balance
Falls
Lead sponsor: Pedreira, Érika, M.D.
Sponsor class: INDIV
First posted: 2015-06-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.

Detailed description: Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. They excluded those who had less than six months of injury, with sensory or perceptual deficit. Patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. Randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. After selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the Dynamic Gait Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. The assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.

Eligibility criteria: Inclusion Criteria:

* patients of both sexes with hemiparesis after stroke of 18 to 65 years.

Exclusion Criteria:

* less than 6 months of injury with sensory or perceptual deficit.

Primary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: avarage 8 weeks
Secondary outcomes:
measure: Number of Falls
timeFrame: avarage 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pedreira, Érika, M.D.
name: Erika Fonseca
role: PRINCIPAL_INVESTIGATOR
References: