louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01436630: Step Test and Six Minute Walk Test in Stroke
Official title: Comparação Entre o Teste de Caminhada de Seis Minutos e o Teste do Degrau de Seis Minutos em Pacientes Com Acidente Vascular Encefálico
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Exercise Tolerance
Step Test
Stroke
Walking
Lead sponsor: Faculdades Metropolitanas Unidas
Sponsor class: OTHER
First posted: 2011-09-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Post-stroke patients

Brief summary: The purpose of this study is to investigate the viability of using the Step Test (ST) in stroke patients, and to compare the functional performance of the physiologic variables in stroke patients during ST and Six Minute Walk Test (6MWT).

Detailed description: To accomplish the study it was assessed a group of 12 post-stroke patients who were admitted in the Rehabilitation Clinic inside the University. As inclusion criteria it was established to be able to walk alone without supervision and with no aids.

Eligibility criteria: Inclusion Criteria:

* To be able to walk alone without supervision and with no aids.

Exclusion Criteria:

* There were no.

Primary outcomes:
measure: Physiological Variables
timeFrame: 6 months
Secondary outcomes:
measure: Performance
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculdades Metropolitanas Unidas
Study officials:
affiliation: Faculdades Metropolitanas Unidas
name: Rodrigo Daminello Raimundo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Camila Torriani-Pasin, Professor
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Carlos Bandeira de Mello Monteiro, Professor
role: STUDY_DIRECTOR
affiliation: Faculdades Metropolitanas Unidas
name: Osmar Aparecido Theodoro Junior, Professor
role: STUDY_DIRECTOR
affiliation: Faculdades Metropolitanas Unidas
name: Talita Dias da Silva, Physiotherap
role: STUDY_CHAIR
References:
Clinical trial NCT02195830: Inferior Vena Cava Collapsibility Index in Severe Sepsis
Official title: Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Severe Sepsis
Septic Shock
Keywords: Sepsis
ultrasound
inferior vena cava collapsibility
Lead sponsor: Teesside University
Sponsor class: OTHER
First posted: 2014-07-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis.

To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients.

The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.

Detailed description: The study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital Emergency Department.

Eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the IVCCI will be calculated at enrolment.

Care will be provided in line with the published guidelines on sepsis management from the Surviving Sepsis Campaign and the College of Emergency Medicine.

A sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* signs and symptoms of infection with 2 or more SIRS criteria (pulse rate \>90/min, Temp \> 38 Celsius \< 36 Celsius, Respiratory rate \> 20 breaths per minute, or white cell count \>12 or \<4 x 10\^9/L)

Exclusion Criteria:

* in relation to this episode of care: Prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.
* Patients who have received more than 20ml/Kg of IV fluid in the pre hospital environment
* Patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension
* Patients receiving palliative terminal supportive care

Primary outcomes:
measure: Mean baseline inferior vena cava collapsibility index
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West yorkshire
Study officials:
affiliation: Teesside University
name: Simon Richards, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01469130: A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
Official title: A Phase I Study of Oral MEK162 in Japanese Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: MEK, Advanced solid tumor
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, MEK162 will be administered to Japanese patients with advanced solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will investigate the safety and tolerability and determine the MTD of MEK162 in Japanese patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically-confirmed, advanced unresectable solid tumors who have progressed within three months before screening/baseline visit.
* Availability of a representative formalin fixed paraffin embedded tumor tissue sample.
* At least one measurable or non-measurable lesion
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Good organ (hepatic, kidney, BM) function at screening/baseline visit.

Exclusion Criteria:

* Brain metastasis unless treated and free of signs/symptoms attributable to brain metastasis in the absence of corticosteroid therapy and anti-epileptic therapy.
* Impaired cardiac function or clinically significant cardiac disease incl. unstable angina pectoris ≤ 3 months prior to starting study drug and Acute Myocardial Infarction (AMI) ≤ 3 months prior to starting study drug.
* Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Incidence of Dose limiting toxicities
timeFrame: 4 weeks
Secondary outcomes:
measure: Incidence and severity of adverse events and serious adverse events, changes in laboratory values
timeFrame: 4 months
measure: Plasma concentration of MEK162 and AR00426032active metabolite of MEK162 and derived PK parameters of MEK162 and the active metabolite.
timeFrame: 2 months
measure: Tumor responses according to RECIST 1.1
timeFrame: 4 months
measure: Levels of p-ERK in tumor and skin
timeFrame: 4 months
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Pfizer Investigative Site
state: Aichi
city: Yufu
country: Japan
facility: Pfizer Investigative Site
state: Oita
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02975830: Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements
Official title: Tracheobronchial Angle in Children - Three-dimensional Computed Tomography Based Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchus
Pediatric Airway
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
First posted: 2016-11-29
Enrollment: 270
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: upto 8years of age

Brief summary: Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children. Majority of pediatric anesthesia textbooks state that the anatomic orientation of the right main bronchus is at less acute angle to the vertical tracheal axis, although these angles tend to be similar in children younger than three years of ageThe visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway.

We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.

Detailed description: Accurate understanding of tracheobronchial anatomy is important for application of various airway maneuvers in anesthesiology in children.

Significant variations and discrepancies in the reported tracheobronchial angles are found in literature.

Various imaging modalities ranging from chest x-ray to helical computed tomography (CT) have been used for measuring the tracheobronchial angles in children and the results are varied with some studies reporting equal angles \[2016\] while others reporting right bronchial angle to be smaller than left bronchial angle \[Kubota\].

The visualization of the air column in tracheobronchial tree in a three-dimensional (3D) CT-based image is clear with the air column simulating the actual internal shape of the airway. The highest quality medical-grade (3D) images are obtained using CT data \[Uchida M\]. Computed tomography (CT) is considered the current gold standard for airway measurements as the air-tissue interface is better delineated by CT imaging \[Reinhardt\].

We hypothesize that RBA and LBA are unequal as children like adults are prone to right mainstem intubation We have measured the right and left bronchial angle using the three dimensional CT based images of the air column in the tracheobronchial tree.

Eligibility criteria: Inclusion Criteria:

* CT scans airways

Exclusion Criteria:

* any disease that is anticipated to distort the normal shape of airways wee excluded from the study

Primary outcomes:
measure: tracheobronchial angles
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00439530: Pharmacologic Study of Oseltamivir in Healthy Volunteers
Official title: Pharmacologic Study of Oseltamivir in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Avian Influenza A Virus
Keywords: oseltamivir
pharmacokinetics
probenecid
avian influenza
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Southeast Asia Influenza Clinical Research Network
First posted: 2007-02-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: "Pharmacologic Study of Oseltamivir in Healthy Volunteers" is a Phase I study in which 8 to 32 adult healthy Thai volunteers will be randomized to one of four drug doses and regimens within each of 4 visits. The study is being conducted at the Bangkok Hospital of Tropical Diseases Research Unit, Faculty of Tropical Medicine, and commenced enrolling healthy volunteers on 23 November 2006. The duration of the study is expected to be approximately four months. The goals of this study are to assess the use of loading dose oseltamivir and the concomitant use of probenecid and to characterize the pharmacokinetic properties of oseltamivir in Thai subjects.


Eligibility criteria: Inclusion Criteria:

* healthy with no underlying chronic disease
* normal baseline laboratory screening
* no regular prescribed medication used in the past 30 days and no over-the-counter medication in the past week
* agree to abstain from self-medication during the study
* negative urine pregnancy test for females and agreement that they will not try to become pregnant until 1 month after the study is completed
* only use non-hormonal methods of contraception for females
* non-smoker for the last 30 days and for duration of the study
* no consumption of alcohol for the last 30 days and for duration of the study
* no use of recreational drugs for the last 30 days and for duration of the study

Exclusion Criteria:

* known hypersensitivity to oseltamivir and/or probenecid
* Hepatitis B virus surface antigen positive
* presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study

Primary outcomes:
measure: AUC 0-12 hrs.
timeFrame: 12 hour
Secondary outcomes:
measure: AUC 12-24 hrs.
timeFrame: 24 hrs
measure: C max
timeFrame: 24 hrs
measure: t max
timeFrame: 24 hrs
measure: t 1/2
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Bangkok Hospital for Tropical Diseases Research Unit, Faculty of Tropical Medicine, Mahidol University
Study officials:
affiliation: Associate Professor, Department of Clinical Tropical Medicine Faculty of Tropical Medicine, Mahidol University
name: Yupaporn Wattanagoon, DTM & H
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02997930: fMRI Connectivity in Fracture Hip Patients
Official title: Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The long-term goal of this study is to evaluate cognitive function preoperatively and develop techniques of intervention in the perioperative period which would optimize brain function and functional recovery following surgery.

Detailed description: In this protocol, subjects who are anticipated to be operated for hip fracture will be studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean diffusivity) data will be compared with age matched controls and correlated with subjective measures of cognition.

Eligibility criteria: Inclusion Criteria:

* Patients 65 years and older
* Patients who have fracture hip and are anticipated to have surgery

Exclusion Criteria:

* Patients who have contraindications for MRI like pacemaker, automatic implanted cardiac defibrillator (AICD), implanted infusion pumps etc.
* Patients who are claustrophobic
* Patients with severe cognitive impairment (who may not be able to cooperate during the cognitive exam and fMRI)

Primary outcomes:
measure: Changes between baseline and follow up visits as assessed by fMRI
timeFrame: Change from baseline up to 90 days
Secondary outcomes:
measure: Changes between baseline and follow up visits as assessed by MoCA
timeFrame: Change from baseline up to 90 days
measure: Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy
timeFrame: Change from baseline up to 90 days
measure: Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
timeFrame: Change from baseline up to 90 days
measure: Changes between baseline and follow up visits as assessed by HVLT
timeFrame: Change from baseline up to 90 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Ramachandran Ramani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06904430: Buckets vs. Braces Prospective Study
Official title: Buckets vs Braces: Is Throw Count a Preventative Measure for Injury in Youth Throwers?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elbow Pain
Shoulder Pain
Keywords: Buckets vs. Braces
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 47
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to determine if there is a difference in shoulder or elbow pain between youth athletes who throw regularly without a brace, those who use a brace, and those who limit their throw count by placing the ball in a bucket during a 12-week study.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 8- 12 years old
* Participation and attendance on at least 80% of practices league team
* Only participating on one baseball team for the next 12 weeks

Exclusion Criteria:

* Patients \<8 or \>12 years of age
* Elbow pain at the start of the season
* History of an elbow or shoulder injury, past surgeries
* Participants currently under the care of a physician for an elbow or shoulder issue
* Participants taking outside private coaching

Primary outcomes:
measure: To determine if there is a difference in shoulder or elbow pain between youth athletes that threw regularly without a brace, those that used a brace and those that limited their throw count by placing the ball in a bucket during a six-week study.
timeFrame: 12 weeks
Secondary outcomes:
measure: To identify quality of life/patient and family satisfaction with the use of limiting throw count
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
Study officials:
affiliation: Children's Hospital of Orange County
name: Pediatric Orthopedic Surgeon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06085430: Kubota Glass Parameter Refinement Study
Official title: Effects of Various Stimulus Characteristics on Myopic Progression Using Kubota Glass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Myopia, Progressive
Vision Disorders
Keywords: myopia
spectacles
Lead sponsor: Kubota Vision Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Length of the eye will be measured in subjects exposed to various stimulus characteristics using an electronic spectacle which presents illuminated targets to the eye. The results will be analyzed to determine which stimulus characteristics may be most beneficial for use in the device.

Detailed description: Axial length measurements will be taken before and after two-hour monocular exposure to various stimulus characteristics using an electronic spectacle which presents illuminated defocus targets to the retina. Areas of investigation include the dioptric amount of defocus, the intensity of illumination, the spectrum of illumination, and the shape of the illumination target. The transient axial length results will be analyzed to determine which stimulus characteristics may be most beneficial for slowing myopic eye growth.

Eligibility criteria: Inclusion Criteria:

* Be of legal age or, if under legal age have written consent of their parent or guardian to participate.
* Sign written Informed Consent (and the California Bill of Rights, if applicable).
* Ages 8-24 (inclusive) and able to understand and assent to participation
* Have need of optical correction for myopia, from -1.00 to -5.00 diopters (D).
* Have a refractive astigmatism of less than -1.00 D.
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/25 or better.
* Be willing and able to follow instructions and attend the schedule of follow-up visits.

Exclusion Criteria:

* Not able or willing to provide informed consent and assent
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Currently enrolled in an ophthalmic clinical trial
* Pregnant or lactating or expect to become pregnant during the trial
* Evidence of systemic or ocular abnormality, infection or disease
* Any systemic disease including autoimmune disease, immunocompromising diseases, connective tissue disease, clinically significant atopic diseases, insulin dependent diabetes, use of medications including corticosteroids and antimetabolites that may affect the eye
* Habitually uncorrected anisometropia ≥ 2.00
* Subjects who have undergone corneal refractive surgery
* Use of a treatment for myopia progression within the past 6 months, including atropine, specialized spectacle lenses, orthokeratology, specialized soft contact lenses

Primary outcomes:
measure: Axial length
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: InOptix Eyecare Center
state: Florida
Study officials:
References: