louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01299467: A Study To Assess The Duration Of Action Of PF-03526299 In Asthmatic Subjects Following Allergen Challenge
Official title: A Randomized, Double-Blind, Third Party Open, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Duration Of Action Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
duration of action
allergen challenge
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen

Detailed description: To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients

Eligibility criteria: Inclusion Criteria:

* Male and/or female subjects between the ages of 18 and 60 years, inclusive.
* A history or diagnosis of asthma that requires the use of beta 2 agonist bronchodilators (eg Salbutamol).
* Women who could become pregnant must use appropriate birth control throughout the study and pregnancy tests must be negative on entering the study and prior to dosing in the clinic.

Exclusion Criteria:

* Subjects who have been hospitalized for the treatment of asthma within three months prior to study entry, or have been hospitalized more than twice in last 12 months.
* Subjects who have experienced a lower respiratory tract infection (eg bronchitis or pneumonia) or significant asthma instability in the 4 weeks prior to study entry.
* Severe additional disease other than asthma

Primary outcomes:
measure: To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced EAR in mild allergic asthmatics as a biomarker of response.
timeFrame: Up to 13 days
Secondary outcomes:
measure: To determine the effect of inhaled PF-03526299 after multiple dosing on allergen-induced EAR in mild allergic asthmatics.
timeFrame: Up to 13 days
measure: To determine whether inhaled PF-03526299 has a sustained duration of action, using allergen-induced LAR in mild allergic asthmatics as a biomarker of response.
timeFrame: Up to 13 days
measure: To investigate the safety, toleration and pharmacokinetics of an inhaled dose of PF-03526299
timeFrame: Up ro 13 days
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06203067: Type 1 Together: A Peer Mentorship Program to Bolster Use of CGM
Official title: Type 1 Together: A Peer Mentorship Program to Bolster Use of Continuous Glucose Monitoring Systems Among Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2024-01-12
Enrollment: 106
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate a new way of helping adolescents with type 1 diabetes consistently use continuous glucose monitoring systems (CGM).

Families who participate will be assigned by chance to one of two groups. One group will continue to see their Endocrinology provider who can give recommendations on ways to use CGM.

The other group will be in our Type 1 Together program for 6 months. This will include:

1. Monthly meetings with a community health worker with expertise in type 1 diabetes self-management,
2. Access to CGM-specific educational resources hosted on a mobile app, and
3. Meeting at least monthly with a mentor family who will provide mentorship on using CGM consistently.

The main questions the study aims to answer are:

1. Do families like the Type 1 Together program?
2. Do more families in the Type 1 Together program have better attitudes towards CGM, use CGM more consistently, and have lower HbA1c?
3. Does the Type 1 Together program reduce racial and ethnic differences in attitudes towards CGM, consistent use of CGM, and HbA1c?


Eligibility criteria: Inclusion Criteria:

* 12 to 17 years old
* Diagnosed with type 1 diabetes for at least 6 months
* Does not use CGM OR uses CGM \< 24 out of the past 30 days
* Use CGM 24 to 30 of the past 30 days but most recent HbA1c was 9% or more
* Able to read and write in English

Exclusion Criteria:

* Type 1 diabetes due to other medical condition (e.g., cystic fibrosis)
* Intellectual disability
* Severe psychiatric comorbidities

Primary outcomes:
measure: Intervention Acceptability
timeFrame: 6 months post-enrollment
measure: Perceptions of continuous glucose monitoring systems
timeFrame: Baseline and 3, 6, 9, and 12 months post-enrollment.
measure: Continuous Glucose Monitoring System Use
timeFrame: Baseline and 3, 6, 9, and 12 months post-enrollment
measure: HbA1c
timeFrame: Baseline and 3, 6, 9, and 12 months post-enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Children's Hospital, Delaware
state: Delaware
Study officials:
References:
Clinical trial NCT06061367: Muscles Strength and Gait Parameteres After TKA
Official title: Influence of Lower Extremity Muscles Strength on Physical Function, Biomechanical Gait Parameters and Reported Outcome After Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis Knee
Gait Biomechanics
Total Knee Arthroplasty
Muscle Strength
Osteoarthritis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 50 years old with knee osteoarthritis

Brief summary: Total Knee Arthroplasty (TKA) is actually the most effective treatment option for patients with end-stage osteoarthritis (OA). However, nearly 20% of patients who underwent TKA remain unsatisfied with their clinical outcome. Investigating modifiable factors that limit knee functioning following TKA we may notice the significance of lower limb muscles strength. Gait pattern is also affected by OA, as arthritic knee joint cannot provide proper range of motion (ROM) and stability.Therefore any deviation in biomechanics should be noticed and analyzed. After TKA patients' physical function may change, but the study should be conducted to prove whether it improves or not. Patient-reported outcome defined by OKS (Oxford Knee Score) and FJS (Forgotten Joint Score) questionnaires will be evaluated.


Eligibility criteria: Inclusion Criteria:

* III° or IV° grade knee osteoarthritis
* Age over 50
* Patients with signed consent

Exclusion Criteria:

* Undergone total hip replacement
* Previous femur fracture in anamnesis
* Undergone corrective osteotomy
* Active/ Chronic neoplastic disease
* Significant deformation of lower limb axis
* Mental disorders
* Muscular disorders

Primary outcomes:
measure: Muscle strength measurement with a use of dynamometer
timeFrame: 6 months
measure: Gait biomechanics analysis - step length
timeFrame: 6 months
measure: Gait biomechanics analysis - gait speed
timeFrame: 6 months
measure: Gait biomechanics analysis - phases of gait
timeFrame: 6 months
measure: Gait biomechanics analysis - step duration
timeFrame: 6 months
measure: Physical function assessment based on standardized test
timeFrame: 6 months
Secondary outcomes:
measure: Patient-reported outcome - Oxford Knee Score
timeFrame: 6 months
measure: Patient-reported outcome - Forgotten Joint Score
timeFrame: 6 months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Orthopedics and Rehabilitation, Medical University of Warsaw
Study officials:
References:
Clinical trial NCT02715167: Predictive Factors in Response to Inhaled Corticoids in Chronic Cough
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis is that a high fractional exhaled nitric oxide can predict the response to inhaled corticoids in chronic cough.


Eligibility criteria: Inclusion Criteria:

* chronic cough

Exclusion Criteria:

* active smoker
* treated by corticoids during the previous month
* use of angiotensin-converting-enzyme inhibitor

Primary outcomes:
measure: Leicester cough questionnaire
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05771467: Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury
Official title: Evaluation of Retinal Microvascular Change That May Develop in After Open Globe Injury With Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Injury Trauma
Keywords: Eye Injury Trauma
Open Globe Injury
Optical Coherence Tomography
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle age, predominantly male

Brief summary: The aim of this study is to evaluate posterior segment changes in the non-traumatic eye after open globe injury.

Detailed description: Globe injuries can be classified as either closed- or open-globe injuries, based on the integrity of the sclera and cornea. Open-globe injury (OGI) is characterized by a full-thickness wound of the ocular wall.

As one of the most severe forms of ocular trauma, open-globe injury (OGI) causes significant vision loss. Timely and meticulous repair of these injuries can improve patient outcomes.

OGI by rupture often occurs at the weakest point of the eye wall, which may or may not be at the actual injury site. The rupture site is most commonly found in the sclera concentric to the limbus, just posterior to the insertion of the extraocular muscles.

After trauma, changes may occur in the non-trauma eye. Retinal and choroidal circulation may change as a result of adaptation mechanisms. In this study, we evaluated the vascular densities of the control group and post-traumatic non-trauma eye.

Eligibility criteria: Inclusion Criteria:

* Be over 18 years old
* Unilateral eye injury

Exclusion Criteria:

* Be under the age of 18
* Usage of systemic drugs or topical ocular drops
* Bilateral eye injury
* Having systemic disease, having ocular pathology that may decrease visual acuity

Primary outcomes:
measure: Corneal Thickness
timeFrame: 10 minutes
measure: Anterior Chamber Volume
timeFrame: 10 minutes
measure: Anterior Chamber Depth
timeFrame: 10 minutes
measure: Anterior Chamber Angle
timeFrame: 10 minutes
measure: Lens Power
timeFrame: 10 minutes
measure: Steep Keratometry
timeFrame: 10 minutes
measure: Tonometry
timeFrame: 10 minutes
measure: Axial Length
timeFrame: 10 minutes
measure: Optic Nerve Head Vessel Density
timeFrame: 10 minutes
measure: Choriocapillaris Flow Area
timeFrame: 10 minutes
measure: Subfoveal Central Macular Thickness
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Aslı Çentinkaya Yaprak
city: Antalya
country: Turkey
facility: Yusuf Samet Atlıhan
Study officials:
affiliation: Akdeniz University Hospital
name: Yusuf Samet Atlıhan, MD, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987167: Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis
Official title: Potential Neuroprotection With ACTHAR Following Acute Optic Neuritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Optic Neuritis
Keywords: acute optic neuritis
Lead sponsor: Neuro-Ophthalmologic Associates, PC
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2013-11-19
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Detailed description: Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Eligibility criteria: Inclusion Criteria:

* unilateral acute demyelinating optic neuritis
* Able to provide informed consent
* age 18 or older
* can perform the above listed electrophysiologic diagnostic testing
* can perform high and low contrast visual acuity and visual field perimetry

Exclusion Criteria:

* prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)
* secondary progressive MS(SPMS)
* primary progressive MS (PPMS)
* undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)
* prior diagnosis of systemic lupus erythematosis
* mixed connective tissue disease
* vasculitis
* sarcoidosis
* neuro-myelitis optica

Primary outcomes:
measure: Neuro-protection
timeFrame: 12 months
Secondary outcomes:
measure: Preservation of retinal nerve fiber layer.
timeFrame: 12 months
Other outcomes:
measure: Preservation and/or restoration of electrophysiological parameters for patients with acute optic neuritis.
timeFrame: 12 months
measure: Structural, Physiological and Metabolic changes during an acute event of optic neuritis
timeFrame: 12 months
Locations:
city: Philadelphia
country: United States
facility: Neuro Ophthalmology
state: Pennsylvania
Study officials:
name: Robert C Sergott, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moster ML, Sergott RC, Leiby BE. Dalfampridine Treatment in Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2017 Sep;37(3):348-349. doi: 10.1097/WNO.0000000000000523. No abstract available.
Clinical trial NCT04999267: Increasing Vaccine Uptake Among Adolescents in the Rural South
Official title: A Tailored School-based Intervention to INcrease VaccinE Uptake Among adoleScenTs (INVEST) in the Rural South
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Hesitancy
Keywords: Human papillomavirus (HPV)
Adolescent
School based intervention
Vaccine
HPV vaccine
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of South Carolina
First posted: 2021-08-10
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The benefits of adolescent vaccines are well known for preventing meningococcal infection and human papillomavirus (HPV)-related pre-cancerous lesions. Yet, many adolescents in the United States (US) remain under-vaccinated, with vaccination rates among rural adolescents significantly lower than among their urban peers. In addition, there are urban-rural disparities in the coverage of HPV vaccine, particularly in Southern states like North and South Carolina, which currently fall below the Healthy People 2020 goal of ≥80% coverage. The goal of the proposed study is to evaluate the feasibility and preliminary efficacy of a school-based intervention for increasing vaccine uptake among adolescents in rural North and South Carolina.


Eligibility criteria: Inclusion Criteria:

- Any public middle school in Cherokee County, South Carolina or Rockingham County, North Carolina school districts

Primary outcomes:
measure: Difference in the Percentage of Adolescents Who Ever Received at Least One Dose of HPV Vaccination in the Intervention Group After the Intervention Implementation Compared With Before Intervention Implementation
timeFrame: Baseline, 9 months
Secondary outcomes:
measure: Difference in Percentage of Adolescents Who Have Completed the HPV Vaccination Series (2 Doses Depending on Age at Vaccination Initiation) in the Intervention Group After Implementation Compared With Before Intervention Implementation
timeFrame: Baseline, 9 months
measure: Fidelity of Intervention Across Intervention Schools
timeFrame: 9 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: Duke University
name: Emmanuel Walter, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05308667: Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients
Official title: Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-04-04
Enrollment: 15
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: In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.


Eligibility criteria: Inclusion Criteria:

* First time and unilateral stroke
* 1-12 months after the incident
* Getting 24 points or more in Mini Mental Status Examination
* Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
* Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers

Exclusion Criteria:

* those who score more than 2.5 points on the Motor Activity Log-28 scale,
* who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and
* Those who do not have adequate communication skills.
* Patients who have visual problems

Primary outcomes:
measure: Fugl-Meyer Assessment-Upper extremity
timeFrame: 30 minutes
measure: Wolf-Motor Function Test
timeFrame: 45 minutes
Secondary outcomes:
measure: Motor Evoked Potentials (MEPs)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Bakırköy Mazhar Osman Ruh ve Sinir Hastalıkları Hastanesi
Study officials:
affiliation: Marmara University
name: Burcu Ersöz Hüseyinsinoğlu, Assoc. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04696367: Impact of Nutritional Deficit in Emergency Surgery
Official title: Impact of Nutritional Deficit in Emergency Surgery: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Surgery
Malnutrition
Keywords: emergency surgery
malnutrition
pilot study
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 59
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: Patients attending two UK hospitals which provide emergency surgery services who require an emergency laparotomy

Brief summary: Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Detailed description: Patients in emergency settings might become malnourished. There are different ways to identify the group as 'at risk' of malnutrition. There are also several different ways to measure outcomes. This pilot study will look at patients undergoing emergency laparotomy, investigate relationships between different selection criteria and outcome measures, and test feasibility of outcome measure collection.

Eligibility criteria: Inclusion Criteria:

* Willing to consent,

  -≥ 18 years old
* eligible for inclusion in National Emergency Laparotomy Audit
* first procedure during admission (\<7 days from admission).

Exclusion Criteria:

* Recent discharge from hospital (within 60 days),
* unable to provide informed consent
* life expectancy \<12 months
* prisoners
* lack mental capacity
* language barrier affecting ability to provide consent

Primary outcomes:
measure: Time without nutrition (measured in days)
timeFrame: within 90 days of admission to hospital
Secondary outcomes:
measure: In hospital complications
timeFrame: within 90 days of admission to hospital
measure: Feasibility of completion of complications at day of discharge
timeFrame: within 90 days of admission to hospital
measure: Change in health utility
timeFrame: Measurements take at baseline, 5 days post-operatively and 90 days post-operatively
measure: Feasibility of completion of EQ-5D-5L (EuroQol- five dimension - five level) at 90 days
timeFrame: 90 days post operatively
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Timothy O'Connor, MBChB
role: PRINCIPAL_INVESTIGATOR
References: