louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05778799: Physical Activity and Sports for People With Special Needs
Official title: Balance Assessment of People With Lower Limb Impairment Practicing Amputee Football
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Dysmelia
Leg; Deformity, Congenital
Keywords: Amputation
Amputee Football
Performance
Balance
Lead sponsor: Józef Piłsudski University of Physical Education
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 66
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Members of 14 teams, field players with lower limb impairment participating in European Amputee Football Championship.

Brief summary: Purpose of this study was to assess the balance level of highly qualified amputee football players in relation to their sports level, training experience, position on the pitch, as well as the type of amputation/dysfunction and disability experience.

Detailed description: The participants were presented with the procedure of the study and informed that they could resign from their participation in the study at any stage. All participants were given the written informed consent form after the detailed written and oral explanation of the risk and benefits resulting from participation in this study Static balance was assessed using AMTI AccuSway stabilographic platform (ACS Model). The study participants performed the single 10 second left- or right-leg stance with eyes open (EO), and single 10 second left- or right-leg stance with eyes closed (EC) (depending on leg amputation). If the first attempt was not successful, study participants were able to do the second attempt. The tests were conducted on a match-free day, approximately 2 hours after a meal, in a sports outfit, in a specially designated room.

Eligibility criteria: Inclusion Criteria:

* participant of European Amputte Football Championschip
* field player (leg amputation or leg dysfunction)
* written consent form

Exclusion Criteria:

* goalkeeper
* injury
* tiredness
* refusal

Primary outcomes:
measure: Center of pressure (CoP) path lenght was measured
timeFrame: Baseline
measure: Surface area of stabilogram was mesured
timeFrame: Baseline
measure: Visual inspection indicator (VII) was measured
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: University of Physical Education
Study officials:
affiliation: University of Physical Education in Warsaw
name: Jolanta Marszałek, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01227499: Differential Diagnosis of STA-PSV in Thyrotoxicosis
Official title: Differential Diagnosis Value of Peak Systolic Velocity of Thyroid Superior Artery Using Color Flow Doppler Sonography in Transient Thyrotoxicosis Caused by Thyroiditis and Graves Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyrotoxicosis
Peak Systolic Velocity of Superior Thyroid Artery
Thyroiditis
Graves Disease
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Zhongda Hospital
name: Fudan University
First posted: 2010-10-25
Enrollment: 169
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: Aim: Graves's disease and thyroiditis can both characterized with thyrotoxicosis, but their clinical outcome and therapy is quiet different. Measurement of iodine uptake is the gold standard to differential diagnosis the thyroiditis or Graves's disease. But the iodine uptake is limited for its availability in china and easily influenced by medicine or food contained iodine.The blood pattern of thyroid CFDS is useful for differentiate the cause of thyrotoxicosis.Most previous studies using the descriptive pattern of thyroid CFDS is easily varied by operator subjective judgement. This study is focus on the role of peak systolic velocity of thyroid superior artery in differential diagnosis of thyrotoxicosis. Methods: Patients with thyrotoxicosis symptoms without recent medicine history were enrolled in two clinical center. Its thyroid function, iodine uptake , CFDS of thyroid and peak systolic velocity of thyroid superior artery is detected. Thyrotoxicosis is defined as TSH level below the low value of normal range. Graves disease is defined as the typical symptoms of graves disease such as graves ophthalmopathy or increased iodine uptake. Thyroiditis is defined as lack of typical symptoms of graves disease or decreased iodine uptake.We use receiver operator curve(ROC) to evaluate its diagnosis value


Eligibility criteria: Inclusion Criteria:

* newly diagnosed without taking any antithyroid drug or beta receptor blocker with TSH level below the lower limits of reference range
* is willing to be enrolled

Exclusion Criteria:

* unwilling
* taking antithyroid drug or beta receptor blocker
* taking foods or medicine rich in iodine in 8 weeks
* women with pregnant or lactation

Primary outcomes:
measure: mean STA-PSV
timeFrame: 2014-04-07
measure: uptake of iodine
timeFrame: December 1, 2013
Secondary outcomes:
measure: PSV
timeFrame: December 1, 2013
Other outcomes:
measure: thyroid funciton
timeFrame: December 1, 2013
Locations:
city: Shanghai
country: China
facility: Xiaolong Zhao
state: Shanghai
Study officials:
References:
citation: Zhao X, Chen L, Li L, Wang Y, Wang Y, Zhou L, Zeng F, Li Y, Hu R, Liu H. Peak systolic velocity of superior thyroid artery for the differential diagnosis of thyrotoxicosis. PLoS One. 2012;7(11):e50051. doi: 10.1371/journal.pone.0050051. Epub 2012 Nov 16.
Clinical trial NCT01213199: Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
Official title: Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Scars
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-10-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects of any race, aged 18 to 50 years inclusive
* Subjects with a past history of acne and with moderate to severe facial atrophic acne scars

Exclusion Criteria:

* Subjects with active inflammatory acne lesions
* Subjects with hypertrophic acne scars

Primary outcomes:
measure: Global Scarring Severity
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Manisha PATEL
state: Maryland
Study officials:
affiliation: Johns Hopkins Medical Institut
name: Manisha J. Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Dermatol Ther (Heidelb). 2018 Jun;8(2):245-257. doi: 10.1007/s13555-018-0231-8. Epub 2018 Mar 16.
Clinical trial NCT00232999: Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Allergic asthma
Allergen challenge
Bronchial hyperresponsiveness
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AllerGen NCE Inc.
First posted: 2005-10-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.


Eligibility criteria: Inclusion Criteria:

* Mild stable allergic asthma
* Positive skin-prick test to at least one common aeroallergen
* Positive methacholine challenge
* Positive allergen-induced early- and late-phase airway bronchoconstriction
* General good health

Exclusion Criteria:

* Lung diseases other than mild allergic asthma
* History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease
* Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium
* Use of tobacco products within one year starting study or smoking history \>10 pack years
* If female, pregnant or lactating or have positive pregnancy test at screening

Primary outcomes:
measure: Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions
Secondary outcomes:
measure: Methacholine PC20 pre- and post-allergen challenge
measure: Anti-inflammatory activity in airways
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Department of Medicine, McMaster University
state: Ontario
city: Sainte-Foy (Quebec City)
country: Canada
facility: Centre de cardiology et de pneumologie de l'Universite Laval
state: Quebec
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: McMaster University and AllerGen NCE
name: Paul M O'Byrne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duong M, Cockcroft D, Boulet LP, Ahmed T, Iverson H, Atkinson DC, Stahl EG, Watson R, Davis B, Milot J, Gauvreau GM, O'Byrne PM. The effect of IVX-0142, a heparin-derived hypersulfated disaccharide, on the allergic airway responses in asthma. Allergy. 2008 Sep;63(9):1195-201. doi: 10.1111/j.1398-9995.2008.01707.x.
Clinical trial NCT05087199: COVID-19 Infection in Patients With Chronic Pulmonary Diseases.
Official title: COVID-19 Infection in Patients With Chronic Pulmonary Diseases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Chronic Pulmonary Disease
Keywords: COVID-19
Chronic pulmonary disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample with chronic pulmonary diseases

Brief summary: This study aims to assess the clinical presentation, radiological patterns and outcome of COVID-19 infection in patients with chronic pulmonary disease.

Inter-relationship between the severity of COVID-19 infection and chronic pulmonary diseases.

Detailed description: The COVID-19 pandemic has led to many difficulties with the diagnosis and routine management of chronic pulmonary diseases such as COPD, Bronchial asthma, ILD and Bronchiectasis as well as raising concerns about the management and outcomes for patients with these diseases who develop COVID-19.

Although there is conflicting evidence on whether patients with chronic respiratory diseases are more susceptible to COVID-19, these patients exhibit a more severe presentation and higher mortality compared with those without chronic respiratory diseases.

Eligibility criteria: Inclusion Criteria:

* Subjects with confirmed diagnosis of COVID-19 infection by:

RT-PCR And Chest Computed tomography and laboratoty investigations. Patients with chronic chest disease including (COPD, bronchial asthma, ILD, bronchiectasis).

Exclusion Criteria:

* Those who are diagnosed with viral pneumonia caused by viruses other than COVID-19.

Those who are not confirmed to be COVID-19 with PCR or by radiological and laboratory investigations.

Primary outcomes:
measure: Effect of COVID-19 on patients with chronic pulmonary diseases
timeFrame: 2 weeks after patient confirmation of infection by COVID-19
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02926599: Potential Optimization Training in Simulation.
Official title: High Fidelity Simulation Performance After a Potential Optimization Training for Anesthesiologist Resident: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: High Fidelity Simulation
Lead sponsor: Claude Bernard University
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Simulated environment allowed safe learning of critical events and knowledge of appropriate response and treatment. Anesthesiology resident education curriculum in Lyon plans several high fidelity simulation session with a large panel of critical events. Anticipation of critical events before they may occur and planification of team resources and priority in the treatment strategy may help to improve team performance during the scenario. The investigators' goal is to compare individual and team performances with or without an optimization personal potential training.

Detailed description: The investigators aim to compare the individual and team performances for resident who were taught personal optimization skills (positive reinforcement, personalized psycho-physiological relaxation, mental rehearsal) and those who didn't.

The investigators are going to compare groups of anesthesiology residents going through same scenarios of simulated critical events in high fidelity simulation session. Scenarios will be recorded to be analyzed by 2 reviewers independently. A specific checklist of appropriate treatment and a non technical skill checklist will be use to cote team performance (OTTAWA and TEAM scales). Stress of the participants will be assessed by visual analogic scale of participants anxiety and stress. The two groups will be compare to see if improvement in team performance is associated with the intervention.

Eligibility criteria: Inclusion Criteria:

* Anesthesiology and Intensive care resident in the simulation education curriculum

Exclusion Criteria:

* Refusal to participate (written approval required)

Primary outcomes:
measure: Performance during simulation
timeFrame: day 1
Secondary outcomes:
measure: visual analogic scale of anxiety
timeFrame: day 1
measure: Visual analogic scales of confidence
timeFrame: day 1
Other outcomes:
measure: psychometric POMS scales
timeFrame: day 1
measure: psychometric STAI scales
timeFrame: day 1
Locations:
city: Lyon
country: France
facility: CLESS
state: Rhône-Alpes
Study officials:
affiliation: CLESS
name: Jean-Jacques, Lehot, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03172299: Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated with Proton Therapy for a Large Choroidal Melanoma
Official title: Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-Vascular Endothelial Growth Factor in Patients Treated with Proton Therapy for a Large Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 57
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 reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Choroid melanoma more than 7mm thick and / or over basal diameter of 15mm treated by proton therapy

Exclusion Criteria:

* Iris melanoma
* Melanoma immediately metastatic
* Pregnant or breastfeeding women
* Known hypersensitivity to aflibercept (anti-VEGF selected)

Primary outcomes:
measure: Occurrence of neovascular glaucoma
timeFrame: at 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Stéphanie BAILLIF, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT00212199: Effectiveness of Brief Counseling for Weight Management
Official title: Effectiveness of Brief Counseling for Weight Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: 1. Obesity
Keywords: Obesity Treatment
Effectiveness of weight management treatment
Counseling for weight management
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-21
Enrollment: 246
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the effectiveness of three different methods for delivering weight management information. Two methods utilize an obesity drug and the third method utilizes brief behavioral counseling sessions only.

Detailed description: There is a growing demand for effective obesity treatments that don't require much time to implement especially in a primary health-care setting where time is especially limited. Brief interventions that might provide benefits similar to those produced by more time-intensive and costly lifestyle interventions would be very useful. There is also increasing interest in the efficacy of primary drug therapies for obesity. The purpose of this 12-month study, and 24-month follow-up, is to examine the efficacy of a brief behavioral counseling intervention alone or in combination with a drug already approved for the long-term management of obesity (orlisat)and compare both interventions to a drug alone condition.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index of 30 to 40
* Male or females ages of 25 to 55 years
* Normal blood pressure or controlled with medicine
* Females not lactating, able to get pregnant or using acceptable birth control
* Current allowed medications prescribed at least 2 months prior to study

Exclusion Criteria:

* Pregnant, planning to get pregnant or becomes pregnant
* Insulin dependent diabetes
* Uncontrolled hypertension
* Prescence or history of significant medical conditions that could impact the outcome of the study
* Prescence of active gastrointestinal disorders
* History of mental disorders including eating disorders
* Weight loss greater than 10 pounds in the last 3 months
* History of alcohol or drug dependency
* Use of any weight-loss medication in the last 6 months
* Known allery to orlistat or any of its components

Primary outcomes:
measure: 1. Changes in body weight at 6, 12 and 24 months.
measure: 2. Changes in body mass index (BMI) at 6, 12 and 24 months.
Secondary outcomes:
measure: 1. Changes in blood pressure at 6, 12 and 24 months.
measure: 2. Changes in lipids at 6, 12 and 24 months.
measure: 3. Changes in serum glucose at 6, 12 and 24 months.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: John P Foreyt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235299: Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
Official title: Free Flap Microcirculatory Monitoring Correlates to Free Flap Temperature Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flap Monitoring
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from a soft tissue defect at any location of the body receiving free flap soft-tissue defect coverage at the Department of Plastic, Hand and Reconstructive Surgery, Medical School Hannover, Germany.

Brief summary: In case of free flap failure, time is of utmost importance as salvage rates have been reported to be inversely related to the time interval between the onset of ischemia and its clinical recognition. Consecutively, monitoring of free flaps remains of major importance. Currently, combined Laser-Doppler and Spectrophotometry is available to determine microcirculation of free flaps in reconstructive surgery as a scientific method of reliable assessment of flap perfusion. The investigators thought to analyze the correlation of free flap skin temperature and free frap microcirculation as an accurate tool of postoperative flap monitoring.


Eligibility criteria: Inclusion Criteria:

* Age between 16 and 65 years

Exclusion Criteria:

* soft tissue inflammation or osteomyelitis, peripheral arterial occlusive disease, vasculitis, chronic kidney or liver disease, cardiac dysfunction, arterial hypotension and any type of vasoactive medication, i.e. ß-blockers, calcium channel blockers, nitroglycerin or equal.

Primary outcomes:
measure: Correlation of cutaneous microcirculation to free flap temperature
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover
Study officials:
References:
citation: Kraemer R, Lorenzen J, Knobloch K, Papst S, Kabbani M, Koennecker S, Vogt PM. Free flap microcirculatory monitoring correlates to free flap temperature assessment. J Plast Reconstr Aesthet Surg. 2011 Oct;64(10):1353-8. doi: 10.1016/j.bjps.2011.04.030. Epub 2011 Jun 12.