louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06100042: Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting
Official title: Multicentre, Prospective, Non-interventional Study Monitoring Therapy Pathways of Asthma Patients Treated With an Extrafine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Asthma
Triple Therapy
Beclomethasone
Formoterol
Glycopyrronium
Real-world
Single-Inhaler
Quality of life
Control of asthma
Adherence
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Gesellschaft für Therapieforschung mbH
First posted: 2023-10-25
Enrollment: 200
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: Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G as per clinical practice.

Brief summary: TriMaximize is a non-interventional study aimed to collect prospective data from asthmatic patients under routine care, for whom their treating physician has decided to prescribe BDP/FF/G (beclomethasone/formoterol/glycopyrronium).


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age;
* Patients with confirmed leading diagnosis of asthma with or without concomitant COPD;
* Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum);
* Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

Exclusion Criteria:

* Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Primary outcomes:
measure: Patient demographics
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of asthma control using Asthma Control Test (ACT)
timeFrame: 12 months
measure: Assessment of quality of life using Mini Asthma Quality of Life Questionnaire (Mini AQLQ)
timeFrame: 12 months
measure: Assessment of adherence to treatment using 12-item Test of Adherence to Inhalers (TAI-12)
timeFrame: 12 months
measure: Incidence of asthma exacerbations
timeFrame: 12 months
measure: Asthma exacerbations
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Adverse drug reactions to BDP/FF/G
timeFrame: 12 months
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova
Study officials:
References:
Clinical trial NCT05561842: Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Official title: Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Cancer Female
Keywords: breast ultrasound
breast cancer
breast biopsy
breast cancer diagnosis
21-325
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 900
Sex: FEMALE
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: Participants will be accrued in medical clinics as determined by the local investigators and local research staff. Informed consent forms approved by each local IRB will be obtained by research staff from each site.

Brief summary: The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided breast biopsies. Researchers will use mHealth devices to create a sustainable and practical way of training radiologists in Nigeria to perform and clinically implement US-guided breast biopsies into their practice.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older female.
* Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which would typically undergo either a blind biopsy or surgical excision at the Nigerian hospital where the patient is seeking diagnosis.

Exclusion Criteria:

* Participants unwilling to sign consent.
* Participants under the age of 18.

Primary outcomes:
measure: Number of successful US-guided breast biopsy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Idi-Araba
country: Nigeria
facility: Lagos University Teaching Hospital
state: Lagos
city: Sagamu
country: Nigeria
facility: Olabisis Onabanjo University Teaching Hospital (Data Collection Only)
state: Ogun State
city: Owo
country: Nigeria
facility: Federal Medical Centre Owo (Data Collection Only)
state: Ondo State
city: Ibadan
country: Nigeria
facility: University College Hospital (Data Collection Only)
state: Oyo
city: Enugu
country: Nigeria
facility: University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
city: Ile-Ife
country: Nigeria
facility: Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)
city: Ilorin
country: Nigeria
facility: University of Ilorin Teaching Hospitals
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eliabeth Sutton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01529242: Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Cutaneous Rash Treatment
Official title: A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Acute Cutaneous Rash
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cutaneous Hypersensitivity
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of acute cutaneous rash in children between 2 and 12 years old.

Detailed description: * double-blind, non-inferiority, prospective, parallel group trial.
* Experiment duration: 05 days.
* 03 visits (day 0, 48 hours and day 5).
* Efficacy will be evaluated for acute cutaneous rash based on symptoms score
* Adverse events evaluation.

Eligibility criteria: Inclusion Criteria:

* Consent of the patient or legal guardian;
* Clinical diagnosis of acute cutaneous rash defined by the presence of erythematous papules on healthy skin, different sizes, itchy and fleeting
* Children aged between 2 and 11 years and 11 months (up to 30 kg);

Exclusion Criteria:

* Participation in clinical trial in 30 days prior to study entry;
* Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
* Patients with any clinically significant disease other than cutaneous rash including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs);
* Patients diagnosed with other dermatoses

Primary outcomes:
measure: Efficacy of treatment in acute cutaneous rash based on symptoms score
timeFrame: 5 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse event occurrences
timeFrame: 5 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Alergoalpha
state: SP
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital Nipo Brasileiro
Study officials:
affiliation: Federal University of São Paulo
name: Dirceu Solé, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04775342: Smartphone and Posture Control In Healthy Adolescents
Official title: Smartphone Dual Tasking and Posture Control In Healthy Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Balance
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Normal Adolescents

Brief summary: This is a study to determine if smartphone use affect posture control in adolescents.

Detailed description: It is within subject repeated measure study to determine if touch screen use affect posture control in healthy adolescents.

200 normal adolescents between 14 and 18 years old will be included.

1st they will be assessed for posture control to determine normal values for their ages, then each child will be given smartphone to play a game while the sound is muted for 15 min then their balance will be re-assessed, finally they will use the phone for another 15 min but the children will use headphone piece this time then re-assess balance.

Eligibility criteria: Inclusion Criteria:

* Children age from 14 to 18 years old.
* Both genders will be included.
* Normal Body mass index (BMI) for age.
* Children using smartphone for at least 1 year.

Exclusion Criteria:

* Obese children.
* children with vestibular or visual problems.
* Children with neurological disorders.
* Children with congenital deformities or musculoskeletal disorders.
* Children with cognitive impairment.
* Injuries or inflammatory conditions involving the extremities.

Primary outcomes:
measure: center of pressure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Esraa Abd Elaziz Anter Abd Elaziz
Study officials:
affiliation: professor at Cairo university
name: Amira M Eltohamy
role: STUDY_CHAIR
References:
Clinical trial NCT02288442: Whole Muscle Exercise Training (WHOLEi+12) in Pulmonary Hypertension
Official title: Exercise Training (WHOLEi+12) in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Therapy
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 40
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 purpose of this RCT is to study the effects of whole muscle training (inspiratory muscle training + aerobic training + muscle resistance training) on muscle power, VO2peak and gas-exchange variables obtained during cardiopulmonary exercise testing, QoL, functional capacity (eg, 6-min walking distance), and maximal inspiratory pressure in patients with pulmonary artery hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosed pulmonary hypertension, class II-III NYHA, no syncope in the last 3 months (stable clinical condition) or chronic thromboembolic pulmonary hypertension

Exclusion Criteria:

* Not meeting the above

Primary outcomes:
measure: Muscle power (upper and lower-body)
timeFrame: 8 weeks
Secondary outcomes:
measure: 6 minute walk distance test
timeFrame: 8 weeks
measure: maximal inspiratory pressure (PImax)
timeFrame: 8 weeks
measure: Short Form 36-Item Health Survey questionnaire version 2 (SF-36)
timeFrame: 8 weeks
measure: Physical activity levels objectively determined with accelerometry
timeFrame: 8 weeks
measure: Peak oxygen uptake (VO2peak) directly measured during cardiopulmonary exercise testing (CEPT)
timeFrame: 8 weeks
measure: Other CEPT variables
timeFrame: 8 weeks
measure: NT-ProBNP
timeFrame: 8 weeks
measure: Performance in the 5-repetition sit-stand-test (5SST)
timeFrame: 8 weeks
measure: Safety assessment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
References:
Clinical trial NCT00266942: Intra-Atrial vs. Extra-Cardiac Technique During Fontan Operation
Official title: The Determination of Differences Between Intr-Atrial vs. Extra-Cardiac Technique During the Fontan Operation: A Retrospective Review
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: Fontan procedure
single ventricle physiology
intra-atrial
extracardiac technique
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Our aim is a retrospective chart review seeking to determine any differences in the main clinical and outcome variables as well as general outcome data such as functional recovery, readmission rates, somatic growth and mortality. An n size of 150 to 200 for each of the 2 groups will give us excellent power to detect potential differences.

Detailed description: The Fontan procedure is indicated as final-stage treatment for pediatric cardiac patients with single ventricle physiology. This procedure, whose aim is to provide for total cavopulmonary disconnect and perfusion of the pulmonary arteries via systemic veins, is performed via two differing techniques: intra-atrial, so-called lateral tunnel technique, employing PTFE graft material and internal atrial baffle, versus the extracardiac technique, using larger PTFE tubing and externally constructed baffle.

There is persistent debate regarding the optimal technique to use, centered around the following main issues: 1) need for use of cardiopulmonary bypass and attendant consequences, 2) rates of thrombosis and embolism, 3) incidence of postoperative protein-losing enteropathy (PLE), 4) incidence of arrhythmias, and 5) baffle patency rates. A handful of small- to medium-sized studies has addressed the above issues, but, importantly, has not used patient data from the same institution. Here at CHOA, there are an estimated 200+ lateral tunnel, and have been up to 125 to 150 extracardiac Fontan procedures, performed in the last 15 years (1.1.1980-3.31.2005). Data from these cases would be potentially very helpful in answering all of these questions.

Eligibility criteria: Inclusion Criteria:

* Children's Healthcare of Atlanta patients
* lateral tunnel procedure during 1.1.1990-3.31.2005
* extracardiac Fontan procedures during 1.1.1990 - 3.31.2005

Exclusion Criteria:

* those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Jason M. Budde, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512142: Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution
Official title: Using Artificial Intelligence for the Detection of Respiratory Diseases Associated With Pollution
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COPD Asthma
Lung Neoplasm
Emphysema
Keywords: complex networks
lung imaging
spectral analysis
geolocation
Lead sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The primary specialized Victor Babes Respiratory Hospital patients

Brief summary: Generating a picture at the city level, through geospatial and temporal grouping a lung diseases associated or exacerbated by pollution (COPD, AB and neoplasm pulmonary or pleural) and correlating this data with pollution data.

Development of an accurate and prognostic HRCT imaging diagnostic tool, computer assisted in the mentioned pathology, by generating an algorithm capable of to detect early the follow-up tomographic imaging lesions, as well as to evaluate objective their speed of evolution.

Validation of the proposed algorithm by comparison with medical diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with COPD and/or asthma and/or pulmonary neoplasm and/or secondary pulmonary, pleural or mediastinal determinations, suspected or confirmed, according to ICD-10.
* Patients will be included regardless of the type of hospitalization, continuous or day.
* The existence of freely expressed consent, carried out according to Ethics standards professional (from the observation sheet).

For stage 2

* The use of HRCT images, in DICOM format, with a maximum cup thickness of 1.5 mm and with an average of 250 cups; no image acquisition errors;
* Imaging monitoring at a time interval;.
* Respiratory function evaluation data available: spirometry +/- the factor of gaseous diffusion (DLco);

Exclusion Criteria:

For both stages:

- Patients who do not have a stable real domicile (eg social cases) or are not from the Timis county

For stage 2

* Patients who do not have HRCT images available or cannot be followed.
* Patients who have insufficient quality HRCT images.
* Patients who have a history of lung surgery.
* Patients who have a history of allergies to contrast agents used in imaging HRCT.

Primary outcomes:
measure: Correlation between lung diseases and pollution
timeFrame: December 2023 - December 2024
measure: Development of a diagnostic algorithm
timeFrame: September 2024 - March 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: "Victor Babes" University Hospital
state: Timis
Study officials:
References:
Clinical trial NCT01264042: Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)
Official title: Iron Supplementation During Pregnancy and Non-Transferrin-Bound Iron (NTBI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Iron Supplementation,
week 24 to 28 at study day
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2010-12-21
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Although the essential role of iron during pregnancy is well established, concerns have been raised that current iron supplements given routinely during pregnancy may also have harmful consequences, such as increased oxidative stress and enhanced risks of infection, pre-eclampsia and impaired glucose regulation. A potential mechanism for the production of adverse effects is the appearance of non-transferrin-bound iron after oral administration of iron supplements. Non-transferrin-bound iron is more readily available to pathogens and could promote injurious free radical reactions that might add to the oxidative stress of pregnancy.

The present study will determine if oral administration of 60 mg of iron as ferrous sulfate during the second trimester of pregnancy is followed by the appearance of non-transferrin-bound iron two hours later. The investigators will examine the influence of a variety of factors, including iron status and previous use of iron supplements. Detection of non-transferrin-bound iron after administration of an iron supplement to pregnant women would be an important new observation that could lead to re-evaluation of current methods of iron supplementation.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman
* Age 18 to 45 years
* singleton pregnancy
* between 24 and 28 of gestation (at study day)
* regular visits at prenatal clinic
* capability and willingness to comply with study protocol
* voluntary signed informed consent

Exclusion Criteria:

* Multiple pregnancy
* Acute or chronic disease or disorder
* Incapability of following the study protocol
* Homelessness
* Active drug/alcohol dependence or abuse history
* Currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study

Primary outcomes:
measure: NTBI
timeFrame: Change between baseline and 2 hours
Secondary outcomes:
measure: Iron Status and History of Iron Supplements
timeFrame: baseline
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Alexander Krafft, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05639842: Pain in Competitive Athletes With Physical Disabilities: Techniques, Support and Perceived Difficulties
Official title: Pain in Competitive Athletes With Physical Disabilities: Techniques for Its Management, Support Received and Perceived Difficulties
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Athletes
Physical Disability
Keywords: Athlete
Physical disability
Chronic pain
Psychological models
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 413
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 413 participants were interviewed on a voluntary basis. Spanish and Latin American nationality.

Brief summary: Pain in physically disabled athletes affects the sporting career directly or indirectly through psychological consequences. Numerous studies address psychological skills in able-bodied athletes and in able-bodied athletes they are scarce.This information is part of a research project aimed at finding resources to help athletes in their pain management.

Detailed description: The purpose of this study is to determine how competitive athletes perceive how pain can affect their sporting careers; what techniques and/or strategies athletes use for pain management and how useful these are; to determine the extent to which athletes with disabilities have received support for pain management and to what extent they have found it useful; and to determine the difficulties they often face in managing their pain.The aim of this questionnaire is to find out how pain, resulting from injury, can affect the sporting careers of competitive athletes with physical disabilities and what techniques they use to manage it.

Eligibility criteria: Inclusion Criteria:

Athletes:

* Competitive athletes.
* Physical disability.
* Age without criteria.

Exclusion Criteria:

* Failure to meet the inclusion criteria.

Primary outcomes:
measure: Cross-sectional surveys
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Sandra Constantino Murillo
Study officials:
affiliation: Universidad Politecnica de Madrid
name: Sandra Constantino Murillo
role: PRINCIPAL_INVESTIGATOR
References: