louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06706596: A Systemic Screening for TB Disease in High-risk Groups in Barcelona
Official title: Implementing a Systemic Screening for TB Disease in High-risk Groups in Barcelona Area
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tuberculosis
Tuberculosis, Pulmonary
Keywords: Tuberculosis
Tuberculosis infection
Tuberculosis screening
Vulnerable populations
Refugees
Migrants
Pulmonary tuberculosis
Lead sponsor: Fundació Institut Germans Trias i Pujol
Sponsor class: OTHER
Collaborators: name: Catalan Public Health Agency
name: Consorci Sanitari de Barcelona (CSB)
name: SMA-TB Consortium
name: INNOVA4TB Consortium
name: Fundació Lluita contra les Infeccions
name: Hospital Vall d'Hebron -Unitat de Drassanes
name: ADVANCE-TB Consortium
name: Germans Trias i Pujol Hospital
First posted: 2024-11-26
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals from populations identified as high-risk for tuberculosis in the Barcelona metropolitan area

Brief summary: The purpose of this screening study is to identify and screen vulnerable population in Barcelona for active pulmonary tuberculosis

Detailed description: If eligible and verbal consent is obtained, individuals:

1. Will attend a small talk/lecture about Tuberculosis (TB) disease
2. Will be interviewed and screened for the presence of TB symptoms: cough, blood in sputum, fever, weight loss, night sweats and chills lasting for \>2 weeks
3. Individuals screened positive for TB will be referred to the hospital for further testing (Chest X-ray, visit, lab tests)

Eligibility criteria: Inclusion Criteria:

-Belonging to a population at high risk for tuberculosis (TB)

Exclusion Criteria:

-Not belonging to a population at high risk for tuberculosis (TB)

Primary outcomes:
measure: Number of individuals who screen positive for pulmonary TB symptoms
timeFrame: 1 day
measure: Number of individuals who are diagnosed with pulmonary TB symptoms
timeFrame: 1 month
Secondary outcomes:
measure: Cost-effectiveness analysis
timeFrame: 1 day
measure: Time spent during screening
timeFrame: 1 day
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: IGTP
Study officials:
affiliation: Fundació i Hospital Germans Trias i Pujol (IGTP-HUGTIP)
name: Cristina Vilaplana, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02202096: A Pilot Randomized Trial of a Comprehensive Transitional Care Program for Colorectal Cancer Patients
Official title: A Pilot Randomized Trial of the Comprehensive Transitional Care Program for Medically Underserved Colorectal Cancer Surgery Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Colorectal Cancer
Comprehensive Transitional Care Program
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary hypothesis is that a comprehensive transitional care program based on the premise of a patient-centered medical home versus routine care reduces emergency room visits and hospital readmissions without increasing costs among cancer patients undergoing surgery at a large safety-net hospital.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of colorectal cancer
* Adults, Age 18 years or older
* Undergoing surgery for either palliative cure or palliation

Exclusion Criteria:

* Patients not expected to survive hospital based on the operating surgeon's opinion
* Children under the age of 18 years

Primary outcomes:
measure: Number of post-operative ER visits and readmissions
timeFrame: up to 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lillian S Kao, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269796: Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder
Official title: Identification of Neuromotor Signs in Preschool Children Suspected of Developmental Coordination Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Skills Disorders
Child Development
Child, Preschool
Keywords: Developmental Coordination Disorder (DCD)
Little Developmental Coordination Disorder Questionnaire (Little DCDQ)
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2)
Preschool Children
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 424
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preschool children aged 3-5 from 39 municipal kindergartens in Thessaloniki, Greece, who responded to the research invitation.

Brief summary: This prospective study aimed to detect neuromotor signs early in preschool children suspected of Developmental Coordination Disorder (DCD). Preschool children aged 3-5 years old from municipal kindergartens in Thessaloniki participated in this study. The Little DCDQ questionnaire and the BOT-2 (Bruininks-Oseretsky Test of Motor Proficiency) were used for assessment.


Eligibility criteria: Inclusion Criteria:

* Preschool children
* Aging from 3 to 5 years old

Exclusion Criteria:

* Diagnosis for medical conditions or mental retardation

Primary outcomes:
measure: Parent Screening Questionnaire for Motor Coordination Difficulties (DCD)
timeFrame: Complete Form - 10-15 minutes
measure: Screening Test for Detection of Developmental Coordination Disorder (DCD)
timeFrame: Complete Form - 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Lamía
country: Greece
facility: Human Performance & Rehabilitation Laboratory, Department of Physiotherapy, University of Thessaly
state: Pthiotis
Study officials:
affiliation: University of Thessaly
name: Ioannis Poulis, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT01277796: Pilot Study Using a Heat Pack to Treat Cutaneous Leishmaniasis
Official title: Pilot Study of Thermotherapy Treatment for Cutaneous Leishmaniasis in Peru With the HECT-CL Device
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Universidad Peruana Cayetano Heredia
Sponsor class: OTHER
Collaborators: name: Tulane University School of Medicine
First posted: 2011-01-17
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Current standard therapies with chemotherapy (CT) for Cutaneous Leishmaniasis (CL) are expensive, toxic/allergenic, frequently ineffective, burdensome, and often unavailable. Thermotherapy is a clinically validated first line alternative for the treatment of Cutaneous Leishmaniasis in South America. However, current heat-delivery modalities are either too costly or lack governmental approval required to be made widely available to endemic areas. The investigators have adapted a reliable, safe, and low-cost heat pack for Cutaneous Leishmaniasis that the investigators have named the HECT-CL device. In this pilot study the investigators will enroll 25 patients who have either failed or are not candidates for pentivalent antimonies. The hypothesis states that the HECT-CL device demonstrates efficacy non-statistically inferior to estimates for current South American Pentavalent Antimonial cure rates (76%) while demonstrating basic safety and tolerability.


Eligibility criteria: Inclusion Criteria:

* with CL diagnosed by skin smear (WHO method), biopsy, culture, PCR
* aged 8-80 years old
* with no more than 3 lesions
* ulcerative and non-ulcerative ulcers less than 4 cm diameter.
* allergy, prohibitive side effects to standard chemotherapy, or other contraindication to antimonial treatment (e.g. cardiac arrhythmia)
* capable of signing an informed consent or having capable guardians (in the case of minors).
* Children ≥ 8 years of age must give written or verbal informed assent along with written consent of their guardians.

Exclusion Criteria:

* lesions less than 2cm from the nose, mouth, ears, or eyes.
* clinically diagnosed with mucosal involvement.
* evidence of lymph node involvement on exam.
* unable or unwilling to commit to the treatment and follow-up plan.
* prior CL treatment within last 1 month.
* pregnant or lactating
* uncontrolled severe systemic illness or immunocompromised state.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Peruana Cayetano Heredia
name: Alejandro Llanos-Cuentas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane Medical School
name: Witzig Richard, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02490696: Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer
Official title: Comparative Study of the Hypoxia Measured in FAZA and F-miso TEP/CT Scan in Patients With Non-small Cell Lung Cancer at the Time of Diagnosis : Correlation With Immunohistochemistry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: PET scan
FAZA
F-Miso
hypoxia
lung cancer
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

Detailed description: The aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer.

Two PET scans will be performed with FAZA and F-Miso tracers. The time between these twi PET scans will be 24 hours.

another 24 hours after the late PET scan, the surgery will be done and a piece of tumor will be collected.

Piece of tumor will be analysed by immunohistochemistry for hypoxia markers.

The results of immunohistochemistry will be correlated with the biodistribution of the two tracers.

Eligibility criteria: Inclusion Criteria:

* Male or female
* More than 18 years old
* Patient with non-small cell lung cancer (histologically proved)
* PS inferior or equal to 1 (good general state)
* Patient must have surgery for their non-small cell lung cancer
* Stage of tumor Superior or equal to 2a without metastasis
* Tumoral fixation with 18-FDG-PET superior to mediastinal background noise
* Written inform consent

Exclusion Criteria:

* Histology other than primitive non-small cell lung cancer
* In situ form at the histological study
* Patient without evaluable target
* No fixation on the pretherapeutic FDG-PET scan
* PS Superior or equal to 2
* neoplastic disease (less than 2 years or progressive)
* Pregnant woman or child-bearing
* Patient Under guardianship or curators

Primary outcomes:
measure: Comparison of hypoxia with FAZA and F-Miso tracer
timeFrame: one year
Secondary outcomes:
measure: overall survival
timeFrame: one year
measure: disease-free survival
timeFrame: one year
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Pierre Vera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Texte E, Gouel P, Thureau S, Lequesne J, Barres B, Edet-Sanson A, Decazes P, Vera P, Hapdey S. Impact of the Bayesian penalized likelihood algorithm (Q.Clear(R)) in comparison with the OSEM reconstruction on low contrast PET hypoxic images. EJNMMI Phys. 2020 May 12;7(1):28. doi: 10.1186/s40658-020-00300-3.
Clinical trial NCT03273296: Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Official title: Effect of Antibiotics on Gut Microbiome and Plasma Metabolome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Microbial Colonization
Keywords: microbiota
metabolize
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: University of California, San Diego
name: Brigham and Women's Hospital
First posted: 2017-09-06
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: In recent years it has been observed that the gut microbiome can produce metabolites into systemic circulation and thus have important health effects even outside the gastrointestinal system. These metabolites may play a role in the pathogenesis of common public health problems such as diabetes, obesity and cardiovascular disorders. Modern techniques of mass spectrometry-based metabolomics from peripheral blood and gut metagenome sequencing now enable detailed examination of these processes. Using samples from the FINRISK 2002 cohort, collected by the National Institute for Health and Welfare, we are currently determining the gut microbiome and plasma metabolome from \> 7000 participants with 15 years of follow-up for various health outcomes. This is one of the largest materials of its kind world-wide. The design does not, however, allow us to draw causal conclusions on the roles of gut bacteria in the composition of plasma metabolome. To enable conclusions which go beyond statistical associations, we now propose an extension to the FINRISK 2002 study, where we alter the gut bacteriome with a short course of antibiotics and then examine whether a change in plasma metabolomics profile will follow. At the same time the trial will give important novel information about the effects of commonly used antibiotics on gut bacteriome and on general health.


Eligibility criteria: Inclusion Criteria:

* Prior participation in the FINRISK 2002 survey and current residence in Helsinki metropolitan area.
* Age range 40-74 years among men and 50-74 years among women.

Exclusion Criteria:

* Known allergy to any antibiotic
* A course of antibiotic during the past year
* Acute infection
* Any major illness (history of myocardial infarction, stroke, diabetes, liver or kidney disease, cancer, psychiatric disease). Uncomplicated hypertension is allowed. Likewise, statin treatment and women's hormone replacement therapy are allowed.

Primary outcomes:
measure: Microbiome
timeFrame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
measure: Metabolome
timeFrame: Baseline: 0 days; repeat assessments 2 days and 28 days after end of antibiotics.
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: National Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Markus Perola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692796: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Official title: Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Pulmonary fibrosis
Pulmonary rehabilitation
Dyspnea
Quality of life
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: Mordecai Palliative Care Research Fund
First posted: 2008-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of Pulmonary Rehabilitation (PR) on shortness of breath, exercise capacity, symptom control, mental health, cognitive function, and quality of life in patients with Idiopathic Pulmonary Fibrosis (IPF). Pulmonary rehabilitation has already been shown to benefit patients with other chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD). We believe that pulmonary rehabilitation will benefit patients with IPF as well.

Detailed description: The goals of this project are to assess the effect of PR on a number of important outcomes in patients with IPF. Once enrolled in the study, subjects will complete a battery of questionnaires and tests that assess symptoms, quality of life, cognition, and mental health, and then subjects will complete a six week outpatient PR program (at National Jewish Medical and Research Center or other PR programs). Subjects will complete the same battery of questionnaires and tests immediately after completion of the PR program and again six months later.

Eligibility criteria: Inclusion Criteria:

* Age 40 years or older
* Diagnosis of IPF according to American Thoracic Society criteria

Exclusion criteria:

* Patients who have completed a PR program within the last two years
* Patients with unstable medical conditions that would make PR unsafe

Primary outcomes:
measure: Exercise capacity
timeFrame: 6 weeks and again at 6 months
Secondary outcomes:
measure: Cognition
timeFrame: 6 weeks and again at 6 months
measure: Quality of life
timeFrame: 6 weeks and again at 6 months
measure: Fatigue
timeFrame: 6 weeks and again at 6 months
measure: Anxiety
timeFrame: 6 weeks and again at 6 months
measure: Depression
timeFrame: 6 weeks and again at 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Medical and Research Center
state: Colorado
Study officials:
affiliation: National Jewish Medical and Research Center (Jeffrey J. Swigris, DO, MS; Assistant Professor of Medicine)
name: Jeff Swigris, DO, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swigris JJ, Fairclough DL, Morrison M, Make B, Kozora E, Brown KK, Wamboldt FS. Benefits of pulmonary rehabilitation in idiopathic pulmonary fibrosis. Respir Care. 2011 Jun;56(6):783-9. doi: 10.4187/respcare.00939. Epub 2011 Feb 11.
Clinical trial NCT00333996: A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior Uveitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Anterior Uveitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious anterior uveitis.


Eligibility criteria: Inclusion Criteria:

* 18 years or older with a diagnosis of non-infectious anterior uveitis in at least one eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Any active ocular infections

Primary outcomes:
measure: Anterior Chamber Cell
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Allergan Inc.
role: STUDY_CHAIR
References:
Clinical trial NCT05134896: Visual Performance With Spatial Light Modulator
Official title: Visual Performance After Optically Correcting the Eye's Aberration With a Spatial Light Modulator
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normal Healthy Eyes
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Eye's aberrations have been known to degrade human visual performance and the visual performance is significantly improved when correcting the aberrations in the central visual field. However, how the aberration correction affects the peripheral visual performance is not well understood. Moreover, how central and peripheral vision interacts remains unclear.

To conduct the study, we will use an adaptive optics vision simulator equipped with a Shack-Hartmann wavefront sensor and a spatial light modulator (see details in procedures section of the protocol). This system is capable of noninvasively controlling the eye's optical quality and evaluating visual performance simultaneously over a wide area of visual space. This study provides insights into the visual performance in the periphery visual field, and interaction between central and peripheral visual fields.

The goal of this study is to evaluate the visual performance at central and peripheral visual fields after correcting the ocular aberrations. An optical system equipped with a liquid crystal spatial light modulator will be used to achieve this goal non-invasively.


Eligibility criteria: Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between the ages of 18 and 60.
* Has normal corneas i.e. no corneal infections, no systemic pink eye, no clinically significant dry eye, and no corneal dystrophies.
* Has refractive errors less than +/- 10.0 Diopters in both eyes.

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Adults between the ages of 18-60 who are unable to give informed consent
* Individuals below 18 years old
* Individuals above the age of 60
* Pregnant women (self-reporting, hormonal changes may alter the refractive status of the eye)
* Prisoners
* Students for whom you have direct access to/influence on grades
* People who do not understand or speak English
* Has clinically significant dry eye.
* Has clinically significant cataract.
* Has spherical refractive error that exceeds the limits outlined above.
* Is unable to hold his or her head steady for the duration of study measurements.

Primary outcomes:
measure: Visual acuity
timeFrame: up to 6 separate sessions (each session taking up to 2 hours)
measure: Contrast sensitivity
timeFrame: up to 6 separate sessions (each session taking up to 2 hours)
measure: Contrast perception
timeFrame: up to 6 separate sessions (each session taking up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: