louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067869: Cytomegalovirus Infection in Patients With HIV-1 Infection
Official title: Participation of Cytomegalovirus Infection or an Autoimmune Process in T Lymphocyte Activation of HIV-1 Infected Patients With Undetectable Viral Load on Antiretroviral Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cytomegalovirus Infections
HIV-1-infection
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (\< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.

Detailed description: T cell activation plays a central role in HIV pathogenesis and is highly correlated to disease progression even in HIV patients virosuppressed on combined antiretroviral therapy since years. The mechanisms underlying this activation in virosuppressed patients are poorly understood. Identifying some factors involved in immune activation that can be targeted by therapies could optimize the treatment of HIV patients. The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (\< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomégalovirus infection and auto-immune disorders.

Eligibility criteria: Inclusion Criteria:

* Patients included in the Aquitaine ANRS CO3 cohort aged 18 years or older (confirmed HIV-1 infection and at least one follow-up in the cohort),
* plasma HIV-1 RNA \<50 copies / ml for at least 24 months under a highly active antiretroviral combination (treatment comprising at least 3 antiretroviral drugs) modified or initiated between 2005 and 2008,
* Follow-up in one of the departments of Bordeaux University Hospital or Libourne Hospital,
* Free, informed and written consent, signed by the patient and the investigator (Consent of the Aquitaine CO3 Cohort and linked to this specific study).

Exclusion Criteria:

* Presence of 2 consecutive measurements of HIV RNA\> 50 copies / ml,
* History of immunotherapy treatments (interleukin-2),
* Hepatitis B or C co-infections,
* Pregnancy
* Breastfeeding
* Symptomatic infectious episode in progress.

Primary outcomes:
measure: Measurement of systemic lymphocyte activation
timeFrame: At the screening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Isabelle PELLEGRIN, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04601012: OCTA Study: Retinal Vascular Changes in Patients With SARS-CoV-2 Infection
Official title: Optical Coherence Tomography Angiography in Patients Affected by SARS-CoV-2 Infection: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participans were older than 18 years with previous diagnosis of COVID-19. They did not present other ophthalmological diseases.

Brief summary: This study evaluates the retinal vascular features using optical coherence tomography angiography in patients that have been affected by COVID-19.

Detailed description: To investigate the potential role of optical coherence tomography angiography in identifying the changes in retinal vessel density in patients that have been affected by COVID-19.

The optical coherence tomography angiography represents a noninvasive diagnostic technique that allows a detailed analysis of retinal vascular features.

Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* diagnosis of previous COVID-19
* absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* absence of significant lens opacities, low-quality OCT and OCT-A images.

Exclusion Criteria:

* age younger than 18 years
* absence of previous diagnosis of COVID-19
* presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
* presence of significant lens opacities, low-quality OCT and OCT-A images.

Primary outcomes:
measure: The measurements of retinal features in patients with previous diagnosis of COVID19, using optical coherence tomography angiography.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples "Federico II"
Study officials:
affiliation: Federico II University
name: Gilda Cennamo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03687112: National Bank Alzheimer
Official title: National Bank Alzheimer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-09-27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alzheimer desease and related disorders patients

Brief summary: The Alzheimer's disease (MY) is a major problem of public health. The French National Database Alzheimer ( BNA) registers(records) all the medical acts made by units of memory(report) and of independent specialists in France.

In 2008, the national Plan Alzheimer 2008 - 2012 had for objective to strengthen the search(research) on the Alzheimer's disease (MY) and for related disorders(confusions), to promote an early diagnosis and to improve at the same time the management of the patients and to support careers(quarries). A specific part(party) of this plan gave rise to the creation of the French national database Alzheimer ( BNA) to supply epidemiological data as well as indicators of activity. Since 2009 The information collected(taken in) in the BNA consists of a set(group) limited by data (CIMA of information minimum Corpus Alzheimer) concerning the demographic, clinical and diagnostic data defined by national consensus. The number of variables is limited to facilitate and to improve the participation in this national database. The participants are the Centers Report (CM)((LECTURE)) and Center Memory(Report) of Resources and Search(Research) (CMRR) and independent specialists. In 2015 more than 500 Centers send CIMA to the BNA.

The plan Disease Neurodegenerative 2014 - 2019 wishes to pursue and to amplify the BNA.


Eligibility criteria: Inclusion Criteria:

* patients consulting in French Memory Centres

Exclusion Criteria:

-

Primary outcomes:
measure: Evolution of the morbi-mortality
timeFrame: 16 years
measure: Evolution of the morbi-mortality
timeFrame: 16 years
Secondary outcomes:
measure: number of the miscellaneous determiners of Access to healthcare or diagnosis
timeFrame: 16 years
Other outcomes:
measure: New therapeutic plans
timeFrame: 16 years
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
citation: Mouton A, Plonka A, Fabre R, Tran TM, Robert P, Macoir J, Manera V, Gros A. The course of primary progressive aphasia diagnosis: a cross-sectional study. Alzheimers Res Ther. 2022 May 10;14(1):64. doi: 10.1186/s13195-022-01007-6.
Clinical trial NCT02224612: A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Official title: A Comparative Evaluation of the Performance and Fit of Pediatric Face Masks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Pediatric Face Masks
children
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-08-25
Enrollment: 96
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Compare the fit of two pediatric face masks in children.

Detailed description: This is a prospective, randomized, open-label comparative observational study to be conducted in up to two (2) facilities with the healthy and non-healthy Subjects (4-12 years of age). The usage of face masks is common practice within hospitals, and masks may be evaluated outside of clinical facilities as well.

Eligibility criteria: Inclusion Criteria:

* 4 to 12 years of age
* conscious

Exclusion Criteria:

* able to wear a mask
* no previous allergic reactions to face masks

Primary outcomes:
measure: Change From Baseline in Carbon Dioxide Levels
timeFrame: Baseline and 2 minutes
Secondary outcomes:
measure: Physical Fit of Pediatric Face Masks.
timeFrame: Immediate
Other outcomes:
measure: Change From Baseline in Respiration Rates
timeFrame: Baseline and 2 minutes
Locations:
city: Mundelein
country: United States
facility: Medline Industries, Inc
state: Illinois
Study officials:
affiliation: Medline Industries, Inc
name: Edward Drower, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664712: Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement
Official title: Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement in the Treatment of Plantar Fasciitis: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasciitis, Plantar
Keywords: focused shock waves
tendinitis
natriuretics
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 44
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: Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.

Detailed description: A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).

Eligibility criteria: Inclusion Criteria:

* plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;

Exclusion Criteria:

* History of previous fractures or ankle and heel surgery;
* Recurrence of previous local painful episodes;
* Lesion of the plantar fascia on US examination;
* Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
* Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.

Primary outcomes:
measure: Change in Visual Analogue Score (VAS)
timeFrame: T0 (recruitment); T1 (three months)
measure: Change in Visual Analogue Score (VAS)
timeFrame: T1 (three months); T2 (six months)
Secondary outcomes:
measure: Change in American Foot & Ankle Score (AOFAS)
timeFrame: T0 (recruitment); T2 (six months)
measure: Change in Foot Function Index (FFI)
timeFrame: T0 (recruitment); T2 (six months)
measure: Roles & Maudsley (R&M)
timeFrame: T1 (three months)
measure: Roles & Maudsley (R&M)
timeFrame: T2 (six months)
Other outcomes:
Locations:
city: Bari
country: Italy
facility: AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Study officials:
affiliation: University of Bari Aldo Moro
name: Biagio Moretti, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03583112: Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients
Official title: Investigation of the Changes of Brain Structure and Function in Premature Ejaculation Patients and the Effects of Dapoxetine on Central Neural Activity in Premature Ejaculation Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Ejaculation
Lead sponsor: Xidian University
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Lifelong premature ejaculation (LPE) is a common male sexual dysfunction with a high prevalence in global. Up to now, the etiology of LPE remains unclear. In recent years, dapoxetine, a highly potent serotonin-transporter inhibitor, has been used for treating premature ejaculation. However, the underlying mechanism of dapoxetine was unknown. Recently, with widespread use of neuroimaging techniques, like positron emission tomography and magnetic resonance imaging (MRI) in basic science, researchers can acquire human data on cerebral base of human sexual behavior, not only in normal subjects but also in patients with sexual dysfunction. Therefore, in order to further understand the biological mechanism of LPE and the brain targets of dapoxetine, the present study would investigate the brain changes of LPE and the effect of dapoxetine on brain activation by using MRI technology.


Eligibility criteria: Inclusion Criteria:

* right-handed male Chinese volunteers
* intravaginal ejaculatory latency time within 1 min
* premature ejaculation diagnostic tool score \>11 for patients, but \<5 for each control.
* patients who never received dapoxetine hydrochloride or other SSRI drugs

Exclusion Criteria:

* smokers
* had medical，neurological or psychiatric disorders
* had alcohol, nicotine, or drug abuse
* received any treatment at least 2 weeks before the experiment

Primary outcomes:
measure: Resting-state brain function measured by Functional magnetic resonance imaging
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The ART Center, The Northwest Women's and Children's Hospital,
state: Shaanxi
Study officials:
affiliation: The ART Center, The Northwest Women's and Children's Hospital
name: Gao
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06129812: An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer
Official title: An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer According to Tumor-vessel Relationship and CA 19-9 Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Neoadjuvant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 1132
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)

Brief summary: An Exploration of Candidates for Neoadjuvant Treatment in Resectable Pancreatic Cancer

Detailed description: The 1,132 patients with resectable or borderline resectable PDAC who underwent surgery between 2007 and 2021 were retrospectively reviewed. Patients with resectable PDAC without contact of major vessels (R-no contact) (n=651), with contact of portal vein or superior mesenteric vein (PV/SMV) ≤180° (R-contact) (n=306), and borderline resectable PDAC without arterial involvement (BR-V) (n=175) were analyzed.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC)
* Between January 2007 and June 2021 at Seoul National University Hospital

Exclusion Criteria:

* Patients who had borderline resectable PDAC with arterial invasion
* Patients who received chemotherapy as initial treatment and did not undergo surgery
* Incomplete follow-up data for analysis

Primary outcomes:
measure: Overall survival
timeFrame: From the date when biopsy results came out until the date of death from any cause or the date of the last visit, whichever came first, assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01397812: Heartsbreath Test for Heart Transplant Rejection
Official title: Validation of Heartsbreath Test for Heart Transplant Rejection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Transplant Rejection
Keywords: Rejection of the Heart Transplant
Heart Transplant Rejection, an immune-mediated allograft injury
Non-cellular or humoral rejection in cardiac transplant recipients
Right ventricular endomyocardial biopsy to detect Heart transplant rejection
Lead sponsor: Menssana Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-07-20
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject is the recipient of a heart transplant within the previous 12 months and is scheduled for a routine endomyocardial biopsy

Brief summary: The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).

Detailed description: This is a 36 month multi-center, open label, unblinded and blinded study on subjects have had a heart transplant within the previous 12 months and are scheduled to undergo an endomyocardial biopsy. The breath test will be performed to identify and validate the predicative algorithms that identify breath biomarkers for heart transplant rejection.

Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to cooperate with study, understand the scope of the study, and gives signed informed consent to participate.
* Subject is the recipient of a heart transplant within the previous 12 months
* Subject is scheduled for a routine endomyocardial biopsy
* Subject is 18 years or older

Exclusion Criteria:

* Evidence of acute intercurrent disease other than rejection reaction

Primary outcomes:
measure: To measure the sensitivity and specificity of the breath test as compared to the primary right ventricular endomyocardial biopsy for the development of an intrinsically safe, painless, and non-invasive detection technique.
timeFrame: 60 days after completion
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia Presbyterian Medical Center
state: New York
city: Philadelphia
country: United States
facility: Hahnemann University Hospital and the Drexel University College of Medicine
state: Pennsylvania
Study officials:
affiliation: Menssana Research, Inc.
name: Michael Phillips, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04282512: Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects
Official title: Evaluation of the Effect of Daily Consumption of Sodium Bicarbonate Water for 15 Days on Blood Pressure in Normotensive Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Nutrition
Blood pressure
Sodium bicarbonate
Lead sponsor: My Goodlife SAS
Sponsor class: INDUSTRY
First posted: 2020-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Group A subjects: first 15-day period drinking a sodium bicarbonate-rich mineral water Group B subjects: first 15-day period drinking tap water Washout period of 15 days Group A subjects: last 15-day period drinking tap water Group B subjects: last 15-day period drinking a Sodium bicarbonate-rich mineral water
Primary purpose: BASIC_SCIENCE

Brief summary: ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.

Secondary objective are:

* Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt intake
* Evaluation on blood pressure of the usual food groups that are the strongest contributors of salt intake.

Detailed description: Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects will begin their first 15-day period with the consumption of St-Yorre mineral water.

Group B will begin the first 15-day period by drinking tap water. After a washout period of 15 days, each group alternates with a new period of 15 days of water consumption monitoring: tap water for group A and mineral water St-Yorre for group B.

For each period salt intake and blood pressure are measured.Three-day food records are also performed for both 15-days periods.

Eligibility criteria: Inclusion Criteria:

* Normal blood pressure between 90/60 and 140/90 mm Hg
* Usually drinks tap water;
* Knowing read and write French routinely,
* Possessing an internet connection at home,
* Possessing and knowing how to use a computer or tablet,
* Affiliated with a social security scheme
* Not Trust
* Having signed the informed consent letter

Exclusion Criteria:

* Pregnant or lactating woman
* BMI greater than 35 kg / m²
* Heart failure
* History of cardiovascular disease
* Hypertension treated or untreated
* Renal failure.

Primary outcomes:
measure: Change from baseline mean number of systolic and diastolic blood pressure at 15 days
timeFrame: Day 1 to Day 3 - Day 13 to Day 15- Day 31 to Day 33 - Day 43 to Day 45
Secondary outcomes:
measure: Sodium intake
timeFrame: Day 1 to Day 15 - Day 31 to Day 45
Other outcomes:
Locations:
city: Mainvilliers
country: France
facility: Institut de Diabétologie Et Nutrition Du Centre
Study officials:
affiliation: INSTITUT DE DIABÉTOLOGIE ET NUTRITION DU CENTRE
name: Saïd Bekka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: