louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04937712: Analysis of SARS-CoV2 Urine Viral Particles and Association With Proximal Tubular Dysfunction
Official title: Molecular Characterization and Cellular Infection Capacity of Urinary Viral Particles Isolated From SARS-CoV-2 and Association With Proximal Tubular Dysfunction, in Hospitalized Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV2 Infection
Proximal Tubule Dysfunction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in CHRU Nancy with severe SARS-CoV2 infection, with lung involvement.

Brief summary: The primary goal is to detect Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) urine viral particles in patients in intensive care units, hospitalized for coronavirus Coronavirus Disease-19 (COVID-19) infection, and correlate the presence of the virus in the urine with proximal tubular dysfunction (defined by the association of at least 2 abnormalities: tubular proteinuria, renal phosphate leak, uricosuria, normoglycemic glycosuria, amino aciduria)


Eligibility criteria: Inclusion Criteria:

* Person and / or trustworthy person who has received complete information on the organization of the research and who has not opposed their participation and the use of their data
* Hospitalized for ≥ 48 hours and ≤ 10 days
* SARS-CoV-2 positive nasopharyngeal sample
* Severity criteria: Lung involvement described as compatible with SARS-CoV-2 on radiography or scanner and partial pressure of oxygne (PaO2) / Fraction of inspired oxygen (FiO2) ≤ 300 mmHg and / or respiratory rate (RR) ≥ 30 / min

Exclusion Criteria:

* Known chronic kidney disease, or initial Glomerular Filtration Rate (GFR) \<60 ml / min / 1.73m2 or Renal Transplant
* Known proteinuria
* Known proximal tubulopathy
* Treatment with Forxiga

Primary outcomes:
measure: SARS-CoV 2 viruria and its correlation with proximal tubule dysfunction
timeFrame: During the first 10 days of hospitalization
Secondary outcomes:
measure: Capacity of infection of urine viral particles
timeFrame: During the first 10 days of hospitalization
measure: Sequencing viral particles to identify possible compartmentalization of the virus
timeFrame: During the first 10 days of hospitalization
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chru Brabois
Study officials:
References:
citation: Kormann R, Jacquot A, Alla A, Corbel A, Koszutski M, Voirin P, Garcia Parrilla M, Bevilacqua S, Schvoerer E, Gueant JL, Namour F, Levy B, Frimat L, Oussalah A. Coronavirus disease 2019: acute Fanconi syndrome precedes acute kidney injury. Clin Kidney J. 2020 Jun 8;13(3):362-370. doi: 10.1093/ckj/sfaa109. eCollection 2020 Jun.
Clinical trial NCT05683912: Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece
Official title: Aflibercept for Diabetic Macular Edema In Real-life Practice in GREece: The ADMIRE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with DME treated with intravitreal aflibercept 2.0mg in routice clinical practice.

Brief summary: ADMIRE was a prospective, observational cohort study of patients with diabetic macular edema (DME). Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to months 12, 24 and 36 after treatment with intravitreal aflibercept in treatment-naïve patients and previously treated patients. Safety was evaluated by recording any patients-reported events.


Eligibility criteria: Inclusion Criteria:

Patients with DM, able to give written informed consent Patients with DME\>320 μm, who need treatment

Exclusion Criteria:

Patients with other retinal diseases than DME Intraocular surgery within the last 6 months

Primary outcomes:
measure: Change in best-corrected visual acuity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: University of Athens
Study officials:
References:
Clinical trial NCT05028712: Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
Official title: Development of a Multi-sensory Rehabilitation Program for People With Ultra Low Vision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Vision Blindness
Visual Impairment
Quality of Life
Functional Visual Loss
Keywords: ultra low vision rehabilitation
multi sensory
functional vision assessment
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is aimed to address one of the big gaps in the current vision rehabilitation protocols for people with profound visual impairment by evaluating a multisensory approach. There are a growing number of clinical trials that recruit people with end-stage eye diseases and the rehabilitation plan following various treatments is not clear. It is important to address this in order to maximize the efficacy of such treatments and to improve the quality of life in people with profound visual impairment.


Eligibility criteria: Inclusion Criteria:

* People with ultra low vision (visual acuity ≤20/1600)

Exclusion Criteria:

* \<12 years of age
* dependent on sighted guide
* cognitive impairment

Primary outcomes:
measure: Change in visual ability
timeFrame: Baseline, 1 month, 3 months, 6 months
Secondary outcomes:
measure: Change in hand-eye coordination
timeFrame: Baseline, 1 month, 3 months, 6 months
measure: Change in hearing ability
timeFrame: Baseline, 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Arathy Kartha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06205212: High-flow Nasal Oxygenation During Preoxygenation and Atelectasis
Official title: The Effect of High-flow Nasal Cannula Applied During Preoxygenation for Prevention of Atelectasis in Patients With Obesity Undergoing General Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia, General
Pulmonary Atelectasis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2024-01-12
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atelectasis after induction of general anesthesia is common even in healthy patients and is clinically problematic, especially in obese patients. We aim to investigate whether preoxygenation with high-flow nasal oxygen during anesthesia induction reduces atelectasis in obese patients.


Eligibility criteria: Inclusion Criteria:

* Adults patients undergoinig surgery under general anesthesia with a BMI of 30 kg/m2 or greater who have given informed consent

Exclusion Criteria:

* surgery time less than 2 hours
* Nasotracheal intubation
* Severe cardiac or respiratory disease
* History of difficult airway
* History of a surgery or anatomical anomaly in the head and neck
* History of Inability to breathe through nose
* Gastric reflux disease

Primary outcomes:
measure: Lung ultrasound score
timeFrame: Immediately after anesthesia induction
Secondary outcomes:
measure: Incidence of atelectasis
timeFrame: Immediately after anesthesia induction
measure: PaO2 to FiO2 ratio and PaCO2
timeFrame: Immediately after anesthesia induction
measure: Hemodynamic variables
timeFrame: During anesthesia induction
measure: Patient Satisfaction Score
timeFrame: During preoxygenation
measure: Lung ultrasound score
timeFrame: In the PACU after surgery
measure: Incidence of Spo2 less than 95%
timeFrame: during 48 hours postoperatively
measure: Maximum body temperature
timeFrame: during hospitalization up to 1 week
measure: Incidence of postoperative pulmonary complications
timeFrame: during hospitalization up to 1 week
measure: length of hospital stay
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: TAE KYONG KIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902912: Effect of Prednisolone Treatment on Uterine Natural Killer Cells
Official title: Effect of Prednisolone Treatment on Uterine Natural Killer Cells and Endometrial Angiogenesis in Recurrent Miscarriage Around the Time of Embryo Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Recurrent Miscarriage
Keywords: recurrent miscarriage
prednisolone treatment
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the role of uNK cells and the association with prednisolone.

Detailed description: Glucocorticoids prednisolone is considered as a potential therapy in women with recurrent miscarriage. However, the evidence for treatment with prednisolone is still inconclusive and the relevant mechanism merits further investigations.

The participants will be invited to take prednisolone oral 10 mg/day and attend our outpaitent clinic to be performed endometrial biopsy.

Eligibility criteria: Inclusion Criteria:

1. Women with a history of 3 or more consecutive miscarriages
2. Women younger than 40 years old

Exclusion Criteria:

1. Allergy to prednisolone
2. Women who have any uterine anomaly
3. Antiphospholipid syndrome
4. Hydrosalpinx
5. Thrombophilia
6. Abnormal thyroid function tests
7. women with diabetes,

Primary outcomes:
measure: the number of uNK cells
timeFrame: at the 1 day of endometrial biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References:
Clinical trial NCT04287712: Detection of Lung Cancer by Plasma Lipids
Official title: Detection of Early-stage Lung Cancer Using Machine Learning and Plasma Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early-Stage Lung Cancer
Keywords: Early-Stage Lung Cancer
Plasma Metabolomics
Lipids
Machine Learning
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Haidian Hospital
name: Jiangsu Cancer Institute & Hospital
name: Peking University Health Science Center
First posted: 2020-02-27
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who with pulmonary nodules or opacity and underwent surgery at the Department of Thoracic Surgery of Peaking University People's Hospital, Jiangsu Cancer Hospital, and Beijing Haidian Hospital were enrolled

Brief summary: There are no reliable blood-based tests currently available for early-stage lung cancer diagnosis. We try to establish a highly accurate method for detecting early-stage lung cancer by combining machine learning with untargeted and targeted metabolomics .

Detailed description: All plasma lipids were first detected by untargeted metabolomics methods and 9 feature lipids of early-stage lung cancer were selected by support vector machine algorithm. Then, a targeted metabolomics method was developed to detect the 9 lipids quantitatively based on multiple reaction monitoring mode. Finally, a detection model was established based on the 9 lipids.

Eligibility criteria: Inclusion Criteria:

1. pulmonary nodules or opacity
2. plan to receive surgery

Exclusion Criteria:

1. history of other malignancies
2. received anti-cancer treatment (chemotherapy, radiotherapy, targeted therapy, etc.) before surgery

Primary outcomes:
measure: Plasma Lipids
timeFrame: All samples were detected together after participants recruitment and sample collection. All samples were detected within 18 months from sample collection.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00845312: Prognostic Features for Mortality in Young Adults With Pneumonia
Official title: Prognostic Features for Mortality in Adult Pneumonia Patients at the Age of Sixty and Beneath.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Age
Mortality
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were admitted with community acquired pneumonia to Rambam Medical Center between the dates January 1, 2004 until December 31, 2008

Brief summary: Pneumonia is a major cause of mortality and morbidity. A large body of evidence concerning the mortality risk factors in elderly patients with pneumonia has been reported; however, less is known about causes of mortality in patients of sixty and less. We noted a relatively substantial rate of short term mortality in this group of patients that were admitted to our institution. Therefore, we aimed to estimate the mortality rate and to identify risk factors for mortality among patients of sixty years old and less that were admitted with community acquired pneumonia.

Detailed description: Community acquired pneumonia (CAP) is a major cause of morbidity and mortality. While there is much data about risk factors for severe outcome in the general population, there is less focus on younger group of patients. Therefore, we aimed to detect simple prognostic factors for severe morbidity and mortality in young patients with CAP.

Patients 60 years old or younger, who were diagnosed with CAP (defined as Pneumonia identified 48 hours or less from hospitalization) between March 1, 2005 and December 31, 2008 were retrospectively analyzed for risk factors for severe morbidity or mortality.

Complicated hospitalization was defined as at least one of the following parameters: hospitalization longer than ten days, admission to intensive care unit and in- hospital mortality. Otherwise, the hospitalization was defined uncomplicated

Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of community acquired pneumonia Age between 18-60

Exclusion Criteria:

Age less than 18 and more than 60 Transfer from another hospital Hospitalization for any cause other than CAP during the 30 days prior to admission Hospital acquired pneumonia Partial antibiotic treatment before admission.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Head Of Internal Medicine "B"
name: Zaher S Azzam, MD
role: STUDY_CHAIR
affiliation: Deputy Head of Internal Medicine "B"
name: Eyal Braun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braun E, Domany E, Kenig Y, Mazor Y, Makhoul BF, Azzam ZS. Elevated red cell distribution width predicts poor outcome in young patients with community acquired pneumonia. Crit Care. 2011 Aug 11;15(4):R194. doi: 10.1186/cc10355.
Clinical trial NCT01104012: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
Official title: The VAPARA Study: Validation of Proteomic Analyses for Allergic Asthma and Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic
Asthma, Allergic
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The asthma and allergic rhinitis patients included in this study are recruted from the Pneumology Departments of the University Hospitals of Nîmes, Marseilles, and Montpellier.

Brief summary: The purpose of this study is to verify and validate the intrinsic diagnostic value in terms of sensitivity and specificity of proteomic profiles determined during a pre-study for discriminating between allergy related asthma and allergy related rhinitis.


Eligibility criteria: Inclusion Criteria:

* signed consent
* never-smokers or non-smoking for at least 2 years + \< 5 packs per year
* capable of understanding the study
* patient is affiliated with a social security system
* positive skin tests (at least one for Montpellier region pneumoallergens)
* treated with nasal or inhaled corticoids, leucotriene receptor antagonists, anti-IgE, Theophylline, anti-histamines, sodium cromoglycate, beta-blockers, benzodiazépine, oral corticoids: all these treatments must be interrupted for at least 72 hours

Exclusion Criteria:

* Co-morbidities: none; no co-morbidities are accepted
* dental infections (any) during the 3 months preceding the study
* suspected alcoholism or drug abuse
* chronic viral infection (hepatitis, HIV)
* patient under guardianship

Primary outcomes:
measure: Proteomic profile of each patient
timeFrame: One day (snapshot)
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique - Hopitaux de Marseille
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Nicolas Molinari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06215612: ctDNA and MRI Parameters in Head and Neck Cancer
Official title: ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Carcinoma, Squamous
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.


Eligibility criteria: Inclusion Criteria:

* Squamous cell carcinoma head and neck
* Planned primary platinum based radiochemotherapy
* ECOG 0-2

Exclusion Criteria:

* Palliative therapy intent
* Not MR eligible

Primary outcomes:
measure: percentage of patients with 50% decrease in ctDNA
timeFrame: 7 weeks after start of radiotherapy
Secondary outcomes:
measure: Completion of all planned MR imagings and blood tests
timeFrame: through study completion, an average of 7 weeks
measure: Decrease of tumor volume
timeFrame: 7 weeks after start of radiotherapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01846312: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Official title: The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who are at risk for developing T1D either by genetic testing or due to family history and identified with one or more islet autoantibodies).

Brief summary: This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).


Eligibility criteria: Inclusion Criteria:

* Subjects with general good health as judged by the investigator
* Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))

Exclusion Criteria:

* Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
* Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant

Primary outcomes:
measure: Fluctuation in islet autoantibodies titers
timeFrame: One-two years dependent on sampling frequency
Secondary outcomes:
measure: Fluctuation in islet autoantibody isotypes
timeFrame: One-two years dependent on sampling frequency
measure: Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)
timeFrame: One-two years dependent on sampling frequency
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: