louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00605540: Chronic Obstructive Pulmonary Disease Markers and Prognosis
Official title: Three-years Follow-up of Diagnostic and Prognostic Markers in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Survival
Exacerbation
Disease markers
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2008-01-31
Enrollment: 133
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pulmonary outpatient clinic

Brief summary: The study aim is to verify the association between the changes in markers of disease and patient´s prognosis in chronic obstructive pulmonary disease.

Detailed description: In a previous study, 133 COPD patients were followed-up during the period of one-year. Analyses of the association between baseline characteristic and the occurence of disease exacerbation was performed. In this study, the patients included in the previous research will be contacted and invited to participate in a complete evaluation after a three-year period. The association of the changes in dyspnea perception, spirometry variables, body composition, quality of life and exercise tolerance measures with disease prognostic will be studied.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosis according to the GOLD criteria

Exclusion Criteria:

* Asthma
* Inability to perform pulmonary function and exercise tolerance tests
* Recent myocardial infarction or unstable angina
* Congestive heart failure: class III/IV

Primary outcomes:
measure: Forced Expiratory Volume in the First Second (FEV1)
timeFrame: Baseline and after three years
measure: Exercise Tolerance
timeFrame: Baseline and after three years
measure: Body Composition
timeFrame: Baseline and after three years
measure: Dyspnea
timeFrame: Baseline and after three years
measure: Health Status
timeFrame: Baseline and after three years
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Botucatu School of Medicine
state: SP
Study officials:
affiliation: Botucatu School of Medicine
name: Irma de Godoy, PhD, MD
role: STUDY_CHAIR
References:
citation: Ferrari R, Tanni SE, Caram LM, Correa C, Correa CR, Godoy I. Three-year follow-up of Interleukin 6 and C-reactive protein in chronic obstructive pulmonary disease. Respir Res. 2013 Feb 20;14(1):24. doi: 10.1186/1465-9921-14-24.
citation: Ferrari R, Tanni SE, Caram LM, Naves CR, Godoy I. Predictors of health status do not change over three-year periods and exacerbation makes difference in chronic obstructive pulmonary disease. Health Qual Life Outcomes. 2011 Dec 9;9:112. doi: 10.1186/1477-7525-9-112.
Clinical trial NCT05037240: Quercetin in the Prevention of Covid-19 Infection
Official title: Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of an Oral Nutritional Supplement Based on Quercetin in the Prevention of Covid-19 Infection for a Duration of 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Azienda di Servizi alla Persona di Pavia
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Quercetin is a flavonol, a subclass of flavonoid compounds. Of the flavonol molecules, quercetin is the most abundant in fruit and vegetables. Quercetin flavonol is characterized by 3 crucial properties: antioxidant, anti-inflammatory and immunomodulatory. The combination of these 3 properties makes quercetin an excellent candidate for dealing with situations in which oxidative stress, inflammation and the immune system are involved. The purpose of the study is to evaluate the effectiveness of an oral nutritional supplement based on quercetin in the prevention of Covid-19 infection.


Eligibility criteria: Inclusion Criteria:

* Absence of Covid-19 infection

Exclusion Criteria:

* Previous Sars-Cov-2 infection demonstrated with antibody positivity through venous sampling
* Demonstrated presence of Sars-Cov-2 through a nasopharyngeal antigenic swab before the start of oral nutritional supplementation

Primary outcomes:
measure: Prevention of Covid-19 infection
timeFrame: Absence of Covid-19 infection at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Mariangela Rondanelli
Study officials:
References:
Clinical trial NCT05155540: Direct Mechanical Thrombectomy Versus Bridging Therapy
Official title: A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thrombectomy
Ischemic Stroke
Large-Artery Atherosclerosis (Embolus/Thrombosis)
Keywords: ischemic stroke
Direct mechanical thrombectomy
Bridging therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, non-randomized, prospective, double-arm clinical trial
Primary purpose: TREATMENT

Brief summary: This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.

Detailed description: This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.

Eligibility criteria: Inclusion Criteria:

* Patients with anterior ischemic stroke due to large vessel occlusion.
* A previous autonomous modified Rankin Scale (mRS) of less than 2.
* A National Institutes of Health Stroke Scale (NIHSS)≥4
* A groin puncture within 4.5 hours of the neurological deficit onset.

Exclusion Criteria:

* Imaging documentation of intracranial haemorrhage
* A premorbid mRS score of 2 or more
* Absence of diffusion perfusion mismatch in CT perfusion.

Primary outcomes:
measure: Modified Rankin Scale score
timeFrame: 3 months
measure: Complication rate
timeFrame: within one week postoperatively
Secondary outcomes:
measure: The National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: at 24 hours postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Faculty of Medicine
Study officials:
affiliation: Alexandria University Faculty of Medicine
name: Mohamed A Abdel Ghani, Master's
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04089540: New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates
Official title: New Intubation Method to Achieve Circulatory Stability and to Reduce Number of Intubation Attempts in Neonates. A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult or Failed
Preterm Infant
Term Infant
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled pilot study investigating a new intubation method in newborn infants. In contrast to the conventional intubation method, in the new method the respirator is connected to the tube prior to insertion into the mouth (oral intubation) or into the nose (nasopharyngeal intubation). As a result, an oxygen flow is already administered via the tube during the intubation process. Heart rate, arterial oxygen saturation (SpO2) and cerebral tissue oxygenation (using near-infrared spectroscopy) are recorded in both the study and control groups during intubation.

Hypothesis

* The new intubation method is safe
* The new intubation method leads to a reduction in the number of intubation attempts
* The new intubation method leads to a reduction of desaturations and bradycardia during intubation
* In the long term, it could lead to a reduction in morbidity and mortality


Eligibility criteria: Inclusion Criteria:

* Preterm and term born neonates who are hospitalized at neonatal intensive care unit, Medical University of Graz, Austria.
* Fulfillment of indication for intubation

Exclusion Criteria:

- Malformation of the upper respiratory tract

Primary outcomes:
measure: Number of intubation attempts
timeFrame: During intubation process
Secondary outcomes:
measure: Duration of intubation process in minutes
timeFrame: During intubation process
measure: Number of desaturations
timeFrame: During intubation process
measure: Total amount of time of desaturations
timeFrame: During intubation process
measure: Cerebral tissue oxygenation
timeFrame: 5 minutes before intubation start till 10 minutes after successful intubation
measure: Morbidity
timeFrame: up to 2 years
measure: Mortality
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz
Study officials:
affiliation: Division of Neonatology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Austria
name: Nicholas Morris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521740: CAREGIVER2, Caregiver's Health Assessment : Clinical and Biological Markers
Official title: Soutien Des Soins Informels Aux Personnes âgées Fragiles : Accompagnement Des Aidants Sur Base d'Une évaluation Clinique et Biologique de la Charge de Soins.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Caregivers
Keywords: biological marker
frailty
burden
nutrition
elderly
Lead sponsor: Centre Hospitalier Universitaire UCLouvain Namur
Sponsor class: OTHER
Collaborators: name: University of Liege
name: University of Namur
First posted: 2015-08-13
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * caregivers of a community dwelling dependent elderly (≥70years)
* controls : poeple who lives with a healthy elderly (≥70years)

Brief summary: Providing care for a disabled elderly may represent a risk for the health of the caregiver. The objective of the study is to assess the impact of caregiving in terms of clinical and biological markers in relation to disability and cognitive impairment.

Detailed description: The investigators hypothesize that an accumulation of stressful events related to care giving may induce a stress response to the caregiver. This stress response can be measured by biological markers (inflammation, transcription and immunity) and also by clinical markers (frailty, physical performance, nutrition). This stress response can be influenced by the subjective burden of the caregiver and by the severity of the disease of the care receiver (Activity of daily life capabilities, cognitive function, behavioral disturbance).

Eligibility criteria: Inclusion Criteria:

* living with the care-receiver ( or with a healthy elderly for the controls)
* care-receiver dependent for at least one Activity of the daily living ( Katz index) or having cognitive disorder ( \>2 Global Deterioration Scale)

Exclusion Criteria:

* institutionalised elderly
* inability to understand and speak french
* Acute disease within the past month
* Anti-inflammatory or immuno-suppressive treatment
* End-of-life care

Primary outcomes:
measure: Levels of biomarkers across groups
timeFrame: at baseline
Secondary outcomes:
measure: Relation between biomarkers, subjective burden and the care receiver situation
timeFrame: at baseline
Other outcomes:
measure: Relation between biomarkers, subjective burden and the care receiver situation
timeFrame: at baseline
measure: comparison of health events
timeFrame: after 12 month
measure: relation between biomarkers at baseline and functional decline
timeFrame: after 12 month
measure: Levels of clinical markers across groups
timeFrame: at baseline and after 12 month
measure: relation between biomarkers at baseline and burden
timeFrame: after 12 month
Locations:
city: Mont-Godinne
country: Belgium
facility: CHU Dinant-Godinne
state: Yvoir
Study officials:
affiliation: CHUDinant-Godinne
name: Marie de Saint-Hubert, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT07009340: Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery
Official title: Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery: Post-discharge Follow-up of Patients From REN-004 Clinical Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post-discharge Outcomes
Lead sponsor: Renibus Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-06
Enrollment: 200
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: Patients who completed REN-004 and have at least 1 year of follow documentation post-discharge

Brief summary: This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.


Eligibility criteria: Inclusion Criteria:

* Patient completed REN-004
* Patient has at least 1 year of follow documentation post-discharge

Exclusion Criteria:

* Patient enrolled in a clinical trial within 1-year post-discharge from REN-004

Primary outcomes:
measure: Post-discharge outcomes for patients enrolled in REN-004 from one study center
timeFrame: 1 year
Secondary outcomes:
measure: Total estimated cost of in hospital and post-discharge
timeFrame: 1 year
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Fort Wayne
country: United States
facility: Lutheran Medical Center
state: Indiana
city: Midland
country: United States
facility: My Michigan Medical Center
state: Michigan
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT04067440: Characterization of the Microbiome in Peritoneum, Jejunum, Rectum and Stool
Official title: Characterization and Comparison of the Human Microbiome in Peritoneum, Jejunum, Rectum and Stool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes Mellitus
Fatty Liver, Nonalcoholic
Leaky Gut Syndrome
Chronic Pancreatitis
Keywords: Microbiome
Obesity
Chronic Liver Disease
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obesity

Brief summary: Characterization of the human microbiome in the jejunum and comparison to the microbiome in the rectum and stool in order to see how the microbial communities change within the intestines.

Detailed description: Subjects to undergo surgery with opening of the jejunum will be sampled with sterile swabs from peritoneum and the inside of the jejunum. A swab will also be taken from the rectum.

The peritoneum is regarded as a sterile place until today. We try to either verify this, we also could find a scientific base for theories like leaky gut or other forms of bacterial migration through the intestinal wall.

Many of these patients undergo bariatric surgery. Many of them do have a dramatic change in glucose metabolism immediate after surgery. Therefore stool swabs will be taken before and 5 days after surgery.

Eligibility criteria: Inclusion Criteria:

* abdominal surgery containing opening of jejunum
* singing of consent

Exclusion Criteria:

* inflammative condition (appendicitis, pancreatitis, Crohn, Colitis ulcerous, cholecystitis and similar)

Primary outcomes:
measure: Characterization of microbiome
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Department of General, Visceral, Vascular and Pediatric Surgery, University of Saarland,
Study officials:
affiliation: Saarland University Hospital
name: Michael Jelden, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04005040: Evaluation of Mobile X-ray Within the Triple Aim Method
Official title: Evaluation of Mobile X-ray Within the Triple Aim Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: X-rays; Effects
Health Impairment
Patient Satisfaction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-07-02
Enrollment: 374
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Background:

In foreign countries, mobile x-ray already is being used where transfer to the radiology department at the hospital may be an obstacle. Using mobile x-ray, the x-ray examination is performed in the patients own home with transportable equipment that reminds of the transportable x-ray equipment that is being used in the intensive care units. At The Department of Radiology (DOR), Aarhus University Hospital there is an ongoing project mobile x-ray for patients living in nursing homes in Aarhus. The project will be evaluated inspired by the Triple Aim Approach in three sub studies.

Overall aim:

The overall aim is to conclude if mobile x-ray improves healthcare for fragile patients.

Hypotheses:

* Patients examined with mobile x-ray have fewer number of hospital admissions compared with patients examined with x-ray at DOR.
* Patients examined with mobile x-ray are more satisfied with their examination compared with patients examined with x-ray at DOR.

Sub study 1 - Population health

Aim:

The primary aim is to study if mobile x-ray improves the health of the defined population measured in hospital admission. Also to study challenges conducting a RCT.

The outcome measures:

The primary outcome is hospital admissions.

Sub study 2 - Experience of care

Aim:

The aim is to study the satisfaction with mobile x-ray compared the satisfaction to x-ray at DOR.

Methods:

Observations, interview and questionnaires.


Eligibility criteria: Inclusion Criteria:

* patients referred to a mobile X-ray examination in Aarhus Municipality

Exclusion Criteria:

* all other patients referred to an x-ray examination

Primary outcomes:
measure: Hospital admissions
timeFrame: one year
Secondary outcomes:
measure: patient satisfaction
timeFrame: one year
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Central Region Denmark
Study officials:
affiliation: University of Aarhus
name: Helene Nørrelund, Decan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vigeland E, Bohm RE, Rostad A, Lysdahl KB. Mobile X-ray service for nursing homes. Tidsskr Nor Laegeforen. 2017 Feb 7;137(3):198-202. doi: 10.4045/tidsskr.16.0035. eCollection 2017 Feb. English, Norwegian.
Clinical trial NCT06692140: Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention
Official title: Randomized Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated with Percutaneous Coronary Intervention in an All Comer Population (The SORT OUT XII Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemia, Myocardial
Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)
Keywords: Drug-eluting stent
outcome
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 3150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention


Eligibility criteria: Inclusion Criteria:

* All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents

Exclusion Criteria:

* Age \< 18 years
* Not able to consent to study participating (eg. intubated patients)
* Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study
* Do not speak Danish
* Already included in the SORT OUT XII study
* Life expectancy \<1 year
* Allergic to study related treatment

Primary outcomes:
measure: Number of patients with target lesion failure
timeFrame: 1 year
Secondary outcomes:
measure: Number of patients with all-cause death
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with cardiac death
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with myocardial infarction
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with definite stent thrombosis
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with probable stent thrombosis
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with target lesion revascularization
timeFrame: 1 year, 3 years and 5 years
measure: Number of patients with target vessel revascularization
timeFrame: 1 year, 3 years and 5 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lisette O Jensen
role: PRINCIPAL_INVESTIGATOR
References: