louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01589874: Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
Official title: Anemia of Inflammation: Investigation on Impaired Iron Regulation in Acutely Ill Patients and Their Clinical Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia of Acute Inflammation
Keywords: hepcidin
anemia
acute inflammation
IL-6
cytokines
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: University of Milano Bicocca
First posted: 2012-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all consecutive patients admitted to Internal Medicine ward because of acute inflammatory illness

Brief summary: Anemia of inflammation (AI), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (RBC) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. Deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients.

Anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking.

Several studies have been performed on pathophysiology of AI in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation.

The aim is to develop effective new strategies to detect and manage AI in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.


Eligibility criteria: Inclusion Criteria (both):

* serum C-reactive protein level \> 3mg/dL
* creatinine level \< 2mg/dL (clearance \> 30%)

Exclusion Criteria:

* any haematological diseases
* cancer under chemotherapy
* AIDS (or HIV+)
* liver cirrhosis
* genetic hemochromatosis
* immunosuppressive therapy
* blood transfusion in the past 30-days

Primary outcomes:
measure: impact of acute inflammatory state on hemoglobin levels
timeFrame: 6 days - 8 days
Secondary outcomes:
measure: impact of acute inflammatory cytokines on hepcidin-driven iron balance and monocytes role in anemia of acute inflammation
timeFrame: 6 days - 8 days
Other outcomes:
Locations:
city: via Francesco Sforza 35
country: Italy
facility: Internal Medicine Department - U.O. Medicina Interna 1/A
state: Milan
Study officials:
affiliation: Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
name: Giovanna Fabio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita' degli Studi di Milano & Fondazione IRCCS Ca' Granda Osepdale Maggiore Policlinico
name: Giovanna Fabio, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01656174: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross
Official title: Procleix® Dengue Virus Assay Testing of Individual Donor Samples From Puerto Rican Blood Donors - American Red Cross
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dengue
Lead sponsor: Gen-Probe, Incorporated
Sponsor class: INDUSTRY
First posted: 2012-08-02
Enrollment: 35035
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: volunteer blood donors from Puerto Rico

Brief summary: The objective of this study is to test individual donor samples (IDSs) with the investigational Dengue Assay on the TIGRIS System and to further characterize the Dengue Assay in the clinical setting.


Eligibility criteria: Inclusion Criteria:

* Donor must meet all the blood collection sites' standard eligibility requirements.
* Donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.

Primary outcomes:
measure: Qualitative detection of ribosomal RNA from Dengue Virus in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors.
timeFrame: Approximately three years
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Creative Testing Solutions
state: Arizona
city: Charlotte
country: United States
facility: American Red Cross National Testing Laboratory
state: North Carolina
Study officials:
affiliation: Gen-Probe, Incorporated
name: Renee Wait
role: STUDY_DIRECTOR
References:
Clinical trial NCT04590274: Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Official title: Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Covid19
SARS (Severe Acute Respiratory Syndrome)
Lead sponsor: International Brain Research Foundation
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.


Eligibility criteria: Inclusion Criteria:

1) Patients must have one or more of the following:

1. confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
2. continued close contact with an individual with suspected SARS-CoV-2 infection
3. at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.

Exclusion Criteria:

1) Patients must not have any uncontrolled disease such as:

1. cardiovascular disease
2. hepatic disease
3. renal disease
4. metabolic disease
5. other diseases or insufficiencies

Primary outcomes:
measure: Percentage of individuals who develop COVID-19 symptoms
timeFrame: 6 months from study start
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: International Brain Research Foundation
name: Philip DeFina, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00285974: Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
Official title: Dosage of Metal Ions in the Blood of Different Metal-on-metal Prostheses, in Correlation With Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective study including 6 groups of 20 patients with a total hip prosthesis. Five different types of metal-on-metal prostheses are studied, and 1 group with ceramic-on-ceramic prostheses acts as control group. Patients undergo a clinical evaluation and blood sampling preoperatively, and 3, 6, 12 and 24 months postoperatively.


Eligibility criteria: Inclusion Criteria:

* Hip osteoarthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Concentration of metal ions in the blood
timeFrame: preoperatively, and 3, 6, 12 and 24 months postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01024374: Evaluation of the Effectiveness of a Product Containing Topical Hydrocortisone in the Treatment of Seborrheic Dermatitis of the Face
Official title: Avaliação da eficácia de um Produto de Uso tópico Contendo Hidrocortisona no Tratamento de Dermatite seborréica na Face.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Seborrheic Dermatitis
Lead sponsor: Allergisa Pesquisa Dermato-Cosmetica LTDA
Sponsor class: INDUSTRY
Collaborators: name: Galderma R&D
First posted: 2009-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects with seborrheic dermatitis on both sides of the face, both sexes, aged 18 to 60 years, skin types I through IV.

Brief summary: Clinical single-blind randomized comparison with the overall objective of evaluating the clinical efficacy of the products Nutracort lotion and Nutracort cream in the treatment of seborrheic dermatitis on the face.

Will be held clinical and perceived efficacy assessment and instrumental measurements. Each product will be applied at half face for 7 consecutive days and all applications will be monitored in the research site. 60 volunteers will be recruited.

Evaluations will be held at the following times: T0 - before the initial application of the product; T1 - 24 hours after starting treatment, T2 - 48 hours after starting treatment, T3 - 72 hours after initiation of treatment, T4 - 96 hours after the start treatment, T7 - 7 days after initiation of treatment.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Subjects with seborrheic dermatitis on both sides of the face
* both sexes
* aged 18 to 60 years
* skin types I through IV.

Exclusion Criteria:

* pregnancy / lactation
* skin condition in the area of application of the product
* diabetes
* immune insufficiency
* subjects that are using systemic corticoids
* subjects that are using immunosuppressors
* skin diseases: vitiligo, psoriasis, lupus, atopic dermatitis
* history of reaction to the product category
* other diseases or medications that might interfere directly in the study or endanger the health of the subject

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01093274: Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy
Official title: Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy, a Prospective Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bowel Preparation
Keywords: colonoscopy
Cathartics
Sodium picosulfate
Polyethylene Glycol
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 200
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: DIAGNOSTIC

Brief summary: Patients intended for ambulatory colonoscopy will be randomized into 2 groups


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients scheduled for elective colonoscopy
* Age 18-80

Exclusion Criteria:

* Renal insufficiency (serum creatinine ≥2.0 mg/dl)
* Symptomatic congestive heart failure
* Recent myocardial infarction

Primary outcomes:
measure: Percentage of patients requiring repeat colonoscopy because of poor preparation
timeFrame: quality of preparation will be assessed during colonoscopy
Secondary outcomes:
measure: Patient's satisfaction as measured by questionnaire and willingness to repeat same preparation on future examination
timeFrame: Questionnaire will be filled before colonoscopy
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Hospital
Study officials:
affiliation: Rabin Medical Center - Beilinson hospital
name: Eyal Gal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04548674: Analysis of the Influence of Desensitizing Treatments on the Pulp Inflammatory Response in Bleached Teeth
Official title: Effect of Different Desensitizing Protocols on the Pulp Inflammatory Response in Bleached Teeth: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulp Inflammation
Keywords: Therapies
Caspase 3
Immunohistochemistry
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This randomized, controlled, blinded clinical trial evaluated the effectiveness of different desensitizing protocols in preventing pulp inflammation after bleaching treatment with 35% hydrogen peroxide (PH) (Whiteness PH 35%).

Detailed description: Thirty healthy third human molars extracted by orthodontic indication were randomized and allocated into five groups (n = 6): CN (negative control): without intervention; CP (Positive control): PH; PMB: PH + photobiomodulation with low power laser; CPP: PH + casein phosphopeptide phosphopeptide amorphous calcium phosphate (CPP-ACPF); NANO: PH + nanohydroxyapatite. The office whitening was performed in two sessions with a single application of 45 min and an interval of 48 hours between them. Pulp tissues were removed for immunohistochemical analysis. Immunostaining was performed for Caspase 3 using an Axio Scope.A1 microscope.

Eligibility criteria: Inclusion criteria:

* Lower third molars class I position A
* Maxillary third molars horizontal position A
* Absence of caries and enamel fracture
* Absence of periodontal disease
* Extraction of third molars for orthodontic reasons
* No allergy to the anesthetic and positive pulp sensitivity test

Exclusion criteria:

* Calcification in the middle third of the root
* Drug users or smokers
* Patients who have already done whitening
* Root apex with incomplete formation and patients with systemic problems that would make surgery impossible

Primary outcomes:
measure: Pulp inflammation
timeFrame: 3 days After extraction of third molars
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade Federal do Pará
state: Pará
Study officials:
References:
Clinical trial NCT05175274: Colchicine Use for Primary Prevention of Coronary Artery Disease
Official title: Colchicine Use for Primary Prevention in People at High Risk of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
primary prevention
adverse events
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
Collaborators: name: Qingdao Municipal Hospital
First posted: 2022-01-03
Enrollment: 6792
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Colchicine has been widely used as an anti-gout medicine in the past decades. Some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. However, the effect on primary prevention has not been observed sufficiently. The objective of this study is to determine whether colchicine reduces the incidence of CAD in patients and its safety for long-term use.


Eligibility criteria: Inclusion Criteria:

1. Males and females who have at least 3 risk factors for CAD. 2. GFR\>90mmol/L. 3 People are within 40-70 years old.4. Patients are not pre-diagnosed with CAD, which is defined by negative results of CT coronary angiography.

Exclusion Criteria:

1. Patients with any pre-existing diagnosis of coronary artery disease.2.Other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.Cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.Currently on treatment with colchicine.5.Patients who are known to be allergic to colchicine.6 Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before recruitment.7.Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.8.Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.

Primary outcomes:
measure: The incidence of CAD
timeFrame: 3 years
measure: Occurrence of adverse events in both groups
timeFrame: 3 years
Secondary outcomes:
measure: MACE events
timeFrame: 3 years
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Mengmei Li
state: Shandong
Study officials:
References:
Clinical trial NCT04971265: Family Supports and Beliefs Survey
Official title: Cognitive Interviewing of Survey Items for a Computer Adaptive Test of Parent Knowledge and Beliefs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beliefs About Child Development
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to see one of four scenarios at the start of the study, while taking the Family Supports and Beliefs Survey \[#1: LowSES, High Societal Supports; #2, Low SES, Low Societal Supports; #3 High SES, High Societal Supports; or #4 High SES, Low Societal Supports\]
Primary purpose: OTHER

Brief summary: Participants will complete a survey (The Family Supports and Beliefs Survey), which will measure their existing beliefs about the role of societal resources in supporting families and young children. Participants will randomly see one of four fictional scenarios and then be asked questions related to that scenario as well as items related to stress and self-efficacy. We hypothesize that the type of scenario a participant is presented with before taking a survey may affect how they answer subsequent questions.

This survey is being administered as part of a broader project designed to test items that are being developed for a new measure, the Survey of Parent/Provider Expectations and Knowledge Computer Adaptive Test (SPEAK CAT).


Eligibility criteria: Inclusion Criteria:

* Must live in the United States

Exclusion Criteria:

* Individuals who cannot complete the survey in English
* Individuals under the age of 18

Primary outcomes:
measure: Beliefs about the role of parenting and family supports on child development
timeFrame: At enrollment only
Secondary outcomes:
measure: Stress and self-efficacy
timeFrame: At enrollment only
Other outcomes:
Locations:
city: Chicago
country: United States
facility: TMW Center for Early Learning + Public Health at the University of Chicago Medicine
state: Illinois
Study officials:
affiliation: University of Chicago
name: Dana Suskind, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01756365: Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency
Official title: Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Limbal Stem Cell Deficiency
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2012-12-25
Enrollment: 54
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I / phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.
Primary purpose: TREATMENT

Brief summary: The study " Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I/phase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.

The trial is open to all genders. The inclusion of 5 minors is planned.


Eligibility criteria: Inclusion Criteria:

All genders

* Adults
* Minors
* LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye

Exclusion Criteria:

* Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye
* Pregnancy
* Breast-feeding
* Incapacitated person
* known allergy to aprotinine (Trasylol (R))
* Hypersensibility to bovine proteins

Primary outcomes:
measure: Anatomic assessment
timeFrame: 1 year
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 1 year
measure: Level of pain
timeFrame: 1 year
measure: Quality of life measurements
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Toronto Western Hospital
state: Ontario
city: Montréal
country: Canada
facility: CIUSSS de l'Est de l'île de Montréal
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre; Centre de Médecine Innovatrice/Centre for Innovative Medicine
state: Quebec
city: Québec
country: Canada
facility: Centre universitaire d'Ophtalmologie CHU de Québec - HSS
state: Quebec
Study officials:
affiliation: CHU de Quebec
name: Ralph Kyrillos, MD FRCS (C)
role: PRINCIPAL_INVESTIGATOR
References: