louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00431405: Cardiovascular Outcomes in the VA's Rheumatoid Arthritis(VARA) Population
Official title: Assessing Risk of Cardiovascular Events in RA Patients Using a Retrospective Cohort From the VARA Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Cardiovascular Disease
Coronary Disease
Keywords: rheumatoid arthritis
cardiovascular disease
coronary disease
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
Collaborators: name: Centocor, Inc.
First posted: 2007-02-05
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Rheumatoid arthritis (RA) is a symmetric, peripheral polyarthritis of uncertain etiology that can lead to joint deformity and destruction. However, the effects of RA are not confined simply to joint involvement. Virtually every organ system can be affected by RA if left untreated. Of particular note is RA's affect on the cardiovascular system. RA patients have a reduced lifespan compared to the general population primarily due to an increased cardiovascular disease burden (1). Recently, RA has been linked to the development of preclinical atherosclerosis in the carotid arteries as measured by ultrasonography (2). Women with RA have also been shown to have an increased incidence of nonfatal myocardial infarctions (3). Despite these studies showing the effects of RA on the cardiovascular disease burden of those who are afflicted, no study to date has compared the number of cardiovascular events in a large RA patient population to a risk factor and age matched control group. Consequently it is the goal of this study to determine whether the cardiovascular event ratio in an RA patient cohort exceeds an age and risk factor matched cohort of non-RA patients. This study will also attempt to ascertain whether specific cardiovascular risk factors contribute to the cardiovascular morbidity and mortality associated with RA and if any standard cardiovascular medicines disproportionately contribute to patient outcome.

Hypothesis: Given the increased cardiovascular disease burden associated with RA patients they are likely to suffer from a statistically significant increased risk of cardiovascular events when compared to an age and risk factor matched cohort.


Eligibility criteria: Inclusion Criteria:

* Patient included in the VA Rheumatoid Arthritis database previously, who by definition will meet criteria for RA.
* Control subjects will not carry the diagnosis of RA.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center-Rheumatology
state: Texas
Study officials:
affiliation: Dallas VA Medical Center
name: Salahuddin Kazi, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolfe F, Mitchell DM, Sibley JT, Fries JF, Bloch DA, Williams CA, Spitz PW, Haga M, Kleinheksel SM, Cathey MA. The mortality of rheumatoid arthritis. Arthritis Rheum. 1994 Apr;37(4):481-94. doi: 10.1002/art.1780370408.
Clinical trial NCT00004305: Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IGA Glomerulonephritis
Keywords: IgA glomerulonephritis
rare disease
renal and genitourinary disorders
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Ohio State University
First posted: 1999-10-19
Enrollment: 105
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N).

II. Compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset IgA-N vs normal controls.

Detailed description: PROTOCOL OUTLINE:

Participants undergo qualitative genetic analysis of complement-related proteins. Studies include: genomic re-arrangement of 4-gene unit, C4 DNA sequence and RNA expression, type-1 complement receptor DNA sequence, Fc-gamma receptor IIIA isoform analysis, classical and alternative complement activation pathway assays, plasma C4 and C4d protein levels, and immunoglobulin patterns in glomerular deposits.

Eligibility criteria: * IgA glomerulonephritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Lee A. Hebert
role: STUDY_CHAIR
References:
Clinical trial NCT02883205: Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist
Official title: Diagnosis of Fabry Disease: Impact of an Educational Brochure Intended for Cardiologist
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathies
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with left ventricular hypertrophy of unknown etiology or of sarcomeric MHC pace, followed in Normandy, has given its consent to the search of Fabry disease

Brief summary: The cardiac Fabry disease are early, frequent and severe, dominated by the frequency of left ventricular hypertrophy. They are responsible for a high morbidity and mortality, reducing life expectancy of 15 to 20 years for men. Fabry disease and heart attacks are still diagnosed late. This delay in diagnosis is due to the non-specificity of clinical, electrocardiographic and echocardiographic disease, but also by a certain ignorance of this pathology in the medical community. The importance of early diagnosis of Fabry disease and heart disease is well established: enzyme replacement therapy is most effective when instituted early, before the onset of irreversible damage such as fibrosis. With the blotter, we now have a simple and robust screening tool for Fabry disease, achievable consultation. Targeted educational interventions to physicians have shown their effectiveness in improving the screening and diagnosis of rare diseases. We offer a prospective observational type before / after study, which aims to assess the value of an educational brochure for cardiologists to improve the screening and diagnosis of Fabry disease in Normandy.


Eligibility criteria: Inclusion Criteria:

* Patient with left ventricular hypertrophy of unknown etiology or of sarcomeric MHC pace, followed in Normandy, has given its consent to the search of Fabry disease

Criteria Exclusion:

* Patients under 18 years patient refusal to participate in the study. Lack of consent to the search of Fabry disease

Primary outcomes:
measure: Number of new cases of Fabry disease diagnosed a year after distribution of educational brochure cardiologists
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Fabien
Study officials:
affiliation: Caen HU
name: Fabien Labombarda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00882505: Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Official title: Comparison of 25-hydroxy Vitamin D Level in Caucasian Women Receiving Vitamin D Supplementation and Not Receiving Supplementation: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess whether vitamin D supplements are sufficient to increase females who are deficient or borderline deficient in vitamin D levels to normal levels.


Eligibility criteria: Inclusion Criteria:

* Premenopausal Caucasian women, ages 18-47
* Subjects in good health
* Tanning bed group: regular tanning bed user at least once a week for previous 10 weeks

Exclusion Criteria:

* Pregnancy and lactation
* Subjects with liver disease, renal disease, multiple myeloma, parathyroid disease, irritable bowel disease, celiac disease, cystic fibrosis and pancreatic disease
* Subjects with hypocholesterolemia and primary hyperparathyroidism
* Subjects taking the following medications:

  * Steroids
  * Orlistat
  * Lipid lowering medication: cholestyramine, statins
  * Antiepileptic drugs: phenobarbital and phenytoin
  * Currently on vitamin D supplements or using any medication contain vitamin D i.e. cod liver oil, topical calcipotriol or history of use within 1 month
  * Rifampicin, isoniazid
  * Ketoconazole
* Subjects currently on UV therapy

Primary outcomes:
measure: For the randomized controlled trial, the primary outcome measure is comparison of the change in vitamin D levels in the vitamin D supplementation group and the placebo group.
timeFrame: 3 months
measure: For the comparative study, the primary outcome measure is comparison of the vitamin D level for tanning bed users compared to the level for non-tanning bed users.
timeFrame: 3 months
Secondary outcomes:
measure: The secondary outcome measures include evaluation of changes in other laboratory parameters associated with change in vitamin D level.
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01916005: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Official title: Diagnostic Value of 18F-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in Prosthetic Valve Endocarditis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthetic Valve Endocarditis (PVE)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of prosthetic valve endocarditis (PVE) remains challenging. In PVE cases, initial echocardiography is normal or inconclusive in almost 30% of cases, leading to a decreased diagnostic accuracy for the modified Duke criteria.

Aims: The investigators sought to determine the value of 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG PET/CT) for diagnosing PVE.

Methods: In two referral French centers (Timone Hospial, Marseille and Georges Pompidou European Hospital, Paris), the investigators plan to include consecutive patients suspected of having PVE. All of the patients will be subjected to clinical, microbiological, and echocardiographic evaluation. Cardiac PET/CT will be performed at admission and the data analysis will be based on visual interpretation and quantitative measurement of FDG uptake (SUVmax). The final diagnosis will be defined according to the clinical and/or pathological modified Duke criteria determined during a 3-month follow-up (gold standard).


Eligibility criteria: Inclusion Criteria:

* unexplained persistent or recurrent fever \>38°C;
* and/or unexplained increased serum C-reactive protein (CRP) level \>10 mg/L; and/or positive blood cultures, independent of the echocardiographic analysis results;
* and/or positive serological testing for Coxiella burnetii, Bartonella spp., Mycoplasma pneumoniae, Legionella pneumophila, Aspergillus spp., or Tropheryma whipplei;
* and/or a mass or a new partial prosthetic valve dehiscence observed using echocardiography.

Exclusion Criteria:

* pregnancy,
* an inability to lie flat,
* a need for urgent cardiac surgery,
* hemodynamic instability,
* cardiac surgery \<1 month ago,
* and a blood glucose level \>1.8 g/L. Patients with a poor PET/CT image quality

Primary outcomes:
measure: the diagnosis of prosthetic valve infective endocarditis
timeFrame: 39months
Secondary outcomes:
measure: the reproducibility of the technique,
timeFrame: 39 months
measure: the comparison of the sensitivity of PET/CT with that of echocardiography,
timeFrame: 39 MONTHS
measure: the rate of detection of embolic events,
timeFrame: 39 MONTHS
measure: the prognostic value of the technique (death/valve surgery)
timeFrame: 39 MONTHS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT02456805: Alternate Formula Feedings in Formula Intolerant Infants
Official title: Efficacy of Alternate Formula Feedings in Formula Intolerant Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2015-05-29
Enrollment: 113
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.


Eligibility criteria: Inclusion Criteria:

* Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
* Infants whose physicians had made a recommendation that the parents change the infant's feeding.
* Full term infants at birth with a gestational age of 37 to 42 weeks.
* Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.

Exclusion Criteria:

* Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
* Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.

Primary outcomes:
measure: Stool Characteristics
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
Secondary outcomes:
measure: Formula Intake
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
measure: Incidence of spit up/vomiting
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
measure: Weight
timeFrame: Change from Baseline (Study Day 1) to Study Day 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Alaska
city: Aurora
country: United States
facility: Aurora Pediatric Associates
state: Colorado
city: Stone Mountain
country: United States
facility: Northlake Pediatric, Associates
state: Georgia
city: Dubuque
country: United States
facility: The Medical Associates Clinic
state: Iowa
city: Springfield
country: United States
facility: Baystate Medical Center, Children's Hospital
state: Massachusetts
city: Canton
country: United States
facility: Clinical Studies, Inc
state: Ohio
city: Richmond
country: United States
facility: Richmond Pediatrics
state: Virginia
city: Oshawa
country: Canada
facility: Optimum Clinical Research
Study officials:
affiliation: Abbott Nutrition
name: John Lasekan, MBA, Ph.D, CCRP
role: STUDY_CHAIR
References:
Clinical trial NCT00759005: Effect of Stress on Heroin-Related Memory Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heroin Dependence
Learning and Memory
Lead sponsor: National Institute on Drug Dependence, China
Sponsor class: OTHER
First posted: 2008-09-25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine whether cortisol and propranolol are effective in the modulation of stress induced heroin-related retrieval enhancement.


Eligibility criteria: Inclusion Criteria:

* Participants had to have met DSM-IV criteria for heroin dependence prior to abstinence.

Exclusion Criteria:

* current use of any medications; current DSM-IV diagnosis of any affective, anxiety, or psychotic disorder; current dependence on any substance besides heroin and nicotine (based on DSM-IV criteria); or risk factors for untoward side effects from propranolol and cortisol (i.e., irregular heartbeats, history of cardiogenic shock, history of severe heart failure, asthma, fungal Infections, hyperlipidemia, history of hypertension, or abnormal ECG or other laboratory findings).

Primary outcomes:
measure: Glucocorticoids enhanced heroin-related memory retrieval in abstained heroin addicts
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Institute on Drug Dependence
state: Beijing
Study officials:
References:
Clinical trial NCT06772298: Study of Oxidized Albumin in Liver Transplant Patients
Official title: Study of Oxidized Albumin in Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Failure
Liver Cirrhosis
Liver Transplant Disorder
Keywords: Oxidised albumin
Complement
Coagulation
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2025-01-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient that are accepted for liver transplantation and put on the waiting list will be included

Brief summary: The overall goal is to describe the oxidation state of albumin before, during and after liver transplantation. This is a pilot observational study in which the oxidative state in 10 patients undergoing liver transplantation will be described. Samples for analysing the oxidation state of albumin, general oxidative damage and anti-oxidant state, the activation of the complement system and factors involved in coagulation will be obtained before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.


Eligibility criteria: Inclusion Criteria:

* Patients on waiting list for liver transplantation

Exclusion Criteria:

* none

Primary outcomes:
measure: Albumin quality
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Secondary outcomes:
measure: Effect of clinical factors on albumin quality before transplantation
timeFrame: Before transplantation.
measure: Effect of clinical factors on albumin quality after transplantation
timeFrame: On postop days 1, 2 and about 30.
measure: Graft outcome in relation to albumin quality
timeFrame: At days 1, 2 and about 30 days after transplantation
measure: Oxidative stress in relation to albumin quality
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
measure: Anti-oxidant capacity in relation to albumin quality
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
measure: Binding capacity
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
measure: Complement system
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
measure: Complement system
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
measure: Coagulation
timeFrame: Before transplantation, before and after reperfusion of the portal vein and on postop days 1, 2 and about 30.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02518698: Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
Official title: Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Castrated resistant prostate cancer
Patients with bone metastases
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 1163
Sex: MALE
Minimum age (years): 55
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Castrated resistant prostate cancer patients with bone metastases

Brief summary: The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.


Eligibility criteria: Inclusion Criteria:

* First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
* Members age ≥ 55 to 89 years at index
* Medicare members with medical and pharmacy coverage; and
* Continuously enrolled during the pre- and post-index periods.

Exclusion Criteria:

* Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
* Members age ≥ 89 years of age at index date

Primary outcomes:
measure: Overall survival of mCRPC patients
timeFrame: Up to 24 months
measure: Number of skeletal related events (SREs) of the mCRPC patients
timeFrame: Up to 30 months
measure: Type of skeletal related events (SREs) of the mCRPC patients
timeFrame: Up to 30 months
measure: Number of patients with mCRPC with bone metastases
timeFrame: Up to 24 months
measure: Type of treatments associated with mCRPC
timeFrame: Up to 24 months
measure: Duration for each treatment identified
timeFrame: Up to 30 months
measure: Distribution of providers by treatment
timeFrame: Up to 30 months
measure: Clinical and demographic characteristics of the mCRPC patients
timeFrame: Up to 12 months
measure: Treatment patterns of mCRPC patients with bone metastases
timeFrame: Up to 30 months
measure: Progression of the disease of mCRPC patients
timeFrame: Up to 12 months
Secondary outcomes:
measure: All-cause healthcare resource utilization for mCRPC patients
timeFrame: Up to 30 months
measure: mCRPC-specific healthcare resource utilization for mCRPC patients
timeFrame: Up to 30 months
measure: All-cause healthcare costs for mCRPC patients
timeFrame: Up to 30 months
measure: mCRPC-specific healthcare costs for mCRPC patients
timeFrame: Up to 30 months
Other outcomes:
Locations:
city: Louisville
country: United States
state: Kentucky
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: