louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00690794: Travatan Z in Ocular Surface Health in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: An Evaluation of the Ocular Surface Health in Subjects Using TRAVATAN Z® Ophthalmic Solution Versus XALATAN® Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-06-05
Enrollment: 726
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 purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* 18 years or older.
* Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
* Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
* Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
* Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
* Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
* Use of contact lenses within 30 days of Visit 1.
* Use of contact lenses during the study.
* Participation in an investigational drug or device study within 30 days of entering this study.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change at Day 90 From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
timeFrame: Baseline, Day 90
Secondary outcomes:
measure: Percentage of Patients With Corneal Fluorescein Staining Score = 0
timeFrame: Day 90
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00728494: Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron/Rebetol and a Patient Assistance Program (Study P04671)
Official title: Evaluation of Compliance of HCV Genotype 1 Infected Patients Receiving PegIntron / Rebetol in Conjunction With a Patient Assistance Program - Non Interventional Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic HCV.

Brief summary: Enrolled patients will be recruited to two parallel groups during therapy for Hepatitis C. Patients in the first one will receive a patient assistance program, and patients in the second group will not. All patients will receive PegIntron and Rebetol according to label.

Detailed description: Non-Probability Sample, Commercial product used according to EU label.

Eligibility criteria: Inclusion Criteria:

* According to PegIntron/Rebetol label.
* Only HCV genotype 1 infected patients will be enrolled in the study.

Exclusion Criteria:

* According to PegIntron/Rebetol label.

Primary outcomes:
measure: The Number of Participants Who Complete Treatment With PegIntron/Rebetol Therapy for Hepatitis C
timeFrame: At the end of the 48-week treatment period
measure: The Number of Participants With a Sustained Virologic Response at 6 Months Post-treatment
timeFrame: Measured at 6 months post-treatment
measure: The Number of Participants Who Relapsed at 6 Months Post-treatment
timeFrame: Measured at end of treatment and 6 months post-treatment
Secondary outcomes:
measure: Average Length of Treatment
timeFrame: Maximum 48-week treatment duration
measure: Average Dosage of PegIntron
timeFrame: Up to 48-week treatment duration
measure: Average Dosage of Rebetol
timeFrame: Up to 48-week treatment duration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00595894: Rheumatoid Arthritis Comorbidity: Bone Health in Men and African Americans
Official title: RA Comorbidity: Bone Health in Men and African Americans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
African Americans
osteopenia
osteoporosis
bone mineral density
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-01-16
Enrollment: 1745
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLEAR enroll African American RA patients from 4 core academic centers in the Southeast U.S. VARA enroll RA patientss from participating VA medical centers.

Brief summary: The objective of the proposed study is to assess bone health and determinants of bone health among select subpopulations of rheumatoid arthritis patients.

Detailed description: The overall hypothesis of this study is that osteopenia and/or osteoporosis are common among African Americans and men with rheumatoid arthritis and there are identifiable genetic and environmental factors contributing to the pathogenesis of bone loss in these groups.

The Specific Aims of the study are to:

1. Determine baseline hip and lumbar spine bone density (BMD) values and osteopenia/osteoporosis prevalence among African American men and women with early RA and among male veterans with established RA.
2. Identify environmental factors and candidate alleles, which confer increased risk of reduced baseline BMD loss over time among African American men and women with early RA and among male veterans with established RA.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of rheumatoid arthritis per ACR guidelines

Exclusion Criteria:

* Patients with diagnosis \> 2yrs (CLEAR study)

Primary outcomes:
measure: Bone mineral density
timeFrame: baseline and at 5 years disease
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Omaha Veteran's Affairs Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Ted R Mikuls, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03585660: Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
Official title: MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 106
Sex: MALE
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 purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).


Eligibility criteria: Inclusion Criteria:

* Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
* Written informed consent.

Exclusion Criteria:

* Patients incapable of giving informed written consent;
* Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
* Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
* Prisoners;
* Minor children (under the age of 18 years old).

Primary outcomes:
measure: Accuracy of HM-MRI
timeFrame: 12 months
measure: Area Under the ROC Curve (AUC) of HM-MRI
timeFrame: 12 months
Secondary outcomes:
measure: Sensitivity of HM-MRI
timeFrame: 12 months
measure: Specificity of HM-MRI
timeFrame: 12 months
measure: Positive Predictive Value (PPV) of HM-MRI
timeFrame: 12 months
measure: Negative Predictive Value (NPV) of HM-MRI
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Aytekin Oto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02517060: Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study
Official title: Neural Mechanisms of Tactile Priming on Social Perceptions - Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Social perceptions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Medical School Berlin
First posted: 2015-08-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adult male and female subjects

Brief summary: The investigators measure brain responses of healthy participants while they perform evaluation tasks inside the fMRI. For each task the participants were primed with tactile stimuli. Results should demonstrate engagement of sensorimotor brain regions after priming, hence confirming embodiment theories.

Detailed description: Brain responses of healthy participants were recorded with functional magnetic resonance imaging (fMRI). While being scanned participants were asked to recommend punishments similar to judges or juries for perpetrators across different scenarios. In addition, participants were primed before reading the scenario by using different materials. Based on recent theories about "embodied cognition" and extralegal factors investigators hypothesize that those primes may influence the harshness of punishments recommended by the participants. If those processes engage sensorimotor cortices, the results would strongly support theories of embodied cognition.

The results would help the investigators to understand the neural correlates of priming processes. These unconscious complex processes of perception may be important for hospital patients. Thus, beneficial haptic experiences during the hospital stay may contribute to successful recovery.

Eligibility criteria: Inclusion Criteria:

* male or female healthy participants
* age 18 - 40 years

Exclusion Criteria:

* cardiac pacemaker
* metallic implants
* ferromagnetic parts in / at the body
* tatoos
* vessel surgery
* tinnitus
* epilepsia
* claustrophobia
* pregnancy

Primary outcomes:
measure: Sensorimotor brain activation
timeFrame: The participantes will be followed up for the duration of fMRI-scan, an exspected average of 1 hour
Secondary outcomes:
measure: Systematic changes for evaluation processes
timeFrame: The participants will be followed up for the duration of fMRI-scan, an exspected average of 1 hour
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Psychiatry und Psychotherapy, CCM, Charité - University Medicine Berlin
city: Berlin
country: Germany
facility: Medical School Berlin
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensvie Care Medicine CVK/CCM, Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02860260: Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke
Official title: Kinetics of Plasma and Serum Levels of Brain-Derived Neurotrophic Factor (BDNF) in Patients With Ischemic Stroke: Effect of Intravenous Fibrinolysis With Rt-PA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: BDNF
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of this study is to show for the first time that treatment with intravenous fibrinolysis using rt-PA in patients with recent ischemic stroke is accompanied by increases in circulating levels of BDNF, which may reflect an increase in BDNF synthesis in the brain.

The analysis of the recovery of functional and cognitive abilities as well as mood at 3 months will allow us to study the impact of BDNF on these parameters. Thus, depending on the results obtained, circulating BDNF could serve as an early marker of these.


Eligibility criteria: Inclusion Criteria:

* Patients (or their person of trust in cases of inability) who have been informed about the research and given their consent to take part
* Patients aged 18 years or older
* Patients who have suffered a de novo recent ischemic stroke \< 12 hours
* Patients who had cerebral imaging (CT-Scan or MRI)
* Ischemic stroke severity, measured by the National Institute of Health Stroke Score (NIHSS), between 4 and 20

Exclusion Criteria:

Patients without national health insurance cover

* Patients with a clinical history of stroke
* Patients with cerebral or sub-arachnoid haemorrhage
* Patients with a transient ischemic attack
* Time of symptom onset unknown
* Patients with severe aphasia at the time of the ischemic stroke defined by a sub-score for item 9 (best language) of the NIHSS ≥ 2
* Patients with dementia prior to the ischemic stroke
* Patients with a significant loss of autonomy prior to the ischemic stroke, defined by a Rankin score ≥ 4
* Patients with aphasia before the ischemic stroke
* Patients with a contra-indication for cerebral MRI
* Pregnant or breast-feeding women
* Adults under guardianship
* Subjects in custody
* Patients who do not speak French

Primary outcomes:
measure: Measurement of plasma levels of BDNF
timeFrame: Change from baseline at Day1, Day 7 and Month 3
measure: Measurement of serum levels of BDNF
timeFrame: Change from baseline at Day1, Day 7 and Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT01014260: Doxycycline Outcomes in Lupus Erythematosus
Official title: Doxycycline Outcomes in Lupus Erythematosus: (DOLE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Cardiovascular Disease
Keywords: Inflammatory markers of cardiovascular disease
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 0
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: Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.


Eligibility criteria: Inclusion Criteria:

1. Patients with a clinical diagnosis of SLE, with a hs-CRP above \> 3mg/L, (high risk level) for the last 3 months, are eligible.
2. Patients must be 18 years of age or older and able to give informed consent.
3. Contraception other than OCPs is necessary if a woman is at risk for pregnancy.

Exclusion Criteria:

1. SLE patients who are allergic to doxycycline or other tetracyclines.
2. Patients who are pregnant or are planning to become pregnant.
3. Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
4. Tetracycline use within the previous 2 weeks of enrollment.
5. Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
6. Patients who are on warfarin.
7. Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.

Primary outcomes:
measure: Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University SOM. 1830 East Monument St, Ste 7500
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michelle Petri, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05093660: Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein in Acute Appendicitis in Pediatric Patients
Official title: Diagnostic Importance of the Circulating Human Leucine-rich α-2-glycoprotein Analysed From Blood and Saliva in Children With Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Appendicitis Acute
Lead sponsor: KBC Split
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from 5 to 17 years of age, presenting with acute abdominal pain consistent with diagnosis of acute appendicitis, to Emergency Surgery Department at the University Hospital Split.

Brief summary: Acute appendicitis is a common and potentially serious medical condition which can be difficult to diagnose, especially in pediatric patients. To help recognize patients with acute appendicitis, number of laboratory and radiological test are used. Previous research has shown that Circulating Human Leucine-rich α-2-glycoprotein (LGR1) in the blood can be elevated in pediatric patients with acute appendicitis. The aim of this research is to analyse whether LGR1 levels in saliva can be used as a less invasive diagnostic method in pediatric patients with suspected acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* children with age from 5 do 17 with acute abdominal pain
* children with clinical signs of appendicitis

Exclusion Criteria:

* previous diagnosis of chronic and/or malignant disease
* children which had previous abdominal surgery
* pregnancy

Primary outcomes:
measure: Level of LGR1 protein in blood
timeFrame: 72 hours
measure: Level of LGR1 protein saliva
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Split
country: Croatia
facility: University Hospital Split
state: Splitsko-dalmatinska
Study officials:
References:
Clinical trial NCT01066260: Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Official title: Efficacy of a Probiotic Formulation on Energy Balance in Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Probiotics
Energy balance
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 80
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Probiotic administration is associated with health benefits on gut barrier integrity and immunological functions of the gastrointestinal tract. Recently, probiotic consumption was proposed to reduce fat mass and body weight in rodents (Lee HY. et al. 2006; Hamad EM. et al. 2009). Changes in energy metabolism might be involved in the effects of probiotics on weight control.

The objective of this study was to assess the efficacy of the consumption of a probiotic formulation on energy balance in overweight subjects.


Eligibility criteria: Inclusion Criteria:

* Body Masss Index (BMI) 25 - 30 kg/m2
* Healthy (determined by medical questionnaire)
* Able to commit to the duration of the study
* Providing consent for participation

Exclusion Criteria:

* History of cardiovascular disease (CVD), diabetes, cancer, renal, thyroid or hepatic disease
* History of gastrointestinal surgery
* History of sleep disorders
* Recent bacterial infection (\< 2 weeks)
* Weight loss \> 5 kg in the last 3 months
* Under antibiotics or treatments (medical or nutritional program) affecting body weight, appetite, energy expenditure lipid-lowering, hypertension or inflammation or glucose control for the last 3 months or taking hormone replacement therapy
* Excessive consumption of products enriched in probiotics (\> 4 servings per week) within the last 4 weeks before the start of the study
* History of drug or alcohol abuse (\> 2 drinks daily)
* Regular smokers (more than 5 cigarettes a day)
* Not eating breakfast regularly or eating breakfast before 6h00.
* Not willing to eat any of the foods to be served in the study for any reason
* Physical activity level \> 150 min of moderate or intense exercise per week
* Concurrent or recent intervention study (within 60 days)

Primary outcomes:
measure: Energy intake
timeFrame: Lunch
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestlé Research Center
state: Vaud
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926560: Study Medication Adherence and Its Determinants in Chronic Disease Through the Example of Methotrexate in Chronic Inflammatory Rheumatism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic Diseases
Keywords: Chronic inflammatory rheumatism
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-10-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) treated by methotrexate in the department of rheumatology in the Nîmes University Hospital

Brief summary: The aim of this study is

1) To describe the level and determinants of methotrexate adherence in patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis) in the department of rheumatology in the Nîmes University Hospital


Eligibility criteria: Inclusion Criteria:

* treated by methotrexate
* patients with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis and psoriatic arthritis)

Exclusion Criteria:

* methotrexate for other diseases

Primary outcomes:
measure: Medication Adherence Measure= Morisky scale
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nîmes
state: Gard
Study officials:
affiliation: CHU Nîmes
name: Cécile Gaujoux-Viala, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: