louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04185285: Percutaneous Coronary Intervention Registry FRIBOURG
Official title: Percutaneous Coronary Intervention Registry FRIBOURG
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Keywords: PCI
Lead sponsor: University of Freiburg
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 17
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All comers

Brief summary: The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital \& university Fribourg.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients treated by percutaneous coronary intervention at our institution
* Able to give informed consent and willing to participate

Exclusion Criteria:

* Unwillingness to participate
* Enable to provide inform consent

Primary outcomes:
measure: Patient-oriented composite endpoints (POCE)
timeFrame: 2 years
measure: Major Bleeding
timeFrame: 2 years
measure: Patient-oriented composite endpoints (POCE)
timeFrame: 5 years
measure: Major Bleeding
timeFrame: 5 years
measure: Patient-oriented composite endpoints (POCE)
timeFrame: 10 years
measure: Major Bleeding
timeFrame: 10 years
Secondary outcomes:
measure: all-cause death
timeFrame: 2 years
measure: any revascularization
timeFrame: 2 years
measure: any myocardial infarction
timeFrame: 2 years
Other outcomes:
Locations:
city: Fribourg
country: Switzerland
facility: Cardiology, university Fribourg Medical Center
Study officials:
References:
Clinical trial NCT00091585: Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors.
Official title: Phase I Open-Label, Multicenter, Dose-Escalation Clinical Study of the Initial Safety and Pharmacokinetic Profiles of Intravenous Administration of SNS-595 in Patients With Advanced Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Sunesis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2004-09-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether SNS-595 given intravenously once every 3 weeks is safe.

Detailed description: Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.

Eligibility criteria: Inclusion Criteria:

* Must give written informed consent
* 18 years of age
* Advanced solid malignant tumors
* Tumor can be measured and evaluated
* Blood tests are within standard limits
* Normal blood coagulation
* ECOG Performance Status equal to 0 or 1

Exclusion Criteria:

* Pregnant or breastfeeding.
* Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
* Requires kidney dialysis (hemodialysis or peritoneal).
* Known bleeding disorder (ie, hemophilia, von Willebrand Disease, coagulopathy, etc.).
* Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
* Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
* Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
* Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Sunesis Pharmaceuticals
name: Daniel C. Adelman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04775056: A Study to Evaluate Vaccines Against COVID-19 in the Real World
Official title: A Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of Vaccines Against COVID-19 in the Real World
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Liver Disease
Hepatic Carcinoma
Lead sponsor: Humanity & Health Medical Group Limited
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects who received COVID-19 vaccines under real-life practice conditions in the World

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have afflicted tens of millions of people in a worldwide pandemic. Considering its high mortality and rapid spread, an effective vaccine is urgently needed to control this pandemic. Recently, mass vaccination campaigns using newly approved vaccines, ranging from conventional viral and protein-based vaccines to those that are more cutting edge, including DNA- and mRNA-based vaccines are beginning in many parts of the world. Randomized clinical trials of different vaccines reported efficacies for preventing COVID-19 in the range of 50% to 95%.

Although these randomized clinical trials are considered the "gold standard" for evaluating intervention effects, they have notable limitations of sample size and subgroup analysis, restrictive inclusion criteria, and a highly controlled setting that may not be replicated in a mass vaccine rollout.

The aim of this study is to evaluate the safety, tolerability, immunogenicity, and efficacy of different vaccines against COVID-19 under real-world practice conditions.


Eligibility criteria: Inclusion Criteria:

* Subjects received COVID-19 vaccines;
* Able to comprehend and provide written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

* Not received any COVID-19 vaccines;
* Not willing to participate and/or give their written informed consent.

Primary outcomes:
measure: Immunogenicity index-seroconversion rates of neutralizing antibody
timeFrame: The 4 weeks after the second dose vaccination
Secondary outcomes:
measure: Safety index-incidence of adverse reactions
timeFrame: Day 0-28 after each dose vaccination
measure: Immunogenicity index-seropositive rates of neutralizing antibody
timeFrame: The 4, 12, 24, and 48 weeks after the second dose vaccination
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity & Health Medical Group
Study officials:
affiliation: Humanity & Health Medical Group
name: George Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01099956: Low Grade Inflammation in Type 1 Diabetes Children
Official title: Low Grade Inflammation in Type 1 Diabetes Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Inflammation
Keywords: type 1 diabetes
children
low grade inflammation
cytokine
CRP
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 children in type 1 diabetes group and 30 children in control group

Brief summary: The study propose to measure the inflammation level in type 1 diabetes children with the cytokine analysis compared to non diabetic children of the same sibling and to healthy children.

Detailed description: The increase of type 1 diabetes incidence, particularly in young children leads to conduce new diagnostic and therapeutic strategies, notably for associated chronic morbidity.Measurement of chronic inflammation, with modification of the balance between pro-inflammatory cytokines and anti-inflammatory cytokines, could lead to detect patients with high risk to diabetes chronic morbidity.

After parental consent, blood sampling will be carried out by micromethod for cytokine (500 µl) and CRPhs dosages and glycemia (100 µl) and glycated hemoglobin (1 µl). Urine will be collected (50 ml) in the morning for further researches.

Eligibility criteria: Inclusion Criteria:

Type 1 diabetes children group :

* Children aged 2 to 17 years
* Type 1 diabetes children

Controlled group :

* Children aged 2 to 17 years
* Brother or sister of type 1 diabetes children

Exclusion Criteria:

* Per os or inhaled corticoid in the previous month of inclusion
* Acute infectious disease in the previous week of inclusion
* Other chronic disease than diabetes type1

Primary outcomes:
measure: Increase of Interleukine 6 in group DTI versus control group
timeFrame: Once at inclusion
Secondary outcomes:
measure: Increase of others cytokines (IL1-beta, l'IL-4, l'IL-10 and TNF alpha) and increase of High sensitivity CRP in group DTI versus control group
timeFrame: Once at inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Children Hospital, Endocrinology Unit
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Pascal BARAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750956: Endocan, VEGF and TNF-alpha Levels in Periodontal Disease and After Treatment
Official title: Effect of Non-surgical Periodontal Treatment on Gingival Crevicular Fluid and Serum Endocan, Vascular Endothelial Growth Factor-A and Tumor Necrosis Factor Alpha Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease
Keywords: endocan protein
VEGF A
TNF-alpha
after treatment
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Total of 40 individuals

Brief summary: The primer aim of the study was to determine serum and gingival crevicular fluid (GCF) endocan levels in periodontal diseases pathogenesis supported with vascular endothelial growth factor (VEGF) and tumor necrosis factor alpha (TNF-α) levels.

Detailed description: The study consist of three groups: periodontally healthy individuals (group 1; n = 20), individuals with generalized chronic periodontitis (group 2; n = 20), the same patients with chronic periodontitis after they had been treated with scaling and root planing (SRP) were considered as Group 3. Clinical measurements were recorded; GCF and serum samples were obtained from each participant before and 6 weeks after therapy. Endocan, VEGF-A and TNF-α levels were measured by enzyme-linked immunosorbent assay.

Eligibility criteria: Group 1 Inclusion Criteria:

* No bone and attachment loss,
* GI=0, PPD≤3mm, CAL≤3mm
* Systematically healthy patients

Group 2 Inclusion Criteria:

* GI\>1, PPD≥5mm, CAL≥5mm with alveolar bone loss radiographically.
* Systematically healthy patients

Exclusion Criteria:

* Aggressive Periodontitis,
* Oral pathologies,
* Patients with any other systemic diseases,
* Pregnant women and those in the lactation period,
* Patients with smoking habit and taking medication
* Patients received periodontal therapy in last 6 months

Primary outcomes:
measure: Endocan levels
timeFrame: 6 weeks
Secondary outcomes:
measure: VEGF levels
timeFrame: 6 weeks
measure: TNF-alpha levels
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: BULENT ECEVIT UNIVERSITY FACULTY OF DENTISTRY DEPARTMENT OF PERIODONTOLOGY
name: ÇİĞDEM COŞKUN TÜRER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569256: Ovarian Hyperstimulation Syndrome and Cabergoline
Official title: The Effect Of Cabergoline On Follicular Microenvironment Profile In Patients With High Risk Of Ohss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome
Ovarian Hyperstimulation Syndrome
Lead sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Cabergoline prevents ovarian hyperstimulation syndrome in high risk patients by disrupting follicular fluid hormone microenvironmentally altering the follicular fluid levels of insulin like growth hormone -I (IGF-I), antimullerian hormone (AMH), inhibin B and hepatocyte growth factor (HGF) levels in women with PCOS and high risk of ovarian hyperstimulation syndrome (OHSS).

Detailed description: Dopamine agonists have been proposed as a prophylactic treatment for OHSS in women with high risk of OHSS, however the possible mechanism of action has not been clearly known. In experimental studies, inhibition of vascular endothelial growth factor based pathway was proposed as a possible action of mechanism of dopamine agonists. However the role hepatocyte growth factor (HGF), insulin like growth factor-I (IGF-I), inhibin B and antimullerian hormone (AMH) on cabergoline action in OHSS prevention has not been known.

Eligibility criteria: Inclusion Criteria:

* Development of more than 14 leading follicles larger than 10 mm and serum estradiol more than 3000 pg/ml at the end of ovulation induction with long luteal ovulation induction protocol.
* Having the criteria of PCOS

Exclusion Criteria:

* Not having the inclusion criteria.

Primary outcomes:
measure: Concentrations of follicular fluid AMH
timeFrame: 1 year
Secondary outcomes:
measure: Concentrations of follicular fluid inhibin B
timeFrame: 1 year
measure: Concentrations of follicular fluid HGF
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Rize University, Faculty of Medicine
name: Emine Seda Guvendag Guven, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05295056: Clinical Performance of the AFGen1 Device Over a 7-day Period
Official title: Clinical Performance of the AFGen1 Device Over a 7-day Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Afib
Irregular Heart Beat
Arrhythmias, Cardiac
Arrhythmia Atrial
Arrhythmias Paroxysmal
Paroxysmal Atrial Fibrillation
Lead sponsor: TriVirum, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-24
Enrollment: 38
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study shall involve approximately 30-50 participants (approximately equal number of males and females, equal number with BMI \< and \> 35) meeting inclusion and exclusion criteria.

Brief summary: AFGen1 is indicated for use on symptomatic or asymptomatic adults who are at risk of developing or who have atrial fibrillation, where a software assisted analysis of ambulatory ECG is needed to identify episodes of Afib. The purpose of this study is to establish the clinical performance of the AFib-Chek device (a.k.a. Device) on human participants.

Detailed description: The primary purpose of this study is to demonstrate that the ECD signal acquired by the AFGen1 device is as of adequate quality and is suitable to support its intended use for the detection of AFib.

Eligibility criteria: Inclusion Criteria:

1. 18+ willing to sign the consent form

Exclusion Criteria:

1. Implanted pacemakers
2. Implanted cardioverter defibrillators
3. Implanted cardiac resynchronization devices
4. Potential life-threatening arrythmias
5. Physical or mental health conditions that would prevent the person from being able to follow instruc-tions regarding participation in the study
6. Open wounds, abraded or irritated skin at the application site
7. Planned to undergo a MRI during the course of the study duration

Primary outcomes:
measure: Quantitative Evaluation
timeFrame: 7 days
measure: Qualitative Equivalence Evaluation
timeFrame: 7 days
measure: Adhesive performance
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Clayton Sleep Institute
state: Missouri
Study officials:
References:
Clinical trial NCT01267656: Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
Official title: Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: rewetting
lubricating
eye drops
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-12-28
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.


Eligibility criteria: Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Use a lens care system on a regular basis.
* Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
* Willing to use drops 4 times per day.

Exclusion Criteria:

* Participating in a conflicting study.
* An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any grade 2 or greater finding during the slit lamp examination
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Aphakic.
* Amblyopic.
* Allergic to any component in the study care products.
* Have had any corneal surgery.

Primary outcomes:
measure: Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
timeFrame: At 1 week follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Stephanie Su, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01086956: Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
Official title: Effect of Adding Sufentanil to Epidural Ropivacaine on Perioperative Metabolic and Stress Responses in Combined General/Epidural Anaesthesia for Geriatric Radical Retropubic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Cancer
Keywords: patients of prostatic cancer aged more than 65 years
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare metabolic and stress responses in combined general/epidural anesthesia in geriatric cancer patients.


Eligibility criteria: Inclusion Criteria:

* elective RRP for prostatic cancer scheduled in the morning (9-11 a.m.)
* patients aged more than 65 years
* ASA physical status I or II
* absence of contraindications to epidural approach
* absence of a history of chronic pain or opioid medication

Exclusion Criteria:

* contraindication to epidural catheterization

Primary outcomes:
measure: plasma glucose, insulin, cortisol, epinephrine, norepinephrine, prolactin
timeFrame: from preoperative baseline to postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Hong JY, Yang SC, Yi J, Kil HK. Epidural ropivacaine and sufentanil and the perioperative stress response after a radical retropubic prostatectomy. Acta Anaesthesiol Scand. 2011 Mar;55(3):282-9. doi: 10.1111/j.1399-6576.2010.02360.x. Epub 2010 Nov 25.
Clinical trial NCT00899756: Epidermal Growth Factor Receptor Mutations in the Blood of Patients With Advanced Non-Small Cell Lung Cancer
Official title: Study of Mutations of Epidermal Growth Factor Receptor in the Blood of Patients With Advanced Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
First posted: 2009-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient diagnosed with NSCLC with archiaved tissue availble.

Brief summary: RATIONALE: Collecting and storing samples of blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at epidermal growth factor receptor mutations in the blood of patients with advanced non-small cell lung cancer.

Detailed description: OBJECTIVES:

* Determine if epidermal growth factor receptor (EGFR) mutation exists in the peripheral blood of patients with advanced non-small cell lung cancer (NSCLC).
* Estimate the frequency of EGFR mutation in these patients.
* Correlate the presence of EGFR mutation in blood with EGFR mutation in primary or metastatic NSCLC tumor block.

OUTLINE: Patients undergo blood collection for analysis of epidermal growth factor receptor mutation by DNA sequencing.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced non-small cell lung cancer
* Must have available tumor tissue block

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Existence of epidermal growth factor receptor (EGFR) mutations in peripheral blood
timeFrame: Day 1
measure: Frequency of EGFR mutation
timeFrame: Day 1
measure: Number of participants with EGFR mutation in peripheral blood and in tumor tissue.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Alex Chang
Study officials:
affiliation: Johns Hopkins Singapore International Medical Centre
name: Alex Y. Chang, MD
role: STUDY_CHAIR
References: