louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02564393: Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis
Official title: Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathophysiological study comparing a " Cystic fibrosis " group to a control group (adults)

Brief summary: The study is defined in 3 stages of in vitro assays :

Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.

This is a transversal study in which we compare :

* Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
* Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects

Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.

Phase 3: Analysis of cell death ( NETose )

This is a transversal study that will analyze :

the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .


Eligibility criteria: Inclusion Criteria:

Patients :

* Men or women over 18
* Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks
* Signed consent

Volunteers :

* Men or women over 18
* Without respiratory antecedent nor known respiratory pathology
* Signed consent

Exclusion Criteria:

Patients :

* In exclusion period of an other study

Volunteers :

* In exclusion period of an other study
* Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study

Primary outcomes:
measure: the DNA concentration secreted into the extracellular environment neutrophil activated
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
References:
Clinical trial NCT04308993: Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease
Official title: Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Stones
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Most patients were elderly (median age, 60 years). The male-to-female ratio was higher than the norm for biliary stones (1:1.4). The most common reasons for failure of conventional endoscopic retrograde cholangiopancreatography (ERCP) were high American Society of Anesthesia (ASA) score (8 patients 53%), technical failure of ERCP (4 patients, 27%), previous Roux-en-Y gastric bypass (two patients, 13%), and post-common bile duct (CBD) injury with T-tube insertion (one patient, 7%). The stone sites were the CBD, gallbladder, and intrahepatic bile duct in nine (60%), three (20%), and three (20%) patients, respectively

Brief summary: Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.

Methods:

Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.

Detailed description: The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.

Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.

Eligibility criteria: Inclusion Criteria:

* complete records

Exclusion Criteria:

* lost follow up

Primary outcomes:
measure: symptoms
timeFrame: at least one year follow up
Secondary outcomes:
measure: ultrasound
timeFrame: one month
Other outcomes:
measure: obstructive jaundice
timeFrame: one day
Locations:
Study officials:
References:
Clinical trial NCT01849393: Evaluating Rewards-Based Adherence and Electronic Medication Monitoring in HIV-Positive Adolescents
Official title: Incentives and Technology Survey 2013: Evaluation of Acceptance of Incentive-Based Adherence Programs and Electronic Medication Monitoring Among HIV-Positive Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus (HIV)
Acquired Immunodeficiency Syndrome (AIDS)
Keywords: Adolescents
Medication Compliance
Rewards-Based Incentive Programs
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-positive adolescents between the ages of 16 and 24 years who are currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic.

Brief summary: The primary objective of this project is to assess the study population's acceptance of two medication adherence support strategies: incentive-based programs and electronic medication monitoring. The study population is adolescents (ages 16 - 24) positive for human immunodeficiency virus (HIV) currently undergoing treatment with antiretrovirals at St. Jude's HIV clinic. Participation in the study will involve completion of a survey: an Audio Computer Assisted Self Interview (ACASI). The duration of the survey is anticipated to be 10-20 minutes. Patient identifiers will not be attached the survey.

Detailed description: Whether or not patients take their medications is one of the most noticeable and important predictors of treatment success or failure for HIV infection. Ways to improve compliance, specifically rewards-based programs and electronic medication monitoring, have shown some success in limited clinical research studies focused on adult subjects. Because the social and developmental factors in adolescents are different from adults, adolescents may not respond to these interventions in the same way as adults. This study will investigate adolescent acceptance and the effectiveness of these programs.

Eligibility criteria: Inclusion Criteria:

* HIV positive
* Ages 16-24 years.
* Participants must understand written or spoken English, because the ACASI used in the study can only be administered in English.

Exclusion Criteria:

* Adolescents with a documented diagnosis of mental retardation or a significant motor or sensory impairment that would preclude participation in the study survey.

Primary outcomes:
measure: Reported perceptions about incentive-based adherence programs and electronic medication monitoring
timeFrame: Once, at enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Mary Westfall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01468493: A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients
Official title: A Prospective Controlled Follow-up of Serum Soluble Urokinase Receptor in the Cyclosporine A-treated Patients With Steroid-dependent and Steroid-resistant Focal Segmental Glomerulosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: FSGS
Keywords: FSGS
suPAR
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1)the patients with steroid-sensitive FSGS;2)the cyclosporine A-treated patients with steroid-dependent and steroid-resistant FSGS;3)the healthy volunteers

Brief summary: The purpose of this study is to determine whether the improved responsiveness to treatment achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be explained by CsA's inhibitory action on the circulating suPAR expression.


Eligibility criteria: Inclusion Criteria:

* Age at entry is between 14 and 70 years
* biopsy-proven primary FSGS
* proteinuria \>=3 g/day
* without corticosteroids or CsA treatment before entry

Exclusion Criteria:

* Chronic Inflammatory Diseases
* malignant tumor
* diabetes mellitus
* contraindications for the treatment of corticosteroids or CsA treatment
* untolerate to or unwilling to accept corticosteroids or CsA treatment

Primary outcomes:
measure: serum suPAR level when proteinuria reduction >=50% or complete remission
timeFrame: 6 months after steriod alone or CsA plus steriod treatment
Secondary outcomes:
measure: serum suPAR level after 6 months of steroid or CsA treatment without remission
timeFrame: 6 months after steroid alone or CsA plus steroid treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nephrology Dept.,Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Nephrology Dept.,Guangdong General Hospital
name: Wei Shi, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01084993: EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
Official title: EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery stenting, transradial, intracoronary
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2010-03-11
Enrollment: 2000
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: RATIONALE:

Transradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.

Major bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.

Peri-procedural anemia is also an independent predictor of mortality and MACE.

With femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.

In a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.

HYPOTHESES:

In patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.

In patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.

Detailed description: OBJECTIVES:

The primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.

Eligibility criteria: Inclusion Criteria:

* At least two of the following additional criteria
* At least 70 yrs old
* Female gender
* Diabetes
* Creatinine clearance \<60mL/min
* History of gastro-intestinal or other organ bleeding
* Baseline anemia
* Current treatment with glycoproteins IIb-IIIa inhibitors

Exclusion Criteria:

* Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months
* Concurrent participation in other investigational study
* Femoral sheath (artery)

Primary outcomes:
measure: Major bleeding and Mace
timeFrame: 24h post-PCI and Discharge
Secondary outcomes:
measure: EFFICACY and SAFETY PARAMETERS
timeFrame: 30 days
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Quebec Heart-Lung Institute
Study officials:
affiliation: Fondation IUCPQ
name: Olivier F Bertrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03138993: Improving Older Adults' Decision Making for OSAT
Official title: Improving Older Adults' Decision Making for Obstructive Sleep Apnea Treatment (Phase 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the feasibility of conducting a randomized controlled trial that tests a patient decision aid for obstructive sleep apnea in older adults with newly-diagnosed obstructive sleep apnea treated in an outpatient sleep clinic. Half of the participants will use a patient decision aid, while the other half will receive general information about sleep.

Detailed description: Patient decision aids are one strategy for helping older adults make informed decisions about treatments. Patient decision aids improve patients' knowledge about therapies and encourage them to actively weigh the risks and benefits of each therapy.

Eligibility criteria: Inclusion Criteria:

1. age \>= 60 years
2. diagnosed with obstructive sleep apnea on a sleep study
3. able to read English-language newspaper text (if needed, using contact lens/glasses)
4. able to write words in a paper booklet
5. scheduled for a sleep clinic appointment with a UCLA sleep provider
6. able to attend a sleep educational session prior to sleep clinic appointment

Exclusion Criteria:

1. unable to provide informed consent
2. dementia
3. mild cognitive impairment diagnosis or Mini-Cog score \< 3
4. treated for obstructive sleep apnea for \> 30 days prior to scheduled sleep education intervention
5. severe physical or mental illness (e.g., hospitalized within past 7 days prior to scheduled sleep education intervention, substance abuse within 90 days of sleep education intervention)

Primary outcomes:
measure: Recruitment rates
timeFrame: Through study completion, an average of 1 year
measure: Enrollment rates
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: The length of time for completing the intervention session
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
References:
citation: Fung CH, Martin JL, Liang LJ, Hays RD, Col N, Patterson ES, Josephson K, Mitchell MN, Sanchez MC, Aysola R, Song Y, Dzierzewski JM, Huang D, Zeidler M, Alessi C. Efficacy of a patient decision aid for improving person-centered decision-making by older adults with obstructive sleep apnea. J Clin Sleep Med. 2021 Feb 1;17(2):121-128. doi: 10.5664/jcsm.8798.
Clinical trial NCT05945771: Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy Young Individuals
Official title: Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Supplementation
Lead sponsor: California Baptist University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine whether grape seed extract (GSE) supplementation could reduce the blood pressure (BP) in response to static exercise and post exercise muscular ischemia (PEMI) in normotensive young adults. In 12 healthy subjects (7 male and 5 female, 24.6±3.4 yr), we compared acute effect of both GSE (600 mg) and placebo (PL: 600 mg) on changes from rest in systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO), and total peripheral resistance (TPR) during static exercise (SE) and PEMI. Subjects completed 2 min of SE at 30% of maximal voluntary contraction (MVC) followed by 2 min of PEMI.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers (SBP \< 120 mmHg, DBP \< 80 mmHg)

Exclusion Criteria:

* cardiovascular and/or pulmonary disease,
* musculoskeletal disorders
* medications that prevent the safe completion of the exercise protocol

Primary outcomes:
measure: Systolic blood pressure (mmHg) by sphygmomanometer
timeFrame: 24 hours
measure: Diastolic blood pressure (mmHg) by sphygmomanometer
timeFrame: 24 hours
measure: Mean arterial pressure (mmHg)
timeFrame: 24 hours
measure: Heart rate (bpm)
timeFrame: 24 hours
measure: Stroke volume (ml)
timeFrame: 24 hours
measure: Cardiac output (l/min)
timeFrame: 24 hours
measure: Total peripheral resistance (mmHg/l/min)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: California Baptist University
state: California
Study officials:
affiliation: California Baptist University
name: Jong-Kyung Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03808571: Cord Blood Nesfatin-1 and Irisin in the Intrauterine Growth Restricted Fetuses
Official title: The Association of Cord Blood Nesfatin-1 and Irisin Level With Fetal Doppler Parameters in Pregnancies Complicated With Intrauterine Growth Restricted Fetuses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nesfatin-1
Irisin
Intrauterine Growth Restriction
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: : The aim of this study is to investigate Cord blood irisin and nesfatin-1 levels in pregnancies with intrauterine growth retardation and to determine whether they are associated with abnormal fetal doppler findings or not.

Detailed description: This study was conducted at Yüzüncü Yıl University Medical Faculty Obstetrics and Gynecology Clinic. The study group included 34 pregnant women ranged from 18 to 45 years old who have intrauterine growth retardation and underwent ceseraen section. 32 pregnant women who had no abnormality on prenatal follow-up and underwent elective ceserean seciton served as control group. The maternal age, height, weight, body mass index (BMI), systolic and diastolic blood pressures were recorded in both groups of patients. Maternal serum total blood count and biochemical parameters were obtained from the laboratory parameters. Gestational week at birth, birth weight, sex, 1st and 5th minute APGAR scores were recorded. Blood samples were collected from all the cases during the cesarean section for measurmenet of nesfatin-1 and irisin by doubly clamped umbilical cord. Blood samples were immediately centrifuged in sterile tubes and maintained at -80 ° C until assessed.

Eligibility criteria: Inclusion Criteria:

* Pregnant women with intrauterine grwoth rectricted fetuses.
* Healthy pregnancies

Exclusion Criteria:

* Pregnant women with chronic medical conditions
* multiple pregnancies
* fetuses with fetal malfomations or genetic syndromes
* pregnant women older than 45 years old

Primary outcomes:
measure: cord blood nesfatn-1 level measurement
timeFrame: 9 months
Secondary outcomes:
measure: Cord blood irisin level measurement
timeFrame: 9 months
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University, Medical faculty, department of obstetric and gynecology
Study officials:
References:
Clinical trial NCT02347371: Heart Transplant Registry of Városmajor
Official title: Follow-up Registry of Heart Transplant Recipients, to Determine Long Term Outcome and Need for Further Interventional and Non-interventional Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder Related to Cardiac Transplantation
Keywords: Heart transplant
Cardiac allograft vasculopathy
Chronic rejection
Immunosuppressant therapy
Lead sponsor: Semmelweis University Heart and Vascular Center
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart transplant recipient, cared for by the Semmelweis University Heart and Vascular Center

Brief summary: The purpose of this registry is to determine the long term outcomes of heart transplantations performed at the Semmelweis University Heart and Vascular Center. All eventual interventional and non-interventional procedures will be accounted for and summarized.


Eligibility criteria: Inclusion Criteria:

* Heart transplant recipient
* \>18 years old
* Signed informed consent
* Cared for at the Semmelweis University Heart and Vascular Center

Exclusion Criteria:

* Denies consent to registry

Primary outcomes:
measure: Outcome of heart transplantation as measured by all-cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Morbidity after heart transplantation
timeFrame: 5 years
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University Heart and Vascular Center
Study officials:
affiliation: Semmelweis University Heart and Vascular Center
name: Béla Merkely, MD PhD DSc
role: PRINCIPAL_INVESTIGATOR
References: