louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00184990: Effect of Selective iNOS Inhibition During Human Endotoxemia
Official title: Effect of Selective iNOS Inhibition During Human Endotoxemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endotoxemia
Keywords: Endotoxemia
Aminoguanidine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Sepsis or endotoxemia is manifested by hypotension, resistance to vasopressors, myocardial depression,and altered organ blood flow distribution. The mechanisms underlying the cardiovascular dysfunction during sepsis are complex; however, they are partially mediated by an uncontrolled production of NO by inducible NO synthase (iNOS).Control subjects received 2 ng/kg E. coli endotoxin, whereas the active intervention group received endotoxin in the presence of selective iNOS-inhibitor aminoguanidine. Hemodynamics, vascular responses to norepinephrine, acetylcholine and sodium nitroprusside, as well as circulating cytokines and other mediators of inflammation were measured. We tested the hypothesis that inhibition of NO-synthesis prevented the LPS-mediated insensitivity to noradrenalin and endothelial-dependent vasorelaxation. Furthermore, we tested whether NO participates in occurrence of the endotoxin tolerance in humans by using the iNOS inhibitor aminoguanidine on healthy volunteers with endotoxemia. At 0; 2 and 4 hours after the LPS challenge whole blood was stimulated with five TLR agonists in vitro and pro- and anti-inflammatory cytokines were measured.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* tendency towards fainting
* alcohol abuse
* nicotine abuse
* drugs abuse

Primary outcomes:
measure: Hemodynamics
timeFrame: 24 hrs after LPS administration
measure: Markers of Inflammation
timeFrame: 24 hrs after LPS administration
measure: Cytokines
timeFrame: 24 hrs after LPS administration
measure: Markers of Renal Injury
timeFrame: 24 hrs after LPS administration
measure: Inducible NO synthase expression
timeFrame: 24 hrs after LPS administration
measure: NO-metabolites
timeFrame: 24 hrs after LPS administration
measure: Mediators of Vascular reactivity
timeFrame: 24 hrs after LPS administration
measure: Sensitivity to norepinephrine
timeFrame: 24 hrs after LPS administration
measure: Endothelial-dependent vasorelaxation
timeFrame: 24 hrs after LPS administration
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Peter Pickkers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05618990: OPTIMIZATION of ADVANCED MR SEQUENCES
Official title: OPTIMIZATION of AVANCED MR SEQUENCES for BRAIN STUDIES in VOLUNTEERS (HEALTHY and PATIENTS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurosciences
MRI
Brain Tumor
Mental Disorders
Stroke
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers or patients with brain lesions

Brief summary: This monocentric methodological study aims at optimizing advanced MR sequences for image quality (reduced artefacts, signal to noise ratio, acquisition time, stability of quantitative measurements) on a new MR unit dedicated to research in clinical and cognitive neuroscience.

Detailed description: Primary goal : Optimization of MR protocols and validation of acquisition parameters of advanced MR sequences on healthy volunteers or patients on a new 3T MR unit dedicated to research in neurosciences.

Secondary goals

1. Perform acquisitions to validate the feasibility of research MR protocols (pilot subjects)
2. reproducibility studies

Eligibility criteria: Inclusion Criteria:

* 18 ans
* Covered by social security
* For women in age of procreation, under efficient contraception
* Written consent

Exclusion Criteria:

* Any MR contraindication
* Claustrophobia
* Pregnancy
* Under judiciary protection

Primary outcomes:
measure: MR sequences optimization
timeFrame: 72 months
Secondary outcomes:
measure: Reproducibility studies
timeFrame: 72 months
measure: Pilot studies
timeFrame: 72 months
Other outcomes:
Locations:
city: Paris
country: France
facility: OPPENHEIM Catherine
Study officials:
References:
Clinical trial NCT02760290: Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
Official title: Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique: Double Blind Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Fever
Ileus
Hemorrhage
Pain
Keywords: Forced Expiratory Volume in 1 second
Forced expiratory vital capacity
Peak expiratory flow
Lead sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cesarean section will performed via intraperitoneally and extraperitoneally. During postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel movement, discharged time will be compared.

Detailed description: Investigators will compared results intra and extraperitoneal cesarean section. Two groups will determine according to random numbers table. After operations, blood count, C reactive proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization time will compare by blind physician. Abdominal, shoulder and incisional pain at postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal results and complications also will compare. Investigators and participants will be blind regarding technique.

Eligibility criteria: Inclusion Criteria:

* Cesarean section for any reasons

Exclusion Criteria:

* Involuntary

Primary outcomes:
measure: Pain Scores as measured by the Visual Analog Scale
timeFrame: 2 days
Secondary outcomes:
measure: Blood count
timeFrame: 2 days
measure: C reactive proteins level
timeFrame: 2 days
measure: Complications
timeFrame: 2 days
measure: Discharge time
timeFrame: 4 days
measure: Forced expiratory volume in 1 second
timeFrame: 2 days
measure: Forced vital capacity
timeFrame: 2 days
measure: Peak expiratory flow
timeFrame: 2 days
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study officials:
affiliation: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
name: Mehmet Baki Şentürk, MD
role: STUDY_DIRECTOR
References:
citation: Tappauf C, Schest E, Reif P, Lang U, Tamussino K, Schoell W. Extraperitoneal versus transperitoneal cesarean section: a prospective randomized comparison of surgical morbidity. Am J Obstet Gynecol. 2013 Oct;209(4):338.e1-8. doi: 10.1016/j.ajog.2013.05.057. Epub 2013 May 30.
citation: Chou CY, Liang PC, Chen CA, Lee CN. Cervical abscess with vaginal fistula after extraperitoneal Cesarean section. J Formos Med Assoc. 2007 Dec;106(12):1048-51. doi: 10.1016/S0929-6646(08)60082-0.
Clinical trial NCT01729390: Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
Official title: Varying the Energy Density and Portion Size of the Main Course After a First-course Salad
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Feeding behavior
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-11-20
Enrollment: 53
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this research is to determine whether varying the energy density and portion size of the main course will affect meal energy intake after consumption of a first course that has previously been shown to enhance satiety. It is hypothesized that increasing either the energy density or portion size of the main course will increase meal energy intake after consumption of the first course. It is also hypothesized that compared to when a first course is consumed, not consuming a first course will increase meal energy intake.


Eligibility criteria: Inclusion Criteria:

* Adults from Penn State and the surrounding community

Exclusion Criteria:

* Currently dieting
* Food allergies

Primary outcomes:
measure: Energy intake
timeFrame: 6 weeks
Secondary outcomes:
measure: Food intake
timeFrame: 6 weeks
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University, Laboratory for the Study of Human Ingestive Behavior
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Barbara J Rolls
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00478790: Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
Official title: Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glaucomas
Pterygium
Keywords: Glaucoma
Pterygium
collagen matrix
OculusGen
trabeculectomy
Anti scarring
pterygium recurrence
tissue engineering
ologen
Aeon Astron
Lead sponsor: Pro Top & Mediking Company Limited
Sponsor class: INDUSTRY
First posted: 2007-05-25
Enrollment: 60
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 the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.

Detailed description: ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).

Eligibility criteria: Inclusion Criteria:

* Age 18 years or over
* Patient able to cooperate with study procedures and able to perform tests reliably
* Patient willing to sign informed consent
* Patient able and willing to complete postoperative follow-up requirements
* Glaucoma：one/both eyes are affected by glaucoma
* Pterygium： patient with pterygium

Exclusion Criteria:

* Known allergic reactions to collagen

Primary outcomes:
measure: the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
timeFrame: 180 day
Secondary outcomes:
measure: the safety via the incidence of complications and adverse events.
timeFrame: 180 day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Qiang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
Clinical trial NCT02859090: Study of the Expression of Heat Shock Proteins in Populations of B Lymphocytes in Human Tonsils
Official title: Single-centre Study of the Expression of Heat Shock Proteins in the Lymphocytes From the Tonsils of Patients With Various Diseases Requiring Tonsillectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillectomy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: It has recently been shown that various HSPs are strongly expressed in B lymphomas. Indeed, HSP90 stabilizes the protein Bcl-6 in diffuse large-cell B lymphomas. Pharmacological inhibition of HSP90 in vitro induced apoptosis in lymphoma cells (Cerchietti et al. Nat. Medicine, 2009, 1369-1376). In addition, HSP110 is strongly expressed in non-Hodgkin lymphomas, and targeting this HSP at the cell surface using specific antibodies could constitute a future therapy (Zappasodi et al. Blood, 2011, 4421-4430). Despite the importance of these proteins in the development of lymphomas, their expression and their role in the activation of normal B lymphocytes and the normal development of germinal centres is not known.

The expression of Heat shock proteins should vary among the different B lymphocyte populations present in the tonsils (naïve B cells, memory B cells, germinal centre B cells).

The aim of this study is to establish an expression profile for heat shock proteins in populations of B lymphocytes in human tonsils


Eligibility criteria: Inclusion Criteria:

* Persons who have provided oral consent
* Tonsillectomy in children or adults

Exclusion Criteria:

* Persons without national health insurance cover
* Adults under guardianship
* Pregnant or breast-feeding women
* Persons with positive HIV or HCV serology

Primary outcomes:
measure: expression of heat shock proteins
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT06011590: QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis
Official title: QRS Microfragmentation in ECG as Predictor of Mortality and Morbidity - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Stratification
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 150000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who presented to the Department of Internal Medicine at the Medical University in Innsbruck between 01.01.2000 and 31.07.2022 and received an ECG recording as part of routine clinical practice.

Brief summary: Over the past decades, several ECG-based parameters have been identified as independent predictors of worsened prognosis in affected patients. In addition to visual assessment of morphology, methods of computer-based machine ECG analysis have gained importance in recent years. These methods allow the detection of systemic abnormalities in ECGs that are not visible to the naked eye. An example of this is provided by the so-called "QRS microfragmentations".

The aim of this evaluation is to retrospectively collect all established as well as new quantitative and qualitative ECG parameters (such as QRS microfragmentation) in a large patient collective. Subsequently, after characterization of the patients, an independent multivariate risk prediction model should be developed based on computer-based ECG analysis using maschnine learning algorithms.


Eligibility criteria: Inclusion Criteria:

* Patients who presented to the Department of Internal Medicine at the Medical University in Innsbruck between 01.01.2000 and 31.07.2022 and received an ECG recording as part of routine clinical practice.
* Age ≥ 18 years
* Residence in Austria

Exclusion Criteria:

* Insuffizient ECG Recording quality

Primary outcomes:
measure: All cause mortality
timeFrame: between 01.01.2000 and 31.07.2022
Secondary outcomes:
measure: Hospitalization
timeFrame: between 01.01.2000 and 31.07.2022
measure: Lenght of hospital stay
timeFrame: between 01.01.2000 and 31.07.2022
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02826590: The Effects of Spinal Mobilizations on Symptoms, Neck 3D Movement, Neck Muscle Electromyography and Sympathetic Nervous System Activity in People With Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 40
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: This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.


Eligibility criteria: Inclusion Criteria:

* Intermittent neck pain
* That worsens or improves with certain neck movements or positions
* Has not been caused by a blow, fall or accident

Exclusion Criteria:

* Cervicobrachialgia
* Has been treated with or is awaiting neck surgery
* Diagnosed with a particular inflammatory disease or spinal condition
* Where treatment with cervical mobilizations is contraindicated

Primary outcomes:
measure: Change in muscle activity assessed by neck muscle electromyography
timeFrame: Baseline and 2 minutes after intervention
measure: Change in 3D neck movement assessed with a 10 camera Vicon system
timeFrame: Baseline and 2 minutes after intervention
measure: Change in sympathetic nervous system activity assessed by measuring right hand finger temperature
timeFrame: Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
measure: Change in sympathetic nervous system activity assessed by measuring right hand finger galvanic response
timeFrame: Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention
measure: Global rating of change scale
timeFrame: Baseline and 10 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Donostia
country: Spain
facility: Atlas Fisioterapia
state: Gipuzkoa
Study officials:
References:
Clinical trial NCT06375590: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Official title: NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bicuspid Aortic Valve
Keywords: Bicuspid aortic valve
TAVI
Navitor
Lead sponsor: Clinique Pasteur
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2024-04-19
Enrollment: 150
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: All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease

Brief summary: The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. NYHA ≥ 2 and/or syncope and/or angina.
3. Symptomatic severe calcified aortic stenosis with AVA \< 1 cm2 AND peak velocity \> 4 m/s or mean gradient \> 40 mmHg or DVI \< 0.25'.
4. Patient judged by the Heart Team as indicated for TAVI.
5. Anatomical suitability for transfemoral-TAVI with Navitor, based on MSCT assessment.
6. Estimated life-expectancy \> 1 year.

Exclusion Criteria:

1. Age \< 18 years
2. Asymptomatic patients
3. Estimated life expectancy \< 1 year
4. Pure aortic regurgitation.
5. LVEF \< 20%
6. No baseline MSCT evaluation.
7. Unsuitable aortic root anatomy for Navitor.
8. Unsuitable peripheral vasculature for transfemoral Navitor.
9. Type 2 bicuspid aortic valve
10. Excessive leaflet calcifications
11. Moderate or severe raphe calcifications
12. Severe LVOT calcifications
13. Perimeter-derived annular dimension exceeding IFU recommendation
14. Dilated ascending aorta \>45 mm

Primary outcomes:
measure: 30-day device success (Rate)
timeFrame: 30-day
Secondary outcomes:
measure: 1 year at least moderate bioprosthetic valve deterioration
timeFrame: 1-year
measure: 1 year severe patient-prosthesis mismatch
timeFrame: 1-year
measure: 30 days and 1 year all-cause and cardiovascular mortality
timeFrame: 1-year
measure: 30 days and 1 year stroke
timeFrame: 1-year
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur
state: Occitanie
Study officials:
affiliation: Clinique Pasteur
name: Didier Tchétché, MD
role: PRINCIPAL_INVESTIGATOR
References: