cyrilzakka/clinical-trials huggingface dataset:
Differential Effects of Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) on Platelet, Endothelial and Vascular Function

The purpose of this study was to determine whether supplementation with oils enriched with long chain n-3 PUFA, either EPA or DHA, had a differential effect on platelet, endothelial and vascular function.

Relatively few studies have made a head-to-head comparison of DHA (22:6n-3) with EPA (20:5n-3). The understanding of this differential effect may be of great interest in populations with low EPA intake such as vegetarians, who may choose to supplement their dietary intake of long-chain n-3 PUFA in the form of DHA-rich algal oil.

This study aimed to investigate the effect of supplementation with oils rich in either EPA or DHA (3g/day, 6 weeks) in healthy young males on platelet, endothelial and vascular function, as well as other CVD risk factors. The primary outcomes were platelet monocyte aggregates and endothelial progenitor cells - novel markers of platelet and endothelial function, measured by flow cytometry, Secondary outcomes included capillary density, measured by capillaroscopy to assess changes in microvascular function, pulse wave analysis, digital volume pulse and ambulatory blood pressure. Other secondary outcomes included lipid profiles (TAG, cholesterol, NEFA), glycaemic control (HOMA, QUICKI) and oxidative stress (isoprostane). The omega-3 index (erythrocyte EPA+DHA) was used as a marker of compliance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* No smokers
* Aged 18-45y old
* Able to understand the information sheet and comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.

Exclusion Criteria:

* Reported history of CVD (myocardial infarction, angina, venous thrombosis, stroke, dyslipidemia), diabetes (or fasting glucose ≥ 6.1 mmol/L), cancer, kidney, liver or bowel disease.
* Presence of gastrointestinal disorder or use of drug, which is likely to alter gastrointestinal motility or nutrient absorption.
* Current smokers; history of substance abuse or alcoholism (previous weekly alcohol intake \>60 units/week); current self-reported weekly alcohol intake exceeding 28 units
* Recent use of hypolipidaemic, antihypertensive, antiplatelet or antithrombotic mediations
* Platelet count above or below the normal range or any history indicative of a congenital or acquired platelet or haemostatic defect.
* Allergy or intolerance to any component of study capsules
* Unwilling to restrict consumption of any source of fish oil for the length of the study
* Subjects reporting consumption of \>1 portion oily fish per week
* Weight change of \>3 kg in preceding 2 months; BMI \<18 and \>32 kg/m2
* Blood pressure\>160/90 mmHg
* Fasting blood cholesterol \> 6.5 mmol/L; fasting triacylglycerol concentrations \> 2.0 mmol/L
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia

Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.

This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia).

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 33 weeks of gestation\<
* Admission to CHU Sainte-JUstien neonatal intensive care unit
* Receiving Parenteral nutrition during the first week of life
* Parental consent

Exclusion Criteria:

* Major congenital anomalies
* Sever perinatal asphyxia
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

Free light chains (FLCs) are low-molecular-mass molecules (kappa and lambda light chains), which are by-products of normal immunoglobulin synthesis and are normally excreted through the kidneys. Presence of light chains in the urine is a marker of tubular dysfunction. In patients with impaired kidney function, serum concentrations and urinary excretion of polyclonal FLCs have been noted to be increased. Increased excretion of FLCs and other low-molecular weight proteins \[cystatin C, NGAL\] in the urine may contribute to progression of chronic kidney disease. Higher Cystatin C has been demonstrated to be related to development of albuminuria. Neutrophil gelatinase-associated lipcalin (NGAL) excretion in the urine is a marker of tubular injury in the kidney and has been shown to be elevated in subjects with type 1 and 2 diabetes mellitus (DM). Angiotensin-converting enzyme inhibitors (Ace Inh) and angiotensin II receptor blockers (ARB) class of drugs are renoprotective in nature and are the first line therapy for treatment of diabetic nephropathy. There is no longitudinal data evaluating the effect of Ace Inh and ARB class of drugs on urinary FLCs (UFLCs).

Our hypothesis is that UFLCs are increased in patients with DM with and without kidney disease and that treatment with Ace Inh and/or ARB will decrease UFLCs in these patients. Additionally, we will explore the change in other low molecular weight proteins \[cystatin C, and NGAL\] in response to treatment with Ace Inh and ARB.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Hypertension
* Estimated glomerular filtration rate (eGFR) \> 30 ml/min
* Use of Ace Inh and ARB for control of blood pressure who are willing to be placed on alternate drug(s) in the washout period for blood pressure control

Exclusion Criteria:

* Pregnancy
* Patients with chronic kidney disease stage with eGFR \< 30 ml/min (CKD stage IV and V)
* Nephrotic range proteinuria (urinary protein \> 3.5 gm/day)
* History or renal transplantation
* History of multiple myeloma
* Known history of hypersensitivity reaction or intolerability to Ace Inh or ARB.
Influenza Vaccine and Pneumococcal Vaccine

Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.

During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥65 years who signed the informed consent

Exclusion Criteria:

* Previous pneumococcal vaccine recipients
* Egg allergy
* History of serious adverse event after vaccination
* Any acute disease or infection
* History of neurological symptoms or signs
* Impairment of immune function or immunosuppressant use
* Bleeding diathesis
* Fever (defined as axillary temperature ³38.0°C) within 3 days
* History of Streptococcal pneumoniae infection within the previous 5 years
Sonification Embodied Associations

The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons with multiple sclerosis compared to age and gender matched controls


Eligibility Criteria:
Inclusion Criteria:

* Time up and Go (TUG) test: 8 sec -- \> 21 sec

Exclusion Criteria:

* cognitive impairment hindering the understanding and execution of the experimental procedures,
* pregnancy,
* hearing impairment,
* amusia
* beat deafness,
* colour blindness.
Hypothermic Oxygenated Machine Perfusion of Extended Criteria Kidney Allografts From Brain Death Donors

Kidney transplantation (KT) has emerged as the mainstay of treatment for end-stage kidney disease. In an effort to address the widening gap between demand and supply of donor organs, there has been an increase in the numbers of "marginal" or functionally impaired renal allografts that had to be accepted for KT over the decades. The use of extended criteria donor (ECD) allografts is associated with a higher incidence of primary graft non-function (PNF) and/or delayed graft function (DGF). Hypothermic oxygenated machine perfusion (HOPE) has been successfully tested in pre-clinical experiments and in a few clinical series of donation after cardiac death (DCD) in liver transplantation. The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in donation after brain death (DBD) KT. Fifteen kidney allografts will be submitted to 2 hours of HOPE before implantation and are going to be compared to a case matched group transplanted after conventional cold storage (CCS).

The present trial is an investigator-initiated pilot study on the effects of HOPE on ECD-allografts in DBD KT. Fifteen kidney allografts with defined inclusion/exclusion criteria will be submitted to 2 hours of HOPE via the renal artery before implantation and are going to be compared to a case matched group of 30 patients (1:2 matching) transplanted after CCS. Besides the clinical evaluation of HOPE-"reconditioned" allograft function, a targeted biomarker analysis is planned using tissue, serum, and urine samples as the translational and basic research aspect of the present study.

Eligibility Criteria:
Inclusion Criteria:

Dialysis-requiring Patients, suffering from end stage kidney disease, listed for KT and receiving ECD organs at the Department of Surgery and Transplantation, University Hospital RWTH Aachen, Aachen, Germany. Informed consent is obtained from all subjects participating in the trial by a qualified member of the study team.

ECD is defined as followed: deceased donors \> 60 years and older, and those aged between 50-59 years with at least two of the following conditions: cerebrovascular cause of death, serum Creatinine greater than 1.5 mg/dL (132.6 µmol/L), history of arterial hypertension

Exclusion Criteria:

1. Recipients of living donor kidney transplants
2. Previous kidney transplantation
3. Participation in other kidney related trials
4. The subject received an investigational drug within 30 days prior to inclusion
5. The subject is unwilling or unable to follow the procedures outlined in the protocol
6. The subject is mentally or legally incapacitated
7. Non-German or non-English speakers
8. Family members of the investigators or employees of the participating department
9. The subject is mentally or legally incapacitated
10. The subject suffers from uncontrolled bacterial or viral infection
Effect of Exercise on Premature Ejaculation

Premature ejaculation (PE) is one of the prevalent disorders in men; its leading sequel such as lack of self-confidence, anxiety, depression and unsatisfactory intercourse in men and their partners. The current study was aimed to evaluate the relationship between ejaculation and physical activity.

Premature ejaculation (PE) is the most frequent sexual dysfunction in males, and its prevalence has been reported as 21-33%. Currently, there are no universal criteria for the diagnosis, or treatment strategies or approaches for PE. Lack of observational studies directed to PE makes comprehension of this sexual dysfunction difficult. The common point for definition of PE is a short duration between penetration and ejaculation, little or no control on voluntary control of ejaculation, and annoying character and negative effect of this condition on the individual. There are various treatment methods since ejaculation physiology and neuroanatomy is not yet clearly demonstrated. According to neurobiological hypothesis of Waldinger, a dysfunction in the serotonin pathway of the central system such as serotonin-2C hyposensitivity and/or serotonin-1A receptor hypersensitivity is a possible cause of lifelong PE. These experimental animal models showed that serotonergic activity at hypothalamic level inhibited ejaculation reflex. Based on this physiological effect, selective serotonin reuptake inhibitors (SSRI), and serotonin agonists increase intravaginal ejaculation latency time (IELT). A number of studies showed that exercise increased the functional effect of serotonin in the human brain.

The effects of physical activity level on human health have attracted interest worldwide. Lack of physical activity forms the basis of various health problems, however regular physical act contributes prevention and treatment of a number of disorders.

In current study, investigators will compare the ejaculation control, IELT, and prevalence of PE between sportsmen that have regular physical activity, and the individuals with a sedentary lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* 18-45-year-old
* sexually active
* heterosexual,without erectile dysfunction
* sexual partner for at least six months, and sexual intercourse at least twice a week

Exclusion Criteria:

* chronic systemic disorders (such as diabetes or hypertension)
* use of narcotic/hypnotic drugs or stimulants
* anabolic steroids
* selective serotonin receptors inhibitors
* previous diagnosis and treatment for PE
Prevalence of Pharyngolaryngeal Reflux in Patients Treated for Obstructive Sleep Apnea Syndrome

The aim of the study is to find, using validated and efficient tools, a laryngopharyngeal reflux in patients receiving polysomnography for suspected obstructive sleep apnea syndrome.

It is proposed to carry out simultaneously, at the Sleep Center of the Polyclinique of Poitiers (CSPP), a polysomnography, a 24-hour Restech pharyngeal pH-metry (day and night), a Peptest (in the evening and in the morning of the polysomnography), with the RSS-12 questionnaire and the RSA score.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 ans)
* Polysomnography planned for OSA assessment
* RPL known or not, suspected or not
* Affiliation to a social security scheme or beneficiary of such a scheme
* Patient having signed the free and informed consent

Exclusion Criteria:

* Minors
* Smoking, alcoholism, chronic or serious disabling pathology
* Medical history of upper aerodigestive tract cancer, radiotherapy
* Recent infection of upper aerodigestive tract, chronic rhinosinusitis
* Permanent nasal obstruction
* Active allergy
* Non-obstructive SAS (central)
* Patient under anti-secretory treatment (IPP) during the 8 days preceding the Restech associated with the PSG
* Refusal to participate in the study
* Protected patients: Adults under guardianship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient
* Hospitalized without consent
Forearm Position in Subpectoral Biceps Tenodesis

The investigators aimed to compare two different forearm positions, extension-pronation (EP) or neutral, for fixation of the long head of the biceps tendon (LHB) in biceps tenodesis.

Long head of biceps pathologies have been regarded as a source of anterior shoulder pain and disability. Tenodesis is preferable surgical choice for especially young patients to to eliminate anterior shoulder pain. The optimal position of the elbow and forearm during tenodesis is a debated topic. The investigators aimed to evaluate pain and strength loss after biceps tenodesis fixed at extension-pronation (EP) and neutral positions. The investigators aimed to find the most appropriate and anatomical arm position that gives better clinical and functional results.

Eligibility Criteria:
Inclusion Criteria:

-Participants with diagnosis of chronic biceps tendinitis

Exclusion Criteria:

- Participants who had undergone rotator cuff repair surgery
Treatment of Advanced Hodgkin's Disease (Stages IIB-III-IV)

The purpose of this study is to compare the toxicities of the COPPEBVCAD vs BEACOPP vs ABVD regimens.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of Hodgkin disease
* Clinical stage IIB, III, IV
* No prior treatment for Hodgkin disease or other malignancy
* Age 18-65 year
* Good cardiac, pulmunar, renal and hepatic function
* Performance status 0-3 (Karnofsky 100- 40)
* Written Informed Consent

Exclusion Criteria:

* HIV positivity
* Large cell, anaplastic, CD30+ lymphoma
In-Stent Restenosis Post-Approval Study

The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a previously implanted (\> 30 days) non-covered stent(s) located in the SFA
* Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
* Patient demonstrates an Ankle Brachial Index (ABI) \<=0.9. If ABI \>0.9 or not measurable, patient is eligible for study if Toe Brachial Index is \<=0.5
* Patient has \>=50% in-stent restenosis and / or an occlusion in a previously implanted (\>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
* Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
* Patient has a reference vessel diameter between 4.0 and 6.5mm
* Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention
* Note: Additional Inclusion Criteria may apply

Exclusion Criteria:

* Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
* Patient has a known intolerance to anticoagulation or antiplatelet therapy
* Patient has known coagulation disorder, including hypercoagulability.
* Patient has major distal amputation (above the transmetatarsal)
* Patient has any previous surgery in the target vessel
* Patient has had previous target vessel in-stent restenosis treated by relining with another stent
* Patient has untreated flow-limiting aortoiliac stenotic disease
* Note: Additional Exclusion Criteria may apply
Comparison of Quality of Vision After Bifocal and Extended Depth of Focus Intraocular Lens Implantation

To compare the visual performance of the extended depth of focus (EDOF) intraocular lens (IOL) to bifocal and spherical monofocal IOL

This study was conducted from 2018 to 2020. This study included patients who were with presence of cataract in both eyes, age between 50 and 80 years, and corrected distance visual acuity (CDVA) of both eyes under 20/40. Phacoemulsification cataract surgery was arranged for both eyes for all patients. The study groups of IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA). The patients were routinely examined preoperatively as well as 1 month after surgery for far and near visual acuity (in LogMAR unit). Contrast sensitivity, wavefront aberration and quality of vision questionnaire was measured at the 1-month postoperative visit. These aforementioned outcomes were recorded and compared between groups.

Eligibility Criteria:
Inclusion Criteria:

* presence of cataract in both eyes
* age between 50 and 80 years
* CDVA of both eyes under 20/40
* Phacoemulsification cataract surgery was arranged for both eyes

Exclusion Criteria:

* complicated cataract
* corneal opacities or irregularities
* corneal astigmatism \> 1.5 diopter
* dry eye (Schirmer's test I ≤ 5mm)
* amblyopia
* anisometropia
* surgical complications such as posterior capsular bag rupture or vitreous loss
* IOL tilt or decentration
* coexisting ocular pathologies
* glaucoma
* non-dilating pupil
* history of intraocular surgery, laser therapy, or retinopathy
* optic nerve or macular diseases
* refusal or unable to maintain follow-up.
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Eligibility Criteria:
Inclusion Criteria:

* Be a currently adapted soft contact lens wearer (\>1 month of lens wear).
* Be at least 18 years of age.
* Refractive astigmatism \<1.00D in both eyes.
* Have clear corneas and be free of any anterior segment disorders.
* Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
* Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
* Require visual correction in both eyes (monovision allowed, no monofit).
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  1. No amblyopia
  2. No strabismus
  3. No evidence of lid abnormality or infection
  4. No conjunctival abnormality or infection that would contraindicate contact lens wear
  5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
  6. No other active ocular disease.
* Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
* Willing to comply with the wear and study visit schedule.

Exclusion Criteria:

* Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
* Require toric or multifocal contact lenses.
* Previously shown a sensitivity to any of the study solution components.
* Any systemic or ocular disease or allergies affecting ocular health.
* Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
* Clinically significant (\>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
* Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
* Keratoconus or other corneal irregularity.
* Aphakia or amblyopia.
* Have undergone corneal refractive surgery or any anterior segment surgery.
* Abnormal lacrimal secretions.
* Has diabetes.
* Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
* History of chronic eye disease (e.g. glaucoma).
* Pregnant or lactating or planning a pregnancy at the time of enrolment.
* Participation in any concurrent clinical trial or in last 30 days.