cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.

This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

Fifteen healthy volunteers will receive in random order 1 gram of intravenous and intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be taken at:

* T0+ 5min (only for IV route)
* T0+30min
* T0+1h
* T0+2h
* T0+3h
* T0+4h
* T0+5h
* T0+6h
* T0+8h (only for IM and PO routes)
* T0+24h

Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers both men and non-pregnant women
* ≥18-≤45-year-old
* Body mass index between ≥18 and ≤30 kg/m2, and bodyweight between ≥50 and ≤100 kg
* Coagulation test results of fibrinogen, D-dimers, prothrombin time and a partial thromboplastin time within normal limits at screening
* Normal renal function based on medical history and laboratory tests
* If a woman, must have a negative urine β-human chorionic gonadotropin (βhCG) pregnancy test at screening and inclusion visits
* Provision of signed informed consent prior to any study specific procedure
* People with public healthcare insurance (in France)

Exclusion Criteria:

* Previous thrombotic event or pre-existing pro-thrombotic disease
* Any history of seizures
* Any chronic or active cardiovascular or renal disease
* Planned general anaesthesia or surgery in the 3 months following inclusion
* Pregnant and/or breastfeeding
* Known allergy to the study drugs or any of the excipients of the formulations
* Use of any prescription or non-prescription medication (other than hormonal contraception) within 7 days before the first dose of the study drug is scheduled
* Inability to give informed consent
* Previous participation during the year in clinical studies compensated for an amount incompatible with participation in this study, verified by recording in the national register of subjects participating in human research trials
* Legal criteria:

  * People deprived of liberty by judicial or administrative decision
  * Adult protected by law (France)
Motivational Interviewing for Colonoscopy

The purpose of this study is to begin to examine the efficacy of a motivational interviewing intervention to increase African Americans' screening colonoscopy rates. The results from this pilot study will allow us to estimate the magnitude of the intervention and mediation effect sizes.

Compared to other racial groups, African Americans have the highest colorectal cancer (CRC) morbidity and mortality rates. Screening colonoscopy can aid in the early detection and prevention of CRC. A motivational interviewing (MI) intervention holds strong promise to increase African Americans' screening colonoscopy adherence and, by doing so, decrease CRC disparities. There is a great need to conduct a randomized clinical trial (RCT) that tests the efficacy of an MI intervention to increase screening colonoscopy adherence in African Americans. The first critical and necessary step in this line of research is to pilot test such an RCT.

Objective/hypotheses: The primary objective of the proposed study is to conduct pilot testing for a future RCT which will formally test the effects of MI on screening colonoscopy adherence in African Americans. The results from this pilot study will directly inform the development of a future RCT.

Specific aims: 1) To estimate the magnitude of the MI intervention effect size; and 2) To estimate the magnitude of the mediation effect sizes (drawn from Self Determination Theory).

Eligibility Criteria:
Inclusion Criteria:

* self-identified as African American
* aged 50 years or older
* attended a non-acute visit with a primary care physician
* received a primary care physician referral for a screening colonoscopy
* deemed eligible for an open access screening colonoscopy
* agreed to have a screening colonoscopy conducted at Mount Sinai
* English speaking

Exclusion Criteria:

* Personal history of CRC or chronic GI disorder
Optimizing Recovery in Trauma Patients by Integrating Enhanced Nutrition Delivery

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Subjects will be randomized 1:1 to either enhanced nutrition or control arm. Subjects randomized to the enhanced nutrition arm will receive oral nutrition supplements (ONS) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers. Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass.

This is a prospective, randomized, controlled trial designed to evaluate the impact of enhanced protein supplementation compared to a standard of care nutrition delivery in critically ill older adult trauma patients. Enhanced protein supplementation supports patients from ICU admission to 4-weeks post-hospital discharge, providing a comprehensive and personalized plan of care carried to completion.

Subjects will be randomized 1:1 to enhanced nutrition or control arm. Subjects randomized enhanced nutrition oral nutrition supplements (Fresenius KCAL shakes) up to 3 times per day while in the hospital and for 4 weeks after discharge. Subjects in the standard of care arm will receive normal nutrition recommendations from their clinical providers.

Participants in both groups will undergo non-invasive tests that measure how much energy (calories) they are using, body composition, and muscle mass. They will also be asked to complete walking and strength tests, and surveys about quality of life.These will be done at hospital admission, day 14 or hospital discharge, and at a one month post-discharge follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 45 years old and presented to the Emergency Department as a leveled trauma
* Patients who have the ability to tolerate oral nutrition
* Patients who have had a standard of care CT scan this admission

Exclusion Criteria:

* Expected withdrawal of life-sustaining treatment within 48 hours
* Traumatic Brain Injury
* Presence of lower extremity fracture(s)
* Mechanical Ventilation
* Subjects for who the Investigator would recommend a different supplement based on their medical condition.
* Prisoner
* Pregnancy for women of child-bearing potential
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic Sclerosis

This study was the extension of the double-blind study GLPG1690-CL-204 (NCT03798366). The main purpose of the study was to see how GLPG1690 was tolerated in participants with systemic sclerosis and whether there were any side effects in a long-term treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants who completed the 24-week treatment period of Study GLPG1690-CL-204 and who according to the investigator's judgment may benefit from long-term treatment with GLPG1690.

Exclusion Criteria:

* Any condition or circumstances that, in the opinion of the investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements.
Ethical and Psychological Support for Health Care Professions in Intensive Care Units in the COVID19 Pandemic Context: Adequacy With Needs and Psychological Impact Crisis and Post-crisis

The intensive care unit occupies a particular place in our health care system. The urgency of the clinical situations, the proportion of deaths encountered, and the daily workload is likely to generate suffering among staff. The health crisis linked to SARS-COV-2 is unprecedented and has leads to the unprecedented mobilisation of care providers, particularly in the ICU. Faced with the massive and growing influx of patients, human, therapeutic and material resources are overwhelmed and the teams are faced with an unusually heavy workload in a context of extreme tension. These professionals are thus exposed to a risk of over-investment, in a context of acute and repetitive stress, over an indeterminate period of time combining workload, emotional intensity with specific ethical issues, simultaneously affecting the professional sphere but also the personal and family sphere (confinement, risk of contamination). Now more than ever, the mental health of caregivers is an important concern, as highlighted by the CCNE. Mental health is understood in the way in which the individual responds specifically to work-related suffering by developing individual and collective defensive strategies. Thus, the issue of mental health in the ICU cannot be considered without taking into account the strategies that professionals put in place to combat stress and to contribute or not to the construction and stabilization of the work collective (collaboration, support). Ethical and/or psychological support systems have been set up in most of the establishments involved in the care of Covid-19 patients. However, the adequacy of these systems relative to the needs of professionals during and after the crisis is not yet known. We hypothesize that the psychological and social repercussions of this pandemic as well as the individual and collective strategies deployed by ICU care providers to deal with it will evolve in view of the progression of the crisis but also of the various types of support, particularly psychological and/or ethical, available to them.


Eligibility Criteria:
Inclusion Criteria:

* The study population is the entire ICU staff of the participating centres, whether they are permanently or transiently assigned to these units and/or the institution, whether they are students or not.

Professionals involved in psychological and ethical support structures may also be interviewed to provide the information necessary to describe and evaluate the organisations and their evolution.

Exclusion Criteria:

* NA
Predicative Value of Multimodal MRI in Moyamoya Disease

Moyamoya disease (MMD) is a nonatherosclerotic cerebrovascular abnormality, characterized by a progressive stenosis or occlusion of the intracranial internal carotid arteries (ICAs) and their proximal branches, with subsequent formation of collateral vessels ("puff of smoke"). In some cases, the posterior circulation can also be involved. MMD has been discovered around the world, but Asians carry the most possibility to develop this disease. Current treatment designed to prevent strokes by improving blood flow to the affected cerebral hemisphere including medical therapy and surgery. In particular, surgery included two general methods: direct and indirect revascularization. Compared with direct bypass, indirect procedures are more technically accessible and may reduce the possibility of complications, such as hyperperfusion. In addition, magnetic resonance imaging (MRI) with derived parameters have shown great potential in evaluating perfusion in patients, and could possibly predict surgical outcome. However, there is still lack of evidence of the predictive value of MRI in evaluating clinical and angiography improvement in patients with MMD.

Imaging protocols:

3D TOF 3SLAB; SWAN; 3D ASL 2.0s; T1; T2; T2 Flair; DWI; tASL 2.0s; DCE; APT-CEST

Imaging evaluation:

1. Transfer contrast volume value measured by DCE;
2. ASL shows CBF in associated regions;
3. Stoke area measured by DWI and Flair;
4. PH values reflected by APT-CEST.

Treatment:

Surgery-indirect revascularization

Follow-up:

Baseline (MRI+DSA); 3-months follow-up (MRI); 6-months follow-up (MRI+DSA)

Eligibility Criteria:
Inclusion Criteria:

* DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery;
* Abnormal vascular network appeared in the brain;
* With the onset of cerebral ischemia/hemorrhage/TIA;
* No cerebral infarction or cerebral hemorrhage occurred within the last month;
* All MRI examination performed according to study protocol;
* Signed informed consent obtained from the patient or patient's legally authorized representative;
* Having complete medical history and clinical follow up;
* Imaging data can be processed.

Exclusion Criteria:

* Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc.;
* Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.
* Pregnancy
Albumin Dialysis in End-Stage Renal Disease: Detoxification Capacity and Impact on Vascular Endothelial Function

The uremic syndrome is mainly related to the retention of a host of compounds, due to altered glomerular filtration and other factors of renal dysfunction, e.g. tubular secretion. Uremic retention solutes are arbitrarily subdivided in three different categories according to their physicochemical characteristics and their subsequent behaviour during dialysis: (i) the small, water-soluble, non-protein bound compounds, (ii) the larger middle molecules, mainly peptides and (iii) the small protein-bound compounds (1).

Although direct proof is lacking, several lines of evidence indicate that albumin is the most important carrier protein. Removal of protein bound uremic retention solutes is limited.

The Prometheus® system fractionates blood into plasma and cellular components, using an albumin-permeable polysulfon filter (AlbuFlow®) with a specially designed sieving coefficient curve (1.0 for 2-microglobulin, \>0.6 for albumin, \<0.3 for IgG, \<0.1 for fibrinogen and \<0.01 for IgM). Due to the high sieving coefficient of the filter for large molecules (i.e. cut-off at about 250 kD) molecules up to the size of albumin (69 kD) easily pass from blood into the secondary circuit which is filled with isotonic sodium chloride solution, whereas larger molecules like fibrinogen (340 kD) cannot pass through the filter. In the secondary circuit the filtered plasma with the albumin-bound toxins flows through one or two adsorbers in a row with maximized adsorption capacity for putative liver toxins that are directly adsorbed ('fractionated plasma separation and adsorption' or FPSA). The purified plasma is then returned to the blood side of the albumin filter. In order to eliminate water-soluble toxins, blood thereafter undergoes hemodialysis using a conventional high-flux dialyser.

We hypothesise that removal of protein bound uremic retention solutes can be improved by FPSA as compared to standard hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* maintenance (\> 3 months) hemodialysis patient
* Stable access, blood flow at least 250 mL/min

Exclusion Criteria:

* Known hemodialysis-related hypotension
Effectiveness of Inhaled Corticosteroids in Preschool Children With Acute Dyspnea and Wheeze

The aim of the study is to investigate whether inhaled corticosteroids after a first hospital admission for acute dyspnea and wheeze is effective in reducing subsequent episodes of these complaints in children aged 1 to 4 years.

Symptoms of dyspnea and wheeze occur frequently in young children with a cumulative incidence of 33% before the age of 3 and up to 50% by the age of 6 years. Most wheezing episodes in preschool children are associated with viral upper respiratory tract infections (episodic viral wheeze). The majority of children with episodic viral wheeze have become asymptomatic by the age of 6 years. About one in three preschool children with recurrent wheeze continue to wheeze after the age of six years, and these children are usually diagnosed with asthma.

Two clinical phenotypes of recurrent wheezing in preschool children can be distinguished. Children with episodic viral wheeze only wheeze with viral upper respiratory tract infections and are symptom free in between episodes. A minority of children wheeze during upper respiratory tract infection and with other trigger factors (such as smoke, fog, exercise) and this is defined as multiple trigger wheeze.

Inhaled corticosteroids (ICS) have been shown to be effective in preschool children with multiple trigger wheeze, but the effect is smaller than that in older children. This justifies a more critical approach towards such therapy, for example by prescribing a trial of ICS for a period of 3 months and evaluating the effect afterwards. Little research has been performed on the effect of ICS in preschool children with episodic viral wheeze. A high dose of ICS (\>1600 ug/d) during an acute episode of dyspnea and wheezing has been shown to be effective, but in a number of small clinical trials maintenance treatment with ICS did not have an effect on the number and severity of episodes of viral wheezing. Contradictory results have been published about the effect of ICS in infants and preschool children with Respiratory Syncytial Virus bronchiolitis. Some studies showed a reduction of wheezing episodes after RSV bronchiolitis in children treated with ICS, two other studies did not show any positive effect.

Prescribing ICS in preschool children can result in adverse effects such as a reduced height growth. Because of the lack of evidence of effect of ICS in episodic viral wheeze, guidelines advise a critical approach towards prescribing ICS in episodic viral wheeze.

Eligibility Criteria:
Inclusion Criteria:

* Children that are admitted to the paediatric ward of the Isala Klinieken in Zwolle for the first time with acute dyspnea and wheezing
* Age 1 - 4 years
* Child and parents must understand the Dutch language well
* Informed consent

Exclusion Criteria:

* Previous use of medication different than short-acting β2-agonists before hospital admission
* Proven RSV bronchiolitis
* Crackles during auscultation of the lungs (suggestive for RSV bronchiolitis)
Safety of Tranexamic Acid in Reducing Blood Loss Myomectomy.

Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of women in the reproductive age group

Although most of them are asymptomatic, 20-50% of fibroids may cause problems such as heavy menstrual bleeding, anemia, pelvic pain, pressure symptoms from extrinsic compression of the colorectal and urinary tract, infertility, and recurrent pregnancy losses, where surgical intervention is often indicated

Eligibility Criteria:
Inclusion Criteria:

* women with myomas

Exclusion Criteria:

* with with malignant lesions
Study of Platelet Activation in Septic Shock Patients

Some studies have shown that antiplatelets agents could reduce organ dysfunction in septic shock in mice and human models. Platelets are actors in immunity and their activation can be complicated by tissue damage with vascular occlusions which can lead to organ dysfunction. Investigators can hypothesize an increase in platelet activation and in leukocyte-platelet aggregates in septic shock.


Eligibility Criteria:
Inclusion Criteria:

EXPERIMENTAL GROUP

* Patient who possibly gave an oral agreement to inclusion and may sign a consent once out of intensive care
* Patients hospitalized in general intensive care
* Patient hospitalized for less than 72 hours
* Patient suffering from severe sepsis, whatever their origin, with hypotension (PAs \<90mmHg) despite adequate fluid resuscitation and vasoactive requiring the use of amines, with hypoperfusion and / or at least one organ dysfunction ( septic shock)
* Patient with a Sequential Organ Failure Assessment (SOFA) score\> 8 (or\> 2 in an organ) in the first 24 hours
* Patient enjoying a social security scheme or equivalent

CONTROL GROUP

* Signed informed consent
* Patient seen anesthesia consultation for orthopedic knee prosthesis of laying or hip with a negative balance infectious
* Patient enjoying a social security scheme or equivalent

Exclusion Criteria:

EXPERIMENTAL GROUP

* Patient on safeguarding justice, guardianship
* Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
* Patient suffering from thrombocytopenia or constitutional thrombopathy
* Pregnant

CONTROL GROUP

* Patient on safeguarding justice, guardianship
* Patient with infectious positive balance (dental, urinary tract) prior to surgery
* Patient suffering from a haematological malignancy (leukemia, lymphoma ...)
* Patient suffering from thrombocytopenia or constitutional thrombopathy
* Pregnant
Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.

Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity, complete eye exam, including IOP measurement, color photos and intravenous fluorescein angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit, best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits.

Retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. CFT \>310 microns 2. Intraretinal or subretinal fluid on SDOCT 3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color photographs.

Final follow-up will be at six months. Data collected will include, change in ETDRS visual acuity from the baseline, change in CFT, number of injections, number of eyes completely dry by SDOCT, and number of eyes with a thrombosed RAM by IVFA.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic macular edema caused by RAM in one of the eyes. If both eyes are involved, the eye with worse central foveal thickness will be enrolled in the study.
2. CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
3. Best-corrected visual acuity of 73 to 24 letters.
4. Willing and able to comply with clinic visits and study-related procedures.
5. Willing to provide informed consent -

Exclusion Criteria:

1. Media opacity
2. pre-retinal fibrosis, retinal detachment, vitreo-macular traction
3. Infectious keratitis, conjunctivitis, blepharitis or scleritis
4. Any ocular surgery during the preceding 3 months.
5. aphakia or uncontrolled glaucoma
6. subfoveal hemorrhage
7. History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
8. Any other ocular disease responsible for decrease in vision.
9. Concomitant ocular disease that can cause increase in foveal thickness
10. Ocular inflammation from any cause
11. Recent (\<3 months) history of a thromboembolic event
12. Pregnant or breast feeding women.
13. Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.