cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Topical Application of Tranexamic Acid for Saving Blood Losses in Patients Subjected to Prosthetic Knee Surgery

To compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed with severe knee osteoarthritis who will undergo prosthetic knee surgery in terms of saving blood loss (estimated blood loss, decreased hemoglobin and Decrease in hematocrit).

Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin. Tranexamic acid binds to plasminogen when it is transformed into plasmin. The activity of the tranexamic acid-plasmin complex on fibrin activity is less than the activity of free plasmin alone.

There are two methods of presentation: one, as an injectable solution; Two as a clear, colorless aqueous solution.

Tranexamic acid in Spain is approved for use in the prevention and treatment of bleeding due to general fibrinolysis. As for its specific indications the investigators find that it is used for the treatment of metrorrhagia, menorrhagia, gastrointestinal hemorrhage, urinary hemorrhagic disorders after prostate surgery, surgery of ears, nose, throat, gynecological, thoracic, abdominal or cardiovascular or to counter associated hemorrhages To the administration of a fibrinolytic drug.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, in the age group: ≥18 and ≤80 years.
* Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be subjected to knee arthroplasty surgery.
* Patients signing informed consent, agreeing to participate in the study.

Exclusion Criteria:

* Patients with concomitant cardiac disease: unstable angina pectoris, acute myocardial infarction, atrial fibrillation, flutter, history of sudden death, severe valve insufficiency.
* Patients with concomitant previous thromboembolic disease: Deep venous thrombosis, pulmonary thromboembolism, thrombotic arterial embolism, Ischemic Vascular Cerebral Stroke, fibrinolytic diseases after consumption coagulopathy.
* Hypersensitivity to tranexamic acid.
* Severe systemic disease: cardio-pulmonary, neurological, renal, infectious or any other type that may impede the development of the study or evaluation of the results.
* History of seizures.
* Patients with severe mental disorder (psychotic disorder, risk of autolysis, manic episode), dependence on toxic substances and / or some physical or psychological limitation to answer.
* Patients receiving oral anticoagulants.
* Patients in litigation for disability claim related or not with the disease.
* Patients who cannot make the necessary visits to carry out the study.
* Patients who refuse to participate or sign informed consent.
* Pregnant and lactating patient's period.
Study to Investigate Whether AFQ056 Reduces Cocaine Use in Patients Diagnosed With Cocaine Use Disorder (CUD)

This study assessed whether AFQ056 had a beneficial effect by reducing cocaine use in Cocaine Use Disorder (CUD) patients as assessed by Timeline Follow-Back cocaine self-report.

This was a randomized, subject- and Investigator-blinded, parallel-group, placebo-controlled study in subjects with CUD. The study consisted of a 17-day screening period followed by a 12-day baseline, a 98-day outpatient treatment period (14-day up-titration dose regimen followed by 84-day maintenance dose), and an End of Study evaluation visit approximately 14 days after the last study drug administration. The total duration for each subject in the study was approximately 20 weeks including screening and baseline.

Eligibility Criteria:
Inclusion Criteria:

* Understand the study procedures and provide written informed consent before any assessment is performed.
* Subjects diagnosed with Cocaine Use Disorder according to DSM 5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Ed.).
* Must use cocaine through snorting (intranasally) as primary route of administration.
* Recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (BE).
* Must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use.

Exclusion Criteria:

* Has current diagnosis of Substance Use Disorder (according to the DSM 5) on alcohol, cannabis or other stimulants, except cocaine.
* Meets current or lifetime DSM 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
* Have current treatment for Substance Use Disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen).
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
* Have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study
* Current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.)
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV).
* Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the CSSRS, if this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.
* Controlled hypertension
Role of 12-lipoxygenase in Platelet Reactivity and Type 2 Diabetes Mellitus

This study investigates the potential protective effects of fatty acid supplementation through inhibition of platelet activation. fatty acids (omega-3 and omega-6) will be evaluated for protection from agonist-mediated platelet activation in platelets from type 2 diabetics and healthy controls. Post-menopausal women with type 2 diabetes mellitus and healthy post-menopausal women will be treated with omega-3 and omega-6 fatty acid supplements to determine protection from platelet activation and thrombosis in this high risk population.

Essential fatty acids such as omega-3 and omega-6 have been shown to play important roles in regulating platelet activation, but the underlying mechanisms have not been fully elucidated as well as their true protection from thrombosis.

12-lipoxygenase oxidized fatty acids are known to play both a pro- and anti-thrombotic effect on platelets depending on the fatty acid. oxidation of arachidonic acid by 12-lipoxygenase resuts in a pro-thrombotic bioactive lipid whereas oxidation of the omega-6 fatty acid DGLA found in plant oil results in formation of a potent anti-thrombotic bioactive lipid. Determining the extent of protection from this and other bioactive lipids produced through oxygenase activity will allow for a better understanding of which fatty acid supplementation may best protect from thrombosis.

Essential fatty acids such as omega-3 (DHA/EPA) and omega-6 (DGLA) appear to be protective. However the underlying mechanism for this potential protection is not well understood. Identifying the mechanism by which these supplements protect from platelet activation may identify new approaches to preventing thrombotic events in this high risk population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects and T2DM patients
* Postmenopausal women with T2DM
* All races and ethnicities
* T2DM patients taking 1st line diabetic treatment (i.e. Metformin)

Exclusion Criteria:

* Fish and plant oil supplements 2 months prior to enrollment
* NSAIDS and aspirin 1 week prior to enrollment
* Cardiovascular event within 6 months prior to enrollment
* Other anti-platelet treatment including PDE and P2Y12 inhibitors
GlideSheath Slender® Versus Conventional 6 French Arterial Sheath: Impact on the Distal Radial Artery Occlusion (SMART)

Compared with conventional artery sheath (TERUMO, Introducer II ), GlideSheath Slender® has more smaller outer-side diameter. The investigators suspected that use of the GlideSheath Slender® can reduce the incidence of distal radial artery occlusion in cardiovascular intervention via dTRA approach.

Distal transradial artery (dTRA) approach has emerged as a new approach in cardiovascular intervention in recent years. Compared to the conventional radial artery (CRA) approach, the dTRA approach dramatically reduced the risk of radial artery occlusion (RAO). In recent years, the incidence of distal radial artery occlusion (dRAO) after dTRA intervention has been reported in the literature, ranged from 0.12% to 5.2%. Outside diameter of artery sheath may affect the incidence of dRAO. Retrospective study reported that an artery/ sheath ratio \> 1.0 was least damaging to the vessel during coronary intervention via dTRA. Compared with conventional artery sheath (TERUMO, Introducer II ), 6 French GlideSheath Slender® has more smaller outer-side diameter (2.46mm vs. 2.62mm). The investigators suspected that use of the GlideSheath Slender can reduce the incidence of dRAO in cardiovascular intervention via dTRA approach.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Palpable distal radial and conventional radial artery

Exclusion Criteria:

* Age ≥ 90years
* Height≥ 185cm
* ST-segment elevation myocardial infarction or Cardiogenic shock
* Contraindications to puncture at the puncture site
* Diameter of DRA less than 1.5mm or RAO
Red Wine and Ageing and Atherosclerosis

The investigators will evaluate 100 regular red wine consumer men and 100 abstainers men from 50 years-old to 70 years-old by coronary risk prevalence, mood status, anthropometric measures, daily caloric ingest, lipid profile, carotid intimal media thickness, brachial flow mediate dilatation, coronary tomographic angiography and leucocyte telomere length.

The sample size has been calculated expecting that regular red wine ingestion would lead to a five year old younger vascular ageing indexes measured by carotid intimal media thickness, coronary artery calcium scores and leucocyte telomere length longer than those abstainers subjects at same age.

The investigators hypothesized that regular wine consumers present less coronary lesion and coronary calcium score on coronary tomographic angiography, lower carotid intimal media thickness and higher mean telomere length due the benefice of wine.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, from 50 years-old to 70 years-old.

Exclusion Criteria:

* asiatic or with manifest atherosclerosis disease
Collagen Injections for the Treatment of Acne Scars and Wrinkles

The purpose of this study is to find out if autologous (your own) fibroblast injections are effective for the treatment of acne scars and wrinkles.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Bilateral acne scars or have moderate to severe wrinkles
* Subjects in good health
* Subjects has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or lactation
* recent Accutane use in the past 6 months
* prone to hypertrophic and keloidal scarring
* have excessively redundant skin in the treatment area or wrinkles longer than 20 cm total
* have a history of autoimmune disorders, organ transplantation, cancer not in remission, active or chronic skin disease
* have a history of basal-cell carcinoma
* have previously received autologous fibroblast treatment
* have undergone any confounding therapy in the lower two-thirds of the face within 1 year or any investigational treatment within 30 days.
* have an allergy to collagen, bovine products, local anesthetics, gentamicin, or amphotericin B
* subjects who are unable to understand the protocol or to give informed consent
* subjects with mental illness
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.


Eligibility Criteria:
Inclusion Criteria:

* Japanese males and females aged 6 to \<65 years at enrollment.
* Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.

Exclusion Criteria:

* Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt during study participation.
* End-stage disease including but not limited to metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal disease with or without dialysis.
* Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months before investigational product administration or history of HSCT, or potential for solid organ transplant or HSCT during study participation.
* Receipt of cytotoxic chemotherapy or blood products within 3 months before investigational product administration or anti-B-cell antibodies within 6 months before investigational product administration through completion of study participation.
* Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
* Documented S pneumoniae infection within the past 5 years before investigational product administration.
Evaluating Quality of Life of AF Patients Following a Bleed

EQUAL-AF is an observational feasibility study which will determine if there is a long-term effect of bleeding for patients diagnosed with AF, who are taking anticoagulants. The investigators will use three validated questionnaires/PROMs (AFEQT, EQ5D-3L, and PACT-Q) to gather data from a patient perspective. Patients will complete all questionnaires no more than 4 weeks following a bleed and a second time 3 months later. As this study tests feasibility, progression criteria will apply. The primary objective is to assess recruitment success to ensure that the patient population is accessible and willing to engage with the research team. Additionally, the investigators will look to identify the need for a specific bleeding PROM which will assess long-term quality of life impact for patients experiencing bleeds while anticoagulated.


Eligibility Criteria:
Inclusion Criteria

* Adult patients (\>= 18 years old)
* Patients who can understand all study information and literature to provide fully informed consent
* Atrial fibrillation (AF) as the primary diagnosis
* Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
* Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

* Pregnant women
* Patients with active cancer
* Patients unable to consent for themselves
* Patient on concomitant antiplatelet therapy
Prophylactic Versus Therapeutic Caffeine for Apnea of Prematurity

Investigators hypothesized that the timing of caffeine administration in either prophylaxis or treatment of apnea of prematurity will affect the apnea response to caffeine

It will be a randomized control trial, patients will be randomly assigned to receive caffeine in a loading dose of 20 mg/kg (equivalent to 10 mg/kg caffeine base) and a maintenance dose of 10 mg/kg/day (equivalent to 5 mg/kg caffeine base) either as a prophylaxis group (1) or therapeutic group (2). Prophylactic caffeine (group 1) will be defined as caffeine prescribed for preterm infants within the first 72 hours of life prior to manifest apnea , therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life .

Preparation and administration of caffeine will be performed by a Neonatal intensive care unit (NICU) nurse.

Statistical Evaluation:

Statistical analyses will be performed with the Statistical Package for Social Sciences-SPSS version 16 software (SPSS Inc, Chicago, Illinois). For categorical variables, the X2 test will be used. For group comparisons, the Student T test will be used in normal distribution and the Mann-Whitney U test will be used in case of abnormal distribution.

For repeating measurements, variance analyses and Friedman variance analyses will be used. For descriptive statistics, percent, minimum-maximum-median, mean, and standard deviation will be used in accordance with the type and distribution of the variable. A P value \<.05 was considered statistically significant. Informed consent will be obtained from parents, and the study will be approved by the local ethical committee.

Eligibility Criteria:
Inclusion Criteria:

* Infants eligible for this study will be newborn infants ≤ 32 weeks with or without a diagnosis of apnea .

Exclusion Criteria:

* Newborn infants with gestational age \> 32 weeks.
* Newborn infants with congenital malformations and chromosomal anomalies.
* Newborn infants with apnea of other causes .
Watchful Waiting Versus Repair of Oligosymptomatic Incisional Hernias

Watchful waiting is non-inferior to surgical repair of asymptomatic and oligosymptomatic incisional hernias in terms of pain and discomfort during normal activities.

Incisional hernias are one of the most frequent complications in abdominal surgery. In Germany, 44.000 incisional hernia repairs per year are performed. Incisional hernia repair is not a low risk operation associated with high recurrence rate and high percentage of postoperative pain. Treatment of incisional hernias represents a significant surgical and socioeconomic problem. Until now, surgical treatment is recommended for patients with incisional hernia independent of symptoms due to the risk of an acute incarceration with serious complications. Studies defining the exact indications for incisional hernia repair and describing the natural course of an incisional hernia including the risk of an acute incarceration are not available to date. Randomized controlled trials having been performed in the past few years show that observation is a reasonable option in mildly symptomatic inguinal hernias. In this study, watchful waiting vs. surgical repair of oligosymptomatic incisional hernias are compared in a prospective-randomized setting for the first time.

The primary endpoint is pain during normal activities measured on the Surgical Pain Scales (SPS) after 24 months follow-up. SPS are a numeric analog scale (NAS) from 0 (no pain) to 150 (maximal pain). The primary endpoint will be dichotomized to no/minimal pain (SPS 0-30) and pain interfering with everyday activities (SPS \> 30). Watchful waiting is non-inferior to surgical repair in case the upper border of the 95 % confidence interval will not include the value of 2.

Secondary outcomes are pain and discomfort during during sports, at rest, patient satisfaction, quality of life, and the frequency of incarceration. The investigators hypothesize that pain intensity during everyday activities is not different in the compared groups and that incarceration frequency is low. If this was the case, a watchful waiting strategy could be applied in oligosymptomatic incisional hernias and risks and costs for surgery could be saved.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* asymptomatic/ oligosymptomatic incisional hernia

Exclusion Criteria:

* no hernia detectable by physical examination
* acute incarcerated hernia
* emergency hernia repair
* pain or discomfort associated with the hernia during normal activities
* local or systemic infection
* ASA score \>3
* inability to complete or comprehend the preoperative questionnaire
* repair with biologic prothesis
Effect of Symphysis Onlay Bone Graft, Injectable Platelet Rich Fibrin (I-PRF) and Xenograft on Horizontal Alveolar Ridge Augmentation in Esthetic Zone

The aim of the study: was to evaluate whether mandibular symphysis Onlay autogenous bone graft mixed with Injectable PRF could offer any advantages for patients undergoing horizontal alveolar ridge widening regarding increase alveolar ridge width compared to mandibular symphysis Onlay autogenous bone graft mixed with Xenograft

Alveolar bone resorption is one of complications post-extraction complications where there is a reduction in the dimensions and quality of the alveolar bone. Alveolar bone resorption is known to occur over time, but resorption in the first few months of tooth extraction is known to be very significant.

The ideal bone graft material should have osteoconductive, osteogenic, and osteoinductive properties and mechanical stability and be free from disease. Osteoconductive is a physical property of a material that provides a framework for the growth of blood vessels and osteoprogenitor cells in bone formation. Osteoinductiveness is the ability to stimulate stem cells to differentiate in mature cells through stimulation by local growth factors. Osteogenicity is the bone growth factors in bone grafts.

Growth factors from PRF such as platelet-derived growth factor (PDGF), transforming growth factor (TGF), and insulin growth factor (IGF) are known to play a significant role in healing and bone regeneration to prevent excessive alveolar resorption after tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Age from 20 to 40 years.
* Both sexes.
* Patients suffering from horizontal alveolar ridge deficiency in anterior maxilla with labio-palatal dimensions less than 4 mm.
* Patients with adequate vertical ridge height compared to the neighboring alveolar bone.
* Patients with good oral hygiene and adjacent teeth bounding the empty span (span ranged from 1 to 4 missing teeth), should have healthy periodontium, intact or properly restored.
* Patients were apparently free from any systemic disease that may affect normal healing process of bone.

Exclusion Criteria:

* Patients suffering from any systemic diseases were excluded from the study.
* Poor oral hygiene and motivation.
* General contraindications to implant surgery.
* Uncontrolled diabetes.
* Irradiation, chemotherapy, or immunosuppressive therapy over the past 5 years.
* Active periodontitis.
* Psychiatric problems.
Randomized Controlled Multicenter Study to Evaluate the Performance of Flexima® Active vs. Sensura® in Patients With Colostomy

The purpose of this study is to demonstrate that the performance of Flexima Active is non-inferior to the performance of Sensura.


Eligibility Criteria:
Inclusion Criteria:

* patient is at least 18 years old
* patient having a colostomy with a diameter less than 50 mm for users of midi pouches or having a colostomy with a diameter less than 65 mm for users of maxi pouches
* patient having a colostomy for at least 1 month
* patient using currently a one-piece flat ostomy appliance with closed or drainable bags
* patient using minimum 1 product per day with closed pouches or minimum 1 product every two days with drainable pouches
* patient capable to apply and remove the pouch himself or with the help of a caregiver (except health care professional)
* patient having a mental capacity to participate to the study (i.e. to understand the study and to answer to the questions)
* patient agrees to test Flexima® Active (size midi or maxi, beige) during 14 days and Sensura® (size midi or maxi, beige) during 14 days
* patient covered by social security

Exclusion Criteria:

* patient receiving or having received, within the last month, chemotherapy or radiotherapy
* patient currently suffering from peristomal skin complications (bleeding or red and broken skin at the time of inclusion)
* patient currently receiving or having received within the past three weeks systemic or local steroid medication in the peristomal skin
* patient already participating in another clinical study or who have previously participated in this investigation
* pregnant or breast-feeding woman