cyrilzakka/clinical-trials huggingface dataset:
Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

A prospective, randomized, double-masked study evaluating the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to sham

This study will evaluate the the ocular efficacy and safety of two doses of the EYP-1901 intravitreal insert compared to sham using a randomized double masked trial design.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a hemoglobin A1c ≤12%
* Study eye with moderately severe to severe NPDR (based on the DRSS levels 47 or 53)
* Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better).

Exclusion Criteria:

* Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
* Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation in the study eye in the last 12 months.
Comparison of 1 Month vs. 12 Months DAPT in Patients Undergoing PCI With Genoss® DES

This study is a prospective, open-label, multicenter, randomized clinical trial to evaluate the efficacy of 1 month dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel followed by clopidogrel monotherapy, compared with 12 months DAPT with aspirin plus clopidogrel in patients undergoing percutaneous coronary intervention with Genoss® drug eluting stents.

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is recommended following percutaneous coronary intervention (PCI). However, the optimal duration of DAPT is still controversial, and current US and European guidelines recommend 12+ months for Acute Coronary Syndrome (ACS) and 6+ months in Chronic Coronary Syndrome (CCS). A meta-analysis comparing short (6 months) and long-term (12 months) DAPT has shown a lower risk of bleeding with no significant increase in ischemia risk associated with short DAPT use.

Monotherapy with a P2Y12 inhibitor clopidogrel has been proposed as a novel alternative to DAPT in patients with atherosclerotic cardiovascular disease. Clopidogrel has shown comparable bleeding events after PCI compared to aspirin, and reduced the risk of subsequent ischemic events. In addition, several trials have reported that clopidogrel monotherapy now has a lower risk of bleeding than antiplatelet drug therapy (DAPT). These results suggest that P2Y12 inhibitor monotherapy has a lower risk of bleeding in patients with PCI and can be compared with DAPT in preventing recurrent ischemic events.

Given that Genoss® Drug-Eluting Stent (DES) has a very low incidence of Stent Thrombosis (ST), short-term DAPT after PCI is now expected to reduce the risk of bleeding with clopidogrel instead of aspirin, without increasing cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be at least 19 years of age
* Subjects undergoing elective PCI with Genoss® Drug Eluting Stents
* Subject who can understand the risk, benefit and treatment alternatives, and when he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure

Exclusion Criteria:

* Subjects presenting with acute myocardial infarction
* Subjects with less than 1 year of life expectancy
* Subjects presenting with cardiogenic shock
* Subjects requiring anticoagulation (warfarin, direct oral anticoagulant), or those requiring antiplatelet agents other than aspirin and P2Y12 inhibitors.
* Subjects with history of intracranial hemorrhage (ICH)
* Known hypersensitivity or contraindications to study medications (aspirin, clopidogrel), or drugs used in the procedure (heparin, contrast media, sirolimus). Those with contrast hypersensitivity can be enrolled if symptom/signs can be controlled by anti-histamines or steroids.
Neonatal Platelet Transfusion Threshold Trial

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).

Thrombocytopenia, defined as a platelet count \<150 x 10\^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk.

The NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (\<27 weeks GA). It will test whether a threshold of 20x10\^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization.

This is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of \< 50 x 10\^9/L (up to 7 postnatal days) or \<35 x 10\^9/L (8 or more postnatal days) will be randomized. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 23 0/7 to 26 6/7 weeks
* Postnatal age of \< 48 hours

Exclusion Criteria:

* Comfort care or withdrawal of care planned
* Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
* Receipt of platelet transfusion
* No receipt of Vitamin K
* Parents/guardian decline consent
This is a Study to Evaluate if Music Therapy Can Reduce Stress and Increase Satisfaction of Patients Undergoing Ambulatory Surgery

Patients who undergo outpatient surgery according to normal practice will be divided into two groups.

The first group (17 patients), before and after their surgery, will listen to relaxing music, namely a slower tempo music that can quiet mind and make patients feel soothed.

The second group (17 patients) will follow the standard surgical pathways according to normal clinical practice, in particular they will not listen to relaxing music.

A questionnaire to evaluate stress and satisfaction will be administered to all the patients before their discharge


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing outpatient surgery
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* Pregnant or lactating women
Self-perceived Health Status and Healthcare Consumption of Idiopathic Scoliosis Patients Treated More Than 20 Years Ago: How Much do Operated and Non-operated Patients Differ?

Adolescent idiopathic scoliosis (AIS) is a common condition that affects millions of patients worldwide. This is characterized by a spinal deformity that leads to a deformation of the trunk, an imbalance of the shoulders and waist folds as well as the appearance of gibbosity.

Posterior arthrodesis correction is a common practice surgery for the treatment of AIS after failure of medical treatment with a corset or functional rehabilitation. Surgery allows functional improvement and is indicated for curves greater than medically treated scoliosis.

The objective of this international study is to have a better understanding of the long-term outcomes (\> 20 years of follow-up) after treatment (surgical and non-surgical) of AIS and to compare the long-term status of the patient with AIS to the general population of the same age, sex and comorbidities.

All of this information will help justify or modify the strategy, techniques and goals of early treatment in adolescence to achieve a better long-term outcome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Adolescent Idiopathic Scoliosis
* Main baseline curve magnitude over 40º
* Aged 10 to 18 years at the time of treatment (surgical or nonsurgical)
* More than 20 years of follow up
* Current contact information available

Exclusion Criteria:

* Non-idiopathic scoliosis
* Younger than 10 or older than 18 at the time of initial treatment
* Less than 20 years of follow up
* Patients unable to understand and answer the questionnaires because of language difficulties or because of cognitive impairments
Improving Blood Safety and HIV Testing in Brazil

Conduct a randomized controlled trial (RCT) to test the hypothesis that offering client-centered HIV counseling and testing (HCT) to blood donor candidates will reduce the risk of HIV contamination in the blood supply and also increase appropriate referrals to preventive and care services to persons in need in São Paulo, Brazil.

Although all donated blood is screened for HIV antibodies, a residual risk of contamination persists due to the immunological window period before antibodies are detectable. Deferral of donors with behavioral risks for HIV is one means to reduce window period contamination; recruitment of voluntary donors from the community (versus family replacement donors) is held to be another. Contrary to expectation, a shift to community donors has not resulted in a decrease in HIV prevalence in units of blood collected by the investigators transfusion service. The investigators preliminary research indicates that some persons at elevated risk use donation as a means of testing for HIV. These test-seeking donors have high trust in the blood bank, do not know other places to receive testing, have low understanding of the immunological window period and believe it is acceptable to deny risk in order to be tested through donation. The test-seeking phenomenon may therefore threaten the safety of the blood supply. Test seeking at blood banks also ill serves persons who need risk reduction counseling because they cannot disclose their true behavior during the donation process and still be tested. Donors also have a low rate of return for test results and therefore do not receive confirmation or referrals to care.

To assess whether HCT at the time of donation will improve blood safety and address prevention and care needs, the investigators will randomize donor candidates to be offered this service on-site. As a biological marker for elevated risk for HIV, the investigators will compare the prevalence of HSV-2 among donors choosing testing to those choosing to donate when offered the choice (Aim 1). The impact of the intervention will be measured as an increase in persons receiving their test results, disclosure counseling and referrals (Aim 2). Secondary outcomes include differences in prevalence of transfusion-transmitted infections (HIV, HCV, HBV, syphilis, HTLV I/II, Chagas disease), donor motivations (e.g., test-seeking vs. altruism), donor deferral rates, use of confidential unit exclusion, satisfaction with procedures of the blood bank and volume of blood available for use. RCT results will provide rigorous evidence for or against the provision of on-site HCT as an effective means to improve blood safety and link individuals to needed health services.

Eligibility Criteria:
Inclusion Criteria:

* Study subjects will be Portuguese-speaking persons age 18-65 years (determined by Brazilian law to be the age of donation), who present to donate blood at our center during the study period and who provide written informed consent.

Exclusion Criteria:

* All those not meeting inclusion criteria.
Generation of Positive Biological Samples to Epoetin for Doping Control.

The study consists of generation of biological samples (in blood and urine) positive to Epoetin alfa for laboratories that wish to perform the analysis of doping controls and maintain accreditation from World Anti-Doping Agency.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male volunteers aged from 18 to 50 years.
2. A health profile devoid of organic or physiological disorders.
3. The ECG and general blood and urine laboratory tests performed before the study should be within normal ranges. Minor or occasional changes from normal ranges are accepted if, in the investigator's opinion, considering the current state of the art, they are not clinically significant, are not life-threatening for the subjects and do not interfere with the product assessment. These changes and their non-relevance will be justified in writing specifically.
4. Body mass index (BMI=weigh/height2) will range between 19 and 27 Kg/m2 and weight between 50 and 110 kg.
5. Understanding and accepting the study procedures and signing the informed consent form.

Exclusion Criteria:

1. Non compliance of the inclusion criteria.
2. Having suffered any organic disease or major surgery in the three months prior to start this study.
3. A prior history of or presence of significant cardiovascular, neurological, haematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease that, in the investigator's opinion, considering the current state of the art, they are clinically significant, are life-threatening for the subjects and could interfere with the product assessment; or which may lead to suspecting a disorder in drug absorption, distribution, metabolism or excretion, or that suggest gastrointestinal irritation due to drugs.
4. History or clinical evidence of psychiatric disorders, alcoholism, drug abuse, or regular use of psychoactive drugs.
5. History of hypertension, seizures, endocrine disorders (such as diabetes and hypothyroidism), coagulation disorders, kidney and/or liver disease.
6. Subjects for which the drug involved in the study is counter indicated.
7. Smokers of more than 20 cigarettes per day.
8. Taking more than 35 g of alcohol per day.
9. Drinking more than 5 drinks containing xanthines per day.
10. Regular use of any drug in the month prior to the study sessions. The treatment with single or limited doses of symptomatic medicinal products in the week prior to the study sessions will not be a reason for exclusion if it is calculated that it has been cleared completely the day of the experimental session.
11. Have taken part in studies with blood donation in the last 8 weeks prior to start this study.
12. History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any excipients.
13. Have been volunteer in another study with drugs in the last 3 months prior to start this study.
14. Subjects with positive serology for hepatitis B, C or HIV.
15. Subjects unable to understand the nature, consequences of the study and the procedures requested to be followed.
Impact of Anti-HLA Donor-specific Antibodies in ABO-incompatible Kidney Transplantation

It was previously suggested an improvement of graft survival in ABO/HLA incompatible kidney transplantation (KT) compared with HLA (human leukocyte antigen) incompatible transplantation. Here, the investigators would analyse clinical, biological and histological results of ABO/HLA incompatible kidney transplant recipients, comparing with ABO or HLA compatible kidney transplantation.

The investigators propose to analyze the clinical, biological and histological course of kidney function, but also to investigate the T and B cells population after KT in ABO incompatible, ABO/HLA incompatible and HLA incompatible kidney transplantation (1 and 7 years posttransplantation in each groups).

Eligibility Criteria:
Inclusion Criteria:

* Patient receiving a KT and followed at least one year in Toulouse Hospital
* Patient who have signed informed consent
* \> 18 years old

Exclusion Criteria:

* Patient under protective measures
* Patients treated for cancer, infectious or immune disease by molecules that could interfere with lymphocyte populations : Interleukin 6 (IL6) blockers, Programmed cell death 1(PD1) and the cytotoxic T-lymphocyte-associated antigen 4 (CTL4) blockers.
* Immunosuppressive treatments withdrawal - Patient in chronic dialysis
* Ongoing pregnancy or pregnancy in the past year
* Past of splenectomy
Daily Disposable Toric Comparative Trial in Europe

The purpose of this study is to investigate the subjective and objective performance of two daily disposable lenses for wearers with astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* Current soft contact lens wearers able to be fit with soft toric lenses in the protocol-specified parameters.
* Achieve 0.5 or better distance visual acuity in each eye at time of dispense.
* Achieve acceptable or optimal fit in each eye at time of dispense.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Habitual daily disposable contact lens wearer.
* Sleeps in contact lenses overnight.
* Currently enrolled in an ophthalmic clinical trial.
* Other protocol-defined exclusion criteria may apply.
Radioimmunoimaging of AL Amyloidosis

The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.

To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis without significant cardiac (New York Heart Association class IV) disease and not be on kidney dialysis. Additionally, after testing, their blood must not contain antibodies to mouse proteins. The study requires an intravenous infusion, given over 10 minutes, of the radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 to 7 days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8 weeks after the antibody infusion.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of AL amyloidosis

Exclusion Criteria:

* New York Heart Association class IV
* patient on renal dialysis
* serum antibodies to mouse protein
Arterial Stiffness Index as a Predictor of Surgically Correctable Primary Aldosteronism

Our main objective is to assess whether aortic stiffness is a predictor of blood pressure response after surgery in patients with an aldosterone producing adenoma or a unilateral adrenal hyperplasia.

Secondary objectives are to investigate whether aortic stiffness predicts cardiovascular , operative and postoperative morbid-mortality at 1 year, to evaluate the benefit of adrenalectomy in patients with primary aldosteronism due to unilateral adrenal hyperplasia and in patients with aldosterone producing adenoma associated with controlateral adrenal morphological abnormalities, and to participate to a national DNA repository of patients with primary aldosteronism.

Eligibility Criteria:
Inclusion Criteria:

* patients with a surgically correctable primary aldosteronism due to an aldosterone producing adenoma or an unilateral adrenal hyperplasia
* primary aldosteronism demonstrated by hormonal essays
* hight resolution adrenal CT scan
* operative decision based on the usual criteria of the different referent centers

Exclusion Criteria:

* patient's refusal to undergo the surgery or to participate in the study
* the patients with PA due to bilateral adrenal hyperplasia or with idiopathic primary aldosteronism, and patients with a biochemical diagnosis of PA without evidence for a lateralized aldosterone excess.
Pathophysiology and Prevention of Perioperative Myocardial Injury: A Prospective Randomized Controlled Trial

Working hypothesis and aims: 1) To explore the pathophysiology of postoperative troponin elevations and 2) whether ranolazine, a new anti-ischemic drug that has no effect on blood pressure or heart rate, prevents postoperative myocardial injury.

High-risk patients undergoing non cardiac surgery will be randomized to receive either Ranolazine or placebo perioperatively and troponin will be measured on the first 3 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

- All patients age 18 and above, undergoing major surgery that require at least 24 hours (overnight) stay in the post anesthesia care unit (PACU) or intensive care unit (ICU), and who either have known history of CAD or at least 3 of the following Revised Cardiac Risk Index (RCRI) criteria29F17: 1) high-risk type of surgery, 2) history of ischemic heart disease, 3) history of congestive heart failure, 4) history of cerebrovascular disease, 5) diabetes mellitus, 6) renal failure (creatinine \> 2mg/ml).

Exclusion Criteria:

* Pregnancy, LV ejection fraction ≤35%, patients with severe valvular disease, patients with poor echocardiographic images, patients who cannot swallow the pill after surgery, refusal to participate
Treatment of Chronic Hepatitis C Infection by Ledipasvir/Sofosbuvir in Naïve Children

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influence their quality of life. Many efforts have been directed toward the investment of effective drugs with high safety profiles and with oral administration for better compliance. The development of a new direct-acting antiviral (DAA) made it possible to achieve these goals.

The calculated sample size of the study was ....participants at 5% level of significance and 80 % power, using the following formula:

N= (Z1-α/2+Z1-β) 2 σ1\* σ2 / δ 2 This study aims to evaluate the safety and efficacy of the combined Sofosbuvir/ Ledipasvir regimen given for 12 weeks in children aged 12-18 years or weighing at least 35 kg with HCV genotype 4 infections.

Patients will receive Ledipasvir-Sofosbuvir fixed-dose combination one tablet (90 mg Ledipasvir, 400 mg Sofosbuvir) taken orally once daily at a fixed time with or without food for 12 weeks. Visits will be arranged at 4, 8, and 12 weeks. Patients will have easy access to the pediatric hepatology unit and the treating physician if any urgent problem happens in between the visits.

The SPSS software version 24, SPSS was used for data processing

Eligibility Criteria:
* Inclusion Criteria:

  * Chronic HCV infection (≥ 6 months).
  * Weighing at least 35 kg.
  * Treatment-naïve children with chronic HCV infection without cirrhosis or with compensated cirrhosis.
  * Parent or legal guardian must provide written informed consent.
* Exclusion Criteria:

  * Patients with comorbidity of chronic medical illness (decompensated heart disease, severe renal impairment (GFR \< 30) or ESRD, uncontrolled DM).
  * Concomitant HBV or HIV infection.
  * Medications (Amiodarone, beta-blockers).