cyrilzakka/clinical-trials huggingface dataset:
Investigational Study of Accommodation Triggering and Control to Allow for the Performance of Refraction Measurements

An investigational study in the control of the user's accommodative state via visual stimuli.

The EyeQue Corporation (EyeQue) is developing devices to measure refraction that can be used outside of the clinic. The refraction devices require the user to perform a series of tests while looking through it to view a visual display. The current devices do not currently account for accommodation and therefore may present inaccurate results for the younger population where the accommodation effect is quite significant. This study is aimed at enabling future EyeQue refraction measurement products to overcome this issue and provide the required tools to allow for accommodation measurement, correction and control. Control of the user's accommodative state will allow for measurement of near vision as well as far vision based on the refractive measurement.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Age 18 through 30 years at the time of consent
* Binocular vision
* Willing and able to give informed consent and follow all study procedures and requirements
* Fluent in English

Exclusion Criteria:

* Spherical correction \> +4D or \< -5D, astigmatism \< -2.5D.
* Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
* Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use EyeQue devices
* Reported or observed eye disease or pathology, including but not limited to:

  * Glaucoma
  * Cataracts
  * Macular degeneration
  * Eye infection
  * Keratoconus
  * Diabetic neuropathy/retinopathy
  * Cytomegalovirus retinitis
  * Color blindness (any color deficiency)
  * Diabetic macular edema
  * Amblyopia
  * Chronic or acute uveitis (cells and/or flare in anterior chamber)
  * Strabismus (exotropia, esotropia, and hypertropia)
  * Macular hole
* Eye surgery within the last 12 months (including Lasik or lens replacement)
* Subject does not have the physical dexterity to properly operate the EyeQue VisionCheck device or the EyeQue app on the smartphone in the investigator's opinion
* PD smaller than 50mm or larger than 75mm.
* Any self-reported mental illness or condition, including but not limited to: claustrophobia, fear of simulators, nyctophobia.
* Any self-reported neurological diseases, including but not limited to: epilepsy, Alzheimer's, nystagmus.
Chronic Subdural Hematoma and Aspirin

The aim of this randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for chronic subdural hematoma with and without discontinuation of low-dose aspirin

Chronic subdural hematoma (cSDH) is one of the most common neurosurgical conditions. Its significantly higher prevalence among patients older than 65 (69%) versus younger (31%) explains why 41% of the patients are taking blood thinners. Antiplatelet therapy in patients with chronic subdural hematoma (cSDH) presents significant neurosurgical challenges. Studies investigating the effect of acetylsalicylic acid (ASA) in cranial neurosurgery are sparse and mostly based on case reports. Given the lack of guidelines regarding perioperative management with antiplatelet therapy, it is difficult to balance the patient's increased cardiovascular risk and prevalence of cSDH. The aim of our randomized, blinded, placebo controlled clinical study is to compare the peri- and postoperative bleeding and cardiovascular complication rates of patients undergoing burr-hole trepanation for cSDH with and without discontinuation of low-dose ASA. We will include patients receiving low-dose ASA as secondary prophylaxis for various reasons (e.g. coronary artery disease (CAD), cerebrovascular disease, etc.) and will randomize them either to a Placebo- or Aspirin-arm. The patients will receive placebo or ASA for 12 days whereas the normal ASA treatment will be resumed 12 days after randomization. Our study primarily seeks to evaluate the risk of recurrence after burr-hole trepanation for cSDH under low-dose ASA treatment compared to placebo treatment. Secondary objectives are to assess the rate of thrombotic events, perioperative blood loss, postoperative anemia, intra- and postoperative blood transfusion rate, and clinical outcome (mRS, GOS, Markwalder score). The study will be performed in cooperation with the Department of Cardiology of the University Hospital of Basel.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing burr hole trepanation for cSDH who are under low-dose aspirin treatment ( Aspirin cardio 100mg once a day) for secondary prophylaxis

Exclusion Criteria:

* Patients under the age of 18years
* A recent (30 days before randomization) major cardiac event (i.e. unstable angina, myocardial infarction, or coronary revascularization)
* A recent (30 days before randomization) active bleeding event.
* Patient with known bleeding disorder (e.g. hemophilia)
* No informed consent
Saroglitazar Magnesium 4 Mg in the Treatment of NAFLD in Women with PCOS (EVIDENCES VII)

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS.

This is a multicenter, phase 2A, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Saroglitazar Magnesium in women with well characterized PCOS. \\

The study will be conducted over a period of up to 34 weeks and will include Screening (Days -28 to -7) Phase, a 24-week Treatment Phase following randomization on Day 1.

The primary endpoint of the study is change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF.

Eligibility Criteria:
Inclusion Criteria:

* Females, 18 to 45 years of age.
* Previously confirmed diagnosis of PCOS:

  1. oligo-and/or anovulation;
  2. hyperandrogenism (clinical and/or biochemical);
  3. polycystic ovary morphology on ultrasonography
* Evidence of NAFLD within 6 months prior to the Screening Visit (Visit 1).
* Alanine transaminase ≥ 38 U/L at Visit 1. Visit 2 ALT must not increase \>30% from Visit 1.
* Hepatic fat fraction ≥10% by MRI-PDFF.
* Willingness to participate in the study.
* Ability to understand and give informed consent for participation.
* Woman who agrees to use the contraceptive methods.

Exclusion Criteria:

* Presence of other chronic liver diseases (hepatitis B or C, autoimmune hepatitis, cholestatic liver disease, Wilsons disease, hemochromatosis, etc.).
* Average alcohol consumption ≥ 7 drinks per week for women in the 6 months prior to enrollment.
* Clinical, imaging, or histological evidence of cirrhosis.
* Patients who have used medications known to cause hepatic steatosis for more than 2 weeks in the past year.
* Prior bariatric surgery.
* Weight loss of more than 5% in the 3 months preceding screening.
* Severe co-morbidities (e.g., advanced cardiac, renal, pulmonary, or psychiatric illness).
* Known allergy, sensitivity or intolerance to Saroglitazar Magnesium, comparator or formulation ingredients.
* Use of antidiabetic and lipid lowering medications if the dose is not stable for at least the 3 months preceding screening.
* Intake of Vitamin E (\>100 IU/day) or multivitamins containing Vitamin E (\>100 IU/day) 3 months before enrollment.
* Use of drugs with potential effect on NAFLD/NASH in the 3 months prior to screening.
* Illicit substance abuse within the past 12 months.
* Pregnant or breast feeding females.
* Women with known Cushing syndrome or hyperprolactinemia.
* Refusal or inability to comply with the requirements of the protocol, for any reason, including scheduled clinic visits and laboratory tests.
* History of myopathies or evidence of active muscle diseases.
* History or current significant cardiovascular disease.
* History of malignancy.
* History of bladder disease.
Renal Function Assessment in Critically Ill Children

Identification of renal dysfunction in critically ill children is often delayed due to lack of accurate methods for evaluation of glomerular filtration rate (GFR). The investigators compared GFR measurement by the gold standard technique iohexol plasma clearance with estimated GFR (eGFR) based on selected established formulas incorporating the renal biomarkers creatinine, cystatin C and betatrace protein.

Acute kidney injury (AKI) is a frequent comorbidity of critical illness associated with poor outcome, including prolonged duration of mechanical ventilation, longer length of stay and increased mortality or progression to chronic kidney disease on the long term. The reported incidence of AKI in critically ill children and neonates varies widely between 10% and 80% depending on the diagnostic criteria. Besides a decline in renal function, also the phenomenon of augmented renal clearance (ARC) and in consequence enhanced clearance of renally eliminated drugs, is increasingly recognized in pediatric intensive care patients. Hence, accurate assessment of renal function is crucial in the intensive care population to guide therapy. But to date consensus is lacking about the reliability of common GFR estimation methods based on the endogenous renal biomarkers serum creatinine, cystatin C and betatrace protein in critical care patients. the aim of this study is to measure GFR in a reliable way by iohexol plasma clearance and evaluate the agreement between the gold standard technique iohexol plasma clearance and biomarker-based formula to estimate GFR.

Eligibility Criteria:
Inclusion criteria:

* patients admitted to the pediatric or neonatal intensive care unit
* 0 - 15 years
* for neonates: gestational age ≥ 37 weeks
* bodyweight \>2.5kg
* intra-arterial and/or intravenous access available for iohexol administration and blood sampling

Exclusion criteria:

* no vascular access in place for iohexol administration and blood sampling
* absence of parental/patient consent
* known hypersensitivity to contrast media or previous history of adverse reaction after administration of contrast agents
* known thyroid dysfunction, or for newborns: mother with known thyroid dysfunction
* extracorporeal circuit (haemodialysis, extra corporal membrane oxygenation (ECMO), peritoneal dialysis)
* patients with chronic kidney disease or congenital kidney anomalies
* preterm neonates (gestational age \< 37 weeks)
* body weight \< 2.5 kg
* dehydrated newborns (i.e. loss of birth weight ≥ 10%)
* planned/expected surgery with extracorporeal circulation within 5 days after inclusion
China Healthy Aging Cohort Study

This is a community-based prospective cohort study in China. The study has been initialized in 2024 and included older residents. The goal of this observational study is to explore the risk factors related to disability and dementia in the elderly Chinese community population, and develop a risk prediction model for disability and dementia.

This is a community-based prospective cohort study in China. Individuals who were aged 60 years or older, had lived in the communities for more than 1 year, and had signed the informed consent form were enrolled in the present study. The study has been initiated in 2024 and aimed to explore the risk factors related to disability and dementia in the elderly Chinese population, and develop a risk prediction model for disability and dementia. This work consists of three steps as follows. First, by integrating the data of the elderly cohort of 4 communities in Beijing, Shenzhen, Haikou and Hangzhou, we plan to establish a Chinese elderly database. Second, to explore the risk factors of disability and dementia in elderly Chinese. Third, to construct risk prediction models of disability and dementia in Chinese elderly.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60 years or older
* Lived in the community for more than 1 year
* Signed the informed consent form

Exclusion Criteria:

* Cannot complete the survey
Local Tranexamic Acid During Vaginal Hysteractomy to Reduce Blood Loss

Assessing the efficiency of Prophylactic use of local tranexamic acid during vaginal hysterectomy to reduce blood loss during operation

This randomized control trial will investigate whether local tranexamic acid is efficient for decreasing bleeding during vaginal hysterectomy.

The investigators will randomize local placebo (saline) vs. local 1 gr tranexamic acid; IV 1gr diluted in 100 ml saline and IV 100 ml saline at the beginning of surgery.

Eligibility Criteria:
Inclusion Criteria:

* 20-90 years old female patients going through vaginal hysterctomy

Exclusion Criteria:

* massive bleeding during operation due to major vessles injury
* known coagulopathies
* sensitivity to tranexamic acid
* medical need in tranexamic acid administration during operation due to bleeding
Bedside Evaluation of Coagulation in Children With Congenital Heart Disease

The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).

The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.

Hemostasis, a main concern during and after any surgical procedure, is traditionally monitored by the following laboratory tests: activated Partial Thrombin Time (aPTT), prothrombin time (PT), fibrinogen, platelets count. They neither provide a reliable estimate of the risk of bleeding, nor allow determining useful interventions.

New investigations of hemostasis are now used and validated during and after surgery: Rotational Thromboelastometry (ROTEM®) and impedance aggregometry. This is a quick bedside functional analysis of the patient's clotting. Children who undergo surgery under cardiopulmonary bypass (CPB) are particularly at risk of bleeding and this population hasn't been studied with large cohort yet.

Hypothesis: Hemostasis in children with CHD, especially when cyanotic, is intrinsically abnormal. The corrective surgery on CPB induces further hemostatic disorders which can be identified by the ROTEM platelet®.

The aim of the study is to evaluate the hemostatic function of the child with congenital heart disease using a Point-Of-Care (platelet-ROTEM ®) system, before surgery and after alterations induced by cardiopulmonary bypass (CPB).

This is a single center, observational, prospective study. Expected duration: 2 years. The investigators plan to include 200 patients with CHD, 100 patients undergoing surgery with CPB and 100 patients with congenital heart disease requiring cardiac catheterization. Recruitment will be conducted by the Division of Paediatric Cardiology.

Inclusion criteria include an age of 0-16 years and a diagnosis of congenital heart disease requiring surgery with CPB or cardiac catheterization. Patients with known dyscrasia or treated with antiaggregant within 10 days/oral anticoagulants within 48h before surgery/catheterization.

ROTEM platelet® test will be performed before surgery/catheterization. Patients undergoing surgery will have a second test within 30 minutes after the end of cardiopulmonary bypass. All patients will benefit from the usual cares.

Eligibility Criteria:
Inclusion Criteria:

* children between 0 and 16 years, born with a congenital heart disease requiring either cardiac catheterization or surgery with cardiopulmonary bypass
* parental and/or patient consent

Exclusion Criteria:

* known hemostatic disorder
* known platelet function disorder
* antiaggregation treatment \<10 days before blood sampling
* oral anticoagulation \<2 days before blood sampling
* intravenous heparin \<6 hours before blood sampling
* patient and parents unable to consent
Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib

This is a non-interventional, multi center post-authorization safety study that includes all patients diagnosed as Unresectable Differentiated Thyroid Carcinoma (DTC) and treated with Sorafenib within a certain period. The investigator should have made the choice of treatment (NEXAVAR) according with the Japanese Package Insert prior to enrolling the patient in this study.

The enrollment period is of 9 months. The observation period for each patient starts when the therapy with NEXAVAR is initiated. Patients will be followed for 9 months or until it is no longer possible (e.g. lost to follow-up); this will be considered the standard observation period. Those patients, to whom a total of 24 month follow up is possible, information on effectiveness including treatment duration and survival status of the patient and of keratoacanthoma and/or squamous cell cancer development will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients who start NEXAVAR treatment for radioactive iodine-refractory unresectable Differentiated Thyroid Carcinoma (DTC)

Exclusion Criteria:

* Patients who have already received NEXAVAR treatment
Biological, Genetic and Environmental Involved in the Complications of Sickle Cell Disease

The objective of the study is to refine our knowledge on the physiopathology of the symptoms and the complications for the patients affected by a drepanocytic syndrome.

The establishment of risk factors and indicators of severity will allow to target better the patients requiring an adequate strategy in order to prevent the installation of some complications or to limit their worsening.

Some additional tubes will be taken during the usual control of blood test of the drepanocytic patient. A sample of urine will be also asked. Tubes, after pre-treatment, will be sent to Erasme hospital.

A series ob biological but also genetic parameters, both at asymptomatic patients and those in aigüe phase of the disease, can be measured either immediately or a little time after the prelevement.

In this way, we can study numerous domains linked to the physiopathology of the drepanocytose (hémolyse, vaso-occlusion, rheology, factors modulators of the clinical expression). The surplus of the collection could be used for other researchs. It's in this context that we also wish to constitute a biobank of serum, plasma and urine for these drepanocytic patients by surplus of taken material.

The study is realized within the framework of an academic collaboration between institutions. The bank of takings will be located in the reference center of the pathologies of the Red Blood Cell (laboratory of medical chemistry of the erasme hospital).

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older with sickle cell syndrome
* Signing an inform consent form after validation on it by the Ethics Committees of the participating centers.

Exclusion Criteria:

* Any pathology concomitant risk of nephropathy
* Severe CVO within the month preceding the sampling
* Transfusions within 3 months prior to sampling
* Pregnant patient or within 3 months post- accouhcement
Short Term Response of Breast Milk Micronutrient Concentrations to a Lipid Based Nutrient Supplement in Guatemalan Women

Research goals include evaluating the relative impact of maternal nutritional status versus recent dietary intake on breast milk micronutrient composition, and evaluating the impact of a maternal lipid based nutrient supplement (LNS) on breast milk micronutrient composition.

The study includes a cross sectional and an interventional component. Maternal dietary intake and nutritional status will be compared to breast milk micronutrient composition in a cross sectional manner.

The short term effect of maternal dietary intake on breast milk micronutrient composition will be examined using an intervention with a controlled diet and LNS. Infants will be test-weighed during the LNS intervention in order to calculate the infant micronutrient intake from the control and LNS intervention days.

Mother-infant dyads will be recruited into the study and the order in which they will receive the 3 treatments will be randomized. All mothers will receive all treatments.

The mothers will be invited to the clinic on 4 separate occasions. During the first study visit, maternal blood will be collected, anthropometric indices will be assessed, and food frequency and demographic characteristic surveys will be administered. During the 2-4 visits, the LNS intervention will take place. Mothers will arrive at the clinic fasted, and a fasted milk collection will occur. Subsequently, mothers will be provided 3 meals based on local foods with low-nutrient density. Milk will be collected for 8 hours at each infant feed (ad libitum). A 24 hour dietary recall will be conducted. Mothers will receive 1) no LNS, 2) A single dose of LNS with breakfast, or 3) A single dose of LNS split into 3 parts with their meals throughout the day. Infants will be test weighed before and after each feed to calculate their nutrient intake from breast milk and the impact of the different supplementation schemes on their nutrient intake.

Eligibility Criteria:
Inclusion Criteria:

* Mother 18-40 years of age
* Apparently healthy, with no acute illness
* Willing to stay in clinic for breast milk sampling, and adhere to all study procedures
* 4-6 months of lactation and ≥ 8 breast feeding episodes per day (usual frequency is \>20 times/day)
* Last birth was a singleton birth
* Only breastfeeding one child
* Child is 4-6 months of age

Exclusion Criteria:

* Current supplement use (iron + folic acid excepted)
* Self reported mastitis or other breast infections
* Reported problems with breastfeeding which might affect study procedures
* Last birth was premature (\>4 weeks pre-term by maternal report)
* Measured body mass index (BMI) of less than 18.5 or a measured mid upper arm circumference (MUAC) of less than 12.5 cm
* Temporary- if the mother or her infant present with an acute illness, (for example flu or diarrhea,) they will be rescheduled to return on a later date when both are apparently healthy.
* Allergy to milk, milk products, or peanuts.
Nalmefene in Alcohol Dependence and Borderline Personality Disorder

The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.


Eligibility Criteria:
Inclusion Criteria:

* Alcohol use disorder according to DSM 5
* Borderline personality disorder according to DSM 5
* CGI-BPD \> 3
* Female have to use contraception

Exclusion Criteria:

* Other axis I disorders
* Severe organic disorder
* Pregnancy or breastfeeding
* Allergy to Nalmefene
* Subjects with Opioids use disorder or in treatment with opioid agonists