cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Thiosulfate Enhanced Organ Preservation Solution in Kidney Transplantation

End-stage renal disease (ESRD) is a significant clinical problem for which dialysis or transplantation is required. The current need for kidneys for transplantation vastly exceeds the supply available from live donors, necessitating the use of kidneys from deceased donors. However, kidneys from deceased donors are associated with reduced viability, as lack of blood supply upon cardiac death increases tissue damage. In addition, the standard protocol for cold preservation of donor kidneys between procurement and transplantation increases the risk of delayed donor kidney function by 23% for every 6-hours of storage. Moreover, compared to other organs, the kidney is particularly prone to transplantation-induced injury due to its high metabolic activities and oxygen consumption. Hence, any minor disturbances in blood supply can easily lead to kidney injury. Therefore, it is not surprising that deceased donor kidneys have a low tolerance for damage associated with lack of blood supply. The focus of the investigators research has been to pioneer the development and supplementation of existing kidney preservation solutions with novel hydrogen sulfide (H2S) donor molecules to improve kidney viability for clinical transplantation. Specifically, the investigators demonstrated that supplementation of standard kidney preservation solutions with non-clinically viable H2S donor molecules significantly increased donor kidney protection and prolonged transplant recipient survival in murine and porcine models of kidney transplantation. Having shown the same salutary effect using sodium thiosulfate (STS; a clinically viable H2S donor drug) in rat kidney transplantation, the investigators aim to repeat this work using STS in porcine and clinical kidney transplantation.

This single-blind study will enroll participants receiving a kidney transplant. Through randomization, half of the participants will receive STS through administration into the pump the kidney is placed on after procurement from the donor and before transplant to the recipient. Participants will be followed for 1-year post transplant where blood and urine will be collected to determine graft function.

Full description pending

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and over
* End-Stage Renal Disease
* Receiving a kidney transplant from a deceased donor (NDD or DCD)

Exclusion Criteria:

* Under 18 years of age
* Inability to provide informed consent
* Living donor kidney recipients
* Pregnant individuals
* Known allergy to study medication or its components (non-medicinal ingredients)
* Multiorgan transplant patients such as simultaneous kidney pancreas or liver kidney transplants
* Currently enrolled in another interventional transplant clinical trial, or another clinical trial that in the opinion of the QI and PI would greatly impact the results of this study.
Feasibility Study on the VERAFEYE System

The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.

Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject is 18 to 80 years of age at the time of consent
* Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
* Subject is able to understand and willing to provide written informed consent

Key Exclusion Criteria:

* Any of the following within 6 months prior to enrolment:

  * Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
  * Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
  * Myocardial infarction
  * Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
  * Dilated or hypertropic cardiomyopathy
* Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
* Any of the following cardiac conditions:

  * New York Heart Association (NYHA) class IV
  * Left ventricular ejection fraction (LVEF) \< 30%
  * Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
  * Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
  * Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
* Body mass index (BMI) \> 40 kg/m2
* Body weight \< 50kg
* Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the ablation, or LAA/ASD closure procedure)
* Life expectancy less than 12 months
* Subjects who are currently enrolled in another study
* Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening

The purpose is to test the hypothesis that microdrop instillation of combined phenylephrine 1.67% and tropicamide 0.33% eyedrops causes at least equal mydriasis compared with standard drop instillation of the same mydriatic regimen, which constitutes routine care for pupil dilation during retinopathy of prematurity (ROP) screening in our neonatal intensive care unit. Comparison, also, will be made to the subsequent adverse events and the drug concentration in peripheral blood samples.

A non-inferiority, crossover, randomized controlled trial will be conducted for this purpose. Participants will be randomly assigned to receive either a) microdrops on their first and standard drops on their second screening examination a week later (M/S group), or b) standard drops first and microdrops a week later (S/M group). Microdrops (6.5 μL) will be instilled using a calibrated micropipette, while standard drops (28-34 μL) will be instilled directly through the commercially available plastic multi-dose mydriatic dropper bottle.

Eligibility Criteria:
Inclusion Criteria:

Preterm infants undergoing screening for ROP, i.e.

* infants with GA \< 32 weeks and/or BW \< 1501 grams
* infants of greater GA and BW with comorbidities, e.g. sepsis, prolonged need for oxygen supplementation etc., as recommended by the attending neonatologist

Exclusion Criteria:

* Unstable clinical condition
* Severe cardiovascular disease
* Congenital anomalies
* Clinical syndromes
* Inotropes' intake during the week prior to enrollment
* Traumatic apoptosis of the corneal epithelium
* Corneal ulcer
* Anatomical variations of the anterior segment
* Infants that are outpatients at the commencement of ROP screening
Effect of Fish Oil on Plasma Triglycerides in Adults

The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.

This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.

Eligibility Criteria:
Inclusion Criteria:\*Gender: Both women and men

* Age: \> or = 18 years
* Ethnicity and race: All ethnic and racial backgrounds welcome
* Fasting blood triglycerides greater than or equal to 150 mg/dL
* Planning to be available for clinic visits for the 12 weeks of study participation
* Ability and willingness to give written informed consent
* No known active psychiatric illness. Exclusion Criteria:\*At screening:
* Daily intake of dietary supplements containing omega-3 FAs within the past month.
* Fasting blood glucose greater than or equal to 126 mg/dL
* Self reported personal history of:
* Clinically significant atherosclerosis (e.g., CAD, PAD)
* Malignant neoplasm
* Subjects currently receiving the following medications (self report):
* Lipid lowering drugs including statins
* Anti-hypertensive drugs: beta-blockers and thiazides
* Body Mass Index (BMI) greater than or equal to 40.
* Pregnant or Lactating
* Inability to communicate effectively with study personnel
Practice Based Nutrition Intervention

This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.

Specific Aim 1 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) improves glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in a within-group analysis.

Specific Aim 2 tests the hypothesis that the nutrition intervention (low fat, low-GI vegan diet) is more effective than standard nutrition care for improving glycemic control, body weight, plasma lipid concentrations, blood pressure, and indices of renal function in individuals with type 2 diabetes

Specific Aim 3 tests the hypothesis that a low-fat vegan diet is sustainable among individuals with type 2 diabetes for a 20-week period, with weekly classes, and in a follow-up period of one year with limited professional support.

Specific Aim 4 tests the hypothesis that a low-fat vegan diet has an acceptability that is comparable to that of standard nutrition care among individuals with type 2 diabetes.

Specific Aim 5 tests the hypothesis that the effects of the dietary interventions on A1c and body weight are reduced in individuals with the A1 allele of the Taq1A and Taq1B polymorphism

Eligibility Criteria:
Inclusion Criteria:

1. a diagnosis of type 2 diabetes mellitus, as defined by a fasting plasma glucose concentration ≥126 mg/dl on 2 occasions or a prior physician's diagnosis of type 2 diabetes with the use of hypoglycemic medications for at least 6 months
2. male or female
3. A1c between 6.5% and 10.5%
4. age at least 18 years
5. ability and willingness to participate in all components of the study
6. willingness to be assigned to either a low-fat, vegan diet or to standard nutrition care
7. diabetes medications unchanged for 1 month prior to volunteering for the study
8. patient of Dr. Mark Sklar

Exclusion Criteria:

1. body mass index \>45 kg/m2
2. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
3. use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
4. pregnancy or plans to become pregnant
5. history of severe mental illness (with current unstable status)
6. likely to be disruptive in group sessions (as determined by research staff)
7. Signs/symptoms of acute uncontrolled diabetes (including but not limited to polyuria, polydipsia, blurred vision, uncontrolled weight loss)
8. unstable medical status
9. already following a low-fat, vegetarian diet
10. an inordinate fear of blood draws
11. inability to maintain current medication regimen
12. lack of English fluency
Outcome Following Orthopaedic Surgery

By investigating the long-term functional status of patients who have undergone various types of orthopaedic surgery we will have a basis for devising guidelines for future patients and surgeons.

The purpose of this database is to explore the long term outcome and functional status of patients undergoing various types of orthopaedic surgery. These data will yield a valuable database that can be used to address future research questions. For example, there are three common surgical treatments for medial osteoarthritis of the knee: tibial osteotomy, Oxford partial knee replacement, or total knee replacement. No clear guidelines exist regarding which treatment options are optimal for which patients. By gathering functional data from patients who have undergone these treatments, we will have a basis for devising such guidelines.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are scheduled to undergo orthopaedic surgery are eligible to be included in the database.

Exclusion Criteria:

* Those patients who do not meet the above inclusion criteria will be excluded from the study.
Evaluation of Two Surgical Strategies for Robotic Implantation of Total Knee Prostheses (Stryker), Cemented Versus Uncemented

Total knee replacement surgery (TKA) is a treatment for advanced tibial-femoral osteoarthritis. This intervention is justified in case of significant discomfort and failure of medical treatment. It aims to replace the native internal and external femoro-tibial joints with a joint between a femoral implant and a tibial implant.

Implants can be cemented or cementless. The longevity of these implants depends among other things on the quality of the bone fixation of the implants. It is therefore essential that this fixation be evaluated. The advantages of an uncemented TKA are the preservation of bone stock, the absence of wear by cement debris and prolonged fixation thanks to osseointegration. These characteristics are all the more interesting in a young population.

Numerous studies have been carried out on the survival of TKA with and without cement. The results found are not unanimous and mainly concern the survival of the implants and the presence of radiological signs of loosening. In addition, no study has evaluated the results of TKA with or without cement implanted using robotic assistance. The precision provided by the robotic system could improve the results of these uncemented implants.

Very few studies are interested in the functional results according to the cementation or not of TKA. And most of these studies do not have a high level of methodological evidence.

We would like to prospectively evaluate the functional results, survival, as well as the rate of radiological border after TKA with or without cement posed with robotic assistance, in the short and medium term.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of internal, external or global femorotibial knee osteoarthritis
* Indication for first-line total knee arthroplasty
* having given informed consent
* Affiliated with a social security scheme
* Patient being able to understand the objectives of the study and willing to comply with postoperative instructions.

Exclusion Criteria:

* Patient with rheumatoid arthritis
* Preoperative flexion less than 90 °
* Prosthesis associated with an osteotomy
* History of surgery on the operated knee, except arthroscopy
* Poor bone quality assessed by the surgeon
* Knee deformation greater than 10 ° preoperatively (HKA)
* Pregnant or breastfeeding Women
* Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care, persons admitted to a health or social institution for purposes other than research
* Adults subject to a legal protection measure
* Patient already participating to another clinical trial that might jeopardize the current trial
Incidence of Covid-19 in School Children

The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. This is why measures to close schools and confine populations have been decreed in a large number of countries, including France. However, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children

The Coronavirus disease 2019 (COVID-19) is causing a global pandemic with high morbidity and mortality among adults and mainly the elderly. Children seem to be little or not affected by this infection. It is estimated that children could be asymptomatic or pauci-symptomatic carriers and thus be vectors of the disease. However, the role of the children in the spread of COVID-19 injection remains unclear.

Measures to close schools and to confine populations have been decreed in a large number of countries, including France. This decision has been based on epidemiologic data of other viral infections having droplet transmission and on data of Middle East Respiratory Syndrome-related coronavirus (MERS-CoV) asymptomatic portage.

Furthermore, there are only a few data on the prevalence of COVID19 disease in children. The deconfinement strategy depends on data on the prevalence of the disease, especially in children.

Therefore, investigators propose to evaluate the incidence of Covid-19 in preschool and elementary schools children in the city of Nice (South of France) during the pandemic period using a local prospective study of 914 children.

This study will start on 11th May 2020, date of school reopening, in order to collect epidemiologic data about Covid-19 carriage among schoolers and to support governmental strategy for the new school year in September 2020.

Eligibility Criteria:
Inclusion Criteria:

Age ranging from 3 to 10 years old

* Children attending to school in Nice
* Informed consent
* French insurance subscribed

Exclusion Criteria:

* Refusal to participate from the parents or the child
* Bleeding disorders
Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)

The investigators will perform a feasibility/pilot trial of two non-pharmacological interventions for ADHD in college students.

College students diagnosed with ADHD will be randomized to three arms of approximately 8 weeks duration: (1) standard care plus a tai chi class, (2) standard care plus an exercise class, and (3) standard care alone. The exercise class will control for the social and motor components of tai chi training. The investigators will determine methodological parameters relevant to a subsequent full scale trial including recruitment and retention rates, acceptance of randomization, adherence to the interventions, and variance in outcome measures. The primary clinical outcome measure of this pilot randomized controlled trial (RCT) will be pre- to post-intervention change in inattention, i.e. the Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L, see Interviews etc. "Converse_S_L"). Secondary measures to be explored will include self- and informant-report, neurocognitive measures, psychophysiological measures, and academic performance. Practice time will be assessed daily and follow-up self-report of ADHD symptoms will be gathered monthly for 3 months beyond the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* University of Wisconsin-Madison enrolled undergraduate
* Documented ADHD diagnosis

Exclusion Criteria:

* Unable or unwilling to participate in the interventions
Head-to-Head Harmonization of Tau Tracers in Alzheimer's Disease

The purpose of this study is to compare/harmonize cross-sectional and longitudinal tau tangle measurements obtained with the tau PET radiopharmaceuticals Flortaucipir and MK-6240 to elucidate the advantages and caveats of their use in clinical trials/practice and provide parameters to integrate their estimates.

This is a longitudinal, multi-site, non-randomized study in which the participants will undergo Flortaucipir and MK-6240 PET scans at baseline and approximately at 18-month follow-up. At each time point, participants will also have an amyloid-β PET scan, magnetic resonance imaging, detailed cognitive tests, and a blood draw for biomarker quantification. The main objectives of this study are standardizing tau PET tracers' outcomes and comparing their performance.

To accomplish our objectives, the investigators propose the following specific aims:

In Aim 1, investigators will standardize tau PET processing methods, convert the tracers to a common scale, compare associations with amyloid-β, atrophy, and cognition, and compare/harmonize Braak staging assessments between tau tracers using cross-sectional data.

In Aim 2, investigators will ascertain the optimal processing method for longitudinal analysis and compare longitudinal changes in tau accumulation obtained with the tau PET radiopharmaceuticals and their associations with changes in amyloid-β, atrophy, and cognition.

In Exploratory Aim 3, investigators will compare cross-sectional and longitudinal Flortaucipir and MK-6240 estimates with plasma phosphorylated tau concentrations.

This study will produce a benchmark dataset to develop methods for tau PET quantification and harmonization.

Eligibility Criteria:
Inclusion criteria:

* Have an informant who will be able to provide an independent evaluation of functioning.
* Willing and capable of undergoing repeated MR/PET imaging.
* Fluent in a language approved by the coordinating center.
* At screening, must have no cognitive impairment, or meet criteria for single- or multiple-domain amnestic mild cognitive impairment or Alzheimer's disease dementia.

Exclusion criteria:

* Inability to provide informed consent by self or by proxy.
* Pregnant or breastfeeding women.
* Have any condition or are taking any medication that could increase the risk to the participant, limit the ability to tolerate or interfere with the results of the tests and procedures (in the opinion of the investigator).