cyrilzakka/clinical-trials huggingface dataset:
Freedom Study: Myfortic in Kidney Transplant Patients

The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 75 years.
* Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.

Exclusion Criteria:

* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
* Kidneys from non-heart beating donors or HLA identical living related donors.
* ABO incompatibility against the donor.
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia

The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia.

The main aims to answer are:

* evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome.
* evaluation of type and sequence of the therapies administered, the response rates, and the adverse events.
* evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome.
* evolution of autoimmune cytopenias into myelodysplastic syndromes.
* a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism.

Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.

This observational study will characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia to evaluate predictors of outcome. Additionally, a subgroup of patients with myelodysplastic syndromes (diagnosed according to current WHO 5th edition 2022) will be included to evaluate the presence of autoimmune activation, and red cell metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autoimmune cytopenias (AIHA/ITP/CIN/AIN)
* age \>/= 18 years
* ability to sign informed consent
* availability to undergo 3 year follow up
* for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \>/= 10% dysplastic features of at least one lineage along with MDS defining cytopenia and/or MDS defining cytogenetics.

Exclusion Criteria:

* any condition impeding the acquisition of the informed consent
* immune cytopenia diagnosis preceding \>/= 6 months the enrolment
Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?

A large number of children with otitis media undergo surgery with ventilation tubes (VTs) placed in the tympanic membrane. This is done to improve hearing and speech development and to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is required to assure that the tubes are functional, hearing loss has been corrected, and potential complications are properly diagnosed and managed. Guidelines regarding follow-up care give different advices concerning when, how and by whom the controls should be made.

The primary goal of this study is to investigate if follow-up care after surgery with VTs of children aged 3-10 years can be done by general practitioners instead of specialists without negative consequences for the patient.

In the study the child's hearing and speech development, middle ear function, subjective complaints and complications will be assessed. User satisfaction and other aspects related to the quality of control will also be assessed.

If the study shows that follow-ups after surgery with VTs can be done on the level of primary care without loss of care quality, specialist health care services will be spared and cost-effectiveness for the overall healthcare system will improve.

Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK (ethics committee) in November 2018.

Eligibility Criteria:
Inclusion Criteria:

* Insertion of a ventilation tube in at least one ear
* patient at Trondheim University Hospital, Molde Hospital, Aalesund Hospital, Kristiansund Hospital, Stavanger Hospital, Hospital North Norway, or Innlandet Hospital in Gjøvik.

Exclusion Criteria:

* Medical syndromes or other co-existing severe disease that possibly result in increased complication rate after insertion of ventilation tubes, i.e. Downs Syndrome, Cystic Fibrosis, Primary Ciliary Dyskinesia
* Auditory processing disorder (APD)
* Severe neurogenic hearing loss (HL) at least one ear (\> 50dB HL in frequencies 0.25 - 4.0 KHz)
* Guardians or children who do not master the Norwegian language
Complications Following Pacemaker or Implantable Defibrillator Cardioverter (ICD) Implantation in Denmark

This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD) implantation.

This study examines possible risk factors with regard to complications following pacemaker or implantable defibrillator cardioverter (ICD)implantation. Furthermore validation af the Danish Pacemaker and ICD Register will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving a cardiac device (pacemaker, cardiac resynchronization therapy (CRT) or implantable defibrillator cardioverter (ICD)), or undergoing a reoperation

Exclusion Criteria:

* none
Survey Assessment of Patient and Provider Impressions of Telemedicine in Radiation Oncology

To understand more about the opinions of patients and health providers on the use of telemedicine in radiation oncology.

Primary Objective:

To characterize patient and provider satisfaction with telemedicine in RO

Secondary Objective:

* To provide evidence for or against the use of telemedicine in radiation oncology (RO)
* To assess the feasibility of and value added by telemedicine in RO
* To describe barriers and facilitators to telemedicine in RO
* To identify preferred use cases for telemedicine in RO

Eligibility Criteria:
Inclusion Criteria:

* Patients will be eligible if they are aged 18 or older and have undergone at least 1 telemedicine encounter (video visit) with the radiation oncology department at MD Anderson or its affiliates within 2 months from the initiation of the study (and prospectively as the study enrolls). This would include weekly see visits, follow-up visits, or consultations
* English speaking
* Access to email and internet to complete the survey
* Attending physicians in the radiation oncology department who have utilized telemedicine will be contacted to fill out surveys reflecting their experience

Exclusion Criteria:

• Protected populations such as adults unable to consent, pregnant women, prisoners, and individuals who are not yet adults will be excluded
Placental Learning Model for Neurovascular Microsurgery for the Management of Intracranial Aneurysms

Training in microsurgical techniques for the management of intracranial aneurysms is carried out during the practical training of the DES in Neurosurgery and during the continuous training of neurosurgeons according to the indications of the patients of the department. Currently, the recent increase in indications for endovascular treatment compared to surgical indications has led to a decrease in surgical indications and in the experience of neurosurgeons. However, there are still surgical indications that are often complex situations that neurosurgeons must overcome with a specific simulation approach.

There are different simulation models for the treatment of intracranial aneurysms. The small animal (rodent) model has the disadvantage of being poorly suited to the reproduction of intracranial aneurysms (different extracranial vessel walls, too small intracerebral vessel caliber) and of being constraining to the establishment. The computerized stimulator model which has the advantage of being able to reproduce the anatomy of a patient but whose haptic sensitivity performance is difficult to reproduce for very fine movements, it is not very accessible because it is expensive. The placental model uses a fresh human placenta, the appearance of the vessels of which is very similar to those found intracerebrally, and dilations on their walls can be performed with a pediatric urinary catheter.


Eligibility Criteria:
Inclusion criteria:

* Woman over the age of 18;
* Placenta considered as surgical waste intended for incineration; with a negative infectious status verified during pregnancy follow-up
* Woman who did not express her opposition, after information, to the reuse of her placenta for educational purposes to improve the practical training of future neurosurgeons.

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject under guardianship or curatorship
* Subject under safeguard of justice
Performance of the Acoustic Based CADScor System in Coronary Artery Disease

The purpose of this study is to determine if the CAD Score, collected from the CADscore system, performs as well as the Coronary CTA in determining Coronary Artery Disease, in low to intermediate risk patients that are referred for coronary CTA.


Eligibility Criteria:
Inclusion:

* Signed ICF
* Male or female, aged 30 years or above
* Symptoms suggestive of stable coronary artery disease
* No history of coronary artery disease(prior myocardial infarction, percutaneous coronary intervention or coronary artery bypass graft).

Exclusion:

* Asymptomatic for angina or chest pain
* Implanted donor heart
* Previous Coronary Artery Bypass Graft(CABG)
* Previous Coronary Stenting or known CAD
* Arrhythmia causing non-sinus rhythm
* Fragile or compromised skin, or abnormal anatomy or significant operation scars in the fourth left int3er Costal 9IC4-L) recording area
* Implanted mechanical heart or mechanical heart pump
* Implanted pacemaker or Cardioverter Defibrillator(ICD), other implanted active electronics or act5ive electronic support equipment closer than 50 cm to the CADScore System.
Effect of MOF on Exercise Blood Pressure

The purpose of this study is to establish an effect of monomeric and oligomeric flavanols supplementation on exercise blood pressure and vascular function in healthy volunteers.

Exaggerated exercise blood pressure (BP) response in healthy subjects is recognized as a risk factor of hypertension and cardiovascular events. Pathogenetically exaggerated BP response is attributed to compromised vascular(endothelial) functions as well as oxidative stress and inflammation. Monomeric and oligomeric flavanols (MOF) are dietary components with well-characterized beneficial effects on the redox homeostasis, endothelial function and microvascular health.

The objectives of the study will be to evaluate the effects of MOF in comparison to placebo on exercise blood pressure, endothelial function, inflammatory and redox status in healthy prehypertensive volunteers. In addition, the study will aim to assess the impact of MOF supplementation on the exercise-induced renin-angiotensin-aldosterone system (RAAS) activation and extracellular matrix remodelling.

After being informed about the study and potential risks all volunteers signing informed consent form will undergo screening to determine eligibility for the study. Eligible subjects will be randomized in the double-blind manner to monomeric and oligomeric flavanols /placebo or placebo/monomeric and oligomeric flavanols sequence (cross-over design) in a 1:1 ratio. Monomeric and oligomeric flavanols are derived from grape seeds extract and will be administered in a dose 200 mg per day.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women with normal to high-normal resting BP (SBP 120 - 139 mm Hg and DBP 80 - 89 mm Hg).
2. Age 35 - 65 years
3. BMI 20 - 32 kg/m\^2
4. Hypertensive response to maximal exercise test defined as SBP ≥ 200 mm Hg (men) and ≥ 180 mm Hg (women).

Exclusion Criteria:

1. Active engagement in the weight loss programs, also including slimming diets.
2. Active smoking or abstinence from smoking for less than one year.
3. Use of medications that reduce BP and/or can potentially influence other study outcomes (ACE-inhibitors, angiotensin receptor blockers, diuretics, painkillers, etc).
4. Intake of polyphenol-containing supplements for two month before and during the whole course of the study.
5. History of diabetes, cardiovascular, respiratory, renal, gastrointestinal, hepatic or other diseases and conditions, which potentially can compromise participation in this study.
6. Intense sporting (\>10 h/week) and/or participation in the competition at the professional level.
7. Pregnancy or breastfeeding.
8. Participation in a clinical trial within 4 weeks prior to inclusion into this study.
9. Vaccination against Covid-19 within two months before the screening/randomization visit or expected vaccination against Covid-19 during the study
Efficacy and Safety of Oral Encochleated Amphotericin B for the Treatment of Cryptococcal Infection

This will be an open label phase I/II prospective cohort study to determine the efficacy and safety of CAMB for the treatment and prevention of cryptococcal infection.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection, informed consent, cryptococcal infection present, diagnosed by either: CSF cryptococcal culture, CSF cryptococcal antigen (CRAG), plasma/serum CRAG

Exclusion Criteria:

* Presence of jaundice or known liver cirrhosis, \>72 hours antifungal therapy, pregnancy or breastfeeding, unlikely to attend regular clinic visits
Influence of Rodenstock Spectacle Lenses on Myopia Progression.

The prevalence of myopia in Singapore is among the highest in the world, with 65 percent of our children being myopic by Primary 6, and 83 percent of young adults being myopic. As such, Singapore is often labelled as the "Myopia Capital of the World". By 2050, it is projected that 80 to 90 per cent of all Singaporean adults above 18 years old will be myopic and 15 to 25 percent of these individuals may have high myopia.

High myopia (spherical equivalent refraction ≤ -5 D) puts one at risk of many eye disorders later in life, such as early cataracts, glaucoma and macular degeneration. These complications often cause significant morbidity and may even be sight-threatening. Hence there is an urgent and growing need for synergistic efforts to counter myopia.

The goal of this clinical trial is to test the efficacy of spectacle lenses in controlling the progression of myopia in children (aged 6-12 years) over a period of 2 years. In addition, this trial aims to evaluate the impact of these spectacle lenses on central visual performance and visual comfort.

Therefore, in this randomised, double-masked clinical trial, one hundred and eighty-five (n=185) subjects aged 6-12 years with mild or moderate myopia (\< -5D) will be randomised in a 1:1 allocation ratio into three strata defined by age 6-8, 8-10 and 10-12 years to ensure age balance between the two arms (control group - single vision lenses and intervention group - myopia control lenses, gender matched). In the control group, after one year (12 months) of wearing single vision lenses, the children will switch to the myopia control lenses (crossover design).


Eligibility Criteria:
Inclusion Criteria:

* All myopic children aged 6-12 years old
* Treatment naïve
* Sphere: -0.5 D till -6.00 D
* Anisometropia \< 1.5D
* Astigmatism \> -1.5D
* Monocular best corrected visual acuity +0.1 logMAR or better, and binocular visual acuity 0.0 logMAR or better

Exclusion Criteria:

* On current myopia control treatments
* Any diagnosed ocular conditions besides myopia or astigmatism.
* No diagnosed ocularmotor conditions (Nystagmus, strabismus, etc.)
* Any diagnosed chronic physical or mental disabilities
* Contraindication in cycloplegia (high IOP, etc.)
* Corneal astigmatism \> 1.5 D; irregular astigmatism
Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist

A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.

The purpose of this study is to determine the efficacy of EA as a treatment strategy in the end stage knee osteoarthritis (KOA) population waiting for total knee arthroplasty (TKA). The research objectives are to 1. To determine the efficacy of EA to provide pain relief, improve function and quality of life in the end stage KOA population who are waiting for TKA. 2. To determine if EA is superior to sham EA or waiting list groups in providing pain relief, improving function and quality of life in the end stage KOA population who are waiting for TKA.

Outcome measures will be collected from all 3 groups at baseline, mid point, completion and 6 week follow up.

Participants will be recruited from the Concordia Joint Replacement Group in Winnipeg, Manitoba.

Inclusion Criteria: participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.

Exclusion Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.

Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.

Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.

Other: allergy to needle components, needle phobia, pregnancy

Eligibility Criteria:
Inclusion Criteria:

* participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.

Exclusion Criteria:

* Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.

Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.

Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.

Other: allergy to needle components, needle phobia, pregnancy
Gender Bias in the Overuse Studies Conducting in Primary Care

The purpose of this study is to analyze whether the differences between men and women in the frequency of adverse events due to ignoring "Do not do" recommendations in primary care setting are due to biological causes or gender bias.

First, using the Delphi technique, a consensus will be reached on those "Do Not Do" recommendations that should be included in the retrospective analysis study. The selection criteria for these recommendations will be if they are considered to persist in clinical practice in primary care, their relationship with factors associated with sex and gender, and if ignoring the "Do not do" recommendation could cause a serious adverse event. Second, a retrospective cohort study will be carried out in which a random selection of medical records will be reviewed to identify the frequency of adverse events due to ignoring the "Do not do" recommendations previously selected by consensus. Investigators will review a total of 1538 medical records of patients (50% of women) who attended primary care consultation from 1st January 2022 to 31st December 2022. Data source will be the electronic record management system of the autonomous community of Valencia, named ABUCASIS. Adverse events will be identified by using an activation tool used in a previous study (SOBRINA study).

Eligibility Criteria:
Inclusion Criteria:

* Attending primary care consultation from 1 January 2017 to 31 December 2019.
* Adult

Exclusion Criteria:

- None
Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant

Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
* Neurological state stable since at least 1 month
* Moderate Handicap (EDSS ≤ 5,5)

Exclusion Criteria:

* Secondary Progressive MS
* Patient having an attack
* Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
* Depressive patient
A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

The objective of this study was to compare the safety and effectiveness of two versions of the Bausch \& Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.


Eligibility Criteria:
Inclusion Criteria:

* Myopia with or without astigmatism.
* Normal Corneal topography
* Willing to have both eyes treated with the laser.

Exclusion Criteria:

* Contraindications to LASIK.