cyrilzakka/clinical-trials huggingface dataset:
Brazilian Reality in the Diagnosis and Treatment of Diffuse Large B Cell Lymphoma - BRA-DLBCL

National, multicenter, non-randomized, retrospective observational study (Real World Evidence-RWE) to analyze the epidemiological profile of diffuse large B cell lymphoma, clinical management, treatment in molecular subgroups, progression profile and patient survival outcomes enrolled and treated within the last 6 years (2017 to 2022), in national cancer reference centers.

Diffuse large B-cell lymphoma management is a challenge in clinical setting, as the heterogeneity of conditions due to the molecular complexity of DLBCL may limit treatment response. Other major factor is that in Brazil we lack evidence of treatment response profiling regarding this molecular complexity. To know the epidemiological profile of DLBCL, together with the first-line treatment profile that has been adopted in reference centers, as well as the management of relapsing, is essentially important in generating evidence that add up to actions targeting the improvement of patient care, providing them with better treatments. The Brazilian reality of clinical presentation, management profile, employed treatments and response rate is little known. Considering the Brazilian reality of a continental country, where healthcare services in reference centers present heterogeneous realities, analyzing clinical routine data may generate important evidence (RWE) to comprise the understanding on treatments effectiveness. Generated evidence has the potential to help understanding the reality of Brazilian patients, as well as supporting new regional researches.

Eligibility Criteria:
Inclusion Criteria:

* Male and female;
* Age above 18 years old;
* Diagnosis of diffuse large B-cell lymphoma (DLBCL) and high-grade non-Hodgkin B-cell lymphoma at all stagings;
* Lymphoma classified for the cell of origin (GCB - Germinal Center B-Cell lymphoma, and non-germinal center);
* Having first life of treatment information available in institutional medical record;
* Having survival data available in institutional medical record.

Exclusion Criteria:

* No medical record of the molecular subgroup classification;
* Diagnosis of diffuse large B-cell lymphoma, confirmed in the year 2016;
* Patients diagnosed with Transformed Lymphomas.
Influence of Medical Student Coping Behaviour Types on Health Related Behaviour and Stress Level on the Day of OSCE

Objective structured clinical examinations (OSCEs) have recently been incorporated in the French medical studies. They will soon be an important part of the national evaluation of the students, therefore being responsible for a high level of stress.

The differents strategies of coping have never been characterized for this particular group of students. We hypothetize that different strategies of coping are associated with different level of stress, thus being an interesting insight to help students to deal with their stress and prevent disorders linked to stress.

We will be using the Brief Cope Scale to assess the different ways of coping, in addition to multiple demographic and health-related questionnaires.

This observational study will be conducted between the 17th and 19th of May at the Claude Bernard University (Lyon, France), during the OSCEs of the 4th year medical students. Their signed consent will be required before inclusion to the study.

Before the test begin, they will be given a few questionnaires to fill, including the Brief Cope Scale, visual analogous scales of their level of stress, level of confidence and level of resourcefulness. Coping methods are categorized in 4 types : positive thinking, active resolution, social support and avoidance. We will also ask them about their physical activity and their quality of sleep prior the OSCEs.

After the test, we will ask them once again their level of stress (visual analogous scale).

The main objective of this study is to demonstrate the link between the different methods of coping and the level of stress on the day of the OSCEs. Secondary objective is to have better insight and understanding over the relationship between coping methods and health-related problematics when linked to anxiety generated by exams.

All these data will be compared to a previous similar study conducted by our team of investigators on the same group of students, during their academical OSCEs in december 2021 (ECOSTRESS).

Eligibility Criteria:
Inclusion Criteria:

* Fourth year medical student of Claude Bernard University participating to the OSCEs of May 2022

Exclusion Criteria:

* No signed consent
Role of Elastin Metabolites in Aortic Remodelling in AS

Around 1-2% of people are born with a 'bicuspid' aortic valve, with only two cusps instead of the common 'tri-leaflet' valve. People with this valve develop dysfunction of the valve (narrowing or leakage) at a much earlier age. It is also more common for them to develop enlargement of the main blood vessel coming out of the heart, the aorta, and some studies suggest that they are also at higher risk of life-threatening tears in the aortic wall. Current guidelines recommend surgical replacement of the aorta at an earlier stage in these patients. The exact mechanism for the dilatation is not clear, and some studies have suggested greater 'stiffness' in the wall of the aorta. In this study, the investigators propose to 1.) study aortic size, stiffness and flow patterns using MRI in patients with bicuspid and tricuspid valves with a narrowing (aortic stenosis, 2.) measure markers in patients' blood that may be important in the process of expansion, 3.) compare the change in MRI and blood markers at before and 12 months after surgery, in patients who are due to have aortic valve replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Age 18 years or above.
* Planned surgical AVR (+/- CABG or aortic root surgery) for severe AS.
* Ability to understand the written information in English.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

* Contraindication to MRI (e.g., non-compatible pacemaker or other device).
* Severe claustrophobia (unable to have MRI scan).
* eGFR\<30ml/min (contra-indication to have contrast agent during MRI).
* Contraindication to Adenosine (severe asthma).
* Significant arrhythmia.
* Other valve disease \> moderate in severity.
* Female participants who are pregnant or lactating.
* Previous aortic valve or aorta surgery, previous CABG or other surgery involving aortic cross clamping.
* Participant in an interventional cardiovascular clinical trial.
Effects of Guiding Catheter on FFR and NHPR for the Assessment of Coronary Artery Stenoses (Disengage@Rest)

The DISENGAGE@rest study is a prospective registry carried out at Federico II University of Naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both FFR and non-hyperaemic pressure ratios values (such as Pd/Pa and the Resting Full-cycle Ratio -RFR), as well as the corresponding clinical impact on decision-making strategies. Consecutive patients with at least one intermediate stenosis (40%-90% by visual estimation) in any of the 3 main coronary arteries will be included.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Patients provides informed consent;
* Documented coronary artery disease:
* chronic coronary syndromes
* acute coronary syndromes presenting with at least one stenosis with indication for invasive functional assessment.

Exclusion Criteria:

* Patients unable to provide informed consent;
* Pregnant women;
* Any contraindication to perform angiographic study or functional evaluation with pressure wire;
* Patients with aorto-ostial stenosis
* Target vessel diameter \< 2mm
Insertion of Different Supraglottic Airway Devices on Manikin

When tracheal intubation and face mask ventilation fail, and the insertion of supraglottic airway devices (SHA) can provide ventilation, protecting the patient from hypoxemia. Supraglottic airway devices have become an important part of difficult airway algorithms. The European Resuscitation Council Guidelines recommend supraglottic airway devices for airway management by non-specialized healthcare providers. Education through simulators contributes to the development of students without direct contact with patients. In this study, it was aimed to compare the success of placement of four different supraglottic airway devices on the manikin of term 5 students who participate to the Anesthesiology and Reanimation internship.


Eligibility Criteria:
Inclusion Criteria:

* Studying in medical school in term 5
* To have completed anesthesiology and reanimation internship

Exclusion Criteria:

* who do not want to participate in the study
* Students with previous experience with four airway devices
Hearing Implant Performance in Adults With Low-Frequency Residual Hearing

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years-of-age or older at the time of surgery.
2. Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
3. Pure-tone average (PTA) (0.5k, 1k, 2k Hz) \> 30 dB HL in the contralateral ear.
4. CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
5. English spoken as a primary language.
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Individuals older than 70 years at the time of surgery.
2. Duration of severe to profound sensorineural hearing loss \> 20 years per self-report.
3. Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
6. Hearing loss of neural or central origin.
7. Diagnosis of Auditory Neuropathy.
8. Active middle-ear infection.
9. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
10. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
11. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator.
12. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
13. Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling).
14. Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation.
15. Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Effect of Saccharomyces Boulardii on Indirect Hyperbilirubinemia and Phototherapy Duration in Very Low Birth Weight Infants

Indirect hyperbilirubinemia is frequently observed in premature infants.Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal system. In this study we aimed to compare the effect of S. boulardii on severity of hyperbilirubinemia and duration of phototherapy on very low birth weight infants.


Eligibility Criteria:
Inclusion Criteria:

* very low birth weight infants

Exclusion Criteria:

* chromosomal anomalies
The Effects of Minimal Shoes in Older People at Risk of Falls: The Feetback Shoe Study

A third of people over 65, and half of people over 80, fall at least once a year. Falls are the most common cause of death from injury in the over 65s and result in a significant financial burden on the whole society. Shoes directly influence balance, gait, and the subsequent risk of slips, trips and falls by altering somatosensory feedback to the foot and ankle. Minimal shoes, that is shoes lacking a firm heel cup, a rigid sole or longitudinal arch support, have shown advantages in strengthening muscles and improving balance as compared to conventional shoes. However, limited research has studied the effect of minimal shoe in older people at risk of falls. The aim of the project will be to assess the effects of minimal shoes in older people at risk of falls, compared to conventional shoes and barefoot.

Study participants will attend a one-day testing session at the Movement Laboratory, University of Liverpool. Participants will be subjected to several standing and walking tests while wearing three types of footwear in a randomised order: (i) a minimal shoe, (ii) a conventional shoe, and (iii) barefoot. Participants' physical function, stability during standing and walking and an activity of lower leg muscles will be assessed in each of those three footwear conditions. Participants will also be asked about perceptions of footwear, regarding a minimal shoe and a conventional shoe. At the end of assessments, participants will be asked to complete several walking bouts while wearing a minimal shoe with "smart" shoe insoles, to determine "smart" insoles' validity in obtaining gait characteristics against a gold standard measure. Finally, those participants who volunteer to take part in a two-week follow-up study, will be asked to wear the minimal shoes with "smart" insoles during daily life for two weeks, After two weeks, they will be asked to fill in an online questionnaire asking them about total time they used the minimal shoes and insoles and about how satisfied they were with them.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 60 years old
* One of the vulnerability criteria for risk falls:

  (i) ≥ 1 self-reported falls after the age of 60; (ii) balance impairment as indicated by a score \<45 on the Berg Balance Scale, by a score \>2 on the simplified Tinetti Gait \& Balance test or via any other validated and reliable clinical instrument used at the recruitment site; (iii) one or two criteria for physical frailty

Exclusion Criteria:

* Macro-vascular symptoms (angina, stroke or a peripheral vascular disease)
* Neuromuscular diseases (Multiple Sclerosis, Alzheimer Disease or Parkinson Disease)
* Diabetes
* Use of a walking aid (cane or walker)
* Ankle, knee, hip surgery ≤ 3 months
* Pain in the lower extremities of ≥ 8 on the numeric rating scale
Efficacy and Safety of the Algorithm for Enteral Nutrition Support

The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease

In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.

Eligibility Criteria:
Inclusion Criteria:

weight-for-age of z-score \<-2; or length-for-age of z score \<-2; or weight-for-length of z score \<-2

Exclusion Criteria:

Any patient with congenital genetic metabolic diseases
Comparison of Post-operation Cardiopulmonary Capacity of Patients Underwent Conventional and Robot-assisted Coronary Artery Bypass Graft and Valve Replacement Surgery

Robotic surgery is one of the most popular minimally invasive procedures for patients with coronary artery disease or valvular diseases. Studies have shown that, as compared to conventional sternotomy, patients underwent robot-assisted bypass grafting or valvuloplasty had less post-operation pain, blood transfusion volume during operation, re-operation rate, post-operation stroke rate and length of hospitalization. However, most studies focused on the comparison of complications of different procedures, and the investigation of cardiopulmonary function recovery is still lacking. Thus our study is to compare the functional outcomes between patients that undergo different surgical procedures.

The study is a prospective cohort study. The experimental group will include 40 patients, consisting 20 after robotic coronary artery bypass grafting and 20 after robotic valvuloplasty. The control group will include 20 patients for each conventional procedure.

Once decided the surgery type, the surgeon will consult the rehabilitation department and the director of this trial for inform consent. The recruitment and allocation will only be done after the patient has decided which type of surgery to receive. However, in case of change of surgery type, the patient will be excluded from the trial.

Cardiopulmonary exercise testing, 6-minute walking test and questionnaires about wound pain and cardiac functional status will be performed before surgery, two weeks after discharge and three months after discharge respectively. Primary outcomes include the change of maximal oxygen consumption (VO2), anaerobic threshold and the result of six minute walking test before and after surgery. Secondary outcomes include the change vital capacity (FVC), resting heart rate, oxygen pulse (O2 pulse), wound pain visual analog scale (VAS) and Duke Activity Status Index (DASI) before and after surgery.

The hypothesis of this study is that patients who undergo robot-assisted surgery will have better cardiopulmonary outcomes than those receive conventional surgery

Eligibility Criteria:
Inclusion Criteria:

* patient who undergo surgery for coronary artery bypass graft or valvular replacement.

Exclusion Criteria:

* pregnant
* patients who receive more than one type of surgery
* severe complications after surgery (ex. respiratory failure, stroke) and stayed in hospital for more than 2 weeks.
* cannot perform the cardiopulmonary exercise testing
* other contraindications for cardiopulmonary exercise testing
Effects of EKKO Versus Conservative Treatment for Gross Motor Functions in Cerebral Palsy Patients

"Cerebral palsy (CP) affects gross motor function variably, with the spastic type notably impacting movement, coordination, and balance. Research highlights that spastic CP, characterized by muscle stiffness, can severely hinder activities like walking and running. Interventions such as gait training and vibrational therapy have shown promise in enhancing muscle function and body movements. A new device, EKKO, uses vibrational waves based on Neurotransmission Cognitive Theory to improve gross motor skills in children with CP by applying mechanical vibrations to nerve points.

This study aims to compare the efficacy of EKKO therapy with traditional conservative treatments (such as range of motion exercises and balance training) in improving gross motor function in children with CP. Conducted over six months with randomized controlled trials, the research seeks to provide evidence-based insights into optimizing rehabilitation strategies for better motor performance and quality of life for CP patients.

Eligibility Criteria:
Inclusion Criteria:

* 1. cerebral palsy (CP)
* Severity: Typically applied to those with mild to moderate CP

Exclusion Criteria:

* Participants without a confirmed diagnosis of cerebral palsy or any other neurological condition
* Severe cp cases may be excluded
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos

This post-marketing, multi-center prospective study will be conducted in a open-label, non-interventional setting, for women seeking fertility treatment and will describe morphokinetic de-selection parameters in human embryos.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-45 years
* In Vitro Fertilisation/Intra Cytoplasmic Sperm Injection treatment in long or short protocol
* Receiving follicle stimulation with Menopur 600/1200 IU
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study

This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
* Prior failure of conservative therapy.
* Radiologic evidence of LSS (L3-L5), Ligamentum flavum \> 2.5mm, confirmed by pre-op MRI and/or CT.
* Central canal cross sectional area ≤ 100 square mm.
* Anterior listhesis ≤ 5.0mm.
* Able to walk at least 10 feet unaided before being limited by pain.
* Available to complete 12 weeks of follow-up.
* Consistent with the intended labeling statement for use.
* Able to use all package components to perform the procedure.
* A signed Informed Consent Form is obtained from the patient.

Exclusion Criteria:

* Prior surgery at intended treatment level.
* History of recent spinal fractures with concurrent pain symptoms.
* Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.).
* Significant / symptomatic disk protrusion or osteophyte formation.
* Excessive / symptomatic facet hypertrophy.
* Bleeding disorders and/or current use of anti-coagulants.
* Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
* Epidural steroids within prior three weeks.
* Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
* Any potential wound healing pathologies that may compromise outcomes, including diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
* Dementia and/or inability to give informed consent.
* Pregnancy.
* Intended treatment that is defined by the product labeling contraindications.
* On Workman's Compensation or considering litigation associated with back pain.