cyrilzakka/clinical-trials huggingface dataset:
Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.

To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance.

Surgical repair of congenital lesions associated with right ventricular outflow tract obstruction frequently requires the destruction of pulmonary valve (PV) competents including the pulmonary annulas. The resulatnt pulmonary insufficiency may lead to late functional deterioration of right ventricular performance. Acute right ventricular dysfunction has been associated with poor pulmonary runoff, tricuspid valve regurgitaion and pulmonary hypertension. Preservation of PV comptence may prevent both early and late right ventricular failure. Total repair of tetralogy of fallot is a corrective surgical procedure that involves closure of the ventricular septal defect (VSD) and relief of right ventricular outflow tract (RVOT) obstruction. The surgeon must decide whether the right ventricular outflow tract size will be sufficient to allow for the entire cardiac output to traverse it without causing extreme elevation in right ventricular pressure or will go for trans-annular patch. Recently interest has shifted to preserving the integrity of the pulmonary valve annulus thus avoiding pulmonary valve regurgitation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective total correction of tetralogy of Fallot.
2. Any age group.
3. Normal pulmonay branches

Exclusion Criteria:

1. Patients associated with other congenital anomalies.
2. Regarding PV morphology, patients with pulmonary atresia , absence of PV.
3. Patients with anomalous coronary artery anatomy obstructs access to the RV
4. Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.
Effects of Rhythmic Auditory Cueing on Stepping in Place in Patients With Parkinson's Disease

Patients with Parkinson's disease have internal rhythm dysfunction, which may affect the rhythmic movements such as walking. Poor regularity of the rhythmic movement may lead to freezing of gait. This study will apply rhythmic auditory cues on the stepping-in-place training and the investigators will examine if the behavior and neuroelectrophysiology would change after auditory cueing training. The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced, and the cortical excitability would be modulated after training.

Parkinson's disease is a common neurodegenerative disease and movement disorder. Due to the degeneration of basal ganglia, patients with Parkinson's disease also demonstrate internal rhythm dysfunction, thus will lead to difficulty in rhythmic movements such as ambulation. For improving the rhythmic movement problem, auditory cues are often used in clinical setting and shows benefits in ambulation and freezing problems. Previous studies often use finger tapping test and ambulation to assess the rhythmic movement problem. No study uses stepping in place movements as a test to examine rhythmic problem. Little study investigates the effects of auditory cues on brain cortical excitability. In this cross-over study, participants will receive 2 times of training include stepping-in-place exercise with and without auditory cues in random orders. Auditory cues are given via the metronome. There is one-week wash-out period between two trainings. Movement tests such as walking and stepping-in-place and transcranial magnetic stimulation (TMS) are carried out before and after each training.

The investigators hypothesize the variation of rhythmic movements such as walking and stepping-in-place will be reduced more, and the cortical excitability would be modulated after the training with auditory cues, comparing with the other training without auditory cues.

Eligibility Criteria:
\[Patients with Parkinson's disease\]

Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease
* No hearing impairment
* Able to walk independently for at least 10m
* Able to follow command (MMSE \>=24)

\[Healthy subjects\]

* No hearing impairment
* Able to walk independently for at least 10m
* Able to follow command (MMSE \>=24)

Exclusion Criteria:

* With other neurological diseases or psychological diseases
* Dementia
* Family history of epilepsy
* History of head trauma, surgery, or metal implants
* Having pacemaker or other electrical stimulators
* History of syncopes or frequent migraines
Evaluation of the Accuracy of the Elastic Fusion MRI-ultrasound Obtained in Vivo by the Koelis™ System

The study aims at quantifying the registration error obtained in routine patients in different parts of the prostate and for operators with different experience in order to assess the average precision of the elastic MR-ultrasound fusion obtained by Koelis™ system.

Patients referred for placement of intraprostatic fiducials before radiotherapy for prostate cancer will be prospectively offered to enter the study.

The fiducials will be placed under transrectal ultrasound guidance, in the prostate apex, midgland and base, according to our routine procedure. A 3D Ultrasound acquisition of the prostate will be obtained at the end of the placement. As per our routine procedure, patients will undergo unenhanced prostate MRI to control the position of the fiducials. An elastic fusion of the MR images and the 3D ultrasound acquisitions will be retrospectively performed by operators of varying experience using the Koelis system. The fiducials (visible on MR and ultrasound images) will be used to quantify the registration error.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient requiring placement of intraprostatic fiducials
* No contra-indication for fiducials placement
* No contra -indication to MRI
* No contra -indication for intravenous injection of gadolinium chelates
* Patient affiliated to the social security system
* Patients who received oral and written information

Exclusion Criteria:

* Patient deprived of liberty as a result of a judicial or administrative decision.
* Patient under guardianship or curatorship.
* Any event preventing or prematurely interrupting the collection of assessment criteria would result in the premature exit of the subject.
3D/4D Ultrasound Contrast Enhanced Imaging (CEUS) for Carotid Plaque Vulnerability

Contrast enhanced 3D/4D (3 dimension/4 dimension) ultrasound (CEUS) provides visualization of the dynamic vascular features of the plaques, in a unique spatial format using three orthogonal planes and angiogram-like images. Therefore, the observer can utilize the entire vascular system in a volumetric manner (3D). The rotation of the intra-plaque neovasculature as viewed in various angles provides a realistic representation that is more easily appreciated. Inter-observer variability for individual plaques has been assessed and inter-observer variability and inter-scan variability (the analysis of multiple images from single patients in longitudinal studies) were dependent on plaque size, with larger plaques showing lower variability. Therefore, the proposed 3D/4D vs. 2D CEUS imaging of the carotid plaque will provide added value for the depiction of the and quantification of intra-plaque blood vessel density by providing a true volumetric viewing area. This data will be correlated to the subsequent surgical specimens. The goal of the protocol is to investigate the correlation of intra-plaque blood vessel density and hemorrhage to 3D/4D CEUS vasa vasorum using quantitative software analyses. The histology methods used for quantification of hemorrhage and vessel density analyses.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects with known carotid artery disease will be included.
* Subject must be able and willing to comply with study procedures and provide a signed and dated informed consent including consent for 3 year annual follow up.
* Subjects will be screened by asking each study subject if they have known or suspected hypersensitivity to any of the components of Optison, blood, blood products of albumin. In addition, each study subject will be asked if they have a right to left or bi-directional or transient right to left cardiac shunts. If any of the above questions are answered in the positive, the patient will not be eligible for inclusion in the study.

Exclusion Criteria:

* Female subjects of child bearing potential will be excluded.
* The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
* History of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
* Has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
* Has known right to left, bi-directional or transient right to left cardiac shunts.
* Any known contra-indications as listed on the current Optison package insert.
SAPIEN 3 Ultra System PMCF

A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

To monitor and review device performance and outcomes of the SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.

Eligibility Criteria:
1. Subject meets the criteria per the Indication and Contraindications according to the current IFUs.

   * Indication for Use: The Edwards SAPIEN 3 Ultra THV, the Edwards SAPIEN 3 THV, and the associated delivery systems are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a Heart Team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% at 30 days, based on the STS risk score and other clinical comorbidities unmeasured by the STS risk calculator).
   * Contraindications: Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis; Inability to tolerate anticoagulation/antiplatelet therapy.
2. Subject has provided written informed consent to comply with all study procedures and follow-up visits
Spirulina Supplementation In Recovery From Damaging Exercise

Exercise can cause muscle damage, leading to a loss in muscle function, increased muscle soreness and inflammation. Evidence supports the use of nutritional strategies to help recovery. Spirulina is a type of algae. It is eaten as a food supplement as it is full of micronutrients, some which provide anti-inflammatory benefits. This work will assess the impact of taking spirulina supplements on recovery from hard exercise. Investigators will measure changes in muscle function, soreness and markers of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Are available and willing to attend St Luke's Campus, Exeter
* Age 18 - 40
* BMI 18.5 - 30 kg/m2
* The participant exercises / plays sport for \> 2 h/week, but doesn't do structured resistance strength training
* Self-reported as healthy (absence of injury or disease)
* Have no known food allergy to algae
* Are not taking any over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
* Non-smoker

Exclusion Criteria:

* Are unable to attend St Luke's Campus, Exeter
* Are out-with age range 18 - 40
* BMI below 18.5 or above 30 kg/m2
* The participant does not exercise
* The participant does regular structured resistance strength training
* Known injury or disease that might influence study outcomes
* Have a known food allergy to algae
* Are taking over the counter or prescribed medication that might interfere with study, e.g. anti-inflammatory medication
* Smoker
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

The purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.


Eligibility Criteria:
Inclusion Criteria:

* All infants \< 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
* Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 \</=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (\~15 min)

Exclusion Criteria:

* Major congenital anomalies including congenital heart disease
* Anomalies that prevent discontinuation of NCPAP
* Undergoing current evaluation for and/or treatment of sepsis
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
* No medical or psychiatric conditions that could put the subject at risk
* Willing to follow contraception guidelines

Exclusion Criteria:

* Clinical signs of COVID-19 indicative of impending hospitalization
* Documented infection in addition to COVID-19 that requires systemic treatment
* Medical condition that could adversely impact safety, in the Investigator's opinion
* Is or planning to be pregnant or lactating
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Has received or will receive during study participation a vaccine for COVID-19
* Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
An Exploratory Study of DS-8500a on Beta Cell Function Using Hyperglycemic Clamp

The objective of the study is to evaluate change in insulin secretory capacity in patients with type 2 diabetes mellitus as determined by hyperglycemic clamp after a 28-day oral administration of DS-8500a at 75 mg in a placebo-controlled, 2 × 2 crossover study. In addition, safety of this regimen will be examined in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 20 years at the time of informed consent
* Japanese patients with type 2 diabetes
* Patients who have HbA1c ≥ 7.0% and \< 9.0%

Exclusion Criteria:

* Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
* Patients receiving or requiring treatment with insulin
* Patients with a body mass index (BMI) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2
* Patients with clinically evident renal impairment (estimated glomerular filtration rate \[eGFR\] of \< 45 mL/min per 1.73 m2) or clinically significant renal disease
* Patients with fasting plasma glucose ≥ 240 mg/dL
Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia

This trial is a multi center, randomized, controlled, excellent effect, open and loading trial design. The subjects are randomly assigned to the experimental group and the control group. The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

By collecting the movement gait information of the patient's healthy side limb, judging the patient's movement intention, analyzing and learning the gait characteristics of the patient's healthy side, so as to drive the movement of the single lower limb rehabilitation training robot and drive the patient's affected side limb to carry out the rehabilitation training suitable for the healthy side limb, which can enable the patient to complete the normal walking process and achieve the purpose of auxiliary rehabilitation. Through long-term walking rehabilitation, patients can gradually recover their normal walking gait.

Eligibility Criteria:
Inclusion Criteria:

* understand the whole process of the experiment, voluntarily participate and sign the informed consent;

  * 18-75 years old for both sexes;

    * Stable vital signs, stable condition, tolerance to low-intensity sitting and standing training;

      ④ Weight ≤ 100kg, height 1.50M \~ 1.90m;

      ⑤ Patients with stroke hemiplegia diagnosed as the first onset, including cerebral infarction and intracerebral hemorrhage, the course of disease is within one month after the onset;

      ⑥ One level of sitting or standing balance, able to wear a single lower limb rehabilitation training robot with the help of medical staff;

      ⑦ The passive range of motion of hip and knee is not significantly limited, and the passive range of ankle can be kept in neutral position.

Exclusion Criteria:

* The range of motion of the joint is severely limited and the walking movement is limited;

  * Skin injury or infection of the lower limb in contact with the robot;

    * History of unstable angina pectoris, severe arrhythmia and other heart diseases;

      ④ History of severe chronic obstructive pulmonary disease;

      ⑤ Other contraindications or complications that may affect walking training;

      ⑥ Pregnant women, women preparing for pregnancy or lactation;

      ⑦ Those who participated in any clinical trial within 1 month before enrollment;

      ⑧ Other circumstances that the researcher believes cannot participate in the clinical trial.
Heading in Football: Impact on Neural Blood Biomarkers

The goal of this observational study is to evaluate the safety of heading in football. We will study the release of biomarkers in blood that reflect microscopic neural damage. The main questions this study aims to answer are:

* Does participation in a football match lead to a change in biomarkers that reflect microscopic neural damage?
* Is the dose of exposure during a football match related to the magnitude of change in biomarkers that reflect microscopic neural damage?

Participants will participate in a regular football match and provide blood samples before and right after the football match. The football match will be recorded on video to count the number of headers of all participants.

The objective of this prospective observational study is to determine the potential impact of ball heading in football on brain integrity as assessed by blood biomarkers for neural damage in a real-world setting. Healthy amateur football players will be recruited to participate in the study. Participants will be invited to play a regular football match for investigation purposes. They will provide a blood sample within one hour before the start of the match and a second blood sample within one hour after the match. Participants will be asked to provide a third blood sample within 48 hours after participation, but this is not obligatory. The football match will be recorded on video to determine the number of head impacts of all participants. Furthermore, participants will wear heart rate sensors and local positioning sensors to determine the internal and external training load and account for the possible confounding effects of exercise on neural blood biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Member of the KNVB;
* 18 years or older;
* Male
* Self-reported fitness to play 70-90 minutes (absence of injury).

Exclusion Criteria:

* Sustained a head injury in the last year;
* History or current neurological condition;
* Regular participation in other contact sports (e.g. rugby, American football, ice hockey, fighting sports);
* (Former) military personnel with a history of fighting/blast exposure
A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and Cachexia

To compare the effects of megestrol acetate and placebo on body weight, anorexia, cachexia, calorie intake, and nutritional parameters of patients with a confirmed diagnosis of AIDS. To determine whether megestrol acetate relative to placebo improves the perception of well-being among AIDS patients with cachexia. To evaluate megestrol acetate's effect on immune function via skin test reactivity, T4/T8 ratio, and total lymphocytes.


Eligibility Criteria:
Inclusion Criteria

Patient must have:

* Confirmed diagnosis of AIDS (CDC definition).
* Documented weight loss or anorexia.
* Life expectancy = or \> 20 weeks.
* The perception that the weight loss is a detriment to their well-being.
* Ability to provide informed consent, read and write English.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions are excluded:

* Dementia or evidence of mental incompetence which would preclude compliance with the protocol.
* Severe diarrhea defined as 5 or more watery stools per day for at least 7 days.
* Active uncontrolled systemic infections at the start of treatment.
* Patients may not be entered for at least 2 weeks after acute infection.
* Clinical or radiologic evidence of ascites or pleural effusions.

Patients with the following are excluded:

* Obstruction to food intake or impaired digestive/absorptive functions.
* Contraindications to megestrol acetate (poorly controlled hypertension or heart failure or deep vein thrombosis).
* Inability to consent or be available for close follow-up.
* Active systemic infections at the start of treatment.
* Clinical or radiologic evidence of ascites or pleural effusions.
* Patients who have been hospitalized or have suffered an exacerbation of their illness associated with weight loss within the past 2 weeks are excluded.
* Menstruating female patients are excluded.

Prior Medication:

Excluded:

* Corticosteroids.
* Anabolic steroids.
* Marijuana.
* Megestrol acetate.
* Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)

Patients may not be started on any therapy designed to treat the underlying HIV infection or which may have a major impact on appetite and/or weight gain.

* Patients who have been started on zidovudine (AZT) within 8 weeks. (Patients may have been previously treated with AZT and failed or may currently be receiving AZT for at least 8 weeks.)

History of substance abuse and questionable current and future abstinence.