cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort (PETER-TRESRIV)

Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve.

It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes

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Patients with systemic right ventricle (mostly congenitally-corrected transposition of the great arteries or transposition of the great arteries corrected by atrial switch) commonly develop significant systemic tricuspid valve regurgitation which is a therapeutic dilemma for the care team. Surgery (valvuloplasty or replacement) is the common and historical treatment but the rate of mortality is high and results about long-term benefit are contradicting. Percutaneous edge to edge repair could be a alternative to surgery.

10 high-risk surgical patients with severe systemic tricuspid regurgitation undergoing a percutaneous repair were included between January 2019 and November 2022. Our study is a retrospective analysis of short and mid-term clinical, biological, echocardiographic and MRI/TDM outcomes with an expected minimum follow-up of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* \> 18-years-old
* Right systemic ventricle
* Severe tricuspid regurgitation
* Symptomatic patient (NYHA 2 - 4) despite optimal medical therapy
* High-risk surgical patient deemed not eligible for surgery by a multi-disciplinary and thus having underwent a percutaneous treatment of tricuspid regurgitation

Exclusion Criteria:

* pregnant
* breastfeeding women
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female participants aged ≥18 years.
2. Urine protein ≥ 0.75 g/24 hours or uPCR ≥ 0.5g/g
3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
4. Participants receiving a RAAS inhibitor must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
5. Participants receiving a sodium-glucose cotransporter-2 (SGLT2) inhibitor or sparsentan must have been on a stable dose for at least 12 weeks prior to Study Day 1 that is projected to remain stable during the study.
6. Kidney biopsy-proven diagnosis of IgAN within 52 week; LN within 12 weeks or C3G within 52 weeks of Day 1 and with evidence of C3 fragment deposition.

Key Exclusion Criteria

1. A ≥50% decline in eGFR within 3 months before screening.
2. Concomitant significant renal disease other than IgAN, C3G, or LN.
3. Uncontrolled hypertension, defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive treatment.
4. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
Check Brain Temp Trial

Despite some controversial results, many patients and animal studies have suggested significant benefit of using hypothermia treatment in stroke patient population. However, certain questions for how to applying this therapy properly such as when to start, what is the optimal temperature, how long is the duration, and what is the best hypothermia technology that may avoid the complications including focal soft tissue injuries are still remain questioned.

In this study, we will utilize the linear relationship of temperature vs. chemical shift in MR Spectroscopy to measure the brain temperatures in normal men.

Brain temperature has an interactive relationship with brain cell metabolism. Hypothermia is a known neuronal protectant therapy. It has been proven to be effective in reducing the brain injury in patients post cardiac arrest. However, the role of hypothermia in brain or spinal cord injury such as in either hemorrhagic or ischemic condition remains unclear. Many questions on hypothermia are unanswered. For example, what is the optimal low temperature in order to have the maximum therapeutic effect? How long should hypothermia be applied for? Is there a regional temperature difference between different parts of brain in physiological or pathological conditions? In order to answer these questions, the first step is to have a reliable way of measuring brain temperature accurately. However, invasive technique such as inserting temperature probe to different parts of brain is not practical. Using body core temperature to estimate the intracranial temperature is inaccurate.

To establish a noninvasive means to obtain and monitor brain temperature in a dynamic environment is the essential step in order to studying hypothermia and answering the questions mentioned earlier. MRI brain thermometry is a fast, direct and non-invasive method to estimate the brain temperature with great accuracy. This technique is based on several temperature dependent physical properties in our brain such as chemical shift between metabolites and water. Currently, there is no standard MRI brain thermometry in physiological and pathological conditions such as stroke. We plan to explore and establish MRI brain thermometry. The first step is to establish temperature correlation on measured water temperature.

Then temperature of different regions of brain will be used to compare to the standardized water temperature in normal people.

Eligibility Criteria:
Inclusion Criteria:

* Normal and healthy

Exclusion Criteria:

* 1. claustrophobia, 2. history of neurological disease. 3. Tattoo and 4. History of lost conscience due to any head injury.
The Effect of Extremely Low-Frequency Magnetic Field on Stroke Patients

A stroke can cause neurological deficits resulting in decreased motor, sensory, and cognitive function, as well as a decline in psychosocial functioning. Early rehabilitation following a stroke incident is of great importance, and interventions should aim for an overall improvement in patient functioning and achieving the highest possible level of independence. In recent years, there has been an emphasis on the need to regulate the inflammation that occurs after a stroke, as it may influence the improvement or deterioration of the patient's condition. Initial studies have also indicated the potential for influencing post-stroke inflammation through physical therapy procedures. In studies on the impact of magnetotherapy on inflammatory processes in post-stroke patients, magnetotherapy is usually applied to the pelvic girdle or the head area. However, the effectiveness of these two application methods has not yet been compared. In this study, investigators aim to compare the effects of magnetotherapy applied to different body areas as a complement to neurological rehabilitation. The study aims to assess the impact of magnetotherapy as a complement to neurological rehabilitation on physical fitness and inflammatory markers in post-stroke patients, to evaluate the effect of magnetotherapy as a supplement to neurological rehabilitation on physical fitness and oxidative stress markers in post-stroke patients, and to assess the differences between the effects of magnetotherapy applied to the pelvic area versus magnetotherapy applied to the head area.

The participants will be divided into three groups: one will serve as the control group, while the other two will receive magnetotherapy to the head or the pelvis, respectively, as an addition to standard neurological therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years
* Ischemic stroke within a maximum of two weeks prior to admission to the ward

Exclusion Criteria:

* Severe functional impairment (FIM score \< 37)
* History of previous strokes
* Other neurological diseases or other conditions that could significantly impair the patient's functioning
* Contraindications to magnetotherapy
* Inability to establish logical verbal communication with the patient
* Lack of informed consent to participate in the study
A Dose Escalation Study of Radio-labeled Antibody for the Treatment of Advanced Cancer

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors.

The purpose of this study is to determine the safety and tolerability in subjects who receive FF-21101(111In) for dosimetry and FF-21101(90Y) for treatment of advanced solid tumors. This is an open label study that will recruit approx 70 patients

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Histologically or cytologically confirmed advanced solid tumor malignancy, refractory or relapsed from prior therapy, or for whom no alternative therapy is available
* At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
* Archival tumor sample available, or be willing to undergo a fresh tumor biopsy, prior to study
* At least one measurable disease site that meets target lesion requirements
* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
* Life expectancy of ≥ 3 months
* Adequate hematologic parameters without ongoing transfusional support:
* Negative serum pregnancy test
* Ability to provide written informed consent

Exclusion Criteria:

* Previous radioimmunotherapy. Previous antibody-based therapy is allowed as long as ≥ 28 days has elapsed from last dose to study treatment.
* Prior radiation to \> 30% of the red marrow or to maximal tolerable level for any organ
* Serious cardiac condition within the last 6 months
* Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of antimicrobials that are considered to be essential for care of the patient
* History of retinal degenerative disease, history of uveitis, history of retinal vein occlusion (RVO), or any eye condition that would be considered a risk factor for RVO or has medically relevant abnormalities identified on screening ophthalmologic examination
* Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior, or currently treated brain metastases are allowed.
* Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
* Known autoimmune disease
* Active infection requiring intravenous (IV) antibiotic usage within the last week prior to the dosimetry portion of the study
* Corticosteroid use within 2 weeks of study treatment
* Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or confound the interpretation of study results
* Pregnant or breast-feeding
Mechanism of Human Cold Pain Perception - Involvement of TRPA1, TRPM8, Nav1.7 and Nav1.8

Animal studies suggest that the transient receptor potential ion channels TRPM8 and TRPA1 are cold sensors and that sodium channels Nav1.8 and Nav1.7 are essential for detecting pain induced by cold temperatures. This study aims to validate these findings in humans.

It is essential for human survival to be able to perceive potentially harmful cold. The perception of slight cooling in animals depends on the ion channel TRPM8, but this may represent a largely separate mechanism from painful cold. In mice, TRPM8 and TRPA1 appear to be involved, but also the sodium channels Nav1.7 and Nav1.8, through their temperature-dependent function. These receptors might be redundant, so that failure of individual receptors only leads to no or only a partial reduction in the detection of cold.

Since results obtained in animals do not always translate to humans, the investigators want to clarify whether TRPM8, TRPA1, Nav1.7 and Nav1.8 are involved in the perception of cold pain in humans.

In order to induce cold pain experimentally, an increasingly cooled solution (down to 3°C) is injected into the skin, and the inhibitors for the mentioned targets are added individually and in combination.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Full legal capacity

To ensure an equal number of each sex in the study population, only volunteers of one sex will be included as soon as the number of subjects with the other sex has reached half of the calculated sample size.

Exclusion Criteria:

* Participant of another study, ongoing or within the last 4 weeks
* Medication intake (except contraception) or drug abuse
* Female subjects: Positive pregnancy test or breastfeeding
* Body temperature above 38°C, diagnostically verified
* Known allergic diseases, in particular asthmatic disorders and skin diseases
* Sensory deficit, skin disease or hematoma of unknown origin in physical examination of the test site
RAD 1501: a Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).

Eligibility Criteria:
Inclusion Criteria:

* Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
* Patients must have an ECOG status of 0, 1, or 2
* Patients must be at least 18 years of age
* Life expectancy must be greater than 12 months
* MRI of brain within prior 12 months to confirm lack of other causes of facial pain
* All patients must be given written informed consent

Exclusion Criteria:

* Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
* Patients with atypical trigeminal neuralgia or headache pain syndromes
* Patients with pain associated with multiple sclerosis or base of skull tumor
* Patients with medical contra-indications to MR imaging (e.g. pacemaker)
Using 32 - Gauge Needles With Lengths of 5 mm and 8 mm on Pain Post-injection, Leak and Blood Glucose

This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.

This is a Clinical crossover trial study. In this study, 100 patients with type II diabetes will be selected based on entry and exit criteria, then randomly divided into two equal groups (group "A" and group "B").In the first three days of the first week of hospitalization, in group "A" insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 5 mm, and in the other group insulin injection with a 90-degree angle and using Nidel 32-Gauge with a length of 8 mm will be done. After a one-day break, in another three days, the types of needles used in the two groups are moved together. After a one-day break, in another three days, the types of needles used in the two groups are replaced together. Then the VAS scale will be used to assess post-injection pain; the amount of leakage after the injection will be measured in two ways Yes/No, according to the researcher's observation. And to check the effect of Needles on controlling patients' blood sugar, their blood sugar levels will be measured based on the routine of hospital units.

After entering the data in SPSS20 software, the collected data will be analyzed using descriptive statistics (frequency, percentage, mean, standard deviation) and statistical tests (t-test, chi-square).

Eligibility Criteria:
Inclusion Criteria:

* Having type II diabetes
* Use injectable insulin for at least two years
* BMI \>18
* Lack of mental illness and mental retardation
* Use insulin pen

Exclusion Criteria:

* Lack of desire to participate in the study
* Having a skin problem in the injection site
Influence of Virtual Reality on Myocardial Revascularization

Coronary artery disease is a dysfunction characterized by the narrowing of the coronary arteries in due to the accumulation of atheromatous plaques. The surgery of myocardial revascularization is a surgical procedure of choice performed in individuals with to improve symptoms and survival. Cardiovascular surgeries of this size in an extended time of rest after the procedure. Such immobility may have repercussions to the functionality of the individual. Thus, the early mobilization with the use of reality in the Intensive Care Units (ICU) emerges as a potential means of of complications in the postoperative period of cardiac surgery.

The study will be performed at the ICU coronary artery of the Hospital de Clínicas Gaspar Viana de Belém-Pará. 40 volunteers will participate in the study.

preoperative period of myocardial revascularization. The oxidative stress (by the method called Optical Morphology by Oxidative Stress, using capillary blood drops), the modulation autonomic heart rate (with a Polar® model RS800CX) and motor function (through the Medical Research Council scale), before and after the application of protocol for cardiac rehabilitation with ergometer, virtual reality and ambulation. Volunteers will be randomized into a control group who receive the cardiac rehabilitation protocol from the hospital and the Early Mobilization Group, which will receive the cardiac rehabilitation protocol plus virtual reality training using Wii video game from Nintendo.

Eligibility Criteria:
Inclusion Criteria:

* Male patients over 50 years of age to 80 years
* Body Mass Index (BMI) between 20 and 30 BMI kg / m2
* Candidates for elective and conventional myocardial revascularization surgery
* Hemodynamic stability with or without the use of positive inotropes

Exclusion Criteria:

* Patients with previous pulmonary diseases, with ejection fraction below 35% or greater than 54%
* Undergo concomitant surgeries and who underwent surgical reoperation and intraoperative death
* Also excluded are those with motor and neurological deficits, as well as contraindications for performing 6MWT
* orthopedic limitations
* unstable angina, HR\> 120 bpm at rest, systolic pressure\> 180 mmHg or diastolic\> 100 mmHg.
Targeting Microvascular Dysfunction in Young Hypertensive Patients

Cholesterol and blood pressure lowering tablets have been shown to be of benefit in patients with established high blood pressure. High blood pressure is a very common medical condition that can lead to vascular complications i.e. problems with the blood vessels in the body. One way of detecting early changes in these blood vessels as a result of high blood pressure is to measure their compliance/flexibility with a noninvasive technique known as ultrasound and with a simple blood test. The investigators are trying to establish whether these early changes in blood vessels can be significantly improved by the use of both a cholesterol and blood pressure lowering tablet at an earlier stage than is currently advised. The investigators hope that the early combination of these tablets will prove more effective than the use of a blood pressure lowering tablet by itself and therefore possibly reduce the risk of long term complications developing.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible for the study, all of the following criteria must be met:

  * All patients must have a diagnosis of essential hypertension with off treatment systolic pressure \>140 mmHg and/or diastolic pressure \>90 mmHg, measured at rest in the seated position on at least two separate occasions, at least 2 weeks apart.
  * Patients will be \< 50 years for men and \< 60 years for women.
  * Female patients of childbearing potential must be using a medically accepted means of contraception (that is, interuterine device, oral contraceptive, implant, DepoProvera or barrier devices). Female patients of childbearing age will be screened with a pregnancy test.
  * Patients will be typically already on antihypertensive therapy.
  * Patients must have a level of understanding sufficient to complete all tests and examinations required by the protocol and are able to understand and give informed consent.

Exclusion Criteria:

* Patients will be excluded from the study if they meet any of the following criteria:

  * A history of diabetes mellitus, coronary artery or cerebrovascular disease, hypertensive retinopathy, hypertensive nephropathy, left ventricular hypertrophy or hyperlipidaemia warranting treatment as defined by the latest NICE guidelines which recommend an age based treatment strategy rather than one driven purely by lipid levels in isolation.
  * Abnormal baseline liver function (defined as AST or ALT \> 3 times upper limit of normal), raised baseline creatinine kinase (CK) (defined as CK \> 200 mmol/L), severe renal impairment (defined as estimated glomerular filtration rate (eGFR) \< 30 mls/minute) or previous adverse event relating to either an ARB or statin in the past.
  * Female patients will be excluded if they are pregnant, intend to be pregnant or are lactating. Female patients of childbearing age will be screened with a pregnancy test.
Current Clinical Practice in the Management of Atrial Fibrillation in Greece: the MANAGE-AF Study

This is a multicenter, 1-year prospective, observational study of Atrial Fibrillation (AF) in Greece, designed to provide real world data regarding the characteristics of AF patients in Greece, as well as current clinical practices and adherence to the 2010 ESC guidelines.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 18 years with any type of AF(first diagnosed, paroxysmal, persistent, long-standing persistent and permanent) according to the classification described in the recent ESC guidelines.
2. All patients should give written informed consent to participate in the study.

Exclusion Criteria:

1. Patients anticipated life expectancy less than 1 year due to a severe concomitant disease.
2. Participation in an another clinical trial, with the exception of epidemiology trials (observational) that do not influence AF management.
3. Patients with mental disability unable to comply with follow - up visits and these who are unable to provide, in written, their informed consent or patients with anticipated inability to adhere to scheduled follow up visits.