cyrilzakka/clinical-trials huggingface dataset:
Determination of the Minimal Concentration of Antifibrinolytics Required to Inhibit t-PA-activated Fibrinolysis

Lysine analogs, like tranexamic acid (TXA) or epsilon aminocaproic acid (EACA), are antifibrinolytic agents routinely administered in children undergoing different surgeries associated with a high bleeding risk (e.g. cardiac, craniofacial, and orthopedic surgeries). Although there is a growing literature regarding the pharmacokinetic characteristics of these drugs in children, the plasmatic concentration required to completely inhibit fibrinolysis remains to be determined. In this in vitro study, the investigators will use an experimental model of fibrinolysis designed for rotational thromboelastometry (ROTEM®) to determine the minimal concentration inhibiting fibrinolysis for both TXA and EACA. In addition, this study will be used to create and validate a new experimental assay to measure fibrinolysis and the effect of antifibrinolytic agents.


Eligibility Criteria:
Inclusion Criteria:

* infants between 2 months of age and equal to or less than 12 months of age
* weigh over 5.0 kg
* either have CHD and are scheduled to undergo an elective cardiac catheterization lab procedure or do not have CHD and are scheduled to undergo a non-cardiac surgery (such as craniofacial surgery, neurosurgery, or orthopedic surgery) in the operating room

Exclusion Criteria:

* undergoing an emergent procedure,
* child in a moribund condition (American Society of Anesthesiology (ASA 5)
* children with a hematological and/or oncological disease
* Jehovah witnesses
* children with preoperative coagulopathy, defined as a platelet count \< 100,000/μL, fibrinogen level \< 100 mg/dL, prothrombin time (PT) and activated partial thromboplastin time (PTT) \> 1.5 normal range
Radiotherapy Treatments for Neoplasms of the Limbs

In this observational study patients treated at European Institute of Oncology with radiotherapy to limbs will be included

Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment. Various primary tumors as well as metastases of various origins can be localized in the upper or lower limbs. Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments.

Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms localized in the upper or lower limbs for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the upper and lower limbs for:

   Primary bone tumors, Primary soft tissue tumors, Primary tumors of the cardio-circulatory system, Primary tumors of the lymphatic system, Primary tumors of the nervous system and skin, Secondary metastases from various origins localized in that district.
2. Signed informed consent

Exclusion Criteria:

1. Radiotherapy in districts other than limbs.
Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart

Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid responsiveness. However, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. Vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. The common carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. It is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.


Eligibility Criteria:
Inclusion Criteria:

* mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment

Exclusion Criteria:

* contraindication for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload)
* contraindication for PLR test (e.g. after trauma)
* lack of possibility to examine the carotid arteries
* bilateral carotid surgery in the past
* bilateral anatomical defects of the carotid arteries
* unstable cardiac rhythm (e.g. atrial fibrillation)
Self-Management Of Asthma By Forced Oscillation Technique

Self-management strategies for asthma, including patients engagement and adherence to personalised action plans with advice on recognizing and responding to deterioration in control with effective treatments can improve asthma outcomes and possibly reduce the risk of future exacerbations. However, the real-life evidence is that asthma control remains sub-optimal in the majority of cases, thus increasing the related socio-economic costs worldwide.

Because an increased variability of lung function remains a hallmark of poor asthma control and exacerbations, its assessment over time could contribute to the success of self-management plans. Previous studies have shown the potential of Forced Oscillation Technique (FOT) as a tool for monitoring increased variability of airway obstruction and for identifying the onset of acute deterioration of airway function.

The aim of this study is to test the hypothesis that a personalised self-management plan including FOT improves asthma control and reduces number of days with increased symptoms compared to conventional asthma treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-65 years old
* Diagnosis of persistent asthma
* Treatment level at study entry:

  * For children 6-11 years: Step2 or Step3 of the GINA document
  * For adolescents and adults 12-65 years: Step2 under daily low-dose inhaled corticosteroids (ICS), Step 3 or Step 4 of the GINA document
* Uncontrolled asthma (ACQ-5 \> 1.5) that, according to the physician, does not warrant an immediate step-up of the treatment
* History of moderate or severe exacerbations in the twelve (12) months prior to baseline visit

Exclusion Criteria:

* Use of oral, rectal or parenteral glucocorticosteroids 30 days before enrolment
* Treatment with leukotriene receptor antagonist (LTRA)
* Treatment with maintenance and reliever therapy (SMART/MART)
* Smoking, current or previous with a history of 10 pack-years or more
* Documented COPD or other concomitant clinically important diseases or cognitive impairment that, according to the physician, may interfere with the subject's ability or safety to participate in the study
* Obesity (for subjects 6-19 years: BMI ≥ 95th percentile; for adults 20-65 years: BMI ≥ 40kg⋅m-2
* For school-age children (6-11 years old): gestational age at birth \< 37 weeks or documented bronchopulmonary dysplasia (BPD)
* Prolonged absence from home during the monitoring period (i.e. at recruitment, expected ≥3 consecutive weeks for ≥2 times during the 9- month monitoring period) Subject currently enrolled in other clinical trials related or involving the study of the respiratory system
* History of near-fatal asthma
* Women who are pregnant, nursing or intending to become pregnant during the time of the study
* Absence of health insurance coverage (applies to French centres only)
Automatic Segmentation of Polycystic Liver

Assessing the volume of the liver before surgery, predicting the volume of liver remaining after surgery, detecting primary or secondary lesions in the liver parenchyma are common applications that require optimal detection of liver contours, and therefore liver segmentation.

Several manual and laborious, semi-automatic and even automatic techniques exist.

However, severe pathology deforming the contours of the liver (multi-metastatic livers...), the hepatic environment of similar density to the liver or lesions, the CT examination technique are all variables that make it difficult to detect the contours. Current techniques, even automatic ones, are limited in this type of case (not rare) and most often require readjustments that make automatisation lose its value.

All these criteria of segmentation difficulties are gathered in the livers of hepatorenal polycystosis, which therefore constitute an adapted study model for the development of an automatic segmentation tool.

To obtain an automatic segmentation of any lesional liver, by exceeding the criteria of difficulty considered, investigators have developed a convolutional neural network (artificial intelligence - deep learning) useful for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients with hepato-renal polycystosis, with or without surgery
* Patients with at least one abdominal-pelvic CT scan without injection or with injection between January 1, 2016 and August 2018
* Patients with good quality and available images

Exclusion Criteria:

* Patients with no CT scan images available
* Patients with bad quality of CT scan images
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.

Primary Objective:

* To evaluate the expression of PSMA via 18F-DCFPyL PSMA-based PET/CT in patients with metastatic HER2-negative, AR-positive breast cancer. Expression of PSMA will be quantified using PSMA-based PET imaging using a novel agent, 18F-DCFPyL, as a non-invasive imaging biomarker of tumor neovasculature in HER2-negative, AR-positive metastatic breast cancer.

Secondary Objectives:

* PSMA PET will be compared with the expression of PSMA in CTCs and diagnostic metastatic tissue from patients with HER2-negative, AR-positive metastatic breast cancer.
* PSMA expression will be correlated with clinical benefit (objective response and progression-free survival) to bicalutamide and ribociclib for patients enrolled in NCT03090165.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%

Exclusion Criteria:

* Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.
* Unable to lie flat during or tolerate PET/CT
* Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
* Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT
Will Adjusting the pH of Lidocaine Reduce the Pain During Injection of Local Anaesthetic?

This study will investigate the influence of adjusting the pH of lidocaine on pain during subcutaneous injection. Each participant will receive two injections on the abdomen with different pH. After each injection, the subject will be asked to evaluate the pain on a Visual analog scale (0-100 mm). It is anticipated that the pain decreases with increasing pH. The aim of the study is to find a simple method for pain reduction that can be used in clinical practice.


Eligibility Criteria:
Inclusion Criteria: fyll inn

* Age 18-65 years

Exclusion Criteria:

* Kidney, heart or liver disease
* Eczema or psoriasis on injection site
* Neuropathy
* Regular use of painkillers
* Hypersensitivity of Lidocaine
* Pregnancy
* Diabetes
Virtual Walking for Neuropathic Pain in Spinal Cord Injury

Spinal cord injury neuropathic pain (SCI-NP) is a common problem, and when severe, is one of the most problematic of secondary conditions that is minimally to modestly responsive to currently available treatments. It is usually described as burning or stabbing, and is located at or below the level at which their sensation changes from normal to impaired; persons with no feeling at all in their legs for example can experience pain in the legs. The purpose of this project is to further investigate the use of a novel visual stimulation treatment; a technique that has shown benefit in other populations with chronic pain secondary to deafferentation. To accomplish this, a novel treatment - virtual reality (VR) walking - will be examined. Should this treatment show benefit, a portable, accessible means of treatment will be available for persons with SCI and for whom transportation to health care providers is often difficult.

This treatment will be investigated in two-phase project:

Phase 1: Determine the efficacy of VR treatments as a home-based approach and determine the effect of VR treatment on reversal of maladaptive cortical reorganization associated with SCI-NP, as has been shown in other populations with neuropathic pain secondary to deafferentation.

Phase 2: Determine the effectiveness and immediate analgesic effect of VR treatment among persons with both tetraplegia and paraplegia.

The primary outcome variable of this research is the severity of SCI-NP with a secondary outcome of level of pain interference with daily activities.

In the phantom pain literature for persons with amputations, treatment paradigms based on visual stimulation, called mirror therapies, have proven helpful. These approaches involve the person viewing a mirror image of their intact limb to produce the visual illusion of a return of the missing limb, often with a marked reduction in pain following. Investigations have demonstrated that such approaches reduce pain in some individuals and that this change is associated with reversal of the functional reorganization in the somatosensory cortex. There has been one study of neuropathic pain in SCI that demonstrated good neuropathic pain relief with a mirror image of the upper half of the individual with SCI with the lower half of their body represented by a rear projection screen generated image of walking legs. We have collaborated with this author, and developed and pilot tested a virtual walking DVD that is presented via virtual reality goggles to enhance the first person sense of immersion. Results were sufficiently encouraging to cause us to seek funding for current, broader project

Eligibility Criteria:
Inclusion Criteria: traumatic onset SCI, at least three months post onset, between 19 and 65; at least 6th grade reading level; neuropathic pain averaging at least 4/10.

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Exclusion Criteria: Unable to independently transfer to the fMRI scanning table, current pressures sores, contraindications to scanning; non-compliance with a pre-assignment task.

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Gyrocardiography- A New Non-invasive Cardiac Measurement Method to Measure Exercise Capacity and Cardiorespiratory Fitness

The goal of this study is to produce a solution to measure the cardiorespiratory fitness (CRF), which can be used by commercially available smartphones without extra equipment, add-ons and special know-how.

This observational study with follow-up is to test the feasibility of a new non-invasive cardiac measurement method (gyrocardiography, GCG) in detecting hemodynamic parameters to measure exercise capacity and cardiorespiratory fitness in healthy subjects.

The objective is to produce a solution which can be used to measure the exercise capacity and cardiorespiratory fitness (CRF) of the exercisers, keep-fit athletes and professional athletes using hemodynamic parameters such as:

* Heart rate and Heart rate variability
* Cardiac Strength profile
* Systolic and diastolic phase
* Breathing frequency
* VO2max

Participants are either athletes or non-athletic persons. The athletes will perform spiroergometry and non-athletic persons ergometry to measure the CRF expressed as VO2max.

Following parameters will be measured during the (spiro)ergometry:

* Maximum workload (W)
* VO2max (ml/kg/min)
* HRmax
* Blood lactate
* Respiratory exchange ratio RER (VO2/VCO2)

The GCG measurements for acquiring the hemodynamic parameters are performed before and after the (spiro)ergometry using smartphone. During a 1- minute GCG measurement, the smart phone is placed on the chest in the middle of the sternum.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* No diagnosed cardiovascular diseases (mild hypertension or hypercholesterolemia are still allowed)
* No medication affecting heart rate (i.e. Beta blocker)
* Signed informed consent

Follow-up visit:

* Belong to non-athletic group
* Intention to change physical activity habits
* Willing to participate to the follow-up visit

Exclusion Criteria:

* Not meeting inclusion criteria
* Declined to participate
* Resting RR before the ergometry \> 180/110mmHg
Study of HR20013 for Injection in Patients With Malignant Solid Tumors

To evaluate the safety and pharmacokinetics of single-dose HR20013 for injection combined with dexamethasone in patients with malignant solid tumors receiving cisplatin-based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older, of either gender
2. Has a diagnosed malignant tumor
3. has never been treated with cisplatin and is to receive the first course of cisplatin-based chemotherapy (≥60 mg/m2)
4. Predicted life expectancy of ≥ 3 months
5. Has a performance status (ECOG scale) of 0 to 1
6. Adequate bone marrow, kidney, and liver function
7. Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
8. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Scheduled to receive any radiation therapy to the abdomen or pelvis from Day -7 through Day 8
2. Scheduled to receive any other chemotherapeutic agent with an high emetogenicity level from Day 2 through Day 8
3. Has taken the following agents within the last 48 hours 5-HT3 antagonists, Phenothiazines, Benzamides, Domperidone, Cannabinoids, Benzodiazepines
4. Subjects receiving palonosetron hydrochloride within 14 days before enrollment
5. Subjects who previously received NK-1 receptor antagonists within 14 days prior to enrollment
6. Subjects with a history of myocardial infarction or unstable angina pectoris
7. Subjects with atrioventricular block or cardiac insufficiency
8. Subjects with poor blood pressure control after medication
9. Subjects with symptomatic brain metastases or any symptoms suggestive of brain metastasis or intracranial hypertension
10. Subjects who have experienced emetic events (vomiting or dry vomiting) or nausea within 24 hours prior to the start of cisplatin
11. Participated in clinical trials of other drugs (received experimental drugs)
12. The investigators determined that other conditions were inappropriate for participation in this clinical trial
Effects of Exercise Training on Blood Pressure Variability

A Randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. Recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).

This study will be a randomized trial, with two intervention arms: 1) Aerobic training (AT) and 2) Combined training (CT) groups. The planned training period will be 12 weeks for each group. Patients of both groups will be asked to exercise three times a week. Each session will last 80 minutes for each group. Population: We will includ 60 male subjects ≥ 45 years old, with established diagnosis of hypertension (of at least one year), treated with pharmacological therapy and with resting BP values under acceptable control (systolic BP \<150 mmHg; diastolic BP \< 90 mmHg) at admission. All groups of anti-hypertensive drugs will be admitted; there will be no restriction on the number of anti-hypertensive drugs taken by the patients. Sustained BP increase during the exercise protocol will be managed with the administration of furosemide (25-50 mg/daily). Patients who will need further pharmacological interventions for lowering BP will be withdrawn from the study. The following exclusion criteria will be adopted: secondary hypertension; significant heart valve diseases; signs and or symptoms of myocardial ischemia during ergometric test; neurological and or orthopedic conditions contraindicating or limiting ET; significant COPD (FEV1 \<50%), or symptomatic peripheral arterial occlusive disease. Patients will be randomly assigned on 1:1 basis to either AT or CT group. The randomization code will be developed with a computer random-number generator to select random permuted blocks.

Exercise training protocols: AT group: every exercise session will include 10 min of warm-up, cool-down and flexibility exercises and 60 min of aerobic exercise with cycling and treadmill at 60-70% of VO2 peak.

CT group: patients will perform aerobic and resistance exercises in the same session. In order to balance the total amount of exercise, exercise sessions of the CT group will be organized as follow: 40 minutes of aerobic training with cycling and treadmill at 60-70% of VO2 peak; 20 minutes of resistance training including the following exercises: leg press and extension, shoulder press, chest press, low row and vertical traction. all the subjects Each strength exercise will be performed by patients at 60% of their maximal voluntary contraction. Patients of CT group will performed also 10 min of warm-up, cool-down and flexibility exercises. The one maximum repetition test (1RM) will be used to determine the RE load.

Eligibility Criteria:
Inclusion Criteria:

* ability to understand the study protocol instructions
* ability to sign the informed consent

Exclusion Criteria:

* sever cardio-vascular condition
* cognitive deficit