cyrilzakka/clinical-trials huggingface dataset:
Chronic Limb-Threatening Ischemia Treated with Intravascular Lithotripsy Observational Study

CALCIO is a multicentre, prospective, observational cohort study that will collect real world data on the use of intravascular Lithotripsy (IVL) with the Shockwave IVL system to disrupt calcified femoropopliteal and crural lesions in patients with chronic limb-threatening ischemia (CLTI). The primary objective of CALCIO is to understand the effectiveness of IVL in promoting wound healing and preventing amputation. The secondary objectives of CALCIO are to evaluate the immediate effectiveness of the treatment in restoring vessel patency as well as its safety and impact on patients' quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)
* Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;
* Treatment with IVl using the Shockwave Medical IVL System.

Exclusion Criteria:

* \< 18 years old;
* Incapacity or refusal to give informed consent;
* Ongoing pregnancy;
* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
Impact of COVID19 on Asthma

The COVID19 pandemic is having an immeasurable impact on the economy and on morbidity and mortality. Knowledge and scientific evidence about this disease is advancing rapidly, but it is not yet known whether asthmatic patients suffering from COVID19 have an exacerbation of asthma, or whether this viral infection has an impact on control and lung function in the short to medium term.

The aim of this study is to define the changes that occur in these two parameters in asthmatic patients suffering from COVID19. To this end, asthmatic patients who have suffered a SARS-CoV-2 infection and who have required an emergency consultation or hospitalisation will be collected in a pneumology consultation and matched by age, sex and severity of asthma with a group that has not suffered the same. Both will be followed for one year, and lung function will be tested at six months and exacerbations and changes in ACT during the following year.

These data are intended to improve the available knowledge on the impact of IDVC19 on asthma patients with a view to making appropriate recommendations, prevention and treatment adjustments in line with the results obtained.


Eligibility Criteria:
Inclusion Criteria:

* 12 -80 years
* Asthma diagnosis according to guidelines
* Follow up on asthma clinics in one of the participant hospitals

Exclusion Criteria:

* Other severe respiratory condition independent of asthma
Safety and Effectiveness of PEG-Intron in HIV-Infected Patients

The purpose of this study is to see if it is effective to give PEG-Intron (PEG-IFN) to HIV-infected patients who are not doing well with their current anti-HIV drug combination (HAART).

At entry, patients undergo HIV genotypic/phenotypic analysis. Patients continue their current antiretroviral regimen but are randomized to receive one of four doses of PEG-IFN or PEG-IFN placebo administered subcutaneously once per week until results of HIV genotyping/phenotyping are available (approximately 4 weeks). Patients who respond with a 0.5 log or greater decrease in HIV RNA at Week 4 have optimized HAART added to their ongoing PEG-IFN regimen and are followed for 24 weeks in an observational study.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Have HIV levels of more than 2000 copies/ml.
* Have failed their current HAART (had a significant increase in their HIV levels with HAART).
* Have a CD4 cell count greater than 200 cells/microL.
* Have had more than 6 months of HAART.
* Have been on their current HAART for at least 6 weeks.
* Agree to use an effective method of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history of a serious mental disorder.
* Are allergic to interferons.
* Are pregnant or breast-feeding.
* Are taking certain medications such as ribavirin, hydroxyurea, and ganciclovir.
Comparing Air Embolic Load in Two Venous Cannulation Methods, 40 Patients Undergoing Elective Valve Surgery.

The goal of this single center prospective controlled observational and interventional trial is to investigate and compare origin of air emboli when different venous cannulation methods is used in patients undergoing cardiac surgery with extracorporeal circulation.

40 consecutive elective patients will be included in two groups, depending on the procedure requiring bicaval or cavoatrial cannulation. After assorted into respective group, patients will be block randomized (five groups consisting of eight patients each) to either intervention group (low venous reservoir volume, 200-300 mL) or control group (venous reservoir volume \> 300 mL).

Primary endpoint is to investigate if the amount of air emboli passing through the oxygenator to the arterial line differs between bicaval and cavoatrial venous cannulation during extracorporeal circulation. Secondary endpoints are the relative difference in amount air emboli between the groups, if there is any correlation between the amount of air in venous line and the amount of air passing through the oxygenator to the arterial line during extracorporeal circulation, and if difference is seen on the amount of air passing through the oxygenator depending on the level of volume in the venous reservoir.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Elective bicaval cannulation (mitral valve repair/replacement (MVR) or MVR + coronary artery bypass grafting (CABG))
* Elective cavoatrial cannulation (aortic valve repair/replacement (AVR) or AVR + CABG
* Planned normothermia (35-37˚C)

Exclusion Criteria:

* Acute heart surgery
* Adult Congenital Heart Disease (ACHD) surgery
* Endocarditis
* Reoperation (primary procedure \> 2 years ago)
* Perioperative iatrogenic adverse events (major bleeding, aortic dissection, other severe complications)
Prevalence and Profile of Aspirin Resistance in Hemodialysis Patients

Dialysis patient could be more aspirin resistant than the general population based on data from chronic kidney disease patients

We will try to describe the profile of aspirin resistant patient in hemodialysis patients

Eligibility Criteria:
Inclusion Criteria:

* all hemodialysis patients on aspirin

Exclusion Criteria:

* low platelets \<100.000
* coagulopathy, bleeding disorders
* patient on plavix
Preoperative Point of Care Ultrasound Guided Fluid Optimization and Intravenous Ondansetron to Prevent General Anesthesia-Induced Hypotension

Hypotension is a common side-effect of general anesthesia induction and is related to adverse outcomes including significantly increasing risk of one-year mortality. Even short durations of intraoperative hypotension have been associated with acute kidney injury (AKI) and myocardial injury.Half of all the patients were fluid-responsive, pointing to volume status as a significant risk factor. Ultrasound measurements of inferior vena cava (IVC) diameter with respiration, including the maximal diameter of the IVC (dIVCmax) at the end of expiration during spontaneous respiration and the collapsibility index (CI), have been recommended as rapid and noninvasive methods for estimating volume status.

In attempt to prevent hypotension after spinal anesthesia induction, Ondansetron, a serotonin receptor antagonist, has been used effectively .

Research Question Can preoperative IVC-US guided fluid optimization and intravenous ondansetron reduce the incidence of general anesthesia-induced hypotension in adult patients undergoing elective non-cardiac non-obstetric surgery?


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18
2. Elective, non-cardiac, non-obstetric surgery under general anesthesia
3. American Society of Anesthesiologists physical status classification I - III

Exclusion Criteria:

1. MAP below 60 mmhg prior to the induction of general anesthesia.
2. Patients treated with angiotensin converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB) on the day of surgery.
3. Patients with heart failure with ejection fraction (EF) \< 40%.
4. Patients with documented acute or chronic renal failure.
5. Patients with hepatic failure.
6. Patients with neuraxial (spinal/epidural) anesthesia performed before induction of general anesthesia.
7. Patients with suspected difficult airway.
8. Patients with documented allergy to Ondansetron or prolonged QT-syndrome.

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Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study

To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)

This is a Phase IIIB, multi-centre, open-label, follow-up study to study C87076 \[NCT00674362\] designed to continue to assess the safety and efficacy of Certolizumab Pegol.

Two different population will enter the study from C87076 \[NCT00674362\] and will be treated with Certolizumab Pegol every two weeks until it is commercially available for the indication of Rheumatoid Arthritis (RA) in the subject's country or region or until further notice from UCB:

Population 1: Are those subjects who failed to achieve remission at Week 20 and/or Week 24 and who completed the Week 24 assessment of study C86076 \[NCT00674362\].The Week 24 assessment (visit 14) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080. The subjects will receive Certolizumab Pegol 200 mg every two weeks. No induction period will be applied to ensure the blinding of study C87076 \[NCT00674362\].

Population 2: Are those subjects who achieved remission at both Week 20 and Week 24, flared up between Week 24 and Week 52 and completed the Week 52 assessment in study C87076 \[NCT00674362\]. The Week 52 assessment (visit 26) of C87076 \[NCT00674362\] will also be the entry assessment (visit 1) for C87080.

Subjects who flared prior to Week 48 in the C87076 \[NCT00674362\] study will receive Certolizumab Pegol 200 mg every two weeks in the C87080 study.

Those who flared at Week 48 or Week 52, will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with established adult rheumatoid arthritis on Disease Modifying Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:
* either failed to achieve remission after 6 months of study treatment
* or flared after the 6 months of study treatment and completed the study (C87076 \[NCT00674362\])

Exclusion Criteria:

* All the concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
* Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women

Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block.

Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships.

The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Term pregnant patients requesting labor analgesia
* Singleton pregnancy
* Term pregnant patients in active labor
* ASA\<4
* No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE

Exclusion Criteria:

* Refusal to consent for the study
* Known spinal deformities
* Previous back instrumentation
* Patients with BMI\>50 kg/㎡ due to anticipated technical challenges in Doppler studies
Effect of Atracurium and Rocuronium on the State and Response Entropy During Isoflurane Anesthesia

Many studies have explored the effects of inhalation anesthetics, intravenous anesthetics, and muscle relaxants on spectral entropy, but most did not monitor the degree of neuromuscular block. In addition, they do not explore the effects of different degrees of neuromuscular blockade on spectral entropy under different concentrations of isoflurane inhalation. Therefore, the present study will evaluate different levels of MAC to quantify the isoflurane concentration, as well as different degrees of neuromuscular blockade

The study will include 40 patients fulfilling the inclusion criteria. They will be randomized into 2 equal groups by a computer generated random numbers table, each consisting of 20 patients, namely group A and group R.

* Group A: Patients will receive Atracurium.
* Group R: Patients will receive rocuronium. No premedication will be given. After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system (made in Ireland), starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system (made in finland).

Baseline RE and SE will be recorded. Anesthesia will be induced by propofol (dose 2-3 mg/kg) and fentanyl as analgesia (dose 1-2 mg/kg). Tracheal intubation will be facilitated with rocuronium (dose 0.6 mg/kg) /atracurium (dose 0.5 mg/kg) after an acceleromyography count of 0. Anesthesia will be maintained with isoflurane in an air-O2 mixture (FiO2 0.6, 2 L/min). Mechanical ventilation will be maintained at a tidal volume of 5-7 ml/kg. Ventilator frequency will be adjusted for maintenance of an ETCO2 of 35-40 mmHg. After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Rocuronium (dose 0.01-0.012 mg/kg/min ) /atracurium (dose 0.005-0.01 mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients American Society of Anesthesiologists physical status (ASA) I to II.
2. Male patients (to avoid bias between gender).
3. Age between 20-50 years

Exclusion Criteria:

* a. Patients receiving any neuropsychiatric medications. b. Patients undergoing neurosurgical operation. c. Drug addiction. d. Body mass index (BMI) more than or equal to 40.
Investigation of Palpation Pressure Sensitivity

The study is planned for searching physiotherapists palpation abilities. There were 2 groups of physiotherapists. They were asked for to push target pressures. After making some exercise, the assesment was done again.

2 groups of physiotherapists with different fields of experience were attended to study. Fingers are positioned on the marked area at the center point of the scale. Therapists were asked to apply pressure to the scale with estimated weights of 0.5 kg, 1 kg, 2 kg and 4 kg. In each measurements, the value on the scale was recorded without being shown to the participants. After the measurements, the participants were made to experiment when the digital screen can be seen, in order to teach the physiotherapists how much pressure they applied to reach the target weight. Participants were given a total of 10 minutes for the trials. Then, the digital screen was hidden again, and the therapist was asked to apply 0.5 kg, 1 kg, 2 kg and 4 kg weight in a randomized order and maintain that pressure for 5 seconds. The weight fixed by the therapist for 5 seconds was noted by the researcher; the participant was not informed about the values on the digital screen.

Eligibility Criteria:
Inclusion Criteria:

* Willing to participate,
* Active working patients as a physiotherapists pediatric, neurologic, orthopedic physiotherapy, manual therapy or osteopathy.

Exclusion Criteria:

* Having a neurological disease (multiple sclerosis, polyneuropathy, etc.) -Having a disease that may cause neurological deficit in the upper extremity (cervical myelopathy, carpal tunnel syndrome, pronator teres syndrome, cubital tunnel syndrome, ---
* Guyon canal syndrome)
* Refuse to participate
People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation

Administration of antiretroviral therapy has brought benefits for infective human immunodeficiency virus-1 (HIV-1)-patients, reducing the number of AIDS-related morbidity and mortality. However, it is responsible for intensifying complications triggered by the chronic inflammatory state associated with virus infection, such as cardiovascular diseases. The current study evaluated effects of single dose (140mL) of Beetroot Juice (BJ) on macro and microvascular endothelial function in HIV-1-patients undergoing antiretroviral terapy, once BJ was shown to be effective in improving these physiological parameters in uninfected individuals.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection for a period of 1 year or greater
* Regular use of high-potency antiretroviral therapy for at least one year

Exclusion Criteria:

* Individuals who are physically active
* Individuals who are allergic to some component of beet
* Individuals who use nutritional and / or pharmacological ergogenics
* Individuals receiving antibiotics or who have osteomioarticular problems
A Study to Assess the Effectiveness of Aflibercept in Routine Clinical Practice in Patients With Diabetic Macular Oedema

Intravitreal aflibercept has been approved for the treatment of visual impairments due to diabetic macular oedema (DMO) in Europe and the US in August 2014 and July 2014 respectively.

The main objectives of this observational cohort field study are to evaluate effectiveness of intravitreal aflibercept and to describe follow-up as well as treatment patterns in anti vascular endothelial growth factor (anti-VEGF) treatment naïve patients with DMO in routine clinical practice in the United Kingdom.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients diagnosed with type 1 or 2 diabetes mellitus.
* Patients diagnosed with DMO with central involvement (defined as the area of the centre subfield of OCT) treated with intravitreal aflibercept (in accordance with routine practice).
* Patients for whom the decision to initiate treatment with intravitreal aflibercept was made as per the investigator's routine treatment practice and prior to study inclusion.
* Patients must provide written informed consent.

Exclusion Criteria:

* Patients under the age of 18.
* Patients with contraindications as listed in the SmPC for intravitreal aflibercept.
* Patients with pre-planned cataract surgery during the observational period.
* Patients previously treated with intravitreal anti-VEGF within 28 days.
* Patients currently or previously treated with systemic anti-VEGF.
* Patients previously treated with intravitreal fluocinolone acetonide steroid.
* Patients participating in an investigational programme with interventions outside of routine clinical practice.
Ultrasonographic and MRI Explorations of Infraspinatus Muscle in Postero-superior Rotator Cuff Tear

The project aims to evaluate the contribution of texture analysis on MRI sections, and the technical feasibility, reproducibility, and clinical relevance of quantitative ultrasound and elastography to characterize the composition and volume of infraspinatus muscle in postero-superior rotator cuff tears. The perspectives are to optimize the imaging to allow a quantitative, objective and reproducible analysis of the muscle tissue and its characteristics.

The rotator cuff of the shoulder consists of 4 tendinomuscular units including the infraspinatus. This complex system fulfils a double role: stabilization/coaptation (raising the arm) and arm mobility (especially external rotation). Rupture of rotator cuff tendons is frequent (\> 80% among chronic shoulder pain). They go with a decrease in muscle volume (amyotrophy) and irreversible fat infiltration. The treatment is medical and then surgical (if necessary). The degrees of atrophy and muscle infiltration (especially infraspinatus) are the criteria of choice for surgery. Actually, they are assessed in MRI according to the classification of Fuchs; it is operator dependent, qualitative and poorly reproducible with a strong inter-observer variability. Our team highlighted (2016) the possibility of using texture analysis software to objectively measure the proportion of fatty tissue on MRI sections of the cuff rotator muscles. This work also showed the possibility of using mode B ultrasound for morphological imaging and shear wave elastography to estimate the elasticity of the infraspinatus. The project aims to evaluate the contribution of texture analysis on MRI sections, and the technical feasibility, reproducibility, and clinical relevance of quantitative ultrasound and elastography to characterize the composition and volume of infraspinatus muscle in postero-superior rotator cuff tears. The perspectives are to optimize the imaging to allow a quantitative, objective and reproducible analysis of the muscle tissue and its characteristics.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 35 years-old and ≤75 years-old
* tendonous, transfixing, postero-superior, unilateral and symptomatic rotator cuff lesions
* controlateral shoulder without symptom, without rotator cuff injuries, without medical ou surgical history
* written informed consent
* affiliation to a social security system

Exclusion Criteria:

* pregnant woman
* patient under legal protection
* contraindications to MRI
* traumatic or surgical or medical relevant history on shoulder
* general or local disease affecting the skeletal striated muscle