cyrilzakka/clinical-trials huggingface dataset:
Multiple Sclerosis and Respiratory and Functional Capacity

It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.

It is known that respiratory functions, physical activities and functional capacities of Multiple Sclerosis (MS) patients decrease with the progression of the disease. However, there is not enough information about the severity of the effects of these parameters in mild Relapsing-Remitting Multiple Sclerosis (RRMS) patients. Our aim in this study is to compare the respiratory functions, physical activities and functional capacities of mild RRMS patients with healthy controls and to examine the relationship between them.

Forty individuals diagnosed with RRMS between the ages of 18-60 and 40 healthy individuals with similar demographic characteristics were included in the study.

Eligibility Criteria:
Patient group - Inclusion Criteria:

* Having a definitive diagnosis of RRMS according to the 2017 McDonald criteria
* Being between the ages of 18-60.
* To be willing to participate in the study.
* EDSS score between 0-3.

Healthy group - Inclusion Criteria:

* Being between the ages of 18-60.
* To be willing to participate in the study.

Patient group - Exclusion Criteria:

* Have other neurological, orthopedic and systemic problems
* Having a relapse 30 days before or during the study
* Changes in medication use in the past 30 days

Healthy group - Exclusion Criteria:

* Have neurological, orthopedic and systemic problems
Analysis of the Levels of HLADR+ Extracellular Vesicles in Women With Preeclampsia as a Early Potential Biomarker

Analysis of the circulating levels of placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia.

The aim of this study is to analyze the levels of circulating placenta-derived HLA-DR+ extracellular vesicles in the first, second and third trimester of pregnancy of women with high and low risk to develop preeclampsia to investigate the potential role of HLA-DR as early biomarker.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women
* Aged \> 18 years

Exclusion Criteria:

* age \< 18 years
* women unable to give informed consent
* infectious diseases
* twin pregnancies
Comparison of the Efficacy and Safety of Continuous and Single-Dose Intravesical Epirubicin Instillation

In this study, the local and systemic side effects, tumor recurrens and progression rates of single or continuous epirubicin instillation during the early postoperative period were investigated in low and intermediate risk non-muscle-invasive bladder cancer.

Bladder cancer (BC) is the seventh most commonly diagnosed cancer in the male population worldwide, while it drops to tenth when both genders are considered. Worldwide, the BC age-standardised mortality rate (per 100,000 person/years) was 3.3 for men vs. 0.86 for women.It is more common, especially in developed countries. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer).

Epirubicin is an anthracycline drug used for chemotherapy. Immediate single instillation of epirubicin has been shown to act by destroying circulating tumour cells after TURB(Transurethral Resection of a Bladder Tumor), and by an ablative effect on residual tumour cells at the resection site and on small overlooked tumours.European Association of Urology Guidelines on Bladder Cancer advocates single immediate postoperative intravesical chemotherapy. Early single-dose instillation of epirubicin immediately after transurethral resection was shown to improve recurrence rates in low and intermediate risk groups.

Immediate single instillation of epirubicin into the bladder can induce an array of irritative voiding symptoms including dysuria, frequency, urgency, suprapubic discomfort, hematuria and pelvic pain. In some cases, patients cannot tolerate these symptoms and may necessitate removal of chemotherapeutic agent for alleviation. Incomplete instillation leads to an increase in recurrence and progression rates. In this study, continuous infusion of epirubicin into the bladder and instillation of a single dose epirubicin will be evaluated in terms of side effects, tumor recurrence and progression rates.

Eligibility Criteria:
Inclusion Criteria:

* Low and intermediate risk NMIBC

Exclusion Criteria:

* High risk NMIBC
* Patients who received intravesical BCG
* Postoperative gross hematuria
* Bladder perforation
* Pregnancy
* Urinary tract infection
* Epirubicin allergy
Biodistribution and Kinetics of 18F-AraG in Non-Small Cell Lung Cancer

This study is to assess the biodistribution and kinetics of a novel T-cell imaging agent in non-small cell lung cancer patients undergoing immunotherapy with and without adjuvant radiation therapy. This study is assessing the change in kinetics that occurs in this patient population to better understand the distribution of this compound in patient disease circumstances.

The overall goal of this project is to evaluate the ability of \[18F\]-AraG, a novel T-cell activation imaging biomarker, to measure T-cell activation before and after treatment with programmed death (PD) PD-1/PD-L1 inhibition and with PD-1/PD-L1 inhibition plus radiation therapy in NSCLC patients. Early preclinical and clinical studies have shown promise for immunotherapy treatments for several malignancies \[1\]. Immunotherapy is expected to grow in importance; however, it presents difficult challenges for response assessment. For instance, successfully treated tumors may actually increase in size after therapy due to inflammation and only later shrink \[2\]. RECIST criteria \[3\] designed to detect early effects of cytotoxic agents by size reduction, or the more recently proposed immune-related response criteria (irRC) \[4\] do not allow an early assessment of immunotherapeutic response since both depend on tumor size change. Furthermore, FDG PET is confounded by inflammatory effects causing hypermetabolism \[5\] \[6\]. Thus, it is imperative to develop new imaging and analysis protocols to evaluate immune-checkpoint blockade approaches. A method that evaluates T cell activation would permit an assessment of a basic first step in the process of assessing immunotherapy efficacy.

There are two main goals associated with this project. We propose to 1) assess the \[18F\]-AraG biodistribution and kinetics, in non-small cell lung cancer (NSCLC) tumor(s) and tumor draining lymph nodes on \[18F\]-AraG PET/CT imaging before and after 1 course of immunotherapy and 1 course of immunotherapy plus radiation 2) correlate (potential) change in \[18F\]-AraG uptake within the tumor(s) or tumor draining lymph nodes with clinical and pathologic response in patients treated with immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* This study is open to all adult subjects with histological confirmation of NSCLC enrolled in the parent protocol.
* Age 21 years of age or greater
* ECOG performance status of 0, 1, 2 or 3 at the time of enrollment.
* Patient with life expectancy ≥ 24 weeks from the time of screening to the study
* Ability to give informed consent

Exclusion Criteria:

* Patients with severe claustrophobia (patients with milder forms of claustrophobia that can be successfully allayed with oral anxiolytic therapy are allowed).
* Severe impaired renal function with estimated glomerular filtration rate \<30 mL/min/1.73 m2 and/or on dialysis.
* Pregnancy
* Breast Feeding an infant
* Unable to tolerate the expected radiation therapy prescription
A Prospective Study for the Treatment of Severe Pulmonary Embolism With Pharmacodynamic Thrombectomy

The mortality of severe pulmonary embolisms admitted to the resuscitation department for circulatory failure remains in the range of 30-40% at the acute phase. Hemodynamic failure is the leading cause of death. These patients frequently have a contraindication to thrombolysis. Surgical pulmonary arterial desobstruction still leads to significant hospital mortality and can't be implemented in all hospitals. Concerning advanced hemodynamic support techniques, they can't always reduce mortality on themselves. There is therefore a need for developing alternative approaches for less invasive pulmonary arterial desobstruction. Data on the efficacy and safety of percutaneous methods of desobstruction are still too limited to implement them in current practice.

AngioJet ™ PE is a device CE marked for intra-arterial desobstruction of pulmonary arteries. It has been successfully tested in more than 25 patients with pulmonary embolism in France. Before considering a request for reimbursement from the HAS it is necessary to have propective data of sufficient quality. This phase 2a prospective study is proposed to evaluate the efficacy and safety of the AngioJet ™ PE catheter use. The resulting data will allow us to submit a Phase 3 controlled study to an upcoming PHRC-type project call.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary embolism objectively confirmed by thoracic angioTDM
* Date of onset of pulmonary embolism 14 days prior to inclusion
* State of shock
* Presence of at least 6 mm thrombus in a main or lobar pulmonary artery
* Contraindication (absolute or relative) or systemic fibrinolysis treatment failure defined by persistence of shock, as defined above, more than 6 hours

Exclusion Criteria:

* Known cardiac pathologies with right-left cardiac shunt
* Target pulmonary artery 6 mm in diameter
* Known heparin allergy or thrombocytopenia
* Known severe hypersensitivity to iodine contrast products
* Severe renal failure defined by creatinine clearance 30 ml/min Pregnant or lactating patient
* Patient not affiliated to social security
* Patient with unhealed lesion due to recent mechanical intervention on the vessel to be treated
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management

Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil).

The two approaches compared are:

Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.

Therapy with an implantable cardioverter defibrillator (ICD) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy.

In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the "shock"-part of the existing electrode is still functional.

There is no longterm outcome data comparing these two strategies. We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004. Incidence of lead failure, type of lead used, approach and outcome were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Implantation of an ICD between 1993 and 2004

Exclusion Criteria:

* None
Use of Direct Oral Anticoagulants in UK

Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. It is important to prescribe the correct dose of blood thinners to the right patients to ensure the treatment works however avoiding complications. In the recent years, new blood thinners have been available; they require less laboratory tests and fewer visits to a doctor compared to older therapies. This study will look at how the general practitioners in the UK prescribe blood thinners according to the instructions given by the product manufacturer. We will use primary care data that is routinely collected by the general practitioners about their patients but without any possibility to identify individual patients. The results will help us to understand the magnitude of deviation from instructions in order to ensure that the patients benefit from the treatment.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged \>= 18 years with at least one year of enrollment with the primary care practice and one year since first health contact recorded in the database THIN(The Health Improvement Network) or CPRD(Clinical Practice Research Datalink) prior to index prescription date will be included.
* Patients with first prescription of DOACs (rivaroxaban, dabigatran, apixaban) during the study period.
* Diagnosis NVAF (any time prior index date or within the 2 weeks after the index date)

Exclusion Criteria:

* Patients having the history of valvular replacement or mitral stenosis (prior to index date or 2 weeks after index-date)
* Patients who have any record of being prescribed their index drug prior to the enrolment period or who qualify as members of more than one cohort on the same day.
Analgesic Efficacy of Multiple Mid-Transverse Process to Pleura (MTP) Block and PCA in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion

This study aims to compare the analgesic efficacy of multiple mid-transverse process to pleura (MTP) block and PCA in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.

Regional anesthesia techniques, mainly epidural analgesia and, more recently, paravertebral blocks, became crucial parts of the multimodal analgesia (MMA) regimen after introducing ultrasound (US) in the regional anesthesia practice. Erector spinae plane (ESP) block and mid-transverse to pleura (MTP) block are the latest developments in postoperative pain therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Exclusion Criteria:

* Patients with pre-existing infection at block site.
* Known allergy to study drugs.
* Coagulation disorder.
* History of psychiatric illness.
* Pre-existing neurological deficits.
* Patient with morbid obesity (body mass index \>40 kg/m2).
* Presence of any pre-operative pain or history of chronic pain.
* History of regular analgesic.
SVT-40776 in Patients Suffering From Overactive Bladder Syndrome

The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from OAB for at least 6 months prior to inclusion

Exclusion Criteria:

* Pregnant and breastfeeding women
* Any medical condition or need for co-medication which interferes with the drug under investigation (SVT-40776) or the comparator (tolterodine)
The Influence of Baseline Sensitivity and Expectation on Exercise-induced Hypoalgesia in Young Healthy Adults

The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. Pain assessment will be done with different intensities of noxious stimuli. In addition, the expectation of how exercise impacts pain will be studied.

The relation between baseline pain sensitivity and the pain response following exercise is not clear. The aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* English proficiency

Exclusion Criteria:

* Acute pain condition
* Chronic pain condition
* Mental health disorder
* Cardiovascular disease
* Any chronic illness
* Difficulty with physical exercise
* Recent surgery
* Pulmonary disease
* Diabetes
* Smoking
* Raynaud disease
* Claustrophobia
Prilocaine or Bupivacaine for Spinal Anesthesiain Pregnant

The planned cesarean section is an intervention with a standard operating time of less than 40 minutes in trained teams. Hyperbaric Bupivacaine is the local anesthetic (LA) reference for these operations. But the duration of its motor block is generally greater than 3 hours. The purpose of this study is to show a reduction in motor block time with hyperbaric Prilocaine by at least 30 minutes, which would allow mothers and their children to return to the maternity ward earlier and thus improve the circulation of patients within the maternity's PACU.

Prospective study, randomized into two parallel groups (Hyperbaric Prilocaïne versus hyperbaric Bupivacaine), double-blind, monocentric (Clinique Saint Roch in Montpellier).

The number of subjects required is 50 patients, 25 per group.

Eligibility Criteria:
Inclusion Criteria:

* Normal pregnancy
* Scheduled caesarean section
* Non-multiple pregnancy
* Age of patient: 18 years and over
* Height of patient: between 155 and 175 cm
* Affiliated patients or beneficiaries of a Social Security System
* Signature of the patient's consent

Exclusion criteria:

* Patient \<18 years
* Pathological pregnancy
* Multiple pregnancy
* Emergency caesarean
* Patients who cannot give informed consent (not French speaking)
* Refusal of the patient
* Contraindications to spinal anesthesia
* Contraindications to Prilocaine
* Contraindications to Bupivacaine
Isosorbide Mononitrate in Induction of Labour

Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

Eligibility Criteria:
Inclusion Criteria:

* Single vertex presentation. 2. Gestational age \> 37weeks calculated from last menstrual period or U/S scanning.

Exclusion Criteria:

1. Patients with rupture of membranes.
2. Previous uterine scar.
3. Fetal malpresentation.
4. Multiple pregnancies.
Technology and System for Minimally Invasive TKA Surgery Robot

Developed a robot for minimally invasive TKA surgery and prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

1. For the current minimally invasive total knee arthroplasty, due to the limitation of the surgical field of view and the scope of operation, and the error of the intraoperative osteotomy saw, it can cause intraoperative damage to ligaments, nerves and blood vessels, postoperative lower limb force lines and prosthesis position Poor, abnormal movement and force of the patellofemoral joint and tibiofemoral joint after surgery can easily lead to clinical symptoms such as rapid wear of the prosthesis, short service life, postoperative knee pain, and even possible problems with surgical failure and revision. Developed a robot for minimally invasive total knee replacement surgery. Minimally invasive total knee arthroplasty is performed by surgical robot and manual operation. According to intraoperative and postoperative imaging observations, the position of the prosthesis, and the evaluation of soft tissue balance during and after the operation, the two methods are compared with the surgical robot and manual operation. Kind of surgery.
2. To prepare for the subsequent CFDA application of the minimally invasive total knee replacement robot system.

Eligibility Criteria:
Inclusion Criteria:

1. No surgery on the knee joint.
2. Age\>55

Exclusion Criteria:

1. Knee surgery history.
2. Severe knee joint deformity (valgus greater than 15° or valgus greater than 20°) or knee joint instability.
3. Severe flexion contracture deformity.
4. Revision and replacement surgery for knee joints.
DVA Risk Pregnancy

Maternal obesity, overweight and hypertensive disorders are among the most important risk factors for complications during pregnancy. Several lines of evidence indicate that overweight or obese women, as well as women with hypertensive disorders show increased risks of preterm birth before 32 weeks. However, an easy to determine, common reliable prognostic factor which allows for the early identifications of risk patients is still lacking. Recently, it has been reported that assessment of endothelial function may be a new promising tool for predicting the risk of adverse pregnancy outcome. As such evidence has been provided that endothelial dysfunction is prevalent among women with preeclampsia and is able to identify women at increased risk of preterm delivery and small-for-gestational-age (SGA) births. Several lines of evidence indicate that functional and structural changes of retinal vessels are altered in vascular related disease and may predict cardio-vascular events. Consequently, the current study seeks to investigate whether flicker induced vasodilatation, a well established parameter to test vascular function in-vivo is altered in women with low and high risk pregnancies when compared to a healthy control group. The data gained from this study may provide the basis for a larger longitudinal trial to assess whether vascular changes in the retina may predict the risk for complication during pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* • Age \>18 years

  * Written informed consent
  * Pregnancy at screening
  * Normal ophthalmic findings, unless the investigator considers a finding clinically irrelevant.
  * Ametropy \<= 3,5 Dpt.

For pregnant women with preeclampsia:

* Systolic BP ≥140 mmHg, or diastolic BP ≥90 mmHg on at least 2 occasions AND
* Proteinuria (≥300 mg/day) after 20 weeks of gestation in preeclampsia
* Pregnant at the time of confirming diagnosis of preeclampsia

For pregnant women with obesity:

• Pre-pregnancy BMI ≥30 as assessed from medical history

According to the WHO BMI classification:

* Underweight (less than 18.5)
* normal weight (18.5-24.9)
* overweight (25-29.9)
* obese class I (30 -34.9)
* obese class II (35-39.9)
* obese class III (40 or more) For non-pregnant control subjects

  * Age \>18 years
  * Written informed consent
  * Not pregnant at screening
  * Normal ophthalmic and medical findings, unless the investigator considers a finding clinically irrelevant.
  * Ametropy \<= 3,5 Dpt.

Exclusion Criteria:

* Diabetes mellitus type I or II
* Renal failure requiring dialysis
* Cirrhosis of liver
* Collagenosis
* Vasculitis
* Paraproteinaemia
* Alcohol abuse
* Amyloidosis
* Clinical signs of polyneuropathy
* Any other clinical finding, unless the clinical investigator considers a finding to be non clinically significant.