cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made.

The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised.

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Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 75 years
* Confluent or destructive heterogeneous emphysema on CT
* Smoking cessation for at least 6m (proven by urinary cotinine levels)
* FEV1 \< 60 %predicted, RV \> 150 %predicted, TLC \> 90 %predicted
* RV/TLC ratio ≥ 0.55
* 6MWD \< 450 meter
* mMRC ≥ 2
* Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician
* LABA-LAMA bronchodilator therapy as a minimum therapy
* Able to sign informed consent

Exclusion Criteria:

* Homogenous emphysema
* PaCO2 \> 60 mmHg with ambient air
* PaO2 \< 45 mmHg with ambient air
* Previous LVRS, lung transplantation, lobectomy
* TLCO or FEV1 \< 20% predicted
* Significant pulmonary hypertension (PaPsyst \> 50 mm Hg)
* Heart failure with reduced EF (\< 40%)
* 6MWD \< 100 meter
* BODE index ≥ 7 and eligible for transplantation
* Active cancer
* Life expectancy \< 3 months
* Significant lung disease other than COPD/emphysema
* Unable to comply with study procedures
The Effectiveness of Vestibulectomy

Women with vulvodynia will fill out a questionnaire and undergo a gynecological examination before and 6 months after vestibulectomy. The investigators hypothesize that pain will decrease.


Eligibility Criteria:
Inclusion Criteria:

* vulvodynia, scheduled for vestibulectomy
CONTECI Program: A New Way to Control Peripheral Arterial Disease Using New Technologies

The current increase in chronic diseases calls for changes to the health system. It is necessary to promote expert patient in chronic disease. The expansion of new technologies gives us new tools to face new challenges, providing efficiency, expertise and autonomy. The characteristics of peripheral arterial disease make possible to promote expert patient and the self-management. In order to bring these concepts together the telemedicine program was created to promote expert patient for increasing the quality of life and satisfaction of patients and improving the efficiency of the health system.

Methods: Randomized clinical trial on patients with peripheral arterial disease in intermittent claudication grade. They were randomized into two groups: intervention arm (IA) using CONTECI program for self-managing and control arm (CA), followed as usual vascular visits.


Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed PAD
* Over 18 years old
* Informed Consent
* Internet Access (patient or family)
* Spanish or Catalan fluidity

Exclusion Criteria:

* Cognitive impairment
* Previous patency arterial surgery
* Sever chronic obstructive pulmonary disease (GOLD III/ IV)
* Patients with decreased survival of 12 months
Clinical Qualification Study of Electroencephalographic Mobile Equipment for the Capture of Emotions

The study aim to determine the reliability of various EEG wireless headsets. Their signal will be compared to standard high-density EEG recording during music listening.


Eligibility Criteria:
Inclusion Criteria:

* Right handed healthy people
* sensitive to "music chill" (Barcelona Reward music Questionnaire\>50)
* having given their participation agreement
* individual with health insurance coverage.

Exclusion Criteria:

* Pregnant women
* individuals in "exclusion period" of another study
* subjects with auditory deficits
A Translational Understanding of Obesity-Related Phenotypes Using Brain Imaging and Manipulation

This study will examine a potential relationship between family history of obesity, that is whether people with at least one parent who had obesity in adulthood compared to people with two parents who did not have obesity in adulthood, and the ability of protein intake to curb further intake of food.

1) Abstract of the study A positive energy balance (greater intake than expenditure) can explain weight gain and, when protracted, leads to overweight and obesity. The major question addressed in this proposal is if the timing of activation of specific regions of the brain is predictive of excessive food intake. Functional near infra-red spectroscopy (fNIR), seldom used in human eating studies, provides data similar to functional magnetic resonance imaging (fMRI) but allows for measurement of brain activation during food consumption. The investigator's pilot fNIR data reveal that varying patterns of regional PFC activation are associated with "loss of control" over eating, and that only 60% of individuals respond to acute protein intake with a reduction in food intake. Using fNIR and an acute protein challenge, the investigator will assess the effect of family history of obesity in humans on the satiation response to protein and concomitant activation of the prefrontal cortex (PFC). It is hypothesized that activation of the human medial PFC before the lateral PFC will result in greater intake of palatable food in those subjects with a proneness to obesity, and that these subjects will be less sensitive to the satiety-inducing effects of a protein preload. These results should provide an innovative and useful method for assessing risk for developing obesity and usefulness of preventative interventions.

Eligibility Criteria:
Inclusion Criteria

* BMI 20-40
* weight stable for at least 3 months
* no parents with history of obesity in adulthood, or at least one parent with history of obesity in adulthood

Exclusion Criteria

* no current diagnosis of psychiatric disorders
* no current diagnosis of neurological disorders
* no current diagnosis or history of anorexia nervosa
* no current diagnosis or history of bulimia nervosa
* no pregnancy within the last 9 months
* not currently breastfeeding
* no use of investigational medication in the past 6 months
* no use of prescription anti-seizure medications.
* no use of prescription antidepressant medications
* no use of prescription antipsychotic medications
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft Lesions

The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting

A large number of studies showed that drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. While there is a plenty of data about the efficacy of DES in complex lesions or diabetics, no randomized data exist about the efficacy of DES in coronary artery bypass graft lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in CABG
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
* In women with childbearing potential a negative pregnancy test is mandatory

Exclusion Criteria:

* Cardiogenic shock
* Target lesion located in the native coronary vessels.
* In-stent restenosis of CABG
* Target lesion located at internal mammary artery graft or free arterial graft
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: clopidogrel, rapamycin, paclitaxel, stainless steel.
* Inability to take clopidogrel for at least 6 months.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
Clinical Effect of Long Round Needle

The goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. The main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. Participants will be selected as the research objects. They will randomly divided into control group (n = 49) and observation group (n = 49). The control group was treated with filiform needle, and the observation group was treated with long round needle. Researchers will compare the two groups to see the differences on the therapeutic effect, safety, Neck dysfunction index (NDI), pain score (McGill pain questionnaire, MPQ), quality of life (Generic Quality of Life Inventory-74, GQOL-74), and levels of inflammatory factors.


Eligibility Criteria:
Inclusion Criteria:

(1) meet the efficacy criteria for disease certificate diagnosis of Traditional Chinese medicine\[4\]In the category of "Arthralgia Syndrome" and "Stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical X-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent.

Exclusion Criteria:

(1) patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
Comparison of Generic and Original Formulation of Clopidogrel

Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.

Clopidogrel is essential for the prevention of vascular events in patients after percutaneous coronary interventions (PCI). Most of our current knowledge with clopidogrel originates from the clinical investigations that had used Plavix®/Iscover® from Sanofi-Aventis as the original formulation of clopidogrel-bisulphate. However, as the patency of Plavix® has expired in November 2009 in Hungary, several generic clopidogrel have been introduced to the market. Some of the generics are using the original bisulphate formulation, while others are with besylate salt of clopidogrel. Despite the differences in the clopidogrel-salts, the different carriers might also modulate the pharmacokinetic/pharmacodynamic profile of each drug. As the consequences of the impaired antiplatelet potency might be devastating, including stent thrombosis, the investigators sought to compare generic clopidogrel to the original blister by different assays of platelet aggregation.

In a prospective, cross-over, open-label, unblinded study the investigators aim to compare platelet activation and aggregation between Plavix® and generic clopidogrel.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the maintenance phase of PCI receiving 1x75 mg clopidogrel and 1x100 mg aspirin
* No planned interruption of the antiplatelet therapy in the next 1 month
* Informed consent

Exclusion Criteria:

* Oral anticoagulant therapy
* Contraindication for aspirin or clopidogrel
* Planned interruption of antiplatelet therapy in the next month
Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft

Allograft patients have a complex care pathway and are left with a large number of prescribed medications.

They have to deal with changes linked to the transplant (change in taste, fatigue, regular monitoring, risk of GVH (graft versus host) complications, infectious risks, change in eating habits, etc.), and a large number of associated drugs (immunosuppressants, anti-infectious prophylaxis and supplements (folic acid, magnesium, bile salts, etc.), which are added to any pre-existing chronic pathologies.

Therapeutic adherence of these patients is a real challenge. Indeed, the success of the transplant and the complications that may arise (graft rejection, GVH, infections, death, hospitalisation, etc.) are closely linked to good or poor therapeutic adherence. Moreover, the majority of these patients are young and are not used to taking many treatments, which will change after the transplant.

Adherence to treatment consists of three phases:

* Acceptance of the disease and the benefits of treatment,
* Compliance: following the instructions of the prescription (dosage and schedule),
* Persistence: consistency of compliance over time.

Support from the care team throughout the management of these patients is necessary for good therapeutic adherence in order to prevent and act early on the difficulties encountered (appearance of side effects linked to the treatments, large number of tablets per day, duration of treatment (1 to 2 years), risk of GVH, significant asthenia and difficulty in concentrating, etc.)

We have a large amount of data on therapeutic adherence and potential non-adherence factors in patients with chronic diseases (diabetes, asthma, cancer, etc.) or in solid organ transplant patients.

On the other hand, there is little data on allograft patients. Most often, a parallel is made between the data present in kidney transplant patients and allograft patients. However, it is necessary to study more specifically the therapeutic adherence in this population.

A recent multicentre cross-sectional study in France on adherence in allograft patients showed that 80% of adult and paediatric patients were not adherent.


Eligibility Criteria:
Inclusion Criteria:

* allograft patients followed by the Limoges University Hospital

Exclusion Criteria:

* patient hospitalised at the Limoges University Hospital for a reason other than allograft
* refusal of the patient to participate in this research
* patient unable to understand the treatment
* pregnant or breastfeeding woman
Comparing Adductor Canal Block and Adductor Canal Block-Local Infiltration Analgesia for Post-operative Pain Management

Anterior cruciate ligament (ACL) reconstruction is one of the most commonly performed surgeries amongst young orthopedic surgery patients. Optimal post-operative pain control helps to reduce the opioid burden and to improve the patient's experience. Regional anesthesia, such as the femoral nerve block (FNB) and adductor canal block (ACB), are commonly used for post-operative pain control after surgery. The ACB has replaced the FNB. This is because the ACB targets the femoral nerve, while avoiding the numbing effects on quadricep muscle strength that make it difficult to move the leg. Another form of pain control is local infiltration anesthesia (LIA), which directly blocks pain in the knee. Similar to the ACB, it avoids the numbing effects on the quadricep muscle.This can help improve patient safety and experience by reducing risks of falls and allowing the patient to move earlier. This can also be associated with decreased time in the hospital and decreased costs. Technically, it is less complex and can be done the shorter period of time.

The purpose of this study is to refine the pain management technique following anterior cruciate ligament surgery. More specifically, the aim of this study is to evaluate the effects of LIA alone, and a LIA-ACB combination on post-operative pain and thigh muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* English speaking or any other language with possibility of adequate translation
* ASA I-III patients
* Age 18-50
* BMI ≤ 38 kg/m2

Exclusion Criteria:

* Refusal or inability to provide informed consent
* Any contraindication to regional anesthesia including coagulopathy or bleeding diathesis,
* Allergy to local anesthetics, or infection at the site of the block
* History of long-term opioid intake (more than 3 months use) or chronic pain disorder (more than 3 months)
* History of preexisting neuropathy in the operative leg
* Revision of ACL repair
Contribution of Immersive Virtual Reality to a Standardized Rehabilitation Program for Upper Limb Chronic Pain: A Single-Case Experimental Design Study

Background: Chronic pain represents a significant public health concern, given its high prevalence and the substantial impact it has on the quality of life of many individuals affected. There is no single, universally effective medical treatment for chronic pain. The gold standard for treatment is a multidisciplinary rehabilitation program. Immersive virtual reality (IVR) represents a novel and promising approach to do rehabilitation, offering the potential to enhance engagement and perception of movement.

The objective of this study was to investigate the improvement of upper limb function in chronic pain patients using an IVR device in occupational therapy sessions during a rehabilitation program.

Methods: The study use a single-case experimental design (SCED) to investigate the efficacy of IVR device in improving upper limb function in patients with upper limb chronic pain. The study was conducted in three phases: baseline, intervention, and follow-up. The SCED will be with multiple baseline across subjects, whereby the patient serves as his own control. A total of 12 participants will be included. The virtual reality sessions will be conducted exclusively during the intervention phase. The primary outcome measure will be the upper limb function, as assessed by the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. Furthermore, the intensity of pain will be quantified using a numeric scale, and the pain self-efficacy will be evaluated using the Pain Self-Effacity Short Form Questionnaire.

Expected results: This method will allow for the comparison of phases within and between subjects to determine whether the IVR sessions improve the function assessed by the Quick DASH.

Conclusion: Further investigation is required to determine the potential benefits of using IVR for upper limb chronic pain rehabilitation, with a particular focus on the development of precise protocols for its use in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain in the upper limb, predominantly in one or both upper limbs, for more than 3 months
* Age between 18 and 65
* Patient affiliated with or benefiting from a social security organization
* Person able to tolerate the virtual reality device
* Informed consent form signed

Exclusion Criteria:

* Upper limb surgery \< 6 months
* Infection or pathology of the central nervous system or active cancer
* Fibromyalgia
* Severe psychiatric or cognitive disorders
* Diabetes mellitus complicated by peripheral neuropathy
* Neurogenic paraosteoarthropathy or recent fracture
* Pregnancy or breast-feeding.
* Poor understanding of the French language.
* Person deprived of liberty by judicial or administrative decision
* Psychiatric disorder
* Person subject to a legal protection measure
* Person unable to give consent
* In connection with the virtual reality device: unstabilized epilepsy, facial trauma \< 3 months, hearing or visual impairment, pain, dizziness or nausea caused by the use of virtual reality.
Vytorin on Carotid Intima-media Thickness and Overall Rigidity

Comparison of the effect on the progression of the carotid intima-media interphase thickness (GIM), arterial rigidity according to the measurement of the pulse wave speed and direct measurement of the carotid and aortic rigidities and an inflammation marker (PCR) in patients with established cardiovascular disease (myocardial infarct, atherosclerotic coronary disease), diabetes mellitus type 2 or equivalent risk of coronary disease and a low density lipoprotein level \> 100 mg/dL, treated with simvastatin, pravastatin or the combination of simvastatin-ezetimibe during a period of at least one year.


Eligibility Criteria:
Inclusion Criteria:

* Ldl-C Levels \>100 Mg/Dl
* Patients Who Have Signed The Consent
* Patients Of ages between 30 and 75 Years Old
* Patients Of Both Genders
* Patients With Established Cardiovascular Disease, Diabetes With Or Without Established Cardiovascular Disease
* Patients Without Previous Treatment With Ezetimibe
Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty

Regional anesthesia and analgesia technics are widely and securely used during orthopedic surgery. Interfascial plane blocks are the latest used ones for analgesia. There are studies in literature indicating that bupivacaine cause myotoxicity. We aimed to examine plasma CPK(creatine phosphokinase) levels to see whether myotoxicity occurs or not after suprainguinal fascial plane block is applied to patients undergoing knee artroplasty surgery.

During 2 months period all elligible patients undergoing knee artoplasty surgery will be included in the study. Different postoperative analgesic modalities will be used according to the anesthesists experience. During routine blood sample tests plasma CPK levels will be tested 3 times of all patients.(preoperative, postoperative 6th hour, postoperative 24th hour) this data will be recorded for 2 months. After this period of time data will be analysed and patients will be grouped according to the analgesic modalities used.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* knee artoplasty patients
* under spinal anesthesia

Exclusion Criteria:

* local anesthetic allergies
* myopathies
* coagulopathies
* Obstructive sleep apne syndrome
* hearth diseases
* liver diseases
* kidney diseases
* thyroid-parathyriod dieseas
* hiperlipidemias using Statins(HMG-CoA reductase inhibitors)
* pregnancy