cyrilzakka/clinical-trials huggingface dataset:
Cannabidiol in Patients With Heart Failure Failure in AHA/ACC Stages A-C

Cannabidiol in heart failure


Eligibility Criteria:
Inclusion criteria

* Men and women (women not pregnant neither in lactation period) between 30 to 75 years-old
* Patients with stage A-C of the American College of Cardiology/American Heart Association classification
* Patients with GDMT and clinical stability within four weeks
* Diagnosis of ischemic or non-ischemic dilated cardiomyopathy
* Participants should sign an informed consent form (ICF) form personally

Exclusion criteria

* Severe primary valvular cardiomyopathy or valvular prosthesis (mechanical or bio-valve)
* History of heart transplant surgery, cardiomyoplasty, left ventricular reduction surgery, valvuloplasty, implantation of a ventricle assist device and surgical cardiac congenital defect correction
* Implantable cardioverter defibrillator within the last three months
* Acute coronary syndromes that required pharmacological or mechanical reperfusion or medical treatment, within 30 days before selection
* Percutaneous coronary intervention within 30 days prior to selection
* Women who are pregnant, or of childbearing potential and are not practicing an effective means of birth control
* Untreated thyroid disease
* Hepatorenal syndrome
* History of seizures
* Hemoglobin: \< 8.5 gm/dL
* WBC count lower than 3000/mm3
* Platelets: \<100,000/mm
* AST or ALT \>2.5 × upper limit of normal (ULN) unless related to primary disease
* Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
* Active cancer of any etiology
* History of psychiatric disorder (depression or PHQ-9 ≥ 10 points , bipolar syndrome, schizophrenia) or suicide attempt.
* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
* Fertile female participants not applying any approved duel anti-contraceptive method
* Inability to comply/assist with study and follow-up procedures
* Patients in cardiovascular rehabilitation programs
* Any person who is not able to give adequate ICF

Elimination criteria

* Progression of heart failure stage according to the American College of Cardiology/American Heart Association classification, since the initiation of the study.
* ALT or AST \>3x normal values with a total bilirubin ≥ 2x normal value.
* Any degree of depression at any stage of the study
Physiological Response and Visual Attention to Visual Food Images in Healthy Subjects and in Functional Dyspepsia Patients

In functional dyspepsia (FD), abnormal cognitive and emotional changes such increased sensitization, anxiety, and depression scores have been reported in addition to the peripheral changes in gastrointestinal tract functions. In this study, investigators will evaluate the activity of autonomic nervous system, emotional response, and visual attention to food and non-food images in 30 male and female FD patients and 30 age/gender-matched healthy volunteers. These data will provide a new finding of the influence of impaired cognitive processing of food on symptom generation in functional gastrointestinal disorder patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, volunteering adults BMI: 18-25 kg/m² right-handed Age: 18-65 years Capacity to give informed consent For FD patients, Diagnosis of functional dyspepsia over the last 12 months certified by a medical record Inconspicuous gastroscopy during the last 6 months certified by a medical record

Exclusion Criteria:

* Visual impairment Severe psychiatric illness (e.g. schizophrenia, severe depression (BDI-II:29-63)), substance dependence and abuse Intake of antidepressants / antipsychotics
The Effects of Telerehabilitation in Chronic Hemiplegic Patients

The present study was conducted to investigate the effects of telerehabilitation on upper extremity functions and activities of daily living in chronic hemiplegic patients.

A total of 40 chronic hemiplegic subjects were included in the study. The patients were divided into 2 groups by simple randomization method. As the Telerehabilitation Group (TR), Group 1 completed the treatment program, which included upper extremity and lower extremity strengthening exercises, for eight weeks, three days a week for 45-60 minutes, 10 repetitions, with online supervision. Group 2 was planned as a face-to-face training group and the same exercises were performed in the clinical setting, accompanied by a physiotherapist. The evaluations were made before and after the treatment. The Modified Ashworth Scale was used for upper extremity spasticity evaluation. The Wolf Motor Function Test was used to evaluate upper extremity functionality. The Barthel ADL Index was used to evaluate Activities of Daily Living (ADL). The Brunnstrom Staging Survey was used to evaluate the level of motor recovery. The Treatment Satisfaction Inquiry Survey was used to evaluate the satisfaction of the patients with the treatment method. Heart Rate (HR) values and oxygen saturation (SaO2) were measured with Pulse Oximetry to monitor vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with stroke between the ages of 40-70
* It has been 12 months since the stroke
* Individuals with upper extremity spasticity level (Modified Ashworth Scale (MAS) score ≤ 3)
* Hand and upper extremity values above 3 according to Brunnstrom motor staging
* Individuals with ischemic, middle cerebral artery involvement will be taken.

Exclusion Criteria:

* Having advanced apraxia and aphasia
* Patients who do not have the cooperation to perform verbal commands and exercise training
* Patients who have undergone any botulinum toxin application in the last 6 months
* Patients with significant visual and hearing loss
* Individuals who do not have the necessary technological competence to provide remote video communication at home will not be accepted.
Assessment of Stress Levels and Depressive and Anxiety Symptoms in Patients With COPD

The aim of the study was to assess the levels of depression, anxiety and stress in patients with COPD qualified for In-hospital pulmonary rehabilitation program

Chronic obstructive pulmonary disease (COPD), manifested by coughing, shortness of breath, sputum production, wheezing and reduced physical performance, is one of the most frequently diagnosed lung diseases. Anxiety and depression have been found to increase the number of acute exacerbations and hospitalizations (thus reducing quality of life), weight, appetite, sleep disorders, fatigue or loss of energy, lack of concentration, pessimism about the future and suicidality. Anxiety has been estimated to occur in 21-96% and depression in 27-79% of patients with COPD, values that are higher than for the general population or other chronic diseases. Pulmonary rehabilitation leads to the improvement to the physical capacity and overall fitness of the patients with COPD allowing restoration of independence in daily functioning. Psychological support is required in order to reduce the negative psychological symptoms related to both the pulmonary disease itself and the comorbidities. In the presented study, the aim was to assess the prevalence of levels of depression, anxiety and stress in patients with COPD qualified for In-hospital pulmonary rehabilitation program.

The program includes the following elements:

Three weeks of pulmonary rehabilitation conducted in an outpatient care facility:

* 5- time a week for 30 minutes a specific respiratory exercises- relaxation exercises for breathing muscles, exercises to increase breathing, prolonged exhalation exercise, chest percussion
* 5- time a week for 20-30 min training on a cycle ergometer
* 5- time a week for 30 minutes a fitness and respiratory exercises - coordination and balance exercises, stretching exercises
* relaxation training by Schultz. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as COPD;
* Pulmonary rehabilitation conducted in ward settings;

Exclusion Criteria:

* inability to self-complete the research questionnaires;
* presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
* initiation of psychiatric treatment during the research project;
* the patient's refusal at any stage of the research project.
A Combination Trial of Copaxone Plus Estriol in Relapsing Remitting Multiple Sclerosis (RRMS)

This is a double-blinded, placebo controlled study of estriol pills versus placebo pills in relapsing remitting multiple sclerosis. The study treatment will be an added on to Copaxone injections in all subjects. The primary outcome measure is a reduction in relapses.

Multiple sclerosis (MS) relapses are known to be significantly decreased during pregnancy. This proposal will establish whether oral treatment with estriol, the major estrogen of pregnancy, induces a decrease in relapses in relapsing remitting multiple sclerosis (RRMS) subjects when used in combination with injectable Copaxone. Previously, in a pilot study, it has been demonstrated that treatment of RRMS subjects with oral estriol for six months resulted in a significant reduction in gadolinium enhancing lesions on serial brain MRIs (Annals of Neurology, 2002; 52:421-428) and caused a favorable shift in immune responses (Journal of Immunology, 2003; 171:6267-6274). This is an add-on study aiming to extend these previous findings by treating longer and focusing on clinical outcomes. The combination of Copaxone injection plus estriol pill (8 mg per day) will be compared to Copaxone injection plus placebo pill in a double blind trial. The duration of treatment will be two years and the primary outcome measure will be relapse rate. Other outcomes will include disability measures and brain MRI outcomes. Safety measures (blood tests and gynecologic evaluations) will also be followed and correlations will be made between serum estriol levels with efficacy and safety. The overall goal of this study will be the development of a new oral treatment, estriol, for RRMS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of relapsing remitting multiple sclerosis
* At least one relapse in the last two years

Exclusion Criteria:

* Patients treated in the past with total lymphoid irradiation, monoclonal antibody, T cell vaccination, cladribine, bone marrow transplantation, azathioprine, cyclophosphamide, methotrexate, mitoxantrone, cyclosporin or Tysabri
* Clinically significant diseases other than multiple sclerosis
Quality of Life Before and After Transcatheter Ablation in Children with Arrythmias

The goal of this clinical trial is to evaluate the improvement in the quality of life after the transcatheter ablation in children from 5 to 17 years old suffering for arrythmia who need a transcatheter ablation (according to PACES recommendations). The main question is:

• to evaluate an improvement in the quality of life in these children, according to different questionnaires?

Participants will answer some questionnaires to get a global evaluation of the quality of life:

* Peds QL 4.0
* Peds QL 4.0 by proxy, which will be completed by the parents
* Ricci and Gagnon questionnaire
* Child Depression Index
* State and Trait Anxiety Inventory


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 8 to 17
* Patients with a rhythm disorder,
* Patients with indication for catheter ablation according to PACES (Pediatric and Congenital Electrophysiology Society) recommendations,
* Patients and/or their parents/legal guardians who have given their non-objection to the study.

Exclusion Criteria:

* Refusal of child or parents/legal guardians
* Unability to understand and/or fill the quality of life questionnaire
Fatigability Compared Men and Women Induced According to the Distance Traveled on an Ultra-marathon in the Mountains

Acute physiological consequences of ultra-marathon running are still unknown, particularly in women. Some studies have suggested that the proportion of fatigue attributable to peripheral and central mechanisms varies between males and females; however, results are contradictory.

The results from the investigators of the present experiment in two studies conducted in 2009 and 2012 showed that:

* A large part of fatigue induced by a mountain ultra-marathon could be attributed to central fatigue in males and that,
* Females exhibited less peripheral fatigue in the plantar flexors than males did after a 110-km ultra-trail-running race.

According to the literature, there seems to be a plateau in fatigue after 12-15 hours of running.

Thus, the main purpose of the present project is to investigate whether sex differences in neuromuscular fatigue in plantar flexors depend on the distance (\> 100 km vs \< 60 km).

Eligibility Criteria:
Inclusion Criteria:

* Subject listed in the race "2019 Mont Blanc Ultra Trail"
* Affiliates or beneficiaries of social security scheme
* Signed consent

Exclusion Criteria:

* Subject having been injured in the previous 3 months
* Pregnant woman
* Chronic joint diseases
* Chronic or central neurological pathologies
* Taking neuroactive substances that can alter corticospinal excitability
* Contraindication to experimental procedures including Transcranial Magnetic Stimulation (TMS)
* Taking corticosteroids in the previous 3 months
Valveless Trocar Versus Standard Trocar in Robot-assisted Complex Partial Nephrectomy

The goal of this clinical trial is to compare two kind of trocar in patients undergoing complex robot-assisted partial nephrectomy. The main question it intends to answer is whether the use of valveless trocars can significantly reduce carbon dioxide absorption.

In the literature there are studies on the benefit of valveless trocars in robotic surgery. There are no studies on the potential effects even in complex kidney surgery. Through this randomized study we want to investigate whether the ability to clear CO2 is better using valveless trocars

Eligibility Criteria:
Inclusion Criteria:

* asa status 1-3
* surgical classification RENAL or PADUA score \>9

Exclusion Criteria:

* BMI\>30
The COPD Optimiser

Rationale: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report pro- vides clinical treatment guidelines for COPD aimed at relieving and reducing the impact of symptoms, and reducing the risk of adverse health events, such as exacerbations. Despite the availability of these COPD treatment guidelines, evidence suggests that available thera- pies may not be utilized to their full potential to optimize disease management and outcomes for patients. So far, there is a lack of knowledge on the optimalisation opportunities of patients with COPD in a primary care setting.

Objective: The primary objective is to describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care population of patients with COPD.

Study design: This is a non-interventional prospective observational study, taking place in a real-world primary care setting.

Study population: Patients diagnosed with COPD are eligible to participate. A limited number of in- and exclusion criteria will be adopted, to make sure the research population closely resembles the real world.

ature and extent of the burden and risks associated with participation, benefit and group relatedness: Study specific involvement is limited to the one visit for the participant. Participants will receive enhanced usual medical care as determined by their physician and will not be randomly allocated to an experimental intervention or care as usual. The partici- pating general practices and participants in the study will be reimbursed for the time spent on this study. Risks of participating in the study are deemed to be negligible. All participants will use their own medication and follow the management plan that is in line with guidelines. The study specific additions to the consultation are administering a (not emotionally demanding) questionnaire and drawing a small amount of blood from the finger, to measure the level of blood eosinophils, using a point-of-care method. This is a test that may cause a slight incon- venience for the patient, although this test is less invasive than typical blood draws that would be part of the newest international guideline.

Primary objective

1. Describe the GOLD-guided management suggestions obtained from the COPD Optimiser, in order to gain insight into optimalisation opportunities in a Dutch primary care pop- ulation of patients with COPD. The endpoint for the primary objective is the number of times that each manage- ment suggestion was given


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of COPD (ICPC R95),
* Capacity to understand and provide written informed consent.

Exclusion Criteria:

* Active diagnosis of Asthma (ICPC R96)
* Patients participating in an interventional clinical trial
Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography

The purpose of this study is to:

1. To investigate the wrist joint synovial blood flow intensity and model by quantitative three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid arthritis before and after initiation of a new medicine and compare these data with routinely used clinical data and laboratory findings, such as pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
2. To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS assessment of the vascularity in wrist joints and knee joints using automatic volume scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients who fulfill the 1987 ARA criteria for RA
* Patients with at least one painful swollen wrist or knee joint observed by a rheumatologist
* Patients who will receive a new medicine, including oral corticosteroid, intravenous methylprednisolone pulse therapy, intraarticular injection with steroid or methotrexate, DMARDs, or biologic agent

Exclusion Criteria:

* Patients with active infection
* Patients with concurrent malignant disease
* Patients with a history of traumatic, septic, or cystal arthritis, previous joint surgery, or arthroscopic synovectomy of any wrist or kneejoint within the past 12 months before the study
* Patients who have severe wrist or knee joint deformity that makes the US assessment protocol unable to complete
Muscle Fatigue in Patients With Multiple Sclerosis

It is stated that 85% of patients with Multiple Sclerosis (MS) complain of gait disorders and 35-90% of them have fatigue. Many factors play a role in the fatigue mechanism in MS patients. Fatigue can increase the symptoms that already exist in MS patients. It is thought that fatigue caused a decrease in muscle strength, making walking worse. There are not enough studies investigating whether fatigue affects gait parameters in MS patients.

The aim of this study is to examine the effects of muscle fatigue on muscle strength, joint position sensation, and gait in MS patients.

Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS) and healthy individuals of similar age and sex to patients will be included in the study. The muscle strength, joint position sensation, gait, and fatigue will be evaluated once.

The investigators will use descriptive statistics and t-tests to compare demographic characteristics between groups and for the categorical variables chi-square. Effect of the group (MS patients or healthy controls), condition (Single task and dual-task conditions), and group × condition interaction will be compared using two-way repeated-measures ANOVA.

Eligibility Criteria:
Inclusion Criteria:

* Participants who 18-65 years of age
* MS patients who are ambulatory (Expanded Disability Status Scale score ≤ 5,5 ) in a stable phase of the disease, without relapses in the last 3 month

Exclusion Criteria:

* Participants who have orthopedic, vision, hearing, or perception problems
The Relationship Between Gait and Severity of Femoroacetabular Impingement

In this study, the spatiotemporal gait parameters of symptomatic femoroacetabular impingement (FAI) patients scheduled for hip arthroscopy are evaluated. Radiological measurements, including the Alpha angle (AA), Lateral Center-Edge Angle (LCEA), and Kellgren-Lawrence (KL) osteoarthritis classification, are recorded from patient files. The relationship between these radiological measurements and walking parameters is assessed. Additionally, the spatiotemporal gait parameters of FAI patients are compared with those of a healthy control group.

Walking assessments provide valuable insights into how Femoroacetabular Impingement (FAI) affects movement and aid in evaluating treatment outcomes. Research indicates that individuals with FAI experience reduced hip motion and slower walking speeds. By analyzing spatiotemporal gait parameters-such as gait velocity, cadence, step length, and vertical center of mass-the impact of FAI on walking can be better understood, leading to the development of targeted treatment strategies. The goal is to explore the correlation between these gait parameters and imaging-based FAI characteristics in affected individuals.

Patients and control groups are compared using the paired samples t-test for parametric data and the Wilcoxon signed ranks test for nonparametric data. The relationship between gait parameters and imaging-based FAI characteristics is examined by calculating the Pearson correlation coefficient (r) for parametric data and the Spearman rank correlation coefficient (rho) for non-parametric data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with femoroacetabular impingement scheduled for hip arthroscopy

Exclusion Criteria:

* Severe hip osteoarthritis
* Hip dysplasia
* Previous ipsilateral and/or contralateral hip surgery,
* Any orthopedic or neurologic pathology that may affect gait patterns
An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy

This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached \>/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
* Progression-free survival of \>/= 9 months reached

Exclusion Criteria:

* N/A