cyrilzakka/clinical-trials huggingface dataset:
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes

This single-center clinical trial is designed to evaluate the CardioFlux magnetocardiograph diagnostic imaging system to predict major adverse cardiac events (MACE) in patients referred for evaluation for coronary artery disease.

This is a single-center, prospective, observational cohort trial to form a registry data set. Patients presenting for cardiac stress testing utilizing Single Photon Emission Computed Tomography (SPECT), cardiac CT angiography (CCTA), or cardiac catheterization will be offered to enroll in the registry and provide informed consent to undergo imaging with a CardioFlux magnetocardiography (MCG) prior to their procedure.

Multiple studies have shown that MCG accuracy is quite high in identifying patients with symptomatic coronary artery disease. This difference is dramatic enough to prove superiority over standard ECGs in diagnosis of vital ischemic and infarction parameters. Genetesis presents a novel MCG analysis system called CardioFlux (CF). This modality takes less than five minutes to complete, is radiation-free, and is an easy to operate system. This clinical trial will enroll patients of all cardiac risk levels presenting for various modalities of cardiac diagnostic testing to have CardioFlux scanning in addition to standard of care. Results will be interpreted and compared to the immediate results of nuclear (SPECT) stress testing, cardiac CT angiography, or cardiac catheterization.

Participants will be followed up at 30 days and 1 year via phone call or chart review. 30 day and 1 year MACE will be recorded and correlated with initial CardioFlux MCG results. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy will be calculated of CardioFlux relative to the incidence of MACE, and in comparison to the above diagnostic modalities.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age at the time of enrollment.
* Patient presenting for cardiac stress testing, cardiac CT angiography (CCTA), or cardiac catheterization.
* Consents to having an magnetocardiogram-CardioFlux study scan.

Exclusion Criteria:

* \< 18 years of age
* Patients unable to fit into device
* Non-ambulatory patients
* Patients with implanted cardiac pacemakers/defibrillators
* Positive response on provided Metallic/Ferromagnetic Device Screening Form
* Atrial fibrillation with rapid ventricular response
* Patients with other sustained or incessant arrhythmias
* Patients with claustrophobia or unable to lie supine for 2 minutes
* Patients require supplemental oxygen at home
* Presence or reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
* Patients scheduled for cardiac catheterization with indication of valvular disease
* Poor candidate for follow-up (e.g. no access to phone)
* Prisoners
* Repeat participants
* Patients participate in other research studies
Are Acceptance and Commitment Related to Treatment Response in Chronic Low Back Pain

The main objective of this study is to evaluate whether acceptance (measured by the AAQ-II questionnaire) is prognostic of algo-functional changes measured by the Oswestry Disability Index, ODI) at 6 months.

The secondary objectives are:

A. To search for correlations between the acceptance score (AAQ-II Questionnaire) and scores for coping (CSQ), avoidance (FABQ), understanding (BBQ), anxiety and depression (HADS) and quality of life (SF-12) at baseline.

B. To describe the kinetics of changes in various parameters (acceptance, coping, avoidance, understanding, anxiety and depression, quality of life, ODI) over 6 months.

C. To evaluate the agreement between two methods of questionnaire presentation: Paper collection versus collection by Tablet PC.

Eligibility Criteria:
Inclusion Criteria:

* The patient has been informed about the study, and is not opposed to the study
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 6 month of follow-up
* The subject has chronic back pain that is not post-operative in nature and that has lasted for more than 3 months
* The subject accepts the re-education curriculum.

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to participate
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The subject has a history of chronic obstructive pulmonary disease, cardiovascular disease, rheumatoid arthritis, lupus, spondylitis or neoplastic disease.
* Patient currently under psychological treatment
Laparoscopic Bursectomy and D2 Lymphadenectomy vs.Laparoscopic D2 Lymphadenectomy in Advanced Gastric Cancer

To investigate the clinical efficacy and safety of laparoscopic bursectomy and D2 lymphadenectomy (LBDL group) versus laparoscopic D2 lymphadenectomy (LDL group) in advanced gastric cancer by prospective randomized controlled clinical trial.

To compare the LBDL group and LDL group in the advanced gastric cancer. A prospective randomized controlled trial will be performed in the GI department, Guangdong provincial hospital of Chinese Medicine from November 2016 to November 2024. The sample size，100 cases with advanced gastric cancer, will be needed after calculated by the statistics. The 100 cases will be randomly divided into two groups: LBDL group and LDL group. Primary outcomes are the 3 years' Disease-free survival (DFS) rate, The secondary outcomes are the 3 years' and 5 years' Disease-free survival (DFS) rate, the 3 years and 5 years Overall survival（OS）rate, operative time, the total blood loss, the intra-operative complication and the post-operative complication, the number of lymph nodes dissected, the number of conversion to open laparotomy, and the other outcomes are the average time of ground activities, the hospital stay. The data in two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. The age limits is 18-80 years old;
2. T3-T4 resectable gastric carcinoma,confirmed by CT and pathology.
3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;
4. American Society of anesthesiologists (ASA) score less than or equal to Level 3;
5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

1. The patients' age limits is Less than 18 years old, or more than 80 years old;
2. The preoperative imaging confirmed that the tumor involve adjacent organs;
3. The tumor have been finding distant metastases;
4. American Society of anesthesiologists (ASA) score more than 3;
5. Criteria of performance status karnofsky is lower than 60;
6. There is a laparoscopic surgery contraindications.
The Effects of EndoActivator on Postoperative Pain and Root Canal Treatment Success

This study evaluates postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Aim: To evaluate postoperative pain and radiographic healing of asymptomatic posterior teeth with chronic apical periodontitis following root-canal treatment performed using EndoActivator for irrigation activation.

Methodology: In this clinical trial, root-canal treatment was performed on 140 posterior teeth with chronic apical periodontitis. After routine canal preparation, patients were assigned to either a control group treated using conventional needle irrigation (CNI) without activation or to sonic irrigation activation with EndoActivator. All treatment was completed in a single visit. Patients provided self-assessments of the severity of postoperative pain at 1, 2,3 and 7 days using a Verbal Rating Scale (VRS) and Wong Baker Face Scale. Patients were recalled at 12 months for clinical and radiographic examinations. Periapical healing was evaluated using a periapical index (PAI), with scores of 1 or 2 considered to represent treatment success and scores of 3, 4, or 5 to represent treatment failure. Data were analyzed using one-way ANOVA and Kruskal-Wallis tests, with differences of P \< 0.05 considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 patient's age
* Being systemically healthy
* Having posterior teeth (molar or premolar) with chronic apical periodontitis lesion (PAI≥3)

Exclusion Criteria:

* Clinically symptomatic teeth
* Patients with complicated systemic disease (ASA 3 - 6)
* Teeth with open apex
* Teeth having curvature more than 20 degree
* Not having enough tooth structure to be isolated with rubber dam
* Patients with severe periodontal defects or deep periodontal pockets (probing depth\> 4 mm)
* A history of taking analgesics 12 hours ago or antibiotics 1 month ago
* Patients who cannot come to control sessions
Quantiferon Gold Test for Detecting Tuberculosis (TB) Infection in HIV/AIDS Patients in South Africa

The purpose of this study is to use a cluster randomized trial to compare the effectiveness of linking the Quantiferon-gold in-tube test (QGIT) with routine CD4 testing to the routine use of the tuberculin skin test (TST), the current standard of care for diagnosing latent tuberculosis infection (LTBI) in South Africa. The investigators hypothesize that QGIT clinics will identify LTBI and initiate isoniazid preventive therapy (IPT) in a higher proportion of patients and in a significantly faster timeframe. The cost-effectiveness of linking QGIT with routine CD4 compared to routine TST will also be evaluated, and the process of implementation of QGIT into the routine cluster of differentiation 4 (CD4) blood draw will be evaluated using a mixed method approach to identify steps that can be modified for future scale-up of the intervention.

The investigators propose a cluster randomized trial in 16 HIV clinics in South Africa to compare time to determine LTBI status in patients in clinics using QGIT and TST and those with TST only. The investigators will take advantage of the excellent HIV services provided in South Africa and link QGIT with CD4 blood collection and provide the first evidence of an operational comparison between QGIT and TST in HIV-infected patients in a country that accounts for one-third of the HIV-related TB in the world. The QGIT study will contribute to the understanding of QGIT performance and implementation in HIV-infected individuals. Careful evaluation of the implementation and operational aspects of the program will provide useful knowledge for future scale-up in this and other HIV clinic settings.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* \>= 18 years of age
* attending one of the 14 clinics during the duration of the study
* eligible to receive TST or IPT according to South Africa guidelines

Exclusion Criteria:

* diagnosed with active tuberculosis
* not eligible to receive TST or IPT according to South Africa guidelines
Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding

Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding

Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work.

Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.

Eligibility Criteria:
Inclusion Criteria:

1. suspected or known small-bowel bleeding
2. age: 16-70

Exclusion Criteria:

1. pregnancy
2. coagulation disorders
3. prior surgery of the small bowel and colon
Vancomycin Study in Multiple Sclerosis (MS)

The overall goal of this study is to elucidate a mechanism by which vancomycin modulates the gut-brain axis in multiple sclerosis (MS). The gut microbiome plays an important role in autoimmunity, including MS. However, the identity of gut microbes modulating neuroinflammation in MS and their mechanisms of action remain obscure. Hence, here the research team proposes to investigate the effects of vancomycin on the gut microbiota composition, peripheral immune function, and brain MRI lesions in MS patients.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 - 50
* newly diagnosed MS (2017 McDonald criteria), CIS or RIS patients, who have experienced symptoms no earlier than the past year
* treatment naive
* able to understand the risks, benefits, and alternatives of participation and give meaningful consent

Exclusion Criteria:

* antibiotic use within the past 90 days;
* pre- or probiotic use within past month or corticosteroids use within the past month;
* use of tobacco products within the past 1 month;
* history of treatment with immunosuppressants;
* history of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV;
* pregnancy or less than 6 months postpartum;
* irritable bowel syndrome and other bowel dysfunction such as constipation;
* history of bowel surgery;
* inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;
* diagnosis with another neurological disease, behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as severe major depression, schizophrenia and presence of psychotic symptoms);
* eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;
* travel outside of the country within the past month;
* contraindication to vancomycin including estimated glomerular filtration rate of \<60ml/min, impaired hearing or known allergy.
* Contraindication to MRI such as implanted metallic objects
Clinical Outcomes of Patients With Resectable Non-Small Cell Lung Cancer Receiving Neoadjuvant Nivolumab Plus Chemotherapy in France

The purpose of this study is to evaluate real-world effectiveness of neoadjuvant nivolumab plus chemotherapy in France.


Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of resectable non-small cell lung cancer (NSCLC)
* Being 18 years or above at the time of their NSCLC diagnosis
* Having initiated a neoadjuvant treatment with nivolumab and chemotherapy outside a clinical trial
* Being indexed in the site database
* Being followed at the site for at least 5 months, except for patients with a record of death

Exclusion Criteria:

• Having any primary tumor other than NSCLC on or before the date of NSCLC diagnosis that required a treatment ending less than 12-months before the nivolumab plus chemotherapy neoadjuvant treatment
Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

Controlled, randomized, double blind study, for the evaluation of tolerance and trichological efficacy of a food supplement: Bioscalin® new formulation versus reference formulation currently on the market and placebo

Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the trichological activity of a food supplement taken for 3 months by subjects of both sexes, aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen phase \< 75%.

In particular the study foresaw the evaluation of the trichological activity of the Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product currently on the market and to placebo.

It was also aim of this study to evaluate treatment tolerance.

Eligibility Criteria:
Inclusion Criteria:

* both sexes;
* age range 18-60 years old;
* with telogen effluvium and a percentage of anagen ratio at inclusion \< 75%;
* no-smokers;
* accepting to follow the instruction received by the investigator;
* disposable and able to return to the study centre at the established times;
* accepting to not change their habits regarding food, physical activity, hair and scalp cleansing;
* accepting to not receive any drugs/cosmetics treatment able to interfere with the study results;
* no participation in a similar study actually or during the previous 6 months;
* accepting to sign the Informed consent form.

Exclusion Criteria:

* Pregnancy (for female subjects);
* lactation (for female subjects);
* subjects not in menopause who does not use adequate contraceptive precautions in order to avoid pregnancies during the study;
* subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, after 2 (T2) and 3 (T3) month-treatment;
* change in the normal habits regarding food, physical activity, physical activity, hair and scalp cleansing during the month preceding the test;
* sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit). The product contains gluten (aroma of grain), then all subjects with celiac disease or gluten intolerance should be excluded.
* subjects whose insufficient adhesion to the study protocol is foreseeable;
* participation in a similar study actually or during the previous 6 months.
* presence of cutaneous disease on the tested area, as lesions, scars, malformations;
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
* Diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy
* anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
* assumption of drugs able to influence the test results in the investigator opinion.
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®

Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.

The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.

Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.

Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in vitro resistant Pseudomonas aeruginosa.

Study hypotheses :

Regarding literature data and in vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.

Primary objective :

To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®


Eligibility Criteria:
Inclusion Criteria:

* Adults and children aged 6 years old and more
* Male or female
* Patients with cystic fibrosis (positive sudoral test, Cl \> 60 mmol/L)
* Followed in a CRCM (CF care centre)
* FEV1 ≥40%
* Informed consent collected from adults or parents or legal guardians and children.
* Affiliation to the National Health Insurance program (Sécurité sociale).

Exclusion Criteria:

* - renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
* recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
* Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :

Cough increase, Sputum increase, Decrease in tolerance to effort, Loss of weight, lack of appetite, Deterioration of respiratory function,

- Medical history of intolerance, toxicity or allergy to tobramycine, hypersensitivity to aminoside
Comparison of HFNC With NIV in Weaning COPD

High flow nasal cannula (HFNC) has been shown to improve oxygenation and facilitate weaning in hypoxemia patients. Some clinical studies show the benefits of using HFNC in COPD patients, including reducing dead space and work of breathing. However, no clinical study has been to investigate the value of HFNC in weaning COPD patients from invasive ventilation. Thus, we proposed a randomized controlled trial to compare the use of HFNC and noninvasive ventilation (NIV) in weaning COPD.

High flow nasal cannula (HFNC) provides high concentration oxygen in a high flow, which exceeds patient's inspiratory flow demand, to improve oxygenation. In a recent meta-analysis of seven trials with 1771 patients, HFNC was shown to improve oxygenation and avoid intubation in patients with severe hypoxemia. The high velocity of the gas can rinse the dead space of the upper airway and reduce CO2 rebreathing, reduce COPD patients' work of breathing and improve the dynamic compliance of respiratory system.

Thus, we proposed a randomized controlled trial to investigate the value of high flow nasal cannula in weaning AECOPD patients from invasive ventilation, with comparison of noninvasive ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Intubated patients with Chronic obstructive pulmonary disease exacerbation
* Meeting extubation criteria (Pulmonary infection control window)
* Age \> 21years and \< 90 years

Exclusion Criteria:

* Tracheotomy
* Combined with severe dysfunction of other organs, including heart, brain, liver, and renal failure;
* Hemodynamic instability
* Contraindication to NIV: cannot use mask, such as facial injury, burns or deformities; cannot cooperate with NIV such as delirium; copious secretions with weak cough ability; gastric over distention, and vomiting;
* Contraindication to HFNC: rhinitis, nasal congestion, deformities or blockage.
* Weak cough ability with copious secretions
* Refuse to participate in the study