cyrilzakka/clinical-trials huggingface dataset:
FLOW-AF: A Study to Evaluate Electrographic Flow™ (EGF) Mapping Technology

This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).

The objective of this study is to evaluate the reliability of Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software) to identify sources of atrial fibrillation and guide ablation therapy in patients with persistent atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
2. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
3. Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation \< 36 months.
4. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
5. Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)

Exclusion Criteria:

1. Left atrial diameter \> 5.5 cm.
2. Left ventricular ejection fraction (LVEF) \< 35%.
3. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
4. Coagulopathy, bleeding diathesis or suspected procoagulant state.
5. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
6. Positive pregnancy test results for female patients of childbearing potential or breast feeding.
7. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
8. Mitral valve stenosis and/or severe mitral regurgitation.
9. Valvular atrial fibrillation.
10. Prosthetic valves.
11. New York Heart Association (NYHA) Class IV.
12. History of myocardial infarction (MI) within 3 months prior to procedure.
13. Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
14. Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
15. Life expectancy \< 12 months based on medical history or the medical judgement of the investigator.
16. Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.
Comparison of the Bioavailability of Metformin Between Medium Dose Linagliptin/Metformin Tablets and Medium Dose Glucophage Tablet Given With Linagliptin Tablet

The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male and female subjects.

Exclusion criteria:

1. Any relevant deviation from healthy conditions.
Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate

This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.


Eligibility Criteria:
Inclusion Criteria:

* Infants with age range from 1-30 days.
* Unilateral complete cleft lip and alveolus.
* Medically free subjects.
* Both males and females.
* Cleft gap more than 10 mm.

Exclusion Criteria:

* Patients older than 30 days.
* Syndromic patients with other defects in addition to cleft lip and palate.
* Patients with bilateral cleft lip and palate.
* Incomplete Cleft lip.
* Patient with previous surgical lip repair or adhesion.
* Patients with previous presurgical infant orthopedic treatment.
* Medically compromised patients.
* Cleft gap distance less than 10mm
Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the UGT2B7 enzyme) and tamoxifen (TAM) toxicity. Pre- \& post-menopausal women (aged ≥18 years) taking TAM (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. Patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. Patients will be excluded if they are undergoing other adjuvant endocrine therapies. Other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. The goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. The investigators expect to treat \~50 new patients per year with TAM at the standard dose of 20 mg/day.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention
* Age 18 years and above
* May be pre- and post-menopausal
* Females
* Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy
* Must use a reliable form of birth control

Exclusion Criteria:

* Pregnant
* Breastfeeding
* Concurrent use of corticosteroids, megestrol, or phenobarbital
* History of allergy to tamoxifen
* Unwilling to have a yearly gynecological exam
Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine

The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.

Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose. The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules. A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented. To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female adults
* Aged ≥ 18 to ≤ 50 years on the day of enrollment
* Written informed consent
* Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years

Exclusion Criteria:

* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Body weight below 40 kg at any visit during the study
* Acute febrile illness (≥ 38.0°C)
* Known hypersensitivity to any vaccine component
* Previous history of a serious adverse reaction to influenza vaccine
* Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
* History of egg protein allergy or severe atopy
* Known blood coagulation disorder
* Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥ 0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
* Known immunodeficiency (incl. leukemia, HIV seropositivity) or cancer
* Known history of psychiatric diseases, particularly dementia
* Investigational medicinal product received in the past 3 months (90 days)
* Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
* Pregnancy or lactation
* Participation in another clinical trial for the entire duration of this trial
* Employee at the investigational site or relative of the investigator
* Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol
Switching to Duloxetine in Patients With Depression

The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD).
* Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.
* Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.

Exclusion Criteria:

* Women who are pregnant or plan to be pregnant or are breastfeeding.
* To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.
* Diagnosed with treatment resistant depression.
* History of bipolar disorder, schizophrenia, or other psychotic disorders.
* To have previously taken duloxetine that didn't work.
* Judged to be at serious suicidal risk in the opinion of the investigator and/or score \>=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).
* A serious medical illness that may need treatment during the study.
* Taking certain medications that are not allowed in this study.
* To have a history of alcohol and/or drug abuse or dependence within the past year.
* To have uncontrolled narrow-angle glaucoma.
* To have allergic reactions to many medicines.
* To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
* To initiate "talk therapy" (psychotherapy) just before or during the study.
* To have chronic pain and you have been taking medicine for it for the last 6 months.
* To have certain liver diseases.
* To have kidney disease or undergoing dialysis.
* Abnormal thyroid stimulating hormone (TSH) concentration.
Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery

Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.

The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients.

The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged from 18 to 60 years old
* ASA I or II class
* Undergo elective intraocular surgery
* Under general anesthesia.

Exclusion Criteria:

* Renal impairment
* Cardiorespiratory abnormalities
* Bronchial asthma COPD
* Restrictive lung diseases
* Liver failure
* Allergy to drugs will be used
* Patient refuse
* Pregnancy-lactation
* Significant obesity
Clinical Study On Lower Limb Robot For Lower Limb Dysfunction After Stroke

The goal of this clinical trial is to learn about effect of lower robot in stroke population. The main question\[s\] it aims to answer are: the efficacy of lower limb robot assisted training in improving walking ability, lower limb function, cognition, and quality of life in stroke patients.The robot group of patients received lower limb robot assisted training combined with routine rehabilitation treatment. The control group only received routine rehabilitation treatment.Compare two groups to explore the therapeutic effect of lower limb robots on lower limb dysfunction after stroke.


Eligibility Criteria:
Inclusion Criteria:

* In line with the diagnostic criteria for stroke in the Diagnostic Criteria for Various Cerebrovascular Diseases issued by the Chinese Medical Association in 2019.
* First stroke or no residual dysfunction after previous stroke.
* Participants have stable vital signs, clear consciousness, and no aphasia.
* The onset time of stroke is between 2 weeks and 6 months after onset.
* Age\>18 years old.
* Presence of hemiplegic motor dysfunction.
* Ability to walk with the help of a single person.
* sign an informed consent form with the Participants or family member before treatment.

Exclusion Criteria:

* Participants have serious musculoskeletal or other mental nervous system disease.
* Participants have contraindications to cardiovascular exercise.
* Moderate to severe contracture of the patient's lower limbs (modified Ashworth scale, MAS\>2 for ankle, knee, or hip joints).
* Presence of progressive or secondary brain injury leading to unstable condition.
* Unilateral neglect or diseases that affect vision.
* Participants have lower limb vein thrombosis.
* Participants present with lower limb non healing ulcers and osteoporosis.
Effectiveness of Dipeptide N (2)-L-Alanyl-L-Glutamine in Trauma ICU Patients: Pilot, Prospective, Randomized and Double Blind Study.

Recent reports suggest that most beneficial results of glutamine have been obtained with the parenteral administration of high doses of glutamine (0.35 g/Kg/d) and in some special group of patients, such as traumatic patients. Nevertheless total parenteral nutrition is not often used in critically ill patients.

The endovenous administration of the the dipeptide N(2)-L-alanyl-L-glutamine in trauma ICU patients can reduce the number of infections, ICU length of stay and mortality.

This benefit can be achieved independently the type of nutrition (enteral or parenteral nutrition), being a pharmaconutrient.

Objective: To evaluate the efficacy of the endovenous administration endovenous glutamine to reduce the number of infectious complications, mortality and ICU length of stay in trauma ICU patients. To achieve this objective we have designed this pilot study to obtain the necessary data to design a bigger trial in the future.

Other objectives include:

* To evaluate the efficacy of glutamine in different patients regarding their severity: patients with an Injury Severity Score\> 25 and patients with lower plasma levels of glutamine.
* To registry the possible adverse events of the endovenous administration of glutamine.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe trauma, as defined by an Injury Severity Score (ISS) \> 10 points were included in the study.
* Traumatic patients who required enteral or parenteral nutrition during the first 48 hours after hospital admission
* Written informed consent

Exclusion Criteria:

* patients whose life expectancy was less than 5 days,
* who were allergic to glutamine,
* Patients included in any other trial
* Cirrhotic patients (Child C)
* Chronic renal failure
SUPPLEMENTATION WITH BETA GLUCAN AND ADAPTATIVE RESPONSE.

Abstract: Studies demonstrate that the use of nutritional supplements containing beta-glucans stimulates the immune system, modulates inflammatory activity, and promotes so-called immune training. Beta-glucans are prebiotics that stimulate the growth and activity of gastrointestinal microbiota and inhibit pathogen growth. Nutritional intervention is crucial for patients\&#39; positive evolution, and providing a supplement with highly bioavailable nutrients can make a difference in their nutritional, metabolic, and immune status. Therefore, the study aims to verify the effectiveness of the innate and adaptive immune response to a nutritionally balanced fermented food, containing oral or enteral beta-glucans, in patients treated at 3 Emergency Care Units in São José do Rio Preto, São Paulo, Brazil. This is a prospective randomized study with a characteristic design involving patients treated in the medical wards of 3 Emergency Care Unit. The following assessments will be conducted: Global Subjective Assessment for adults and Mini Nutritional Assessment for the elderly, Sociodemographic, and Laboratory Evaluation.


Eligibility Criteria:
Inclusion Criteria:

Patients admitted to the medical clinic ward

Exclusion Criteria:

Patients unable to swallow
Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes

Lipoprotein-associated phospholipase A2 (LP-PLA2) is a good marker of cardiovascular risk and inflammation. This study aims at the characteristic and clinical significance of LP-PLA2 test in patients with type 2 diabetes(T2D).

The investigators recorded clinical factors, serum levels of glucose, HbA1c, lipids and LP-PLA2 in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016. The relationship between levels of LP-PLA2 and diabetic complications are analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.

Exclusion Criteria:

1. Patients use systemic steroidal anti-inflammatory drugs.
2. Patients are pregnant.
3. Patients with an acute infection.
The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis

The primary outcome of this study is to evaluate the effect of radiofrequency turbinate reduction as an initial treatment on clinical improvement (using visual analogue scale based on total nasal symptoms score, peak nasal inspiratory flow, and turbinate size using ImageJ), inflammatory mediators (ELISA from nasal secretions was performed to measure ECP, IL-5, and HSP-70), and remodeling markers (through nasal biopsy followed by immunohistochemistry examination to evaluate MMP-9, TIMP-1, and PAI-1).

In this randomized, controlled trial, 32 patients with moderate-severe persistent AR were randomly divided into 2 groups. Intervention group received radiofrequency turbinate reduction followed by intranasal steroid and antihistamine H-1(AH-1), control group received intranasal steroid and AH-1. Both groups were evaluated for clinical improvement in week 4 and 8 after treatment, inflammatory mediators and remodeling markers in week 4 after treatment.

The study compares 2 groups of moderate-severe persistent allergic rhinitis (AR). The intervention group receives radiofrequency turbinate reduction followed by pharmacology treatment (intranasal steroid and AH-1) while the control group receives only pharmacology treatment.

Diagnosis of AR will be made through clinical history, physical examination, and skin puncture test. Patients aged 18-55 years old with moderate-severe persistent AR who come to the outpatient clinic and have signed the informed consent form will be included in this study. Moderate-severe AR is defined as having AR symptoms for more than 4 days in a week and more than 4 weeks, with symptoms affecting the subjects' quality of life. Patients will be assigned to two groups of treatment randomly with a single blind block randomization.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate-severe persistent allergic rhinitis who come to the outpatient clinic and has signed the informed consent form.

Exclusion Criteria:

* Smokers
* Septum deviation in nasal valve without septal swell body
* Unilateral inferior turbinate hypertrophy caused by septum deviation
* Pregnant
* Severe systemic disease
* Acute rhinitis or rhinosinusitis within 6 weeks before the study period
* Nasal polyp
* Nasal or paranasal tumor
* Subjects who had received other methods of inferior turbinate reduction, posterior nasal neurectomy, functional endoscopic sinus surgery, Caldwell Luc
* Subjects who had received topical steroid for 4 weeks before the study period
* Coagulation disorder
Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years

The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.

Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly.

Although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients.

Preliminary data indicate that systemic necrotizing vasculitides (SNV) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects.

In this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (CYC then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
* Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
* within or after the 65th of anniversary
* Age ≥ 65 years

Exclusion Criteria:

* Any cytotoxic drug within previous year
* Co-existence of another systemic autoimmune disease, e.g., SLE, RA
* Virus-associated vasculitides
* HIV positivity
* Malignancy (usually excluded unless approved by the trial coordinator)
* Age \< 65 years
* Inability to give informed consent