cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of the Acute Effect of Water-Pipe Smoking on the Endothelial Function and the Respiratory System

Title: The acute effect of narghile smoking on endothelial Function, and exhaled breath condensate (EBC) and pulmonary function tests in healthy volunteers.

Objectives: To evaluate the acute effect of one cession of narghile smoking on endothelial Function, airway inflammation as assessed by exhaled breath condensate (EBC) in healthy volunteers.

Design: Prospective study evaluating these parameters before and after 30 minutes of Narghile smoking. The changes in inflammatory parameters pre and post smoking will be evaluated blindly.

Sample size: 50 participants Participant selection: Adults subjects who smoke Narghile . Intervention: Each subject will undergo evaluation including a respiratory questionnaire, endothelial Function , pulmonary function tests , exhaled breath condensate (EBC) and carboxy- hemoglobin levels . All measurements will be evaluated before and after one cession of 30 minutes narghile smoking.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 Y.O.
* Have smoked Water-pipe at least once before.

Exclusion Criteria:

* Breast feeding Women.
* S/P Bacterial Or Viral infection, Last 2 weeks
* P.O. Steroids
* Water-pipe smoking, last 24 hours
* Cigarette smoking, last 6 hours
* Intensive exposure to smoke (fire), last 24 hours
* S/P Intensive Care Hospitalization, last 3 months
Efficacy of an Education Protocol in the Correction of Inhalation Techniques in COPD

This study evaluates the implementation of an education protocol and its impact on the correct inhalation technique in COPD patients presenting errors or mistakes. There will be 4 sessions, in each one the inhalation technique will be evaluated using a checklist of steps. Whenever errors are found, the correct use of each device will be educated through verbal explanation and written material will be delivered.


Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD diagnosed by spirometry (presence of a postbronchodilator FEV1 / FVC ratio \<0.7)
* Over 40 years old
* Use any of the following devices: metered dose inhaler, HandiHaler, Turbuhaler, Diskus, Aerolizer
* Have at least one error in the inhalation technique
* Signature of informed consent.

Exclusion Criteria:

* Artificial airway
* Cognitive impairment noted in the medical history
* Hearing loss that complicates the compression of simple orders
* Bilateral amaurosis
* Functional dependence for the use of inhalers
* Presence of abnormal movements in the upper limbs that interfere and / or impede the correct use of the devices
Impact of Levagen+® Palmitoylethanolamide (PEA) in a Cross-Over Trial Examining Stress and Cognition in University Students

The goal of this randomised cross-over trial is to learn about the effects of Levagen+® Palmitoylethanolamide (PEA) supplementation on cognition, wellness and well-being in young and healthy university students.

The main question it aims to answer is:

• Does the PEA supplementation affect parameters of stress, mood, cognition and well-being in university students?

Participants will complete 2 baseline on-site visits during which they will be assigned to Levagen+® Palmitoylethanolamide (PEA) treatment or placebo arm each time and:

* complete anthropometric measurements, questionnaires and surveys,
* undergo blood and saliva sampling
* complete a cognitive assessment (CANTAB)
* a randomly chosen cohort will also measure heart rate variability (HRV) over 3 days.

Researchers will compare the PEA treatment group to the placebo to see if there is a significant difference.

The study will investigate the effect of Levagen+® Palmitoylethanolamide (PEA) supplementation on parameters of stress, well-being and cognition at defined time points. Assessments will be made using a combination of a range of stress measures, which will include physiological and psychometric parameters.

Physiological measures will include assessments of known biomarkers of the principal stress-sensitive physiological systems, the hypothalamic-pituitary-adrenal axis, and the autonomic nervous system, while psychometric measures will include established instruments to assess general health, somatic stress symptoms, academic stress, response to stress, cognition, and mood.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females
* 18 to 40 years of age
* Fully enrolled full-time university students from London

Exclusion Criteria:

* Consumption of \>14 servings of alcohol/week
* Any learning disability (e.g. dysphasia)
* Any neurobiological disorders (e.g. autism)
* Smokers Any allergies/health issues related to items being ingested
* Any serious illnesses or those on chronic medication
* Any pregnant or lactating women
* Any woman who is trying to conceive
* Any chronic gastrointestinal disorders
* Any chronic menstrual disorders (e.g. PCOS)
* Any subjects who have undergone menopause or undergoing the perimenopause transition
* Any eating disorders
* Any depression/mental disorders
* Any obese sedentary (not physically active) individual, according to BMI values
* Any abnormal blood pressure levels
* Shift work
A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers

This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be normal healthy adult volunteers with no significant abnormalities in medical history, physical exam, vital signs or lab evaluations at the screening visit
To Evaluate The Performance Of Two Monthly Replacement Silicone Hydrogel Contact Lenses After 1-month Of Wear

To evaluate the performance of two monthly replacement silicone hydrogel contact lenses in habitual FRP CL wearers when worn for 1-month.

This study will be a prospective, randomized, double-masked, single-site, 1-month cross-over design involving bilateral eye daily wear of two different monthly replacement CL types. Each lens will be worn bilaterally for approximately one month.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Self-reports having had a full eye examination within the previous 2 years;
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is a habitual wearer of frequent replacement contact lenses;
6. Anticipates no difficulty wearing the contact lenses for 6 days/week and 8 hours/day during the study;
7. Has refractive astigmatism no higher than -0.75DC in each eye;
8. Can be successfully fit with both study lens types;
9. Achieves at least 0.4 logMAR VA monocularly and at least 0.2 logMAR VA binocularly with each study lens type.

Exclusion Criteria:

1. Is participating in any concurrent clinical research study;
2. Has any known active ocular disease and/or infection;
3. Has an unstable systemic condition that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
4. Is using any systemic or topical medications in an irregular routine that in the opinion of the investigator may affect vision or contact lens comfort across the 2-month study duration;
5. Has known sensitivity to the diagnostic sodium fluorescein to be used in the study;
6. Is an employee of the Centre for Ocular Research \& Education.
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries

Objectives: To compare the safety and efficacy of oral atenolol versus oral metoprolol as a premedication for controlled hypotensive anesthesia during nasal surgeries.

Background: Mucosal bleeding is the most frequent complication with nasal surgeries, as it interferes with the optimal visualization of the intranasal anatomy, increases operation time, and consequently increases blood loss. There are several pharmacological and non-pharmacological techniques for the appropriate control of intraoperative bleeding.

Patients and Methods: This was a prospective, randomized, double-blind, phase four, comparative clinical trial; carried out on 60 patients, who were candidates for nasal surgeries under general anesthesia at our hospital. Patients were randomly allocated into two equal groups; group A, received oral atenolol, and group M, received oral metoprolol.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≤ II
* Age from 21 to 50 years

Exclusion Criteria:

* ASA physical status \> II
* Age \< 21 years or \> 50 years
* Pregnant women
* Breastfeeding
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Diabetes Mellitus
* Hypertension
* Ischemic heart disease
* Rheumatic heart disease
* Heart failure
* Heart block
* Sick sinus syndrome
* Sinus bradycardia
* Chronic hypotension
* Anemia (Hb \< 10 g/dl)
* Renal or hepatic dysfunction
* Central nervous system disease
* Allergic fungal sinusitis
* Patients on beta-blockers
* Alcohol or drug abuse
* Anticoagulation therapy,
* Bleeding diathesis
* Agents influencing autonomic nervous system
* Allergy to the study drugs
* Any contraindication of oral intake
Improving the Experience of Exercise Among Individuals With Internalized Weight Bias Using Acceptance-based Strategies

The goal of this study is to test whether an acceptance based intervention can modify the relationship between heart rate and perceived exertion/negative during physical activity among individuals who have a high degree of internalized weight bias.

In this two-phase pilot, we will first test in a controlled setting whether an acceptance-based intervention can modify the relationship between Heart Rate and perceived exertion/negative affect during moderate intensity physical activity among individuals high in internalized weight bias (Phase 1) and then evaluate these mechanisms in real-time during uptake of a two-week physical activity prescription (Phase 2). Using a 2x2 factorial design, we will randomize individuals with Body Mass Index (BMI) ≥25, high and low internalized weight bias, and insufficient activity (\<60 min of moderate physical activity/week) to receive a 90-minute acceptance-based intervention workshop versus a multi-health behavior education condition prior to completing a 30-minute session of supervised, moderate intensity treadmill walking. Heart rate, self-reported perceived exertion and affect will be assessed throughout physical activity.

For Phase 2, all participants from Phase 1 will receive a two-week physical activity prescription consistent with National Guidelines (150 minutes moderate intensity aerobic physical activity, recommended in 30-minute bouts) to determine the effect of treatment condition on subsequent adherence to physical activity. Physical activity adherence will be monitored with Actigraphy and Ecological Momentary Assessment (repeated daily surveys via smartphone) will be used to evaluate participant self-efficacy, intention, motivation for physical activity in near real-time.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old,
* BMI 25-40 kg/m2
* insufficiently active (\<60 minutes of moderate intensity activity per week).
* High/low internalized weight bias
* Access to personal smartphone device and willing to download free smartphone app for data collection

Exclusion Criteria:

* Comorbid issues that might interfere with ability to engage in physical activity
* Factors that would influence ability to complete study protocol (e.g., cognitive, psychological)
* medication that would affect heart rate (e.g., beta blocker),
* women who are nursing or pregnant
Speckle-tracking Tricuspid Annular Plane Systolic Excursion

The study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.

1. Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography.
2. This study intends to validate the use of speckle-tracking echocardiography to measure the distance the tricuspid annulus moves during the systolic phase. The guideline articles regarding right ventricular function suggest m-mode measurements from the transthoracic approach and the same measurements may underestimate the actual distance on transesophageal echocardiography. This speckle-tracking technology will allow this distance to be measured despite its often non-parallel motion to the ultrasound beam, which otherwise limits the reliability of the valve recorded.
3. All subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management.
4. No interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography.
5. No follow-up, study will be completed at the time of image acquisition.

Eligibility Criteria:
Inclusion Criteria:

* All subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects.

Exclusion Criteria:

* Subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.
Photobiomodulation Protocols in the Analgesia of Chemotherapy-induced Oral Mucositis in Children

Chemotherapy-induced oropharyngeal mucositis (OM) negatively impacts the quality of life of adult and pediatric patients by causing pain, dysphagia, dysgeusia and dysphonia.

Photobiomodulation (PBM) by low level laser therapy (LLLT), light therapy of low level of red and infrared wavelengths (630-1000 nm) has been recommended since 2014 in patients treated with high-dose chemotherapy for bone marrow transplantation. Available pediatric studies highlighted positive/promising results of PBM with excellent safety and no adverse effects. Nevertheless, a wide variety of application parameters is described in the literature, with no consensus guidelines.

Considering the lack of standardized protocol of photobiomodulation in the pediatric population as well as the burden and cost of a daily application, investigators have decided to conduct, for the first time in children of 3 years of age or older, a multicenter, randomized, double-blind, non-inferiority clinical trial to compare two PBM protocols with same PBM parameters, combining red and infrared wavelengths, but with different frequencies of laser application (daily versus every other day), in the treatment of chemotherapy-induced OM of WHO grade 2 or higher.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female children aged ≥ 3 years and \< 18 years.
2. Hospitalization in an oncology or hematology department in the participating centres.
3. Patients with oropharyngeal mucositis of grade 2 or higher (WHO grading system) related to cancer chemotherapy, including conditioning for Hematopoietic Stem Cell Transplantation (HSCT).
4. Written informed consent of both patient's holders of parental authority, and patient's assent when applicable.
5. Patients affiliated to a French Social Security insurance or equivalent social protection.
6. Absence of any physical or psychological disability that may interfere with the LLLT application.

Exclusion Criteria:

1. Patients with a solid cancer lesion in the area of low-level laser application.
2. History of cervicofacial radiotherapy.
3. Application of low-level laser therapy for oral mucositis within 2 weeks prior to randomization.
4. Hyperthyroidism defined by TSH \< 0.4 IU/mL at inclusion.
5. Patients susceptible to epilepsy seizure.
6. Patients with pacemaker.
7. Patients refusing to wear retinal goggles during low-level laser 1. Patients with a solid cancer lesion in the area of low-level laser application.
8. Patients protected by law (guardianship and safeguarding of justice).
9. Pregnant female patients as determined by positive serum pregnancy test at screening.
10. Lactating female patients who are actively breast feeding.
11. Participation in another clinical trial involving oral care.
Evaluation of Prognostic Monitoring for Triple Negative Breast Cancer Patients

The relationship between immune inflammation-related protein complexes in blood of triple negative breast cancer patients and recurrence or metastasis of breast cancer will be studied.

200 patients with triple negative breast cancer will be followed up. Peripheral venous blood was collected every 3 to 6 months. Change regularity of breast cancer-specific immune inflammation-related protein complexes in blood at different follow-up time points will be studied. The relationship between disease-specific protein complexes and pathological state of patients will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Postoperative pathology confirmed invasive breast cancer after surgery for breast lump
* Breast cancer-related chemotherapy and radiotherapy completed
* triple negative breast cancer patients
* age ≤ 60 years old

Exclusion Criteria:

* Male
* Aged above 60
* Breast Carcinoma in situ
* Women in pregnancy or breastfeeding
* Suffering from other malignant tumors
* Non-compliant patient
Cervical Cytology DNA Methylation for Cervical Cancer Screening

Cervical cancer represents one of the foremost causes of cancer-related morbidity and mortality among women worldwide. Given the current limitations, such as the low specificity of human papillomavirus (HPV) testing and the relatively low sensitivity of cytological examinations, there is a pressing need for a novel, non-invasive, safe, and precise screening method. This study aims to undertake a multicentre, real-world investigation, incorporating at least 10 sub-centres and enrolling 30,000 participants. Histopathological examination results will serve as the 'gold standard' for evaluating the screening efficacy of human PAX1 and JAM3 gene methylation assays (PAX1m/JAM3m), HPV testing, and cytological examinations. Furthermore, the study seeks to elucidate the relationship between DNA methylation levels and persistent HPV infection, while also assessing the applicability of PAX1m/JAM3m across diverse clinical settings. By focusing on alterations in DNA methylation levels within cervical exfoliated cells as the primary research trajectory, this study aspires to furnish novel insights and theoretical foundations for the prevention and management of cervical cancer, targeting PAX1m/JAM3m. The ultimate objective is to facilitate the clinical implementation of an enhanced cervical cancer screening protocol, thereby addressing the deficiencies of current screening methodologies, achieving greater precision in cervical cancer screening, and effectively reducing the incidence of cervical cancer while mitigating the risks of overdiagnosis and overtreatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* With uterine cervix intact
* Given consents to participate the study
* With detailed follow-up outcomes

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Donepezil Double Blind Trial for ECT Memory Disfunction

This is a double blind randomized investigation of donepezil for patients suffering from schizophrenia, undergoing ECT.

Patients will be randomized to receive either donezepil or plasebo, in order to gauge whether donezepil has a protective effect on memory disfunction, while patients are treated with ECT. Several parameters will be invistigated at baseline: general psychopathological measures, memory function scales, side effects scales. The same measurements will be taken throughout the trial and one month after ending the ECT.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia, Schizoaffective disorder, schizophreniform disorder patients who meet criteria for diagnoses by DSM-IV criteria and evaluated by the Structured Clinical Interview for DSM-IV (SCID)

Exclusion Criteria:

* History of serious neurological disorders including neurodegenerative deseases, mental retardation, substance and/or alcohol dependence.
* Pregnant women
* Patients who recieved ECT within 6 month
* Patients whith contraindication to Donepezil treatment.
* Patients with Lithium treatment
Pain in Inflammatory Joint Diseases

Our primary objective is to better understand the etiology and consequences of chronic paint by using an explorative approach to identify phenotypes and endotypes of patients with inflammatory arthritis, with a special focus on central sensitization and cognitive functioning as a key element in chronic pain. We will also examine the risk factors and clinical impact of these factors on pain, disease activity and treatment effects in a longitudinal study of patients with inflammatory joint disesases.


Eligibility Criteria:
Inclusion Criteria:

* All patients who initiate or switch biological or targeted synthetic DMARDs

Exclusion Criteria:

* None
Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa

A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.

Reconstruction of interdigital commisures in patients with severe skin syndactyly using laminar grafts that will be uniformly and systematically taken with an electrical or compressed air dermatome on an aseptic area and with the same extent and depth in microns in all patients.

Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non - adherent dressing (control) will be implanted in the other half.

Patients will initially be followed up every two days until epithelisation occurs (approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.

Eligibility Criteria:
Inclusion criteria:

* Patients of both sexes over 28 days of age.
* Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated.
* Patients whose legal guardians have given written informed consent for participation in the study before any study procedure is performed.
* Patients aged ≥ 12 years who have given written informed consent for participation in the study before any study procedure is performed.

Exclusion criteria:

* Women of childbearing age not using effective contraceptive methods (oral contraception)
* Pregnant or nursing women
* Documented or suspected hypersensitivity to any of the therapeutic agents included in the study, including anaesthetic drugs.
* Patients with a history of malignant tumor in the past 5 years
* Patients with a diagnosis of active tuberculosis at the time of recruitment
* Patients with prior positive markers for any of the following pathogens: hepatitis b and c, hiv-1 and hiv-2
* Patients with a history of clinically relevant hepatic, gastrointestinal, haematological, pulmonary, or neurological disease no directly related to epidermolysis bullosa.
* Any other medical condition which, in the investigator´s judgment, might interfere with optimal participation in the study or involve a significant risk for the patient.
* Alcoholism, drug addiction, psychiatric disorders, or other factors present in legal guardians which,in the investigator´s judgment may complicate patient participation in the study.