cyrilzakka/clinical-trials huggingface dataset:
Are Mindfulness Programs in the Workplace Effective at Reducing Stress

The objective of this study is to determine whether a mindfulness coaching program was efficacious at reducing work stress, improving psychological and physical health outcomes, and improving work outcomes. The target population is employed adults (18 years and older) working in the industries of media, consulting, and healthcare.


Eligibility Criteria:
Inclusion Criteria:

* Employees who are eligible to take the company's health risk assessment and/or biometric screening
* Employees who are eligible for medical health benefits

Exclusion Criteria:

-
Heart Failure and Sleep Apnea: Exercise Training and Continuous Positive Airway Pressure

Introduction. Heart failure is the result of primary ventricular dysfunction followed by neurohormorais changes, distribution of cardiac output, peripheral circulation, the skeletal and respiratory muscles, which determine their clinical and prognosis. Despite the advancement in treatment, morbidity and mortality remain high. Physical training appears as a therapeutic strategy, because most of its beneficial effects is by inducing changes in peripheral physiological changes resulting from heart failure. Associated factors that may contribute to its progression and worse prognosis, now beginning to be studied, such as sleep apnea, the diagnosis provides important prognostic information and a potential therapeutic option for these patients.

Objectives. Demonstrate the benefits of physical training for patients with heart failure and sleep apnea, and compare treatment with CPAP alone and associated with the exercise program. Will also be assessed risk and adherence to physical training.

Material and Methods. The design will be prospective, longitudinal, randomized consecutive patients. After screening and baseline evaluations the patients will be randomized into Group 1 (CPAP, n = 20), Group 2 (CPAP + Physical training, n = 20), Group 3 (Physical Training, n = 20) and Group 4 (Control without intervention, n = 20). Outcomes (baseline and 3 months): Quality of sleep (polysomnography), Quality of life (Minnesota and SF-36), sexual function (QS-M and QS-F) and functional capacity (cardiopulmonary exercise testing and isokinetic testing). Physical training: aerobic and resistance exercises three times a week for three months. CPAP therapy:after polysomnography for titration with ventilator servo-assisted, and outpatient follow monthly, for three months.


Eligibility Criteria:
Inclusion Criteria:

* Age range 20-70 years
* New York Heart Association Class II-III
* Clinically stable for one month
* Ejection fraction \<40%
* Peak VO2 \<20 ml/kg/min
* Stable and optimized medical therapy at least one month before the study
* B-blocker therapy
* Clinical and polysomnographic diagnosis of sleep apnea (IAH\>10)

Exclusion Criteria:

* Patients with previous treatment of sleep apnea
* New York Heart Association Class IV
* Clinical instability
* Poor adherence to drug treatment
* Myocardial infarction or revascularization within the past two months
* Unstable angina
* Symptomatic arrhythmias (pacemaker and defibrillator)
* Obstructive aortic or mitral valvular disease
* Hypertrophic cardiomyopathy
* Abnormal exercise testing
* Pulmonary arterial pressure \>50mmHg
* Chronic obstructive pulmonary disease
* Intermittent leg claudication
* Musculoskeletal disorders or psychiatric disease that prevents the patient from understanding and following the exercise prescription safely
Promoting Adherence to Treatment for Latent TB Infection Through Text Messaging

The purpose of this pilot study is to determine whether regularly scheduled medication reminder text messages (SMS) are effective in increasing latent tuberculosis infection (LTBI) treatment completion.

We aim to determine the feasibility and acceptability of text reminders for improving adherence in latent TB patients. Specific objectives of the current study are to: 1) Assess the feasibility of the intervention as indicated by participant recruitment and retention and; 2) Evaluate the acceptability of the intervention, as indicated by intervention adherence, outcome measurement rates, and feedback from participants.

Data will be used to design a definitive trial which will test the hypothesis that the intervention will improve medication adherence, as measured through an increase in treatment completion rates, and result in higher self-reported medication adherence, fewer missed appointments and doses, and a shorter course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Consent to the study
* Own a mobile phone which operates on a telecom provider supported by our SMS platform
* Initiating or actively receiving treatment for LTBI at the Pima County TB Clinic in Tucson, AZ
* Prescribed self-administered therapy
* Report not having prior or current active TB disease
* Know how to and are able to receive SMS messages
* At least 18 years of age

Exclusion Criteria:

* Do not meet inclusion criteria
* Do not consent to study
Effect of a Culturally-based Intervention on Sexual Risky Behavior Among Young American Indian Adolescents

Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior compared to youth who do not receive the program.

Youth who participate in the Circle of Life (COL) program will report less sexual risk taking behavior and fewer pregnancies compared to youth who do not receive the program.

Eligibility Criteria:
Inclusion Criteria:

* 10-12 years old at baseline
* A member of participating Native Boys and Girls Club
* Signed Parental Consent Form
* Signed Parental Permission Form
* Signed Child Assent Form

Exclusion Criteria:

* None Noted
Study of the Proteome and Cytokines During Inflammatory Syndromes of Different Etiologies.

The hypotheses of our research are based on the fact that various pathological states, infection, cancer, inflammatory disease, can induce an inflammatory syndrome, through different pathways, even though the clinical presentation can be identical. The identification of biological markers specific to an etiology would therefore allow a faster diagnosis and improve care for patients. We thus took an interest in the three groups of diseases most frequently responsible for an inflammatory syndrome, infections, cancers and auto-immune diseases. To achieve this, various methods will be used.


Eligibility Criteria:
Inclusion Criteria:

Patients presenting an inflammatory syndrome, defined by elevated C-reactive protein (CRP\>50mg/L), whose etiology is related to infection, cancer or an inflammatory disease.

* Patients not on treatment (corticoids, immunosuppressive drugs) during the 7 days preceding inclusion
* Age: 18-90 years
* Patients covered by the National Health Insurance Agency
* signed written informed consent form

Exclusion Criteria:

* - Any patient not meeting the inclusion criteria
* Pregnant patients
At-home Bleaching Using Clear Aligners

The aim of the present project is to clinically evaluate the bleaching effectiveness, tooth sensitivity, gingival irritation and patient´s satisfaction during a at-home bleaching with 10% carbamide peroxide using a conventional bleaching tray or a clear aligner.

Forty patients (n=40) will be randomized as to which side will receive the type of bleaching tray, conventional or clear aligner. The at-home bleaching will be performed with 10% carbamide peroxide (Opalescence PF 10%) for 2 hours for 4 weeks. The color will be assessed at baseline, after one, two, four weeks, and at 1 month after bleaching treatment using subjective color guides (VITA Classical and VITA Bleachguide 3D-MASTER) and a objective digital spectrophotometer (VITA Easyshade). The intensity and absolute risk of tooth sensitivity and gingival irritation will also be determined with a visual analog scale (EVA 0-10). Patient´s satisfaction will be evaluated at baseline, after one and two weeks, and at 1 month after bleaching treatment with an apropriate questionnaire using a visual analog scale (EVA 0-10). Color change between groups will be compared by paired Student´s t-test. The absolute risk of tooth sensitivity and gingival irritation for both groups will be compared by McNemar test. Also, odds ratios, confidence intervals, and Spearman correlation will be determined. The intensity of tooth sensitivity, gingival irritation and patient´s satisfaction will be compared by paired Student´s t-test. The level of statistical significance accepted will be 5% for all analyses.

Eligibility Criteria:
The inclusion criteria will be the following:

* Patients over 18 years of age.
* Patients with vital teeth without restorations, single crowns, implants and/or bridges at the level of the anterior teeth.
* Absence of cavities in the teeth to be whitened.
* Patients with satisfactory oral hygiene, and periodontally healthy, who are not undergoing periodontal maintenance and who do not use chlorhexidine rinses. Patients with recessions without sensitivity are included.
* Absence of sensitivity, measured based on stimulation with the air from the syringe.
* Patients who are at least in A2-A3 color (Vita Classic Guide)

The exclusion criteria will be the following:

* Patients who have previously undergone whitening (less than 5 years).
* Patients undergoing orthodontic treatment.
* Patients with white spot or developmental alterations (dentinogenesis imperfecta, amelogenesis imperfecta) or with stains (tetracyclines or fluorosis).
* Patients with a history of trauma to anterior teeth.
* Patients who require internal whitening.
* Smokers.
* Pregnant or lactating women.
* Allergy to any component of whitening.
* Alterations of the oral mucosa (desquamative gingivitis, OLP, leukoplakias, etc.).
* Medical conditions considered by the researchers that may compromise the study or the individual safety of the patient.
* Patients with poor oral hygiene.
* Patients with previous hypersensitivity.
Clinical Research Center for Dementia of South Korea (CREDOS)(or CRCD)

The objective of this study is to present evidence-based medicine for development of clinical practice guideline through prospective study of Alzheimer's disease(AD) and mild cognitive impairment(MCI) in korea

The specific aims of this study is (1) construction \& maintenance of cohort for Alzheimer's disease(AD) and mild cognitive impairment(MCI); (2) study of epidemiology, rate of progression, risk factor, prognostic factor; (3) study of biomarker such as neuropsychological assessment, peripheral \& CSF markers, neuroimaging(both structural \& functional)

Eligibility Criteria:
Inclusion Criteria:

* Alzheimer's disease(AD) and mild cognitive impairment(MCI)will be enrolled in the study.

  1. the diagnostic criteria of Alzheimer's disease(AD) according to DSM IV or NINCDS -ADRDA
  2. the diagnostic criteria of mild cognitive impairment(MCI) A. Memory or other cognitive complaint preferably corroborated by an informant B. Objective memory impairment or other cognitive for age and education C. Largely intact general cognitive function D. Essentially preserved ADL E. Not demented

Exclusion Criteria:

* Exclusion criteria are current neurological or other psychiatric disorders, as well as a history of epileptic seizures, substantial brain damage or neurosurgical operation, according to established safety criteria.
Assessment of NfL and GFAP Levels, Atrophy of the Macula GCC by OCT and Whole Brain Atrophy by MRI to Predict Evolution of Neurological Disability in MS Patients

The investigators hypothesize that serum neurofilament-light chain (NfL) levels at baseline and decrease of the macular ganglion cell complex (GCC) thickness at one year vs. baseline are as good as progression of whole brain atrophy at one year vs. baseline to predict later evolution of neurological disability in multiple sclerosis patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given their informed and signed consent.
* The patient must be insured or beneficiary of a health insurance plan.
* The patient is at least (≥)18 years old.
* The patient has experienced a CIS, has currently a RRMS or progressive MS with:

  * Less than 10 years of disease duration;
  * With or without DMD;
  * EDSS score 0 - 7.0.

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The patient refuses to sign the consent.
* It is impossible to correctly inform the patient (Inability to understand the study, language problem).
* The patient is pregnant or breast-feeding.
* Patient has a bilateral optic neuritis or other significant ophthalmological antecedent.
* Patient with MRI contra-indications.
* patient has a contraindication to gadolinium injection
* The patient has bilateral optic neuritis or other significant ophthalmological antecedent
* Patient is having a relapse or has had a relapse in the last 3 months
* The patient has a severe psychiatric illness
* The patient has severe chronic alcoholism
Safety of Everolimus in Combination Therapy, in Patients With HER2-overexpressing Metastatic Breast Cancer

This study will look at different dose levels and regimens of everolimus combined with weekly trastuzumab and vinorelbine therapy in patients with HER-2 overexpressing metastatic breast cancer.


Eligibility Criteria:
Inclusion criteria:

* Female or male patients ≥18 years with WHO performance status ≤ 1
* HER-2 overexpressing metastatic breast cancer cells confirmed by histology
* Progressive disease on prior trastuzumab alone/or in combination with other anticancer agents, or relapsed any time after completion of this therapy
* Patients neurologically stable with adequate bone marrow, liver and renal function

Exclusion criteria:

* Patients receiving endocrine therapy for breast cancer ≤ 2 weeks prior to study treatment start
* Patients currently receiving chemotherapy, immunotherapy or radiotherapy or who have received these ≤ 4 weeks prior to study treatment start or patients who have received lapatinib ≤ 2 weeks prior to study treatment start
* Patients who have previously received vinorelbine or mTOR inhibitors

Other protocol-defined inclusion/exclusion criteria may apply
Home Diagnosis and Treatment of Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) is a common and underrecognised condition. The diagnosis of OSA is typically made after an in-lab polysomnography (PSG) which requires an overnight stay in a sleep laboratory. Many sleep laboratories have long waiting lists for PSG. There are a number of portable devices which may be useful in home diagnosis of OSA, however there is limited data on outcomes of OSA diagnosed and treated at home. In this study we propose to compare diagnostic accuracy of a home monitoring device with a PSG and outcomes of OSA therapy when implemented at home vs in the sleep laboratory.

We will randomise patients suspected to have OSA to either home evaluation and treatment (using a portable monitor and auto-CPAP) or in-lab evaluation with a PSG and manually-titrated CPAP. We will obtain sleep, sleepiness and quality of life questionnaires, vigilance testing and blood pressure at baseline and after 1, 2, 4 and 12 weeks of therapy. We will also assess and compare compliance with CPAP therapy in each arm of the study.

Eligibility Criteria:
Inclusion Criteria:

* adult ( age \> 18)
* suspected OSA
* no coexisting heart or lung disease
* not in a safety-sensitive occupation

Exclusion Criteria:

-
Oxidative Stress and Oxysterols Profiling in Patients With Carotid Revascularization

The combination of aspirin and dipyridamole, two antiplatelet drugs, is approved in Italy for the secondary prevention of cerebral embolism in patients with carotid atherosclerosis.

Besides antiplatelet activity, Dipyridamole has additional pharmacological action, including vasodilation and antioxidant properties.

A role for oxidative stress has been suggested in acute cerebrovascular disease. In this study the investigators want to test the in vivo antioxidant activity of dipyridamole in patients who are candidate to take the drug under approved conditions of the Italian Drug Regulation Agency, i.e. secondary prevention of TIA/Stroke in patinets with carotid stenosis (\>= 70%).

To test the hypothesis that dipyridamole acts as antioxidant in vivo, oxysterols (products of cholesterol autoxidation) and vitamin E are measured in plasma before and after 6 months therapy after carotid endoarterectomy. Since dipyridamole is approved as combination preparation with aspirin, a control group of patients taking aspirin alone is enrolled.

Outcome measures: plasma biomarkers (oxysterols and vitamin E) change at two time points: baseline and 6-months therapy.

Dipyridamole has been shown to act as potent antioxidant in vitro. The aim of the present study is to analyze if dipyridamole retains the antioxidant in vivo in man.

The investigators identified a clinical setting where dipyridamole is approved for clinical use, i.e. secondary prevention of stroke, to test the hypothesis that dipyridamole given orally could affect circulating markers of oxidative stress, in particular reduction in oxysterols (autoxidation products of cholesterol) and increase in vitamin E concentration.

Methods. Two arms are included in the study: a) dipyridamole plus aspirin (in Italy the use of dipyridamole is approved in combination with aspirin); b) aspirin alone as comparison arm. Patients eligible for endoarterectomy for the presence of carotid stenosis \>= 70% are randomized in the two arms. The study is open labeled for the patient and clinical investigators who have in charge the patinets . The study is blinded for the technicians performing biomarker assessment and investigators responsible for data analysis.

Blood is taken at baseline (before surgery) and after six months of treatment. Oxysterol profiling and vitamin E are measured by isotope dilution gas chromatography and mass spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Patients with carotid atherosclerosis eligible for carotid endoarterectomy (stenosis \>= 70%) with previous TIA or Stroke

Exclusion Criteria:

* Congestive heart failure, chronic liver disease, chronic kidney disease (GFR \< 60%), cancer, use of antioxidant supplements in the previous 3 months, autoimmune diseases
An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)

This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)

Exclusion Criteria:

* Contraindications for bevacizumab according to SmPC
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

Clinical trial to evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis

CT-P17, containing the active ingredient adalimumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to Humira. The purpose of this study is to evaluate usability of subcutaneous auto-injector of CT-P17 in patients with moderate to severe rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patient aged 18 to 70 years, inclusive.
* Patient must be able and willing to self-administer subcutaneous (SC) injections via auto injector (AI).

Exclusion Criteria:

* Patient who has previously received investigational or licensed product; biologic or targeted synthetic disease-modifying antirheumatic drugs for the treatment of rheumatoid arthritis and/or a tumor necrosis factor (TNF) α inhibitor for any purposes.
* Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Virtual Reality Compared to Nitrous Oxide for Labor Analgesia

The purpose of this study is to determine if non-invasive distracting devices (Virtual Reality headsets) are non-inferior to conventional therapy (nitrous oxide) for addressing maternal needs during labor who desire non-epidural pain relief.

The investigators will use a commercially available consumer-grade virtual reality (VR) device and nitrous oxide, a standard of care therapy for laboring women desiring non-epidural analgesic, to determine satisfaction with pain relief with each therapy.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy at \>34 weeks
* Regular uterine contractions
* Pain \> 2/10
* English speaking

Exclusion Criteria:

* BMI \> 40
* Preeclampsia with severe features
* Use of IV analgesics during labor
* Diabetes requiring insulin therapy
* Claustrophobia
* History of epilepsy
Innovative MRI to Localize the Epileptic Zone

The goal of EPI-CATCHER is to outline the clinical potential of multiparametric quantitative MRI (mqMRI) and of GABA-edited magnetic resonance spectroscopy (GABA-MRS), combined with machine learning tools, as imaging biomarkers to localize and delineate the EZ.

After informed consent, patient candidate to resection surgery will undergo two extra MRI sessions before surgery: one for multiparametric quantitative MRI (mqMRI) and one for GABA-edited magnetic resonance spectroscopy (GABA-MRS) In parallel, a group of healthy volunteers will also undergo the two MRI sessions described above, to collect reference data.

Eligibility Criteria:
Inclusion Criteria:

* Patient group

  * Patients aged 18-65 years,
  * Patients with drug-resistant focal epilepsy,
  * Patients with MTLE suspicion, with normal MRI or hippocampal sclerosis, and candidate for surgery,
  * Negative pregnancy test for child-bearing aged woman,
  * Obtained signed informed consent from patient
* Reference group

  * Male or female, 18-65 years,
  * Obtained signed informed consent from participants,
  * Negative pregnancy test for child-bearing aged woman

Exclusion Criteria:

* Patient group

  * Patient without social security system
  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations.
  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
  * Contraindication for MRI,
  * Contraindication for injection of MRI contrast agent (Gd-Chelate),
  * Evidence on neuroimaging (CT or MRI) of a brain lesion in the same hemisphere as the EZ (tumor, stroke, cerebral edema with midline shift and a clinically significant compression of ventricles, or subarachnoid hemorrhage, or intracerebral parenchymal hematoma (petechial small hemorrhages are NOT a non-inclusion criteria),
  * Severe leucoariosis
  * Pre-existing dementia
  * Pregnant, breastfeeding women
* Reference group

  * Person who is participating in another therapeutic trial
  * Person with a psychiatric disorder, an epilepsy, or a brain lesion susceptible to impact the MRI readouts
  * Person without social security system,
  * Inability or unwillingness of the individual to provide written informed consent, according to national regulations,
  * Impossibility of collecting information on exposure (subjects recently arrived in France, foreign language, etc.),
  * Contraindication for MRI
  * Contraindication for injection of MRI contrast agent (Gd-Chelate)
  * Pregnant, breastfeeding woman.