cyrilzakka/clinical-trials huggingface dataset:
Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free

The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Smoked at least 100 cigarettes in lifetime
* Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days)
* Diagnosis of lung cancer
* Able to read and write English
* Not currently enrolled in a smoking cessation program
* Has a working telephone
* Has a valid home address

Exclusion Criteria:

* Current use of tobacco cessation medications
* Another household member enrolled in this study
* Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff
* Moffitt clinical trial participant at time of enrollment
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion

Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.


Eligibility Criteria:
Inclusion Criteria:

* From January 2009 to December 2010 enrolled 872 patients with EGC

Exclusion Criteria:

* EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion
Accuracy of Detection of Dental Caries from Intraoral Images Using Different ArtificiaI Intelligence Models

The goal of this observational study is to evaluate the diagnostic accuracy of different deep learning models in detecting dental caries from intra oral images taken by a professional intra oral camera in children. The main question it aims to answer is:

What is the diagnostic accuracy of different deep learning models in detecting dental caries from intra oral images taken by a professional intra oral camera in children compared to the conventional clinical visual examination?


Eligibility Criteria:
Inclusion Criteria:

* Child dentition having at least one decayed tooth.

Exclusion Criteria:

* Child dentition with developmental enamel defects.
* Children with any systemic medical condition.
* Parent / child refuse to participate in the study.
* Uncooperative child.
COPE Program , Mental Health, Mother- Infant Interaction, Sense of Competence

The aim of the study is to:

- Evaluate the effect of creating opportunities for parent empowerment program on maternal sense of competence, mental health outcome and mother-infant interaction.

RESEARCH HYPOTHESES

* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high level of competence than those who don't.
* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit less stress level than those who don't.
* Mothers of preterm neonates who receive creating opportunities for parent empowerment program exhibit high interaction than those who don't.

The mothers of preterm neonates will be assigned into two equal groups as follows:

* Study group (group II) mothers of preterm neonates who will receive COPE program.
* Control group (group I) mothers of preterm neonates who will not receive COPE program.

* Research Design: A quasi-experimental (pre-posttest) research design will be used.
* Setting: The study will be conducted at the Neonatal Intensive Care Unit at Smouha Specialty Hospital in Alexandria.
* Subjects: A convenience sampling of 60 mothers of preterm infants who admitted to the previously mentioned setting
* During the 1st day of preterm admission to NICU data concerning characteristics of neonates and their mothers' in both groups will be obtained from medical records using tool I.
* The pretest will be conducted to the mothers of neonates on the 1st day of admission in the NICU to assess mothers' sense of competence and perceived stress by interviewing them to collect data using tool II, III and mother infant interaction in both groups by observation using tool IV.
* After completion of the pretest, the mothers in the study group will receive COPE program, then at the 7th day of the study posttest will be done for both group

Eligibility Criteria:
Inclusion Criteria:

* The mother age more than 20 years, educated and has no experience of premature birth
* The mother has no postpartum discomforts (such as, bleeding, depression or pain
* Premature neonates( gestational age 37 weeks)
* Birth weight \< 2500 g or \> 1500 g (LBW)
* Five-minute Apgar score \> 7
* Neonate not with any medically restricted conditions (e.g., intraventricular hemorrhage or intracerebral hemorrhage (grades III and IV).
* Neonate not on ant ventilation assisted devices, such as ventilator or CPAP

Exclusion Criteria:

-
Healthy Aging Through Functional Food

The purpose of this study is to determine whether dietary inducers of glyoxalase 1 are effective in improving metabolic and vascular health.

The aim of the study is to evaluate dietary inducers of glyoxalase 1 for effects on metabolic and vascular health in overweight volunteers at risk of developing type 2 diabetes. The research objectives are:

(i) To evaluate dietary inducers of glyoxalase 1 for effects on markers of glucose metabolism during an oral glucose tolerance test (oGTT), (ii) To evaluate dietary inducers of glyoxalase 1 for effects on vascular function on three levels, using finger fold capillary density by capillaroscopy (FFCD), arterial stiffness by aortal pulse wave velocity (aPWV) and flow mediated dilatation (FMD); and effects on metabolic and pro-inflammatory markers in circulating blood and urine.

Eligibility Criteria:
Inclusion Criteria:

* BMI 25 - 40 kg/m2 (\>23 kg/m2 for Asians), with normal, impaired fasting or impaired postprandial glucose.
* No other relevant morbidities.
* Women will be preferably post-menopausal.

Exclusion Criteria:

* Severe hypertriglyceridemia.
* Uncontrolled hypertension, cardiovascular disease, relevant renal or hepatic disease, diabetes, and other relevant morbidity.
* Excess alcohol consumption, smoking, acute pharmacological treatment with drugs affecting glucose metabolism such as steroids and antibiotics.
* Anticoagulants.
* Intake of herbal remedies.
* Food allergies.
Efficacy Assessment of Three Non Pharmacological Therapies in Alzheimer's Disease

ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of cognitive training, reminiscence therapy and a "made-to-measure" program on the progression rate of dementia.

ETNA3 is a multicentric randomised clinical trial conducted in France to evaluate the impact of non pharmacological treatments on the progression rate of dementia: Three non pharmacological treatments are being studied: cognitive training therapy, reminiscence therapy and a "made-to-measure" program. Nearly 40 "Memory Clinics" are participating. 800 patients suffering Alzheimer's Disease in the mild to moderate stage of the disease will be included. For each therapy, a standard intervention protocol has been defined. The main objective is to determine whether any or several of these non pharmacological treatments can delay the severe stage of dementia during a 2-year follow-up. The secondary outcomes assess cognitive abilities, functional abilities in activities of daily living, behavioural disturbance, apathy, quality of life, depression, caregiver burden and resource utilization

Eligibility Criteria:
Inclusion Criteria:

* Patients in the mild to moderate stages of Alzheimer's Disease : MMSE score between 16 and 26 ; and stages 3 to 5 of the Global Deterioration Scale
* Patients over 50 years of age
* Patients with social security affiliation

Exclusion Criteria:

* Patients suffering other type of dementia
* Institutionalized patients
* Patients with psychiatric disorder
* Patients with severe pathology in the terminal stages
* Patients receiving non pharmacological therapies other than that proposed in the study
* Enrollment in a pharmacological trial in the first 6 months
Early Haemadsorption in Major Burns

Major deep burns (\>20% body surface, involving deep skin layers) and associated severe inflammatory reaction and their complication are one of the biggest challenge of intensive care. Haemoadsorption therapy, including the CytoSorb treatment is a promising novel therapeutic approach, but only case-studies are available in the literature yet. Based on data from septic shock patient treatment the investigators hypothesize that CytoSorb is beneficial in early treatment of burns. The investigators aim to conduct a randomised-controlled study to assess the clinical effectiveness (based on score systems including MODS, SOFA, APACHE II, KDIGO, ABSI), 7 and 28 days survival, intensive care length of stay, length of mechanical ventilation, resuscitation fluid need and ino/vasopressor drug doses and the presence and severity of organ dysfunctions, particularly renal dysfunction. The investigatora plan to conduct basic research to elucidate the pathophysiological background of clinical effect, including the measurement of inflammatory and anti-inflammatory cytokines, presence and severity of oxidative stress (lipid peroxidation, protein oxidation, reduced/oxidised glutathion levels) and organ dysfunction markers (kidney injury molecule -1, neutrophil gelatinase-associated lipocalin, cystatin-C, uromodulin).


Eligibility Criteria:
Inclusion Criteria:

* informed consent of our patient or next of kin,
* TBSA \>20% with 2/b depth of burn

Exclusion Criteria:

* non-thermal burn injury,
* need for acute haemodialysis (intoxication),
* immunosuppressive treatment, chronic steroid use (\> 3 months),
* known malignant disease,
* end-stage renal insufficiency or renal transplantation,
* Child C hepatic cirrhosis,
* gravidity,
* potentially lethal burn (Baux index \>120) or comorbidities
Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs)

This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs).

Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions. Traditional treatment outcomes for TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance. This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing.

Eligibility Criteria:
Inclusion criteria:

* Females Age 25-55
* TMD Research Diagnosis Criteria (RDC) clinical diagnosis of myofacial pain with or without disc displacement, arthralgia, arthritis, or arthosis
* Three or more significant systemic conditions, e.g. depression, fibromyalgia, GI or reproductive disturbances, upper respiratory problems, etc. in the preceding 2 years.

Exclusion criteria:

* Diagnosed organic or medication induced major mental illness (e.g., schizophrenia, bipolar)
* Other neurological diagnoses (epilepsy, Parkinsons)
* Pregnancy
Establishment of the National Epidermolysis Bullosa Registry

OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB).

II. Generate a large data bank of clinical, historical, and genetic information concerning these patients.

III. Accumulate donated tissue specimens, including selected cells and DNA, from selected patient subsets for the establishment of permanent tissue cell banks.

IV. Promote and facilitate research in EB.

PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. Clinical, epidemiological, and laboratory data are collected.

Medical and family histories are obtained in a detailed interview in person, by phone, or by mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. A pedigree chart is completed on the first affected family member entered.

Selected patients are followed at least biannually. A study duration of approximately 10 years is anticipated.

Eligibility Criteria:
* Clinical diagnosis of epidermolysis bullosa
Psychiatry Study: Parkinson Disease

Main objective:

To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.

Secondary objectives:

To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.

Prospective, longitudinal, controlled, multicentric, randomised, open study.

Subjects: 3 groups of 40 patients (n=120): one group of patients profiting from a structured program of preoperative cognitive remediation (SICRPPD group: Specific Individual Cognitive Remediation Program in Parkinson's Disease), one group of patients profiting from a preoperative non structured accompaniment (ICM group: Intensive Care Management), one control group (CG group: Control Group).

Required sample size: The sample size of 40 patients/group will allow to demonstrate with a significance threshold of 5% and a power of 80% a difference of evolution of the global SAS SR score of 0.75 SD between 2 of the 3 groups. For an intended SD of 0.2 units, the threshold corresponds to a difference of 0.15 units, minimal significant change.

Intervention: The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.

Evaluation tools: Patients will be met before and after the intervention for clinical evaluations and scales making: For the psychiatric evaluation: Mini International Neuropsychiatric Inventory (M.I.N.I.), Starkstein Apathy Scale, Montgomery and Asberg depression scale (MADRS), global functioning evaluation scale (EGF) and Hamilton anxiety scale (HAMA)/ For the social adaptation evaluation: Social Adjustment scale Self Report (SAS SR)/ For quality of life evaluation: 39-item Parkinson's Disease Questionnaire (PDQ-39)/ For the daily life activities, 'motor' symptomatology and treatment complications evaluation: Unified Parkinson's Disease Rating Scale (UPDRS, parties II, III, et IV).

Main criteria: change in the global score of the SAS SR scale.

Secondary Criteria: change in scores of the PDQ-39 (quality of life), HAMA (anxiety), Starkstein (apathy), MADRS (mood), EGF (psychologic, social, professional functioning, and depending on the psychiatric symptomatology) questionnaires.

Statistics: parametric and non parametric tests will be done for p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained
* Obtained informed consent

Exclusion Criteria:

* Absence of social security
* Patient unable to be compliant
* Major patient under guardianship
The Influence of Different Factors on Workers' Disability Due to Low Back Pain

The purpose of this study is to determine, in Spanish workers, the influence of different factors (personal, psychological, work related and clinical) on the risk of being on sick leave during the 18 months after baseline assessment, and on the duration of that sick leave.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who get their checkups at participating health services
* With a labor contract that won't make it likely that they stop work before the next 18 months, for causes other than their health
* Who sign the informed consent form

Exclusion Criteria:

* Don't sign the informed consent form
* Inability to fill our the questionnaires
* Bedridden
* Rheumatologic inflammatory disease, cancer or fibromyalgia
* Suspicion of fibromyalgia
* Red flags for systemic disease
* Criteria for surgery
* Criteria for urgent referral to surgery
Comprehensive Behavioral Intervention for Tics

The purpose of this protocol is to examine treatment outcomes of youth receiving the Comprehensive Behavioral Intervention for Tics (CBIT) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.


Eligibility Criteria:
Inclusion criteria

* A current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Tic disorder (e.g., Tourette's Disorder/syndrome, Persistent (Chronic) Motor or Vocal Tic Disorder, or Provisional Tic Disorder) or caregiver/youth report of clinically impairing tic symptoms
* Ability for youth to speak/read English sufficiently
* At least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in English.

Exclusion criteria

* A current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder.
* Youth currently receiving psychotherapy elsewhere and/or have previously received CBIT.
* Currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded
* Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay treatment).
The Effect of Aerobic Exercise on Nomophobia and Anxiety

It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in nomophobic university students.

It was aimed to examine the effect of aerobic exercise on nomophobia and anxiety in nomophobic university students. There is no study in the literature examining the relationship between aerobic exercise and nomophobia in young people. Since our study will be the first to investigate the subject, we foresee that it is scientifically important and will shed light on future studies. In addition, national or international publications are planned after the study is completed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who scored above 22 points on the Beck anxiety scale and 60 points or higher on the nomophobia scale

Exclusion Criteria:

* any condition that may prevent the participant from exercising
Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Eylea for Central Retinal Vein Occlusion (CRVO)

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of CRVO. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years.

For each patient, data are collected as defined in the case report form at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

There will interim analysis of study data: 6 months after last patient first visit and J-PSUR(Japanese-Periodic Safety Update Report )


Eligibility Criteria:
Inclusion Criteria:

* Patients who start EYLEA treatment for CRVO

Exclusion Criteria:

* Patients who have already received EYLEA treatment
* Patients who are contraindicated based on approved label
Reassessment Strategy in the Diagnosis of Coronary Heart Disease in Elderly

Despite the effectiveness of beta-blockers and antiplatelet agents for secondary prevention of coronary heart disease, this treatments are underused in the elderly because of diagnosis uncertainty and underuse of efficient treatment.

in a first time, diagnosis reassessment with invasive technique if necessary. in a second time, treatment reassessment.

not desired

Eligibility Criteria:
Inclusion Criteria:

* patients 75 of age or older hospitalized in a geriatric service and suspect of coronary heart disease

Exclusion Criteria:

* acute myocardial infarction
Wound Antiseptic Study With Hypochlorous Acid & Iodopovidone

The purpose of this study is to determine whether hypochlorous acid is an effective antiseptic agent to prevent surgical site infection.

A topical antimicrobial that decrease the bacterial bioburden of surgical wounds without impairing the wound's ability to heal is a need. A stabilized form of hypochlorous acid has been demonstrated in vitro and in animal studies to possess properties that could fulfill these criteria but it is imperative to assess its efficacy and safety in humans.

To assess hypochlorous acid efficacy and safety, it was designed a clinical controlled randomized trial to compare hypochlorous acid to iodopovidone, the gold standard, in preoperative scrub of surgical area.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old, who are going to be operated
* Classification of surgical wounds according to the National Research Council as class I or II
* Risk index classification of the American Society of Anaesthesiology (ASA) as ASA 1 or 2

Exclusion Criteria:

* Patients requiring mesh or prosthesis or orthesis
Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane of Distorted Neck-anatomy

Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .

The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.

Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .

The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomized to use other palpation or ultrasonography. All attempts are video-taped.

Eligibility Criteria:
Inclusion Criteria:

* Participants in a airway management course

Exclusion Criteria:

* Unwillingness to participate