cyrilzakka/clinical-trials huggingface dataset:
Promoting Child Inhibitory Control Skills Around Food

Today's environment provides many hedonic stimuli that promote consumption of unhealthy energy-dense snack foods. It is widely recognized that a systems approach is required to deal with this complex problem. However, individuals, particularly children, also need to develop the personal capacity to deal with tempting stimuli and inhibit responses to these energy-dense foods. Therefore in this proposal, we will focus on enhancing higher level executive functions, particularly inhibitory control, which is needed to counterbalance impulsive behavior and is crucial for growth and development. We have chosen to focus on developing inhibitory control in preschool-age children because executive functioning/inhibitory control and eating habits are developing at this time. Among preschool-age children, inhibitory control is fostered through social play-based curriculums and has been found to be related to greater school readiness and academic skills. Therefore, the goal of this proposal is to adapt a play-based curriculum, the Tools of the Mind program, to promote greater inhibitory control skills in preschool children and decrease consumption of energy-dense snack foods. In Phase I, we will develop and pilot a Child Inhibitory Control Play-based Program (CHIC Play) among children age 4- to 6-years old. We will adapt the learning tools used in the Tools of the Mind curriculum and employ naturalistic play scenarios, drawings (visual support), and games to teach children to inhibit their responses to energy-dense snack foods. Once developed, we will test the efficacy of CHIC Play in the preschool setting. Parent groups will also be conducted to support the adoption of these skills at home. The primary outcome of interest is caloric intake and age- and gender-adjusted percent of daily caloric intake as measured by the Eating in the Absence of Hunger (EAH) free access procedure and a snack time procedure. Inhibitory control skills will also be measured using executive functioning tasks. Feasibility and acceptability of this program will be determined from parent, child, and teacher surveys. The purpose of this study is to develop a new innovative method of decreasing energy-dense snack food consumption by promoting the development of inhibitory control or impulse control. If successful, this program has the potential to play a role in the treatment and prevention of childhood obesity.


Eligibility Criteria:
Inclusion Criteria:

* 1) child age between 4 and 6 years
* 2) child BMI ≥5th %ile (Children below this BMI percentile may have an underlying biological mechanism that influences eating behaviors.)
* 3) active parental consent

Exclusion Criteria:

* 1) child with major psychological diagnosis, developmental delay, or other medical disorder that affects weight, eating behaviors, and cognition
* 2) food allergies to the foods used in the study
* 3) plans to leave the preschool within the timeframe of the study
Experimental Study With Pretest/Posttest Groups Which the Intervention Group Have the System Which Sends Reminder Notifications Directing Them to the Website Containing BSE Training Along With the Illustrations Created for the Practice Prepared by the Researcher on the Determined Ideal Day

H0: Among the intervention and control groups of reminder notifications relating to self-examination

H01: Average breast cancer fear score and H02: There is no difference in the average score of breast cancer health beliefs.

H1: Among the intervention and control groups of reminder notifications relating to self-examination

H11: Average breast cancer fear score H12: Breast cancer is different in terms of average score of health beliefs

Newly Enrolled Students in the Nursing Programs at Girne American University and Eastern Mediterranean University Will Participate in This Study as an Experimental Study With a Pretest/Posttest Control Group. The Students Will Receive the Same Training. Contrary to the Control Group, the Intervention Group Will Have the System Which Will Send Reminder Notifications (Via the Web Base) Directing Them to the Website Containing BSE Training, Along With the Vector Illustration to be Created for the Concurrent Practice Prepared by the Researcher on the Determined Ideal Day. Users Will Receive a Notification Twice Via the Website and Email That Includes Re-examination Seven Days Following the End of Their Period. Depending on the Permission They Grant to Their Phones, Users Will be Able to Access the BSE Training Materials on the Website by Clicking on the General Reminder Notification or the Router, Using Their Browsers, and Logging in to Their Accounts. The Data on the Frequency of BSE With the "Breast Cancer Fear Scale" and "Champion's Health Belief Model Scale" Will be Collected From the Users at the End of the Three-month Period of Using the Website, Which Will be Developed in Order to Raise the Chances of Early Diagnosis by Encouraging BSE.

Eligibility Criteria:
Inclusion Criteria:

* Who is over 18 years old,
* Eastern Mediterranean University and Girne American University, newly enrolled female students in the Nursing Department of the Faculty of Health Sciences

Exclusion Criteria:

* People who do not meet the criteria
Impact Of Mindfulness Breathing Versus Storytelling On Non- Specific Insomnia In Elderly

This study will be conducted to compare between effects of mindfulness breathing and storytelling on insomnia in the elderly.

Sufficient sleep is essential for optimum health just a few of the numerous processes occurring during sleep include memory consolidation, clearance of brain metabolites, and restoration of nervous, immune, skeletal, and muscular systems. Despite the significance of adequate sleep, insufficient or disturbed sleep is extremely common. For instance, thirty percent of employed adults report obtaining 6 or fewer hours of sleep per night, approximately one-third of all adults report significant sleep complaints, and the two most common sleep disorders, insomnia and sleep-disordered breathing (SDB), each have prevalence rates exceeding 10% in the adult population. Unfortunately, current approaches to treatment are limited .

Story telling is another common soothing bedtime routine for children that uses pictures and writing. It is also a nursing intervention that can be implemented to comfort hospitalized children with acute illness and increase enthusiasm. Story telling is a recommended activity that enhances sleep duration in children. Furthermore, it is considered a positive bedtime routine, in addition to praying and brushing teeth, compared to maladaptive bedtime routine, such as watching television, playing with gadgets, and playing games with high-level activities .

Eligibility Criteria:
Inclusion Criteria:

* Patients who have non-specific insomnia for one month at least.
* Their ages \> 65 years.
* Medically stable patients.
* Current complaint of poor SQ (score \> 5 of the SQ scale)
* Body mass index ≤ 35 kg/m2.

Exclusion Criteria:

* Patients having a well-structured diagnosis of relevant brain illness or
* any disease directly affects sleep.
* Any patient with unstable medical condition
* History of chronic insomnia
* Indication of receiving treatments for depression and anxiety
* Hearing problem
Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects

The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity;
* History of allergic conjunctivitis within the last 2 years;
* Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit;
* Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms;
* Understand and sign an informed consent form;
* Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Contraindications or hypersensitivity to study medications or their components;
* Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye;
* Any ocular condition that could affect the study outcomes;
* Presumed or actual ocular infection or history of ocular herpes in either eye;
* Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease;
* Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products);
* Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease;
* Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit;
* Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator;
* Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit;
* Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids;
* Use of cold compresses on the eyes during the course of the study;
* Cannot be dosed in both eyes;
* Cannot avoid contact lens wear during the course of the study;
* Therapy with another investigational agent within 30 days of baseline visit, or during the study;
* Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods;
* Other protocol-specified exclusion criteria may apply.
VAXZEVRIA Japan Post-Marketing Surveillance (PMS) for the Subjects With Underlying Disease at High-risk for Worsening COVID-19

To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine.

To provide more information on safety profile of VAXZEVRIA in Japanese subjects, specific drug use result study in subjects with underling disease at higher risk of worsening COVID-19 is planned as an additional pharmacovigilance plan.

The present study aims to collect information on adverse drug reactions (local/systemic reactions), adverse events (including Shock/ Anaphylaxis, Thrombosis in combination with thrombocytopenia, Immune-mediated neurological conditions ,Vaccine-associated enhanced disease(VAED) including Vaccine-associated enhanced respiratory disease(VAERD) and Thrombosis) or COVID-19 infection after VAXZEVRIA vaccination and to evaluate the safety of this vaccine

Eligibility Criteria:
Inclusion Criteria:

1. The subjects with underlying disease at high-risk for worsening COVID-19.
2. The adults (in the case of a minor aged less than 20 years, the parent or the legal guardian) who are able to enter their symptoms in the health observation diary and who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.

Exclusion Criteria:

None
Computer-Aided Prevention System

Stroke is one of the most frequent and life-threatening diseases in Europe. About four stroke events occur per day in Luxembourg alone, and about 30% of these patients are affected by recurrent stroke within the following five years. Thus, new methods of primary and secondary prevention are needed to better control lifestyle-related risk factors.

The development and maintenance of a healthy lifestyle (smoking cessation, healthy nutrition, moderate physical exercises etc.) is a major objective concerning the primary and secondary prevention of cerebro- and cardiovascular diseases. CAPSYS is a computer-based lifestyle coaching system developed by researchers from the Public Research Centre (CRP) Henri Tudor in Luxembourg in collaboration with neurologists from the Centre Hospitalier de Luxembourg (CHL), which aims at supporting patients in performing appropriate behavior changes in order to minimize their individual risk factors. Patients can access CAPSYS by dialing a local-rate telephone number and answer to a set of previously known questions concerning their current nutrition, physical activity, blood pressure, smoking etc. In an interactive voice response approach, questions are issued by the system in natural language using text-to-speech, and the patient can provide the required values using the phone keypad. Based on the gathered values for each patient, the system automatically generates personalized verbal feedback at runtime and presents it to the patient during the phone dialog. Depending on the individual development of the patient's risk factors, the system feedback can contain advice for improvement, praise for healthy behavior and motivation to pursue a certain goal.

The user acceptance and effectiveness of the CAPSYS system is evaluated in a six-month randomized controlled study with participants recruited at CHL's neurology department.


Eligibility Criteria:
Inclusion Criteria:

* At high risk of stroke:

  * Already suffered a stroke or Transient Ischemic Attack (TIA) or
  * At least two risk factors for stroke:

    * High blood pressure
    * Overweight
    * Low physical activity
    * Smoking
    * Unhealthy diet

Exclusion Criteria:

* Inability to fill out or to understand the informed consent
* No signed informed consent
* Dementia
Copeptin Serum Level in Liver Transplant Recipients

The study aim is to measure perioperative copeptin concentration in blood of liver transplant recipients and to assess whether there is a correlation between its level and hemodynamic derangement.


Eligibility Criteria:
Inclusion Criteria:

- Patient undergoing liver transplantation

Exclusion Criteria:

* Serum creatinine \> 1,5 mg/dl
* Retransplantation
* Patient refusal
* CRRT or dialysis preoperatively
Myocardial Metabolism in Patients With Dilated Cardiomyopathy

Dilated cardiomyopathy (DCM) is characterized by a metabolic shift from fat to carbohydrates and failure to increase myocardial glucose uptake in response to workload increments. The investigators aimed at verifying whether this pattern is influenced by the presence of abnormal glucose tolerance (AGT).

A catheter is advanced into the coronary sinus by fluoroscopy to withdraw venous blood. A unipolar pacing catheter is positioned into the right atrium. Arterial sampling is done from the femoral artery introducer catheter.

The study protocol consisted of 3 steps (Rest, Pacing and Recovery), during which timed blood samples are collected to measure plasma NEFA and glucose. After the instrumentation is completed, Rest arterio-venous sampling is performed at time -15 min and 0 min. After the 0 min, heart rate is increased by atrial pacing to 110 bpm for 3 minutes and to 130 bpm for 3 additional minutes and arterio-venous sampling is repeated at the end of each step (at time 3 and 6 min). Pacing is then stopped and at time 1, 5, 15 and 30 min into the Recovery period other pairs of arterial and venous samples are withdrawn.

Eligibility Criteria:
Inclusion Criteria:

For patients with dilated cardiomyopathy:

* Myocardial left ventricular ejection fraction (LVEF) \<40%
* left ventricular end-diastolic diameter (LVEDD) \>56 mm

For patients without dilated cardiomyopathy:

* LVEF \>50%
* LVEDD \<56 mm.

Exclusion Criteria:

* NYHA class IV
* Atrial fibrillation
* Previous myocardial infarction
* Valvular heart disease
* Myocarditis
* Pericarditis
* Severe to moderate systemic arterial hypertension
* Fasting hyperglycaemia (\>7.0 mmol/l)
* Treated diabetes, autoimmune diseases, neoplasia, kidney, liver or respiratory failure
Use of FlexHD as Post Trapeziectomy Spacer

The objective of this study is to show that using FlexHD® (or HADM) to fill the empty space created by removal of the trapezium improves the subject's outcome and subsequent functionality of the basilar joint arthroplasty procedure.

Subjects will be followed for 12 months post basilar joint arthroplasty procedure with an interposition arthroplasty technique using a spacer constructed from human acellular matrix (HADM). Their postoperative DASH scores, grip strength, pinch strength, pain scale scores, quality of life and trapezial space on radiographs are compared to their preoperative scores. Study visits will coincide with standard clinical course visits including: Pre-operative visits and follow-up visits at week 6, month 6, and year 1 post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female \>18 years of age
* Be willing to undergo thumb basilar joint arthroplasty with the use of acellular dermal matrix
* Basilar Joint Arthritis Eaton Stage III or IV
* Be in good health other than the arthritis
* Have realistic expectations of surgical results
* Understand and be willing to follow all aspects of the study protocol and have signed and dated the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed

Exclusion Criteria:

* Have collagen-vascular, connective tissue, or bleeding disorders
* Be a smoker or have smoked in last 2 months
* Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability
* Have regional sympathetic dystrophy
* Be pregnant, lactating or expecting to be within the next 24 months
Postendodontic Pain on Using Max-i-Probe vs NaviTip as Irrigation Needles

The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth.

The aim of this prospective, randomized, clinical trial was to evaluate the effect of the side-vented Max-i-Probe versus the end-vented NaviTip as endodontic needles during syringe irrigation on post-operative pain in adult patients with symptomatic irreversible pulpitis in posterior mandibular teeth. Medical and dental history was obtained from all participants in this trial and clinical examination for teeth was performed. Participants with symptomatic irreversible pulpitis were included. After access cavity preparation, participants were randomly assigned to one of the following groups: experimental group (Max-i-Probe) or control group (NaviTip). One-visit root canal treatment was performed . Each patient received a 48-h diary to record postoperative pain. Post-operative pain was measured at the following time points: 4, 12, 24 and 48 hours after root canal treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 16-65 year old.
2. Medically free.
3. Mandibular posterior teeth with symptomatic irreversible pulpitis.
4. No sex predilection

Exclusion Criteria:

1. Pregnant females.
2. History of allergy to any medication used in the study.
3. Preoperative premedication less than 6 hours before procedure.
4. Cracked teeth and teeth with badly-decayed crowns.
Dietary Conjugated Linoleic Acid (CLA) Intake Among Students in Italy

40 healthy subjects were recruited using advertisements posted at the Catholic University of Piacenza, between January and October 2012. Height (using a stadiometer) and weight (using a Gima scale) of each subject were measured and the body mass index (BMI) was calculated (kg/m2). Subjects who satisfied inclusion criteria were instructed on how to document all food and drink consumed daily for 3 days using a diary previously used in the Italian National Survey INRAN-SCAI. They were asked to eat as usual in subsequent 3 days to emulate as best their habits. They were educated to report also the place, time, number and quantity of serving portions consumed. If they were not able to weight exactly each portion, a photographic atlas developed for the Italian component of the European Prospective Investigation into Cancer and Nutrition (EPIC) study was used. At the end of the three days the food diaries were checked and for each subject the energy intake was estimated.


Eligibility Criteria:
Inclusion Criteria:

* self-reported healthy
* not suffering disorders of lipid metabolism and from eating disorders.

Exclusion Criteria:

* pregnant or breast-feeding,
* subjects consuming an energy-restricted diet
* vegan or vegetarians.
Rescue FMT with Bezlotoxumab for Recurrent C. Difficile Infection

The goal is to evaluate the benefit of adding bezlotoxumab to repeat fecal microbiota transplantation (FMT) in patients with recurrent Clostridioides difficile infections after failure of FMT alone.

Initial failure of FMT in breaking the cycle of recurrent C. difficile infections is associated with a greater risk of subsequent failure. Previous analysis showed that FMT failure is associated with delayed repair of fecal microbiota at one week after administration. The hypothesis underlying this trial is that increased symptom-free interval by administration of bezlotoxumab can improve the outcomes of a second FMT.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent.
2. Diagnosis of recurrent C. difficile infection based on symptoms and laboratory confirmation.
3. Failure of standard antibiotic therapies prior to the initial FMT

Exclusion Criteria:

1. Pregnancy.
2. Class III or above heart failure.