cyrilzakka/clinical-trials huggingface dataset:
The Influence of Parental Behavior on the Course of the Pediatric Dentistry Session

The aim of the experiment is to analyze the impact of the behavior of the accompanying parent on the behavior of the child during a first dental session according to the age group.

I will receive the children for consultation at the CHU Saint Pierre - César de Paepe site, to assess the impact of parents' behavior on the child.

First, I will make a first contact with the child in the waiting room using the CORAH scale (self-assessment based on diagrams) which will allow him to assess his temperament in the face of dental care. . Then, I will have the parents / caregiver sign informed consent and authorization to film.

Once the child enters the practice, the video recording will be initiated: the installation on the seat, the confidence building and the care provided will be filmed.

These videos will then be analyzed by several practitioners from different categories (experts in pedodontics, general dentists, dental students, etc.) using the Venham hetero-assessment scale modified for the behavior of the child and of a scale of parental cooperation. These practitioners will be selected via the ADUB (association of dentists of Université Libre de Bruxelles) and some of them could be external to the hospital.

Following this study, the results obtained will be described and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* be in the correct age group and agree to participate in the study

Exclusion Criteria:

* not be in the right age group, refuse to participate in the study
Access to Resources for Patients With PTEN Hamartoma Tumor Syndrome

The purpose of this study is to gain a better understanding of access to clinical and research resources for families of children affected with a phosphatase and tensin homology (PTEN) mutation. Ultimately, the researchers hope to be able to use this information to develop a standard of care for affected individuals and their family members. Family members/legal guardians of an individual with a PTEN mutation enrolled in the Rare Diseases Clinical Research Network (RDCRN) Contact Registry will be invited via email to participate in this study.

The purpose of this study is to investigate access to clinical care and clinical research for patients with PTEN hamartoma tumor syndrome. This research will entail an anonymous online survey sent to families/caretakers of affected children. The survey will inquire: (1) basic clinical information about the child, such as diagnoses (both genetic and neurodevelopmental), level of functioning (estimated IQ) (2) clinical specialists that the child sees or needs to see (3) how families learn about clinical trials/research relevant to their child (4) basic demographics about the parent/caretaker completing the survey.

Specifically, this survey will collect information pertaining to:

* Number of affected children in household
* PTEN mutation type of affected children
* Age and gender of affected children
* Age, neurodevelopmental disorders, medical problems, IQ, and access to clinical care (specialists currently being seen, specialists not able to see and why) of most affected child
* Research methods and mediums for disorder-specific treatment options for affected children
* Reasons behind not participating in clinical research options
* Facts (gender, age, if PTEN mutation carrier, work status, relationship to affected children, days per week of caregiving responsibilities, education level) about participant completing survey.

In total, the survey should take no more than 15 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Family members, specifically a parent, legal guardian, or relative, of a child who meets the following:

   * Age 3 to 17 years old at the time of survey completion
   * Reported diagnosis of a PTEN mutation
2. Enrollment in the RDCRN Contact Registry

Exclusion Criteria:

1. Inability to provide informed consent and complete survey
2. Inability to read and understand English
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome

The purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status.

from this study will help us develop a better treatment for in the future.

Premature infants are at an increased risk of postnatal growth failure and as well as developing short or long-term impaired neurodevelopment and cardio metabolic health.

For many years, it has been recognized that ideal growth is attainable with sufficient sodium intake and a positive sodium balance. The results of this study could have a significant impact on the care of preterm infants.

Infants will be randomized into one of two groups. One group will receive sodium supplementation as guided by a urine sodium concentration algorithm, one group will be managed by current standards. Randomization will occur at 2 weeks of postnatal age

Standard of care group Care for the participant will remain the same as if they were not in the study. Nutritional information, including sodium intake will be collected on three separate days weekly for 8 weeks. Stool samples will be collected for determining intestinal microbiome at 2 weeks, 5 weeks, 8 weeks and the day they are discharged from the hospital.

The study team will also collect detailed health information from participants hospital stay from the medical chart. Which will include gestational age, birth weight, sex, race ,ethnicity, mode of delivery and exposure to any steroids, antibiotics and clinical diagnoses.

Sodium supplementation group:

Participants will receive sodium supplementation per the urine sodium concentration algorithm. Urine sodium will be determined weekly, and if urine sodium concentration is below set value, dietary sodium supplementation is provided.

Eligibility Criteria:
Inclusion Criteria:

* Birthweight \>500 grams and
* Gestational age at least 25 0/7weeks but less than 30 weeks.
* \<14 days of age at time of randomization

Exclusion Criteria:

* Non-English speaking parents
* Major congenital anomalies
* grade underlying renal dysfunction (serum creatinine \> 1.0 mg/dL or increase of \>0.3 mg/DL between any two consecutive measurements)
* use of diuretics at the time initiation of intervention (approximately 14 days of age) But this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels
* any structural genitourinary criteria.
Effect of Baby Wipe Solutions on Fecal Enzyme-induced Irritation

This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.

This is a single-center, prospective, single-blind pilot study to determine baby wipe formulations on an adult dermatitis model.

Biophysical measurements will be taken at each test sites.

Eligibility Criteria:
Inclusion Criteria:

* 1. Fluent in English, willing and able to read, understand, and sign the informed consent form (ICF) 2. Ability to complete the course of the study and comply with instructions; 3. Females aged 18 to 40 years, in good general health as deemed by the investigator (no physical required).

  4. Caucasian individuals with Fitzpatrick skin type I, II, or III (See Appendix I).

  5. Individuals free of any systemic or dermatological disorder including a known history of allergies or other medical conditions which, in the opinion of the investigator, could interfere with the conduct of the study, interpretation of results, or increase the risk of adverse reactions.

  6. Anticipated ability to complete the course of the study and to comply with instructions.

  7. Females practicing an acceptable method of birth control (abstinence is acceptable). Females of child-bearing potential must have practiced an acceptable method of birth control for the past 3 months and be willing to continue using the same method throughout the duration of the study. Acceptable methods of birth control, include: 1) Systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change the type of birth control during the study); 2) Condom with spermicide; 3) IUD; 4) Vasectomized partner; and 5) Abstinence. Females who are post-menopausal (for at least 1 year) or have had a permanent sterilization procedure (i.e. hysterectomy, tubal ligation, bilateral oophorectomy) do not need to have additional birth control methods.

Exclusion Criteria:

* 1. Individuals with any visible skin disease, skin condition (e.g., back acne) including baseline erythema assessment \> 0.5, or tattoos in the test area (mid to upper back).

  2. Individuals with abnormal skin pigmentation at the test sites, which might interfere with subsequent evaluations of dermal responsiveness.

  3. Individuals with recent prolonged sun or tanning bed exposure in the test area 4. Individuals with excessive dryness or redness at the sites of application. 5. Individuals with a known hypersensitivity to any of the components of the insult, controls, or adhesive tapes.

  6. Subjects must not have applied any lotions, creams, powders, or oils to their backs the morning of the study. Additionally, two hours must have passed since bathing or showering.

  7. Women who are pregnant or nursing. 8. Individuals who have participated on a study involving the test sites (back) in the previous 30 days.

  9. Individuals participating in another clinical study 10. Individuals with open or healing cuts/incisions, abrasions, lesions, pustules, fissures, or broken mucosa/skin in the test area
Study of the Efficacy of 4 Treatments for Fecal Incontinence in Community-dwelling Women

This is a RCT aimed to assessing efficacy of kegel exercises,biofeedback, electrostimulation and transcutaneous neuromodulation on women with fecal incontinence, measuring its impact on anorectal physiology, cortical plasticity, clmical severity and the quality of life.

Fecal incontinence is a prevalent condition with a major impact on quality of life. Currently four treatments are being used in clinical practice: Kegel exercises (K), biofeedback (BF), electrostimulation (ES) and transcutaneous neuromodulation (NM). Results in the literature are discordant and lack methodological rigour making scientific evidence weak.

The aim of this study is to assess the efficacy of these four treatments on community-dwelling women and their impact on anorectal physiology, on clinical severity and on QoL.

This is a randomized control trial. Patient physiology was studied with anorectal manometry and endoanal ultrasonography; clinical severity was assessed with Cleveland and St. Mark's scales, and QoL with the Faecal Incontinence Quality of Life (FIQL) and the EuroQol's EQ5D questionnaires. Urinary incontinence (UI) was also evaluated by means of International Consultation on Incontinence (ICIQ) score. Patients were randomized and assigned to K (control), BF+K, ES+K or NM+K, given active treatment for a 3-month period, and then evaluated again with identical tests and parameters to identify changes.

Eligibility Criteria:
Inclusion Criteria:

* Age higher than 18
* To be woman
* Have had incontinence episiodes at least from 6 month since the beginning of the study
* Have had incontinence episodes during the last month prior the beginning of the study
* The patient is able to understand the nature and impliations of the study and, therefore, to decide her participation.

Exclusion Criteria:

* Not meeting inclusion criteria
* Have very mild condition (Wexner \<4)
* To be unable to perform / understand the treatments properly
* Being pregnant
* To have used treatmets for fecal incontinence within the last six months prior to the start of the study
* If, at reserarcher's criteria, the patient has not the proper conditions to perform and finish the treatments.
Does Subtotal Cholecystectomy Rate for Acute Cholecystitis Change With a Previous ERCP?

Study is designed to investigate whether the history of ERCP is associated with subtotal cholecystectomy rates in patients underwent laparoscopic cholecystectomy operations with the diagnosis of acute cholecystitis.

The results of patients who underwent surgery for acute cholecystitis in a single center between January 2016 and December 2019 were included and evaluated retrospectively.

Primary outcome was subtotal cholecystectomy rate. Secondary outcomes were conversion to open, complications and serious complications. Within examining demographic findings, operative records (rates for subtotal cholecystectomy and conversion to open, operative duration) and follow-up results (postoperative complications, serious complications, length of hospital stay and mortality) for all cases were investigated. Complications that Clavien-Dindo Score ≥ 3 accepted as serious complication. Intraoperative detection of gallbladder perforation was also noted and included in comparison. Any biliary tract complication that needed any percutaneous or endoscopic intervention to handle was named as "biliary leak" in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients operated with the diagnosis of acute cholecystitis with an age greater or equal to 18 years old in a single center between January 2016 and December 2019

Exclusion Criteria:

* Initial and direct preferance of open method
* Being diagnosed with malignity after histopathological evaluation
* Being operated just before one week after ERCP or after more than six weeks after ERCP
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus

The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid reflux patients are experiencing in the esophagus (swallowing pipe).

The following procedures will be performed at the Screening Visit:

* Obtain informed consent.
* Obtain information about your age and gender.
* Evaluate whether you qualify for the study.
* Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including the date of testing.
* Make sure that you have not used any investigational medications or participated in a clinical trial in the 30 days prior to the Screening Visit.
* Obtain medical history.
* Record medication history (including concomitant medications).
* Obtain vital signs.
* Conduct a physical examination.
* If a Bravo pH study has not been done within 8 weeks, instruct the patient to discontinue their medication for GERD during the 7-10 day washout period.
* Instruct the patient to discontinue the use of all prohibited medications during the applicable time intervals and not to start any new concomitant medications during the trial.
* Distribute Gelusil tablets to be used as "rescue medication"; instruct the patient that no more than 6 Gelusil tablets per day or 21 tablets over any 7-day interval will be allowed.
* Schedule the patient to return for the Qualification Visit, or for pH monitoring and the Qualification Visit. Only patients with abnormal pH monitoring will be able to enter the treatment period.

Procedures that will occur during the Treatment Period:

* You will receive Zegerid 1 hour before breakfast and at bedtime for at least 14 days and no longer than 28 days
* At the end of the Zegerid treatment period, you will undergo 48-hour Bravo pH monitoring on Zegerid therapy for two days. You will complete a symptom survey and quality of life survey after the completion of the pH study.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include adult men and women (aged \<=18 years) with previously established, biopsy-proven diagnosis of BE (any length intestinal metaplasia without dysplasia or adenocarcinoma)

Exclusion Criteria:

* Exclusion criteria include a history of esophageal, gastric, or duodenal surgery (including antireflux surgery or endoscopic antireflux procedures), except for simple ulcer closure
* Zollinger-Ellison syndrome
* Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach
* Positive for H. pylori.
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography

The proposed study aims to compare (a) volume contrast administered for Optical Coherence Tomography (OCT) Imaging, (b) length of clear OCT images, and (c) electrocardiographic changes immediately after contrast injection between iso-osmolar and low-osmolar contrast agents. The proposed study is a prospective, single-centered, randomized controlled, study that will compare an iso-osmolar vs. a low-osmolar contrast agent in patients undergoing clinically indicated coronary OCT imaging. Each patient will be randomized to OCT acquisition.

Patients referred to the Cardiac Catheterization laboratory for clinically indicated coronary angiography and coronary OCT imaging will be identified by a study team member and screened for eligibility. The proposed study is a prospective, single-center, randomized, controlled, study that will compare an iso-osmolar vs a low-osmolar contrast agent in patients undergoing clinically-indicated coronary OCT imaging. Each patient will be randomized to OCT acquisition. Eligible patients will be approached to obtain informed consent by a member of the study team. Once consent is obtained and inclusion and exclusion criteria are verified, patients are randomized to undergoing OCT image acquisition with iso-osmolar contrast media(IOCM) first or with low-osmolar contrast media first (LOCM).

Then the patients undergo coronary angiography and OCT imaging as per clinical standard of care. However, during the OCT imaging acquisition based on their randomization assignment the patient will undergo the 1st OCT imaging run with either iso-osmolar contrast media or with low-osmolar contrast media. Following this a 2nd OCT imaging run of the same coronary vessel will be done using the other contrast media that was not used during the first run. Therefore, each patient will serve as a comparator to themselves, but also to each other. The electrocardiogram will be recorded during and for 30 seconds after each injection and analyzed offline for detection of any changes

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or greater
2. Willing and able to give informed consent. The patients must be able to comply with study procedures
3. Undergoing clinically-indicated coronary angiography and OCT

Exclusion Criteria

1. Baseline electrocardiographic changes hindering interpretation (such as left bundle-branch block, and \>1 mm ST segment depression)
2. Emergency cardiac catheterization (for example in patients with ST-segment elevation acute myocardial infarction)
3. Inability to provide symptomatic assessment
4. Known allergy to contrast
Effects of Motor Imagery and Action Observation Training on Neck Reposition Sense in Patients With Chronic Neck Pain

This study evaluates the influence of motor imagery or action observation training on joint position error in patients with chronic neck pain. This variable is a measure of proprioception and cervical motor control. A group of patients will receive an action observation training of neck movements, another will receive a protocol of motor imagery of the same movements and the last group will be a placebo group, through the viewing of a documentary video.

Motor imagery is defined as a dynamic mental process of an action, without its real motor execution. Action observation training consists of watching an action performed by someone else. Both motor imagery and action observation have been shown to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality.

Both motor imagery and action observation are interventions that can generate adaptive neuroplastic changes on a cortical level, leading to a decrease in chronic pain. These rehabilitation techniques are used in pain treatment and impaired movement injuries that could be due to a nervous system alteration.

The effectiveness of motor imagery is controversial; several studies have presented unfavorable outcomes from this technique. Some variables, such as the duration of the sessions, the time employed the type of motor task or the number of sessions can influence the outcomes of these studies. Thus, it is necessary to clarify the controversial aspects of motor imagery, which lead us to perform this study.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 65 years
* Medical diagnosis of NSCNP with more than 6 months of evolution of neck pain

Exclusion Criteria:

* Patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries o a history of arthrodesis
* Systemic diseases
* Vision, hearing or vestibular problems
* Severe trauma or a traffic accident that had an impact on the cervical area.
Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult

A dose randomized, double-blind, placebo controlled, single and multiple dosing, dose-escalation phase I clinical trial to investigate the safety, tolerability and pharmacokinetic characteristics of Zebinix (Eslicarbazepine acetate) after oral administration in healthy Korean and Caucasian adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers aged 19-45 years at screening
* Subjects who weigh more than 50kg with a body mass index(BMI) of 18.0\~28.0 kg/m2 at screening
* Subjects who are fully understood after being given the detailed explanation of this clinical trial and willing to give written informed consent for participation prior to the screening test
* Subjects who are qualified to participate in this clinical trial through the physical examination, clinical laboratory test and interview by the investigators

Exclusion Criteria:

* Clinically significant presence or treatment history of cardiovascular, hepatic, renal, gastrointestinal, respiratory, neurological, hematological, endocrine, psychiatric
* Clinically significant surgical history
* Clinically significant family history
* Clinically significant atopic syndrome
* History of hypersensitivity or clinically significant hypersensitivity to drug including carbamazepine and related compounds
* History of alcoholism or drug abuse or show a positive response to an abuse drug in the urine drug screening test
* Consistently consume alcohol or cannot stop drinking during the clinical trial
* Smoker
* Significant infection or inflammatory finding at screening visit
* History of gastrointestinal disorders or surgery which may have an effect on the safety and pharmacokinetic evaluation of the investigational products (except for simple appendectomy and herniotomy)
* Have used prescription drugs or herbal medication within 2 weeks of initial administration or who have used over the counter(OTC), health functional food or vitamins within 1 week of initial administration (but, if the other conditions are suitable according to the judgment of the investigator, they can participate in the clinical trial), or subjects who have expected to take it
* Have participated in any clinical trial (or bioequivalence study) and administered any investigational product within 6 months
* Positive for HbsAg, anti-HCV and HIV antigen-antibody reaction tests at screening
* Have donated any whole blood or apheresis or received blood transfusion within 3 months of initial administration of this clinical trial
* Have dietary restrictions or cannot take the food provided by the institution
* Cannot communicate reliably with the investigator
* Subjects who are determined by the investigator to be ineligible for participation in this clinical trial due to clinical laboratory test results or other reasons