cyrilzakka/clinical-trials huggingface dataset:
The Pharmacokinetic Interaction Between Celecoxib and Rebamipide

This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and rebamipide in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight ae least 50kg and BMI(body mass index) within the range of 18 to 27kg/m2
* Agreement with written informed consent

Exclusion Criteria:

* Subject with symptoms of acute disease within 28days prior to study medication dosing
* Subject with known for history which affect on the absorption, distribution, metabolism, excretion of drug
* Subject with clinically significant active cardiovascular, respiratory, renal, endocrine, hematologic, gastrointestinal, neurologic, autoimmunologic disease or malignant tumor
* Subject with unsuitable clinical test through the medical checkup(medical history, physical examination, ECG, laboratory test) within 28days prior to study medication dosing
* Subject with any of the following findings; i. AST(sGOT) or ALT(sGPT) \> 1.5 fold normal value or ii. Total bilirubin \> 1.5 fold normal value
* Subject with clinically significant allergic disease (except for mild allergic rhinitis, mild allergic dermatitis seems to be not need for medication)
* Subject with known for hypersensitivity reaction to celecoxib, rebamipide, sulphonamide analog
* Subject with asthma, acute rhinitis, nasal polyp, angioedema, urticaria, allergic reaction to aspirin or any other NSAIDs(including COX-2 inhibitors)
* Subject with hereditary disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
* Use of any prescription medication within 14 days prior to study medication dosing
* Use of any medication(Over-the-counter medication, oriental medication, vitamin) within 7 days prior to study medication dosing
* Subject who has been taken meal which affect on the absorption, distribution, metabolism, excretion of drug
* Subject who is not able to taking the institutional standard meal
* Whole blood donation within 60days, component blood donation within 20days or receiving blood transfusion within 30days prior to study medication dosing
* Participation in any clinical investigation within 60days prior to study medication dosing
* Continued excessive use of caffeine (caffeine \> five cups/day), alcohol(alcohol\>30g/day) and severe heavy smoker(cigarette \> 10 cigarettes per day)
* An impossible one who participate in clinical trial by investigator's decision including for reason of laboratory test result
Exhibitionnists's Cognitive Mecanisms

Exhibitionism is a paraphilia, which is defined according to the DSM 5. The estimated prevalence in men is between 2 to 4% (The prevalence of exhibitionistic disorder in females is even more uncertain but is generally believed to be much lower than in males).

At judiciary level: approximately 30% of apprehended male sex offenders are exhibitionists. They have the highest recidivism rate of any sex offender; about 20-50% are arrested again.

The studies are old and not very prolific on the subject of exhibition. The available data are lacking, there is no clinical evaluation scale for exhibitionism. The diagnosis is essentially based on facts with judicial characteristics "did patient show himself? ", "Does he enjoy showing off?". Investigators have no data on the cognitive distortions that support this particular acting out, the (specific) triggering factors and the potential psychological vulnerabilities of exhibitionists Some cognitive and sensory mechanisms may be involved in the origin and development of the processes underlying the act (Johnston and Ward 1996). The investigators will rely on the identification of anticipatory, relieving and permissive beliefs as a schema that can explain cognitive processes leading to acting out (Johnston and Ward, 1996). The goal is to apply this approach to exhibitionism. It should be noted that this model of thoughts (anticipatory, relieving and permissive) is taken up in the field of addiction. Exhibition is generally presented in the literature as a possible addictive disorder (Jon E. et al). The investigators will investigate whether there are specific factors precipitating exhibitionnism's acting out, other than the general precipitating factors or the recidivism risk factors known in sexual violence (SONAR, STATIC-99, PCL- R, SVR-20...). The investigators will also study the psychological vulnerabilies of these subjects.


Eligibility Criteria:
Inclusion Criteria:

* male \> 18 years
* followed in Resource Centre for Interveners with Perpetrators of Sexual Violence of Montpellier UH
* exhibitionnists
* agree to participate

Exclusion Criteria:

* dementia
* severe intellectual desability
* decompensated psychiatric didease
Reresveratrol Administered to Healthy Male Subjects

Heme oxygenase 1 (HO-1) serves as a protective gene. The aim of this clinical trial is to evaluate the HO-1 stimulation of resveratrol in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male patient aged between 18 and 45 years (inclusive) at screening.
* No clinically significant findings on the physical examination at screening.
* Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
* Non-smoker (for at least 1 month)
* Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to resveratrol or any excipients of the resveratrol formulation.
* Treatment with any investigational drug within 3 weeks prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of resveratrol.
* Smoker
* Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Regularly intake of resveratrol rich food
* Positive results from the hepatitis serology at screening.
* Positive results from the HIV serology at screening.
* Presumed non-compliance.
* Legal incapacity or limited legal capacity at screening.
The Effect of an Acute Increase in Plasma IL-6 on Glucose Tolerance When a Meal is Administered Intraduodenally

The aim of the study is to investigate and clarify whether the effect of IL-6 on glucose tolerance and insulin secretion are secondary to the changes in gastric emptying.

The literature provides no information regarding a role for interleukin-6 (IL-6) in the regulation of beta cell function (glucose or meal-stimulated insulin secretion) in humans. Previous studies infusing IL-6 into humans have primarily focused on insulin action and the effects on peripheral insulin sensitivity whereas a potential effect on insulin secretion has been neglected.

We have demonstrated that an acute increase in IL-6, obtained by a single bolus of IL-6, potentiated glucose-induced insulin secretion in a glucagon-like peptide-1 (GLP-1) dependent manner in mice1. In mice, IL-6 enhanced insulin secretion in a dose- and glucose-dependent manner, along with increasing concentrations of GLP-1. Interleukin-6 had no effect on insulin secretion in GLP-1 receptor knock-out mice or in mice treated with the GLP-1 receptor antagonist. Thus, in mice, GLP-1 has proven an essential mediator of IL-6 actions on beta cell function.

Importantly, a single bolus of IL-6 also significantly increased glucose-stimulated insulin secretion in several mouse models of obesity and diabetes (diet-induced obesity, the ob/ob and the db/db mouse).

Own data show that an infusion of IL-6 causes a significant delay in the rate of gastric emptying (GE) after a mixed meal in healthy young men. Data showed that this delay in GE is associated with much improved glucose tolerance and insulin secretion (unpublished data).

In the present study we wish to investigate whether the beneficial effects of IL-6 on postprandial glucose tolerance and insulin secretion are dependent on a delay in gastric emptying. We will bypass the ventricle and infuse a mixed meal directly into the duodenum of healthy young men.

This study has the potential to show that the known effect of IL-6 on postprandial glucose tolerance is dependent on a delayed GE.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 35 years
* Healthy (based on screening)

Exclusion Criteria:

* Smoking
* BMI \< 18 and \> 25 kg/m2
* Evidence of severe thyroid, liver, lung, heart or kidney disease
A Novel Patient Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest

This study will test the feasibility and acceptability of deploying a decision aid for surrogate decision makers of comatose survivors of cardiac arrest early during hospitalization. This decision aid is to inform, educate and support decision makers charged with determining goals of care during post-cardiac arrest treatment.

Survival and neurological recovery after out-of-hospital cardiac arrest are highly variable, driven in part by inconsistent hospital care following successful resuscitation. International guidelines for post-cardiac arrest care recommend delaying neurologic prognostication until 72-hours after resuscitation because early prognostication is imprecise and may precipitate inappropriate withdrawal of life sustaining therapy (WLST). Early WLST has been observed in-post cardiac arrest care. In order to encourage better guideline concordant care, the study proposes the implementation of an educational tool to support and inform surrogate decision makers in post-cardiac arrest care and neuro-prognostication. This pilot study will test the feasibility of implementing an educational tool for surrogate decision makers, the acceptability of such an intervention and early measures of knowledge translation. This study will inform the creation of a randomized controlled trial to test the ability of the tool to encourage guideline concordant timing of post-cardiac arrest neuro-prognostication.

Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years of age and older
* Identified as a surrogate decision maker for patient who is a comatose survivor of out of hospital cardiac arrest

Exclusion Criteria:

* Illiterate or poor proficiency (unable to read decision aid)
* Non-english speaking
Comparative Clinical Evaluation of BioFlx, Zirconia, and Stainless-Steel Crowns in Primary Molars

This study will be conducted to:

Evaluate and compare the clinical success, periodontal changes, and wear of antagonist teeth for three types of prefabricated crowns in primary molars: BioFlx crowns, Zirconia crowns, and Stainless Steel crowns.

A randomized controlled clinical trial with three parallel groups, will be set up and reported according to the revised Consolidated Standards of Reporting Trials statement. The study will be conducted on 51 children with 51 molars aged between 4 and 7 years with a lower primary molar indicated for crown restoration. The children will be selected from the Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. They will be randomly divided into three equal groups (17 molars/each). Sequence generation and concealment will be done by a biostatistician who is not involved in the study. Group I (control group) will include stainless steel crowns, group II (study group) will include Zirconia crowns, group III (study group) will include BioFlx crowns. After obtaining the written consent form from the parents or guardians, the children will be randomly enrolled, and teeth will be assigned to the groups to receive the selected crowns. Clinical evaluation will be done concerning crown retention, color stability, secondary caries, periodontal changes, and wear of the opposing natural enamel. All crowns will be evaluated at the 3rd, 6th, 12th, and 18th months.

Eligibility Criteria:
Inclusion Criteria:

* Children who are free from any systemic disease.
* Children with a carious lower primary molar indicated for crown restoration.
* Teeth with an intact antagonist and neighboring primary molar.
* Cooperative children with scores 1 and 2 (positive or definitely positive) according to Frankl's behavior rating scale.

Exclusion Criteria:

* Children with extremely poor oral hygiene.
* Teeth showing radiographical furcation involvement or root resorption.
* Children with para-functional habits, bruxism, or deep bite.
* Teeth with inadequate non-restorable crown structure.
Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period

The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.

This study is double-blinded randomized controlled trial, whose aim is to compare the proportion of successful extubation of preterm infants immediately after the extubation. Methods: Participants will be recruited from neonatal intensive care unit (NICU) and they will be divided into two groups (supine and prone) and positioned in their respective groups after extubation. A clinical evaluation form and a parameters collection form (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature) will be used and filled before extubation and 48 hours after by the professional staff of the NICU. It will be considered a successful extubation all participants who staying extubated for 48 hours after extubation.

Eligibility Criteria:
Inclusion Criteria:

* Newborns less than 37 weeks of gestation age (calculated by doctor using the method of Capurro/Ballard)
* Newborns undergone to invasive mechanical ventilation in the first week of life, for more than 48 hours

Exclusion Criteria:

* Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation
A Study of LUMIGAN® RC in the Clinical Setting

This study will evaluate bimatoprost 0.01% (LUMIGAN® RC) in patients with elevated intraocular pressure (IOP) due to primary open angle glaucoma (POAG) or ocular hypertension (OHT) in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Elevated IOP due to either primary open-angle glaucoma or ocular hypertension
* Determined by the treating physician to require treatment with LUMIGAN® RC

Exclusion Criteria:

* None
Mindful Movement Program in Improving Quality of Life in Older Female Breast Cancer Survivors

RATIONALE: Mindful movement is a self-directed activity of mindfulness (intention, attention, and attitude) and physical movement. A mindful movement program may be effective in improving well-being in older women who are breast cancer survivors.

PURPOSE: This randomized clinical trial is studying how well a mindful movement program works in improving quality of life in older female breast cancer survivors.

OBJECTIVES:

* To test the effects of the 12-week Mindful Movement Program on quality of life in older female breast cancer survivors.
* To test the effects of this program on mindfulness outcomes in these participants.
* To compare mindfulness qualities in the experimental group with the control group.
* To determine the qualitative benefits of this program as described by these participants.

OUTLINE: Participants are randomized to 1 of 2 intervention arms.

* Arm I (Mindful Movement Program \[MMP\]): Participants undergo a 2-hour MMP session once weekly for 12 weeks. Participants are encouraged to practice intentional-mindful movement at home 5 minutes daily during weeks 1-4, 10 minutes daily during weeks 5-8, and 15 minutes daily during weeks 9-12. Mindful movement is a self-directed activity incorporating mindfulness concepts and physical movement. Mindfulness consists of the three core elements: intention (reasons for participating in a mindfulness intervention), attention (observing experiences in the present moment), and attitude (nonjudgmental openness and acceptance of experiences). Each MMP session includes verbal sharing with a partner and the group and movement individually and with a partner, while focusing on the elements of mindfulness. Music is incorporated into some portion of each session.
* Arm II (control): Participants undergo no intervention. All participants complete questionnaires for sociodemographic and individual characteristics, quality of life (including psychological, social, spiritual, and physical well-being, anxiety and depression, fear of recurrence, body image, and upper body symptoms), movement, and mindfulness (including attention, self-compassion, and intention) at baseline and weeks 12 and 18.

PROJECTED ACCRUAL: A total of 75 participants (45 in the experimental group and 30 in the control group) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Breast cancer survivor

  * At least 12 months since completion of treatment (chemotherapy, biotherapy \[e.g., trastuzumab\], or radiotherapy)
* No evidence of metastatic disease

PATIENT CHARACTERISTICS:

* English speaking
* Not under acute psychological distress
* Not using an assistive device (cane, walker, or wheelchair)
* Able to participate in the Mindful Movement Program by a medical release from the patient's physician
* Pregnancy allowed

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Concurrent selective estrogen-receptor modulator permitted
* No other concurrent treatment
The BEAR Therapeutic Program for Women

The current study aims to test a novel therapeutic intervention for women who have a history of interpersonal trauma. The Building Empowerment and Resilience (BEAR) Therapeutic group incorporates psychological skills, psychoeducation, and physical empowerment training, all within a therapeutic process. It will be implemented iwith women who have experienced interpersonal trauma (physical, sexual, or emotional abuse/neglect). The investigators aim to understand how this program effects one's self-efficacy and whether the program can reduce rates mental health problems (such as depression and anxiety) and reduce the rates of revictimization. Women who participate in the BEAR group must be able to attend in-person sessions. The control group can be remote.


Eligibility Criteria:
Inclusion Criteria:

1. Women ages 18-70
2. History of physical, sexual, and/or emotional abuse/neglect/violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.

Exclusion Criteria:

1. Active, significant substance abuse
2. Significant medical conditions that would preclude safe participation in the study
3. High levels of depression with significant suicide risk
4. Psychiatric instability
5. History of assaultive behavior or is judged to be at potential risk to assault others.
Feasibility and Safety of the Routine Distal Transradial Approach

The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.

Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.

400 patients were enrolled.

Eligibility Criteria:
Inclusion Criteria:

* patients referred for CAG and/or PCI

Exclusion Criteria:

* ST-elevation myocardial infarction
* sudden cardiac arrest
* hemody-namic instability
* chronic kidney disease (stages 4-5)
* forearm artery occlusion
* previous unsuccessful ipsilateral TRA
* unfavorable RA diameter
* ultrasound unavailability
The Incidence of Metabolic Syndrome Among Obese Children in Our Region

The aim of this study is to determine the prevalence of metabolic syndrome amongst obese children in our region with a body mass index (BMI) above the 95th percentile for age and sex.


Eligibility Criteria:
Inclusion Criteria:

* Children with BMI over 95 percentile

Exclusion Criteria:

* Obesity secondary to medication use
* Obesity secondary to genetic disease
Concussion Screen Use Recovery Time

A two-year parallel randomized clinical trial study to examine the effect of screen time (ST) restriction, exercise alone, and combined ST-restricted-exercise when compared to stretching only (control group) on sports related concussion recovery time among adolescents aged 12 to 17 years. Study hypothesis 1 - There will be significant differences between the treatment and the control arms' mean recovery time (days). Study hypothesis 2 - The ST-restricted \& exercise treatment arm will have a significantly shorter mean recovery time (days) compared with the other treatment arms and control arm.

The investigators will randomize a sports related concussion (SRC) treatment protocol (n=313) of Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) pediatric SRC patients (aged 12-17 years) to one of four treatment groups:1. Screen Time (ST) restricted group, 2.Exercise group, 3.ST restricted \& exercise group, and Control \[stretching only\]) group. The treatments will occur for the first 72-hours following the first clinic appointment. The investigators will monitor treatment adherence and 24-hour movement behaviors over a 72-hour period using the ActiGraph GT9X Link and heart rate monitor; a state-of-the-art research grade wearable device that our research team has expertise in administering and analyzing in field-based studies.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects
* Age 12-17 years of age presenting to the Children's Health Andrews Institute for Orthopaedics and Sports Medicine (Andrews) concussion clinic in Plano, Texas, to be treated for a diagnosed SRC
* Patients who suffered a sport-related concussion within 72-hours of first clinic visit

Exclusion Criteria:

* Patients who suffered a sport-related concussion outside of 72-hours of first clinic visit
* Is not diagnosed with a SRC
* Is already taking part in another study that measures their physical activity, sleep, screen-time, or is related to concussion
* Has a current diagnosis of and treatment with medication for attention deficit/hyperactivity disorder, learning disorder, depression, anxiety, or a history of more than 3 prior concussions (because these factors are associated with delayed recovery
* Has a co-existing musculoskeletal injury that may impact their ability to be physically active during recovery
* Has an increased cardiac event risk according to the American College of Sports Medicine criteria
* Has a symptom severity score of less than 5 points on the post-concussion symptom scale during the initial clinical examination
* Has an ability to exercise to exhaustion without symptom provocation during the initial clinical examination
* Has limited English language proficiency