cyrilzakka/clinical-trials huggingface dataset:
Respiratory Problems and Caries in Children With Bruxism

The aim of the present study are to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.

Objectives: The aim of the present study was to determine whether there is an association between respiratory problems and dental caries in children who exhibit the habit of bruxism.

Method: Patient histories were taken and clinical exams were performed on 90 children for selection and allocation to one of two groups. For the determination of bruxism, a questionnaire was administered to parents/guardians and an oral clinical exam was performed based on the criteria of the American Academy of Sleep Medicine. Thirty-three male and female children between four and seven years of age participated in the present study - 14 children with bruxism and 19 children without bruxism. The data were statistically analyzed using the chi-square test, with level of significance set at 5% (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Children with either the complete primary or mixed dentition who were not in dental treatment

Exclusion Criteria:

* Children in dental treatment
Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification

The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. The investigators will use kinetic modeling techniques to design a study that allows the absolute flow quantification. To make this study practical, the investigators will develop a protocol that includes the acquisition of both the rest and stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow will be validated against the flow measured with cardiac MRI scans. Patients with high CAD risk will be recruited for the clinical trial. Data from these human subjects will be used for determination of the performance of the developed algorithm. With the proposed rapid scan with absolute quantification capabilities, the investigators expect to increase the diagnosis accuracy while maintaining the patient throughput.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
2. \> 20 years old.
3. Not under infection or other conditions inappropriate for being recruited.
4. Without myocardial infarction within one week.
5. With stable blood pressure.
6. Subjects with normal kidney functions and without allergic reactions to MRI contrast agents.

Exclusion Criteria:

1. Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
2. Pregnant subjects or subjects who are currently breast-feeding.
3. Those currently under radiation therapies.
4. Patients with pleural effusion.
5. Patients who are allergic to SPECT tracers.
6. Patients with serious psychological disorders.
7. Patients with asthma.
8. Patients with stroke within a week.
9. Patients with AV block.
10. Patients with sinus syndrome.
11. Subjects who are currently under other clinical trials.
12. Subjects with poor kidney functions who are inappropriate for MRI contrast agents.
13. Subjects with pacemakers.
14. Subjects with Claustrophobia.
15. Subjects who cannot hold breath for cardiac MRI studies.
Heart Rate Variability and Anxiety During Urinary Bladder Catheterization

This is a prospective, randomised study investigating the physical and psychological experience of intermittent catheterization in adult individuals following spinal cord injury (SCI).

Given that intermittent catheterization is the recommended method of bladder management in individuals with SCI, it is crucial that the potentially negative cardiovascular and psychological responses to this procedure are examined. Individuals will undergo self-catheterization, then two standard of care catheterization procedures performed by an experienced urology nurse, while either blinded to or aware of time of catheterization. Continuous cardiovascular monitoring will be in place throughout all three procedures. Assessment of anxiety will be administered pre- and post- each procedure.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18-70 years of age
* Any chronic traumatic SCI with either motor sensory complete injury (AIS A/B, N=10) or motor sensory incomplete injury (AIS B/D, N=10).
* At least 1 year post injury, and at least 6 months from any spinal surgery
* Hand function sufficient to perform intermittent catheterization for management of urinary bladder drainage
* Must provide informed consent and be able to understand and complete study-related questionnaires (must be able to understand and speak English or have access to an appropriate interpreter as judged by the investigator)
* Willing and able to comply with clinic visit and study-related procedures

Exclusion Criteria:

* Signs or known current urinary tract infection, or other inflammatory conditions of bladder/urethra
* Currently taking beta blockers or other medications that may affect heart rate
* History of ureteral injury
* History of any urinary diversion procedures, including but not limited to bladder augmentation, cystectomy, neo bladder, pouch reservoir, ileal conduit, Mitrofanoff appendicovesicostomy
* For women of childbearing potential, currently pregnant
* A member of the investigational team or his/her immediate family Presence of severe acute medical issue and use of any specific medication or treatment that, in the investigator's judgement, would adversely affect the participant's participation in the study
Carotid Plaque Assessment Using 18Fluorine (18F) -Sodium Fluoride Positron Emission Tomography (PET) /MR

Carotid plaque can lead to ischemic stroke. Treatment of asymptomatic carotid plaque, based on degree stenosis, is still controversial. Beyond the degree of stenosis, the composition of the plaque could reflect the vulnerability and the risk of ipsilateral ischemic stroke. Identification of new predictive factor of ipsilateral ischemic stroke in patients with carotid plaque could help to screen high risk patients and to guide the treatment. The aim of the study is to assess 18F-sodium fluoride uptake among carotid plaque in recently symptomatic and asymptomatic patients. Investigators conduct a pilot case-control study. Twelve patients (6 recently symptomatic and 6 asymptomatic) with carotid stenosis (≥50% NASCET) will have a 18F-sodium fluoride PET/MR. Standardized uptake value (SUV) and tissue-to-background ratio (TBR) will be measured among carotid plaques.


Eligibility Criteria:
Inclusion Criteria symptomatic patients:

* age\>18
* Carotid plaque ≥ 50% symptomatic (ischemic stroke on CT or MR) during the last 15 days or asymptomatic
* ability to give informed consent
* affiliation to social security

Exclusion Criteria:

* Modified Rankin score ˃ 3
* Contraindication to MRI
* Renal failure (creatinine clearance by cockcroft ˂ 50 ml / min)
* Pregnancy / Breastfeeding
* Hypersensitivity to the active substance or excipients
Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions

The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation. The main disadvantage of the historical Crush technique is the low success rate of the final kissing balloon inflation. An improvement came with the introduction of double kissing crush stenting aiming for the shorter protrusion and kissing balloon dilation performed before and after main branch stent implantation. The double kissing crush provides a significant reduction in major adverse cardiovascular events compared to Provisional stenting, Crush, and Culotte techniques. Recently, a novel modified mini-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired, and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon), and this causes less disruption of the stent cells. To date, no data compares the mid-term outcomes of double kissing crush and controlled balloon-crush stenting techniques in patients with complex coronary bifurcation lesions. Hence, this study aimed to determine the clinical results of double kissing crush and controlled balloon-crush techniques under mid-term follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>18
* PCI with either DK-crush or Controlled balloon-crush
* Complex coronary bifurcation lesion (Medina 0.1.1, Medina 1.1.1)

Exclusion Criteria:

* Non-complex bifurcation anatomy
* Bail-out 2-stent (reverse modified mini-crush)
* ST-elevation myocardial infarction
* Cardiogenic shock status
* In-stent restenosis
* A previous of coronary artery bypass grafting
* Implantation of bare-metal stent
* End-stage hepatic or renal disease
* \<1-year life expectancy
High Flow Nasal Cannula vs Low Flow Oxygen Therapy in Bronchiolitis

Bronchiolitis is the most common respiratory infection of the lower respiratory tract that affects 11-12% of infants in their first year of life. Approximately 1-2% of patients with bronchiolitis require hospital admission because of poor feeding and/or breathing difficulties. The standard treatment for bronchiolitis is represented by oxygen-therapy and hydration while neither steroids nor epinephrine nor bronchodilators are recommended. One of the techniques of administration of oxygen in bronchiolitis is represented by the high flow (HFNC) or by a system in which oxygen is delivered to 2L/kg through nasal cannulas. The HFNC provides humidification, heating and oxygen, ensuring a minimum positive pressure, reduces breathing load and allows for better nutrition. The main aim of therapy with high flows is to reduce the days of oxygen therapy and the cases of intubation. However, up to now, there have been few studies on the use of HFNC in Pediatric Emergency Units. The Cochrane review on this topic, updated in May 2013, included only one randomized controlled trial (RCT) on a pilot study of 19 subjects comparing HFNC with oxygen administered via "head box". The oxygen saturation was higher in children HFNC after 8 (00% versus 96%, p=0.04) and 12 hours (99% vs 96%, p=0.04) but similar in both groups at 24 hours. The authors concluded that the available evidence is insufficient to determine the effectiveness of HFNC.

The aim of this study is to evaluate in a large number of cases the effectiveness of treatment with high flow versus standard treatment, in children with bronchiolitis referred to a Pediatric Emergency Department.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of bronchiolitis
* age \>28 days and \<6 months
* Oxygen saturation (SaO2) \<92%
* respiratory rate \>60 breaths/min
* dyspnea with respiratory distress assessment instrument (RDAI) score ≥8
* daily milk or food intake less than 2/3 than normally assumed

Exclusion Criteria:

* chronic diseases or syndromes
* respiratory diseases (i.e. bronchopulmonary dysplasia)
* heart diseases
* preterm birth (before 36 weeks of gestational age)
Effect of Evaluative Conditioning on Intensity of Physical Activity of Patients Doing Cardiac Rehabilitation

The hypothesis is that, compared to those in the control group (i.e., diet-related evaluative conditioning), participants in the Physical Activity (PA) group (i.e. PA-friendly evaluative conditioning) will exhibit (1) a higher intensity (power setting) on an ergocycle during a free Physical Activity session in their rehabilitation program and (2) A greater increase in the implicit attitude score.

The primary objective will be to evaluate the effect of evaluative conditioning (EC) on the intensity of physical activity produced by post-myocardial infarction patients involved in a cardiac rehabilitation program.The secondary objective of this study will be to evaluate the mediating effect of implicit attitude change in the effect of evaluative conditioning on adopted behaviors.

More specifically, post-myocardial infarction physical activity has been shown to reduce cardiac morbidity and mortality. Indeed, exercise improves cardiovascular health through mechanisms such as lowering blood pressure, weight reduction, and increased insulin sensitivity. Although there are no formal guidelines for physical activity (PA) after Myocardial Infarction, patients are encouraged to achieve 150 minutes of low-to-moderate intensity PA per week.

Nevertheless, despite the growing body of scientific evidence and the widespread dissemination of information about the benefits of PA, the recommendations have been difficult for post-myocardial infarction patients to comply with. There is evidence to suggest that post-cardiac rehabilitation patients struggle to maintain sustained PA. This may be due to a number of barriers, including fatigue, mood disorders, a lack of motivation, or kinesiophobia.

Continued improvements in monitoring physical activity and the development of policies and programs to increase activity levels appears to be a necessity. This may reduce the burden of physical inactivity and noncommunicable diseases (eg, cardiovascular disease). Therefore, one of the major challenges is to succeed in identifying the main determinants playing a role in the lack of adoption of regular PA. Indeed, targeting these determinants would ultimately allow us to improve the PA promotion strategies already in place for the population. However, maintenance of a practice over time is a complex issue that may be influenced by a multitude of factors. Among these, previous work suggests that the identification of motivational determinants of physical activity represents a relevant research object in this context.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have given written informed consent to participate in the trial
* Patients must be aged18 to 75 years old
* It must be less than 6 months after a first episode of myocardial infarction treated medically or by revascularization

Exclusion Criteria:

* Patients with a disability preventing the performance of a bimanual test or an ergocycle task
* Patients who are unable to give written informed consent or who have refused to sign the consent form
Efficacy and Safety of Primary Teeth Anesthesia Using Nasal Spray in Children

68 healthy children from the Department of Pediatric Dentistry at Damascus University who require treatment for their primary maxillary second molars will be randomly assigned into one of two groups: experimental or control groups. In the experimental group, a lidocaine hydrochloride-epinephrine hydrochloride nasal spray will be applied to anesthetize upper second molar before the commencement of treatment.

To assess the efficacy of this kind of anesthesia, a specific scale will be used by an external observer after capturing some video files of the performed treatment.

To assess the safety of this procedure, vital signs will be recorded before and after treatment.

Acceptance of the nasal spray will be recorded based on the child's behavior before and after treatment using Frankl scale.

If anesthesia was not sufficient to proceed with the procedure, a rescue anesthesia would be used. Rescue anesthesia consists of an infiltration injection of lidocain hydrochloride 2% with epinephrine hydrochloride (1:100,000). In the control group, an intra-oral lidocaine-epinephrine injection will be applied due to treatment. Safety, efficacy and acceptance will be assessed in the same manner to what is performed in the experimental group.

The most common method for anesthetizing maxillary teeth is infiltration injection of an anesthetic agent. This approach carries several disadvantages. First is the child's fear of pain. Infection is also a risk for providers, through exposure to blood-borne pathogens via needle stick.

Fear of a painful dental injection and subsequent avoidance behavior are significant barriers to regular visits to the dentist.

Importantly, patients' fear of injections can delay needed dental care. Surveys indicate that 30-40 million people in the US avoid going to the dentist because of fear of pain and anesthetic injections.

Therefore an anesthetic procedure that would avoid the discomfort of a local anesthetic injection thus obviating fear and anxiety about receiving a "shot," would greatly benefit dental patients. Further, for procedures involving more than one maxillary tooth on the same side, a trans-nasally applied anesthetic agent that could anesthetize multiple maxillary teeth at once instead of use of repeated infiltration injections would be a major convenience for patients and dentists.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy children between 7-10 years.
2. With a need for pulpotomy or a restorative dental procedure requiring local anesthesia for a single vital primary maxillary second molar with no evidence of pulpal necrosis.
3. Normal lip, nose, eyelid, and cheek sensation.
4. No history of allergy for lidocaine-hydrochloride or epinephrine-hydrochloride.

Exclusion Criteria:

1. Frequent bleeding form the nose (≥ 5 per month)
2. Inadequately controlled active thyroid disease of any type.
3. Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
4. History of allergy to or intolerance of lidocaine or epinephrine.
Depression Prevention Program for American Indian Adolescents During and After Pregnancy

This study will determine the effectiveness of the "Living in Harmony" depression prevention program in preventing depressive symptoms among pregnant American Indian adolescents during pregnancy and after giving birth.

Pregnancy among reservation-based American Indian adolescents has become increasingly common. Numerous psychosocial and environmental factors have put this population at high risk for pregnancy-related depression. Depression during pregnancy and after giving birth is associated with reduced quality of life for both young mothers and their children. Many reservations lack mental health services; therefore, an inexpensive intervention is needed to prevent depressive symptoms among pregnant adolescents who live on reservations.

The duration of this study will vary for each participant, depending on the time of study entry. Participants will be randomly assigned to receive weekly sessions of either the "Living in Harmony" program, consisting of cognitive behavioral therapy (CBT), culturally-relevant education, and support; or general depression-prevention education and support. Participants' depressive symptoms will be assessed at study entry, at 4, 12, and 24 weeks after giving birth, and study completion. Interviews and self-report scales will be used to assess participants.

Eligibility Criteria:
Inclusion Criteria:

* At 28th week or earlier of pregnancy
* Center for Epidemiologic Studies-Depression Scale (CES-D) score of 16 or higher
* Identified (by others and by self) as an American Indian
* Currently live on an American Indian reservation
* Parent or guardian willing to give consent, if applicable
* Willing and able to comply with all study requirements

Exclusion Criteria:

* Diagnosis of major depressive disorder
* Current psychiatric disorder or condition requiring intervention or treatment
* Current participation in another mental or behavioral health study
Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers

The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.

This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.

Eligibility Criteria:
Inclusion Criteria: - Body mass index (BMI) between 18 and 30 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria: - History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Manual Therapy for Pregnancy Related Back Pain

More than 50% of women experience pain in the lumbopelvic area during pregnancy. The prevalence of pain increases with the duration of pregnancy. Trunk muscles are needed to sustain low levels of activity for an extended duration. Preventing muscles from fatiguing is very important. Manual therapy techniques can minimize loading of the spine while improving muscular endurance and preventing fatigue. Moreover, inhibition of the trigger points of the spinal musculature is an important factor to consider.

Tui-Na massage and positional release therapy are both of the common manual therapies used recently for low back pain. However, no studies have compared their effects on pregnancy related low back pain in third trimester.

Eligibility Criteria:
Inclusion Criteria:

* low back pain
* mild to moderate disability concurring to the Oswestry Disability Index (up to 40%),
* age ranged from 20 - 40 years

Exclusion Criteria:

* Current physical therapy or medical treatment for low back pain,
* contracture or surgery affecting the lumbar spine,
* scoliosis,
* pathologies such as inflammatory diseases,
* skin diseases,
* congenital diseases,
* neurological diseases,
* dislocations, neoplasms,
* disc prolapse,
* visual or auditory problems