cyrilzakka/clinical-trials huggingface dataset:
The Antibacterial Effect of Nanosilver Fluoride on Primary Teeth

To assess the antibacterial effect of Nanosilver Fluoride (NSF) in relation to caries activity in dentin caries lesions of primary teeth in comparison to Silver Diamine Fluoride (SDF).

Fifty children aged 4 to 6 years old with active dentin caries lesions (score 5 according to International Detection and Assessment System (ICDAS II) criteria) will be enrolled in the study. They will be equally and randomly allocated into 2 groups: a group receiving NSF and a control group receiving SDF treatment. Microbiological samples will be collected from the carious lesions and from unstimulated saliva at the baseline and at the 1 and 3 months' follow-up appointments. Bacterial counts will be assessed using Mitis Salivarius agar (selective culture media for S. mutans) and Rogosa agar (selective culture media for lactobacilli), and the results will be expressed in colony-forming units. Data regarding the children's oral health will be collected and their dmf index will be scored. The arrest of active carious lesions will be measured at the follow-up appointments according to ICDAS II criteria.

Eligibility Criteria:
Inclusion Criteria:

* The presence of at least one active carious lesion on a primary tooth.
* Completion of an informed consent to participate in the study.

Exclusion criteria:

* Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling, abscess, obvious discoloration of the tooth, or premature mobility.
* Reported usage of local or systemic antibiotics, chlorhexidine or fluoride mouthwashes within the last 2 weeks.
* Children presenting with special health care needs or undergoing medical treatment for chronic or acute diseases affecting salivary flow.
* Allergy or sensitivity to silver or any of the materials included in the study.
* Child weight less than 10 Kg (to avoid concerns for toxicity).
Effect of Elastic Bandage on Balance in Chronic Ankle Instability

Purpose: To report the immediate and prolonged (one week) effects of elastic bandage on balance control in subjects with chronic ankle instability.

Material and methods: Twenty-eight individuals successfully completed the study protocol, of whom 14 were randomly assigned to the elastic bandage group (7 men, 7 women) and 14 were assigned to the non-standardized tape group ( 9 men, 5 women). To objectively measure postural sway we used computerized dynamic posturography with Sensory Organization Test and Unilateral Stance test. We analyzed the following Sensory Organization Test parameters: the composite Sensory Organization Test score, the composite Sensory Organization Test strategy and the Sensory Organization Test condition 2 and its strategy. In addition, we studied the centre of gravity sway velocity with open eyes and close eyes during the US test.


Eligibility Criteria:
Inclusion Criteria:

Subjects with Chronic Ankle Instability

Exclusion Criteria:

Neurologic disease Vestibular disease
Comparison: Constant-rate Infusion Plus Demanding Dosing VS Variable-rate Feedback Infusion Plus Demanding Dosing

In the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently.

In the case of the existing iv-pca, the analgesic drug was injected into the patient at a constant rate (ex. 1 ml / hr) and additional pain was controlled through the bolus dose (1 ml).

As a result, the analgesic effect was insufficient, or the effect was excessive, causing side effects (nausea, vomiting, sedation, dizziness). Especially In spinal surgery, the degree of pain sharply decreases from day 1 to day 2. Classic iv-pca with constant infusion rate can not reflect this result. But in the case of the newlys developed PCA, the infusion rate is increased according to the patient's need for bolus button, so that the pain can be controlled more efficiently. If the bolus button is not pressed for a certain period of time, it is expected that the injection rate will be reduced and the side effect caused by the analgesic agent will be decreased.

Eligibility Criteria:
Inclusion Criteria:

* Spine fusion surgery at Chung-Ang University Hospital with IV- PCA under general anesthesia

Exclusion Criteria:

* Unrecorded type of anesthetic agent
* Denial to the study
* Brain disorder
* Cardiopulmonary disease
* Psychiatric disorders
Trajectories for Active and Healthy Aging

The objective of the present study is to identify which psychological and motivational factors can help foster Virtual Reality (VR)-based interventions. Specifically, the main question is:

- Does the combination of VR-based interventions and motivational messages grounded in Self-Determination Theory (SDT) impact older adults' motivation for physical activity and their physiological indicators related to exercise? Older adults will participate to a 4 week intervention where they have ti engage in a physical activity program under different conditions: with and without VR, with and with out motivational messages.


Eligibility Criteria:
Inclusion Criteria:

* over 65 years old
* to be fluent in Italian
* to have an informant familiar with their daily functioning
* needed to be available for the full duration of the study
* to be free from a history of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder), nervous system infections or disorders (e.g., epilepsy, brain tumor, large-vessel stroke, major head trauma), or current metabolic or systemic conditions (e.g., B12 deficiency, renal failure, cancer)

Exclusion Criteria:

* severe sensory or motor impairments that would hinder task performance (e.g., blindness, total hearing loss, severe upper extremity deformities or paralysis)
* susceptibility to motion sickness (as confirmed by the Motion Sickness Susceptibility Questionnaire)
* intellectual disability (as assessed by the MMSE).
Infrared-LED During Physical Training for Rehabilitation, Physical Performance and Body Aesthetics

The investigators hypothesis is that the infrared-LED illumination during treadmill training can enhance physical performance in postmenopausal women. The basis for such a hypothesis is based on the fact that the light therapy during the intense metabolic stage caused by exercise may be more efficient.

Phototherapy improves cellular activation via absorption of photons by chromophores present in the protein components of the mitochondrial respiratory chain - mainly NADH dehydrogenases and cytochrome C oxidase, which leads to increased electron transport, production of ATP, and tissue regeneration (skin, muscle, bone, and nerves). Moreover, phototherapy stimulates the anti-inflammatory effect with analgesia and vasodilatation. Regarding body aesthetics, phototherapy increases microcirculation, lymphatic drainage, as well as collagen synthesis for the treatment of cellulite. The objective of this study was to develop and evaluate the effects of a new clinical procedure: infrared radiation originated from LEDs associated with treadmill training in postmenopausal women. LED arrays were developed for an irradiation of a large area, such as hip and quadriceps muscles, main actuators during stance and swing phases. These body parts are furthermore areas where there is incidence of osteoporosis, mainly at the femur, localized fat deposits, and cellulite. Infrared radiation (850 nm) was selected because this spectral range shows better skin penetration compared to red interval.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Caucasian
* 50 and 60 years of age
* Healthy

Exclusion Criteria:

* Neurological disease
* Inflammatory disease
* Pulmonary disease
* Oncological disease
* Cardiac disease
* Endocrinopathy
* Musculotendinous or articular injuries
* Hormone replacement therapy or osteoporosis drugs
* Cigarette smoking
Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair

Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.


Eligibility Criteria:
Inclusion Criteria:

* male or female \>= 18 years;
* scheduled for advanced EVAR for abdominal aortic aneurysm.

Exclusion Criteria:

* Pregnancy;
Medtronic HAMMOCK Post Approval Study

This study is being conducted to satisfy the post-CE approval requirement.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who require aortic or mitral valve replacement of their native valve.
2. Subject is geographically stable and willing to return to the implanting site for all follow-up visits.
3. Subject is of legal age to provide informed consent in the country where they enroll in the study.
4. Subject has been adequately informed of risks and requirements of the study and is willing and able to provide informed consent for participation in the clinical study.

Exclusion Criteria:

1. Subject requires concomitant replacement of the aortic and mitral valves.
2. Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve.
3. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.


Eligibility Criteria:
Inclusion Criteria:

* 10 years of age or older
* Documented diagnosis of HAE (Type I or II)
* Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
* Willing and able to give informed consent

Exclusion Criteria:

* Patients with a serious intercurrent illness or serious active infection
* Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
* Receipt of an investigational drug or device, within 30 days prior to study treatment
* Pregnancy or breastfeeding
* Diagnosis of acquired angioedema (AAE)
* Patients who had not completed their Day-7 follow-up procedures for a previously treated attack
Association Between Smoking, Brain Activity, Genes, and ADHD

The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD).

The study investigated the underlying mechanisms of smoking in young adults by examining the associations between smoking, brain activity, dopamine genes, and attention deficit hyperactivity disorder (ADHD). Four groups of young adults were recruited: (1) smokers with ADHD; (2) nonsmokers with ADHD; (3) normative control smokers; and (4) normative control nonsmokers. Smoking was assessed via questionnaires and salivary cotinine levels. Brain activity was examined via functional Magnetic Resonance Imaging (fMRI). Each nonsmoker underwent an fMRI scan during an experimental task consisting of mathematical problems. Smokers underwent two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence. The association between the DRD4-7 repeat allele and smoking was explored.

Eligibility Criteria:
Inclusion Criteria:

1. Smokers with ADHD

   * Cigarette smoking for the last year
   * ADHD diagnosis
2. Nonsmokers with ADHD

   * No history of regularly smoking cigarettes
   * ADHD diagnosis
3. Normative control smokers

   * Cigarette smoking for the last year
   * No history and diagnosis of ADHD
4. Normative control nonsmokers

   * No history of regularly smoking cigarettes
   * No history and diagnosis of ADHD

Exclusion Criteria:

* Children under the age of 18
* Adults above the age of 45
* Pregnancy or planning to become pregnant
* Any major medical illness
* Any mental disorders that require medication (except stimulant medication)
* Any contraindications to fMRI scanning
* Not speaking English
Impact of Interprofessional Training and Co-ordination on Early Identification and Proactive Approach to End-of-life Situations in the Context of Primary Care

More than 300,000 people die each year in France from a disease that may require palliative care. Nevertheless, only a small proportion of these patients are able to access this care, in particular because of a too late identification.

While several factors may hinder access to specialized palliative care resources, one of the major barriers to the initiation of palliative care, and particularly to the implementation of quality end-of-life care, Remains the failure to recognize that patients with advanced chronic illness are actually approaching the end of their lives.

However, it is now clearly established that early integration of palliative care in the care of people living with a serious, incurable and progressive disease:

* has an impact on the quality (and sometimes the expectation) of life of these people,
* avoids aggressive treatments and unplanned hospitalizations,
* is associated with lower health costs than other end-of-life patients. Primary health care providers have a major role to play in facilitating access to palliative care, but their practice has been hampered in our country by the fragmented and poorly coordinated nature of primary care and Negligible in terms of training. However, they remain the first contact of the patients with the system of care, and are also structuring for the continuation of the patient's journey within the health system.

The first hypothesis is that the work of genuine interprofessional primary care teams in multi-professional health centers (MSPs), coupled with adequate training in the use of simple tools, can contribute to the early identification of patients approaching End of life, to meet their palliative care needs.

However, various European programs (Gold Standards Framework in the UK, NECPAL in Catalonia, RADPAC in the Netherlands) have shown that identification alone is not enough to increase access to specialized palliative care. The second hypothesis is that it must be articulated for this with a training of the professionals to carry out conversations of anticipated planning of the care with their patients.


Eligibility Criteria:
Inclusion Criteria:

* Being a multi-professional health care home (MSP)
* At least one specialized palliative care resource available in the MSP territory (USP, EMSP, palliative care network)

Exclusion Criteria:

* Health centers, group medical practices, clinics
* Less than 3 general practitioners (GPs) and / or absence of nurses (FDI) within the MSP
Effect of Physical Activity on Metabolic Syndrome in Pregnancy & Fetal Outcome

The purpose of this study is to examine the effect of exercise during pregnancy upon maternal metabolism, including weight gain, fat distribution, and levels of glucose and cholesterol. We will also conduct a pilot study to examine the feasibility of studying the health of infants born to women in this study.

Obesity and overweight have become important public health problems in the United States, and measures are urgently needed to address these issues. For many women, pregnancy is a time of excessive weight gain and decreases in physical fitness, both of which may be followed by postpartum weight retention. Women who develop hypertension or diabetes mellitus during pregnancy are at higher risk for development of these disorders in the future. Because of the implications of pregnancy-related weight gain and the metabolic changes during pregnancy for future maternal health, interventions to maintain or improve fitness during pregnancy may have important downstream health effects. In addition, maternal metabolic parameters and the intra-uterine environment have important implications for neonatal outcomes and subsequent child health. This study will provide data about the effects of an intervention to increase vigorous physical activity during pregnancy on short-term maternal and fetal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women 18-45 years old receiving prenatal care at MAMC

Exclusion Criteria:

* Women do not have a gallbladder
* Who do not speak English
* Are over 14 weeks pregnant at study entry
* Do not plan to deliver at MAMC
* Have medical contraindications
* Unwilling to participate in exercise intervention program
* Are under 18 years of age
* Currently engaged in a regular vigorous exercise program
Ranolazine for the Treatment of Chest Pain in HCM Patients

The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Left Ventricle wall thickness \>/= 15mm in the absence of other condition causing hypertrophy
* Baseline Angina/Shortness of Breath Frequency of \> 2 episodes per week
* Willing to provide informed consent

Exclusion Criteria:

* Severe stenotic valvular disease
* Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion
* Significant (\>60% stenosis) coronary artery disease
* Acute coronary syndrome within 30 days
* Severe heart failure defined as LV systolic dysfunction with Ejection Fraction \<40% or NYHA class 4 symptoms
* Severe renal impairment (glomerular filtration rate, \<30 mL/min/1.73 m2)
* Moderate-severe hepatic impairment (Child-Pugh classes B and C)
* Hospitalization for cardiac reason within 3 months of enrollment
* Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies
* Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors
* Active myocarditis, pericarditis, or restrictive cardiomyopathy
* Non-cardiac terminal illness with expected survival less than 6 months
* Women who are of childbearing potential
* Inability to perform or adhere to study protocol
The Role of Butirprost® in Combination With Antibiotics in Chronic Bacterial Prostatitis (CBP) Treatment

Bacterial prostatitis (BP) is a common prostatic infection characterized by pain and urinary symptoms, often with negative bacterial cultures from prostatic secretions. It affects young and older men bimodally and significantly impacts quality of life (QoL). Treatment typically involves antibiotics, but a multimodal approach with additional nutraceuticals may enhance outcomes. This work aims to assess the efficacy of Butirprost® in association with fluoroquinolones in patients with Chronic Bacterial Prostatitis (CBP).


Eligibility Criteria:
Inclusion Criteria:

* patient aged between 18 and 50 years
* symptoms consistent with CBP
* positive Mears-Stamey test

Exclusion Criteria:

* patients younger than 18 years
* history of neurological disease, urinary stones or cancer
* allergy to fluoroquinolones or any components of Butirprost®
* post-void residual \> 50 mL
* Use of alpha-blockers or 5-alpha-reductase inhibitors (5-ARI)
* previous prostatic surgery, antibiotic treatment within four weeks prior to the study
* refusal to provide informed consent and incomplete follow-up data
* Patients testing positive for certain pathogens like Chlamydia trachomatis (Ct), Ureaplasma urealyticum, Neisseria gon-orrhoeae, herpes simplex virus types 1 and 2 (HSV-1/2), and human papillomavirus (HPV)
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty

The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.

Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.

Eligibility Criteria:
Inclusion Criteria:

1. Skull defects without the possibility to be covered with the missing own bone
2. Size of the defect ≥ 16 cm2
3. Age ≥ 18
4. Written informed consent of the patient

Exclusion Criteria:

1. Active tumor
2. ASA 4 classification
3. Allergic disposition to ceramic or titanium
4. Concomitant participation in other clinical trials
5. Pregnant or nursing women
6. Expected low compliance
7. HIV positive
8. Active drug abuses
Effects of Phototherapy by Low-level Light-emitting Diode Therapy (LEDT) on Clinical, Biochemical, Biomechanical, Histologic and Genetic Responses of Muscle Performance of Young Males Submitted to Physical Strength Training

Muscle performance is largely influenced by modulations in gene expressions of muscle tissue. In this context, light-emitting diode therapy (LEDT) has been used to improve muscle performance in experimental models and human researches. Thereby, the investigators examined modulations in gene expression of muscle tissue as well as biochemical, biomechanic and histologic adaptations influenced by exercise associated to LEDT.

This study assessed muscle performance in isokinetic dynamometry and led press device, gene expression by RT-PCR, lactate, creatine kinase and morphology of muscle tissue by immunohistochemical analysis

Eligibility Criteria:
Inclusion Criteria:

* healthy males aged between 18 and 28 years with a body mass index (BMI) equal to or less than 26 kg/m2,
* moderated pattern of physical activity

Exclusion Criteria:

* previous injury to the femoral quadriceps or hamstring muscles (within 6 months prior to study),
* osseous or articular disorder in the lower limbs,
* cardiovascular system disorders,
* systemic disease, and
* taking prescription medicines or using dietary supplements such as muscle mass builders.
A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)

Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)


Eligibility Criteria:
Inclusion Criteria:

* Clinical and Laboratory evidence of blood stream \&/or systemic candida infections

Exclusion Criteria:

* Possible candida contamination
* Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections
* Acute or moderately severe liver disease
* Abnormal liver function tests
* Abnormal blood clotting for patients on blood thinners