cyrilzakka/clinical-trials huggingface dataset:
Different Methods for Reducing Buccal Infiltration Local Anesthesia Injection Pain

Local anesthetic injection is considered one of the most annoying dental procedures. The use of topical anesthesia is considered a routine procedure in the dental clinic especially for children. However, the taste and application procedure of the topical gel may not be pleasant for all children.

The introduction of the Buzzy device is considered a distraction measure in the medical field. Alanazi et al., 2019, studied the effect of using the Buzzy device with cold and vibration compared to the conventional infiltration technique using 30-gauge needle. They concluded that the use of the Buzzy device resulted in better patients' acceptance and significantly lower Wong-Baker scores.

Ballard et al., 2019, mentioned in their systematic review the efficacy of the Buzzy device for pain management during needle-related procedures, they concluded that the use of the device may be promising. Ghaderi et al., 2013, evaluated the effect of cooling the injection site on pain perception before infiltration of local anesthetics. They found that cooling the injection site before infiltration of local anesthetics in the buccal mucosa for 1 min, reduced pain perceived by pediatric patients.

The investigators used the topical anesthesia, Buzzy device (using vibration only and using cold and vibration) or precooling on pain during buccal infiltration local anesthesia injection.

Eligibility Criteria:
Inclusion Criteria:

* Children in the mixed dentition stage,
* Age range 6-12 years old,
* Need extraction to a maxillary molar,
* Cooperative and medically free.

Exclusion Criteria:

* Exclusion will be performed if the parent refused the participation of their children in the research.
Comparison of Hemodialysis With Medium Cut-off Dialyzer (Theranova) and High Flux Dialyzer

The aim of this study is to evaluate the removal of midle molecules and inflammatory cytokines with the Theranova-500 ™ dialyzer (medium cut-off membrane, Baxter®) versus a high flux dialyzer Elisio-21H ™ (High-flux membrane, Nipro®) in chronic hemodialysis.

Evaluation of nutritional parameters, inflamatory parameters and oxidative stress will also be carried out.

Finally, the investigators will compare hepcidin levels and the erythropoietin resistance index between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient suffering from chronic terminal renal failure excluding nephropathy with myelomatous cylinders, hemodialysis for more than 6 months,
* Patient under dialyser Elisio-21H ™ for more than 3 months
* Patient including the protocol scheme and able to comply with it
* Free subject, without guardianship or curatorship or subordination
* Patients benefiting from a Social Security scheme or benefiting from it through a third party
* Non-opposition given by the patient after clear and fair information on the study

Exclusion Criteria:

* Age \<18 years
* Patient with an associated pathology (evolutionary cancer, progressive infectious disease or chronic inflammatory disease) that may excessively influence CRP levels (CRP\> 60 mg / L)
* Patient following another protocol of research or period of exclusion of another protocol
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergencies .
* Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy ).
Immobilization Without Reduction vs. Reduction Under General Anesthesia in Metaphyseal Fractures of the Distal Radius

Distal radius metaphyseal fractures are the most frequent in the pediatric population. The current treatment for angulated or shortened fractures is effective. Still, it exposes children to anesthetic risks supported by the pain generated by the reduction. Due to the excellent remodeling capacity of bone at an early age, it is questionable whether an anatomical reduction is necessary.

The clinical experiment's objective is to compare the functional result of immobilization without reducing angulated or displaced metaphyseal fractures of the distal radius against fractures brought to reduction under general anesthesia. Means difference in function subdomain of the upper limb of the PROMIS® scale is the primary outcome. The secondary results are wrist mobility, radius alignment, wrist articular relationships, and surgical complications.

The participant will be recruited in one center. If participants and their parents accept to participate in this study, treatments will be randomly allocated using the Big Stick Design technique with a maximum tolerated imbalance of 2. The sequence will be generated by a research assistant who is completely independent of the study, does not know the purpose of the study and the interventions. Each of the random numbers will be stored in an opaque envelope sealed externally with the order in which they should be opened.

Patient registration and follow-up information will be stored in REDCap®. Clinical and radiographic outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Children from 5 years to 10 years
* Unilateral metaphyseal distal radius fracture
* Fracture shortening of 0 to 10mm or angulation of 10 ° to 20 ° in the oblique plane. (AO 23-M 2-3 or 23r-M 2-3)
* Admission in the first 14 days after the fracture

Exclusion Criteria:

* Polytrauma: Injury Severity Score (ISS)\> 16
* Associated fracture in the same limb.
* Neuromuscular pathology (e.g., cerebral palsy, spinal muscular atrophy, Duchenne disease)
* Open fractures.
* History of fractures, septic arthritis, or osteomyelitis in the same limb.
* Neurological or vascular injury in the fractured upper limb.
* Known alteration of bone metabolism (e.g., osteogenesis imperfecta, rickets, osteopetrosis, skeletal dysplasias, lysosomal storage diseases).
* Congenital longitudinal deficiency.
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer

This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia

The study is designed to assess the rate of completion of planned oncology therapy in the absence of a hematological event defined as episodes of febrile neutropenia and treatment discontinuation due to neutropenia. A completion rate of 80% is considered of clinical relevance as to benefit breast cancer patients who are at a higher risk of having ethnic neutropenia where as a completion rate of 60% is considered poor and to justify additional safety studies. A two stage design with a total of 35 patients is used to test if the completion rate is at least 80% versus if it is below 60% with 80% power at a significance level of 5%.

An exact confidence interval of the completion rate will be calculated. Investigators estimate there will be no more than a 10% rate of febrile neutropenia. Due to the small sample size, the analysis of secondary endpoints will be descriptive and will not include specific hypothesis testing.

Eligibility Criteria:
Inclusion Criteria:

1. Self-identified Black, African or African American women of ≥ 18 years of age with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease)
2. ER-positive and/or PgR-positive tumor based on local laboratory results
3. HER2-negative breast cancer based on local laboratory results (test to be used as per local practice)
4. Patients must be appropriate candidates for letrozole or fulvestrant therapy
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
6. Adequate bone marrow function:

   * Absolute Neutrophil Count (ANC) ≥ 1,000/mm3 (1.0 x 109/L);
   * Platelets ≥100,000/mm3 (100 x 109/L);
   * Hemoglobin ≥9 g/dL (90 g/L).

Exclusion Criteria:

1. Current use of food or drugs known to be potent inhibitors or inducers of CYP3A4
2. Active uncontrolled or symptomatic brain metastases. Previously treated and clinically stable, as per Investigator's judgment, brain metastases are permitted.
3. Previous CDK4/6 inhibitor

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An 8 Week Study Looking At The Efficacy, Toleration And Safety Of SS-RBX For Stress Urinary Incontinence.

A study designed to assess the efficacy, toleration and safety of SS-RBX for the treatment of stress urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* Clinically significant stress urinary incontinence

Exclusion Criteria:

* History or evidence of any relevant confounding urological or neurological disease
The Role of Acupuncture for the Treatment of Obstructive Sleep Apnea in Patients With Hypertension

Recent evidences from small studies show potential benefit of acupuncture in the treatment of obstructive sleep apnea (OSA). These studies did not evaluate the benefit of the treatment on the cardiovascular system.

Primary end-point:

To investigate the effects of acupuncture in improving OSA severity among hypertensive patients.

Secondary end-point To investigate the effect of acupuncture in improving the quality of life and sleep assessed by the Short Form 36 (SF-36) questionnaire and Pittsburgh Questionaire (PSQI); To investigate the effect of acupuncture in blood pressure and arterial stiffness


Eligibility Criteria:
Inclusion Criteria:

* 5\<apnea-hypopnea index (AHI)\<30 e/h

Exclusion Criteria:

* body mass index \> 35 kg/m2
* Previous OSA treatment
Dietary and Lifestyle Habits During the Pandemic of COVID-19 in Greece

The aim of this study was to examine potential changes in children' and adolescents' dietary and lifestyle (physical activity, sedentary behaviour and sleep) habits during the quarantine that was implemented in Greece due to COVID-19. An online survey in a random sample of families across Greece was conducted. Parents self-reported their children's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.

Since December 2019, the world is facing a new disease (COVID-19), which is caused by the Coronavirus (Sars CoV-2). WHO declared the disease of COVID-19 as a pandemic in February 2020. Since then, many countries around the world have imposed lockdown (quarantine at home), as the main measure to prevent the spreading of the disease. In Greece, the lockdown was officially imposed from March, 23rd, 2020. This unprecedented situation may have caused changes in adults' and children's dietary and lifestyle habits.

Data were collected via an online survey consisting of 70 questions. Study participants were enrolled after signing an informed consent form. The questionnaire self-reported by volunteers (parents of children aged between 2-18 years old). The survey had 3 sections. The first section focused on participants' sociodemographic data (e.g. gender, age, city of residence and socioeconomic level). The second and third sections contained questions about the parents' (section 2) and their children's (section 3) dietary and lifestyle habits before and during quarantine.

The scientific community raises concerns about the health implications that will be caused due to the COVID-19 lockdown. The results of this study are expected to shed light into children and adolescents, as well as their parents', changes in dietary and lifestyle behaviours and feed the development of effective strategies to prevent the adoption of unhealthy lifestyle behaviours and weight gain in the event of a second wave of COVID-19 in the coming months.

Eligibility Criteria:
Inclusion Criteria:

1. Parents of children and adolescents, aged 2-18 years.
2. During the lockdown period due to the COVID-19 pandemic in Greece.
3. Parents signed an informed consent form prior to their participation to the study

Exclusion Criteria:

1. Parents of children \<24 months old.
2. Parents of children \>18 years old.
3. Parents not living in Greece.
4. Parents who did not sign the consent form.
GnRHa for Luteal Phase Support in GnRH Antagonist Protocol Cycles

Evaluation of the effect of adding a single dose of gonadotropin releasing hormone agonist (GnRHa) as a luteal phase support on the outcomes of intracytoplasmic sperm injection (ICSI) following GnRH antagonist protocol

Endometrial preparation for embryo transfer (ET) will be started after oocyte retrieval by giving 800 mg/day natural progesterone vaginal supplement + 4 mg/day estradiol oral supplement. The patients will be randomly divided into 2 groups for luteal phase support: (i) Group A (GnRHa group) in which the luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval, and (ii) Group B (control group) in which the luteal phase support will be continued only by the same regimen started on the day of oocytes retrieval until 2 weeks after ET

Eligibility Criteria:
Inclusion Criteria:

* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.

Exclusion Criteria:

* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities.
* Myoma.
* Previous uterine surgery.
Evaluation of Free Gingival Graft Timing

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft. The primary objective is to assess the influence of the tissue graft timing on the outcomes of the guided bone regeneration. The secondary goal is to compare the complications that may arise following the two procedures before implant placement.

Eligibility Criteria:
Inclusion Criteria:

* • At least 18 years old

  * No uncontrolled medical conditions or medications that will affect their bone healing.
  * Good oral hygiene is defined as a full-mouth plaque score ≤25%11.
  * Must be able to read and understand the informed consent document.
  * Has a need for implants to replace missing tooth/teeth in at least 1 quadrant of the mouth.
  * Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan.
  * The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required.
  * The patient is not pregnant or breastfeeding.

Exclusion Criteria:

* Active infectious diseases.

  * Liver or kidney dysfunction/failure.
  * Uncontrolled diabetes (HbA1c ≥ 8.5).
  * Active cancer treatment - such as active chemotherapy radiation therapy, or radiotherapy performed within ≤12 months from the procedure.
  * Taking medications that will affect their bone healing (for example, bisphosphonates and long-term anti-inflammatory medications).
  * Metabolic bone diseases that affect bone healing such as osteoporosis.
  * Pregnant or lactating women (self-reported).
  * Current tobacco and Marijuana smokers have 10 or more cigarettes per day, and former smokers (\&gt; 10 cigarettes) who quit \&lt; 10 ago (self-reported).
  * Poor oral hygiene.
  * Vertical loss of bone at the edentulous ridge.
  * History of periodontal disease.
  * The patient is pregnant or breastfeeding
Development and Validation of "Ready-to-Use" Inhalable Forms of Hydroxychloroquine for Treatment of COVID-19

In this project, we aimed at developing new "Ready-to-Use" inhalable forms of HCQ that can be used directly through nebulization or using dry powder inhalers (DPIs). These inhaled forms would allow a simple and direct delivery of the drug (HCQ) specifically towards the throat and the lung which are the main sites for the COVID-19 viral infection. Hence, the drug can be available at higher concentrations in the throat and lungs as compared with the currently used treatment protocols, while minimizing the drug systemic concentrations and its presence in other body organs, and thus enhancing the drug efficacy with significantly limiting its side effects. Besides, using inhalable forms can be more convenient to patients suffering from gastrointestinal complications from the disease that can limit the absorption of oral forms. Moreover, the proposed inhalable forms are designed in such a way to hide the drug from the immune system (confer stealth characteristics) using FDA-approved excipients to minimize/avoid any immune response towards the drug as was noted towards it in its oral form that's used in the treatment protocol of COVID-19. In addition, the inhaled formulations will be designed to maintain the overall simplicity and scalability of the preparation which is critical during this urgent pandemic situation. The cost of the final formulation is also taken into consideration since the drug is intended for treatment of thousands or probably millions of patients around the world including countries with limited economic capabilities.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 year
* Laboratory (RT-PCR) positive of SARS-COV-2 (Moderate cases)
* Chest CT with pneumonia.
* SaO2/SPO2 ratio \> 93% or PaO2/FIO2 ratio \> 300 mmHg under the condition in the hospital room.
* Welling to participate and able to give fully informed consent

Exclusion Criteria:

* Severe and critical illness.
* Retinopathy and other retinal diseases.
* Arrhythmias.
* QT ≥ 400 msec
* Receiving cardiac drugs
* Severe liver disease.
* Pregnancy or lactation.
* Previous treatment of COVID-19.
Effect of Vegetation in Kindergartens on the Immune Response of Children

This study evaluates the effect of vegetation cover on certain Interleukin-10 and immunoglobulinE (IgE) among children (3-5 y old). Children will either be in a kindergarten that does not have forest floor and agricultural land in the backyards, or alternatively they will be in a kindergarten that does have forest floor and agricultural land in the backyards.

High vegetation cover is assumed to change immunoglobulinE (IgE) and interleukin-10 concentrations in blood serum. Children living in high-green kindergarten are compared with those kindergarten living utilizing backyards with a low-green cover.

Eligibility Criteria:
Inclusion Criteria:

- children living in study kindergartens

Exclusion Criteria:

* immune system deficiency, e.g. HIV-infection
* a drug decreasing immune system response, e.g. oral corticosteroid
* immune system disorder that affects immune response, e.g. rheumatoid
* colitis ulcerosa, Crohn disease, diabetes
* cancer
* age less than 3 or more than 5
* born outside Finland
* intellectual disability
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures

The development of optical coherence tomography (OCT) and its application for in vivo imaging has opened entirely new opportunities in ophthalmology. The technology allows for both noninvasive visualization of the morphology and measurement of functional parameters within ocular tissues to a depth of a few millimetres even in nontransparent media. Until now the resolution of commercially available OCT systems is, however, much lower than that provided by light microscopy.

Recently, an ultrahigh-resolution OCT system was developed by our group providing resolutions of 1.7 and 17 µm in axial and lateral direction, respectively. This axial resolution is about four times better than that provided by standard OCT systems. It allows to perform in vivo imaging with a resolution close to biopsy of tissue and to visualize structures of the anterior eye segment with a remarkable richness of detail. The prototype was applied for in vivo imaging of the cornea including the precorneal tear film.

The goal of the planned pilot study is to apply this innovative imaging modality for visualization of the ultrastructure of the different parts of the anterior eye segment structures in diseased subjects, as well as in patients who underwent minimally invasive glaucoma surgery (MIGS). The obtained in vivo cross sectional images and three-dimensional data sets are hoped for contributing to the knowledge about the anatomy and physiology of the corresponding tissues. This could allow for a better interpretation of clinical features and findings obtained in slit lamp examination.


Eligibility Criteria:
Inclusion Criteria:

* For patients with meibomian gland dysfunction (MGD):

MGD as evidenced by clinical features and gland expression (MGD Grading Scheme, Appendix I (Opitz, Harthan et al. 2015))

* For cataract patients:

Cataract as evidenced from slit lamp examination, stage range between NII-NIII, CII-CIV, PII-PIII according to The Lens Opacity Classification System II (LOCS II) (Chylack, Leske et al. 1989) (Appendix II)

* For patients after minimally invasive glaucoma surgery (MIGS):

Patients with history of MIGS secondary to glaucoma

* For patients with demodicosis:

Demodicosis as evidenced from slit lamp examination and presence of Demodex confirmed by microscopic examination of the eye lashes (Liu, Sheha et al. 2010)

* For patients with conjunctival pathologies (cyst, naevus, pterygium):

Conjunctival pathologies with a clinical diagnosis of the respective

* For patients with Acanthamoeba keratitis:

Acanthamoeba keratitis as evidenced from slit lamp examination and confirmed by polymerase chain reaction (PCR) analysis of corneal epithelial and tear samples and culture isolation (Lehmann, Green et al. 1998)

* For aniridia patients:

Anirida as evidenced from slit lamp examination

Exclusion Criteria:

* Presence of any abnormalities preventing reliable measurements as judged by the investigator
* Pregnancy, planned pregnancy or lactating