cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Toothbrushing Techniques in Plaque Removal and Caries Lesion Control

The aim of the study is to evaluate the effectiveness of cross-toothbrushing technique compared with anteroposterior and biofilm removal and control of caries lesions in first permanent molars.

220 children between 5-7 years with at least one permanent molar erupting will be selected, with a maximum score of ICDAS 3. These children will be randomly allocated into two groups according to the technique adopted. The teeth will be evaluated by ICDAS, laser fluorescence (DIAGNOdent), QLF and subtraction radiography at baseline and after 15 days, 3, 6, 9,12,18,24 months.

Eligibility Criteria:
Inclusion Criteria:

* erupting primary permanent molar

Exclusion Criteria:

* caries ( ICDAS 4,5 and 6),
* enamel defects,
* sealant,
* restoration
Aortic Stenosis in Elderly : Determinant of Progression

Aortic stenosis (AS) is AS is caused by calcium deposits in the aortic valve. Calcification is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. The only treatment is surgery. There are evidences that AS is a regulated process with similarities to atherosclerosis but determinants of AS progression are unknown. The study aims at evaluating these determinants and more specifically the role of lipids, inflammation and platelet aggregation.

Aortic stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS prevalence increases with age and with aging of the population, AS is a major public health problem. AS is due to calcium deposits within the aortic valve. Calcium deposit is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. There is currently no effective medical therapy. Once the stenosis is severe and patients symptomatic, outcome is poor unless surgery (aortic valve replacement) is promptly performed. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, AS progression is highly variable from one individual to another and determinants of AS progression are poorly known. Their identification is crucial if we want to develop new medical strategies. The aims of the present study are to identify the determinants of AS progression and more specifically to evaluate the role of lipids, inflammation and platelet aggregation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years
* AS with mean transmitral gradient \> 10 mm Hg and aortic valve area \< 2 cm2
* No surgical indication

Exclusion Criteria:

* Rheumatic or congenital AS
* Associated valvular disease grade ≥ 2/4
* Indication for surgery (severe AS (aortic valve area \< 1 cm2 or \< 0.6 cm2/m2 of body surface area and symptoms or congestive heart failure or left ventricular ejection fraction \< 50%)
* Renal insufficiency (creatinine clearance \< 30 ml /min)
* Left ventricular outflow tract obstruction
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.

The investigators propose a prospective trial to investigate pre-radiation holmium laser enucleation (HoLEP) in men with bothersome lower urinary tract symptoms (LUTS) and prostate cancer who have elected for radiation therapy as the primary treatment modality for their prostate cancer. The investigators hypothesize that pre-radiation HoLEP may decrease their overall LUTS and may decrease their need for subsequent radiation therapy. The goal with this study is to better understand the overlap between prostate cancer and LUTS, as well as determine if primary surgical treatment for the LUTS with HoLEP can also serve as a possible treatment modality for concurrent prostate cancer. This information may provide further information to inform future standard of care practices for patients with prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence
* Patients must be diagnosed with prostate cancer by pathological tissue analysis
* Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer

Exclusion Criteria:

* Patients who are under 18 years of age are not eligible
* Patients who have a diagnosis of bladder cancer are not eligible.
* Patients with prior treatment for prostate cancer are not eligible.
* Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.
* Patients with known metastatic prostate cancer are ineligible
* Patients who are enrolled in other surgical or international trials at the time of this study are not eligible
Comparing the Acute Effects of Different Exercise Approaches in Patients with Multiple Sclerosis

Multiple Sclerosis (MS) is the second most common neurological disorder in young adults after trauma. Treatments developed today can slow progression and reduce symptoms. Exercise therapy is a useful rehabilitation practice in MS to manage symptoms, restore function, optimize quality of life, ensure well-being and increase participation in daily life activities. In this study, it is planned to investigate the acute effects of conservative and virtual reality (VR)-based aerobic exercise applications and standard exercises that frequently form the rehabilitation programs of individuals with MS in clinics. For this purpose, patients with MS who met the inclusion criteria were given two-week intervals; Conservative aerobic exercise, virtual reality-based aerobic exercise and standard exercise practices will be performed. With the data obtained from this study, it is aimed to investigate the safety of aerobic exercises performed using VR tools that can be used in telerehabilitation applications, which are thought to have a very important place in MS rehabilitation in the future, in terms of acute body temperature increase, cognitive and physical fatigue caused by conservative methods and fNIRS cortical effects of VR-based aerobic exercise applications. It will be possible to prove it with objective methods such as.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as Relapsing Remitting MS by neurologist according to the McDonald Criteria.
* 18-55 years old.
* EDSS score \< 4.5
* Mini mental examination test score ≥ 24
* No MS attack in the last 6 months.
* No visual or vestibular deficits.
* Signed the written consent form.

Exclusion Criteria:

* Having previous full immersive VR experience.
* Having an additional neurological disease.
* Spasticity in any muscle of the upper extremity \> 3, according to MAS.
* Continuing the active physical therapy and rehabilitation program.
Safety and Immunogenicity of an Intranasal RSV Vaccine Expressing SARS-CoV-2 Spike Protein (COVID-19 Vaccine) in Adults

This study evaluates an investigational vaccine that is designed to protect humans against infection with SARS-CoV-2, the novel coronavirus causing COVID-19 disease. The investigational vaccine, MV-014-212, is a live attenuated vaccine against respiratory syncytial virus (RSV) that is expressing the spike (S) protein of SARS-CoV-2. MV-014-212 is administered as drops or a spray in the nose. Specifically, this study analyzes the safety of, and the immune response to, the vaccine when administered to healthy adults between the ages of 18 and 69 years who are seronegative to SARS-CoV-2 and have not received a prior vaccine against COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults ≥18 and \<56 years (Cohort A) and ≥56 years and \<70 years (Cohort B) as determined at the day of signing informed consent
* SARS-CoV-2 RT-PCR (nasal swab) negative at Day 1 pre-dose
* Women of childbearing potential (WOCBP) or male subjects with partners who are WOCBP must agree to practice contraception during their study participation from the signing of informed consent for at least 3 months after the final MV-014-212 administration.
* Written informed consent

Exclusion Criteria:

* Diagnosis of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, pulmonary fibrosis, cystic fibrosis). Resolved childhood asthma is not exclusionary.
* Immunocompromised state due to comorbidities or other conditions as detailed in the study protocol
* Nasal obstruction (including due to anatomic/structural causes, acute or chronic rhinosinusitis, or other causes)
* Receipt of any other SARS-CoV-2, other experimental coronavirus, or experimental RSV vaccine at any time prior to the study
* Healthcare worker, long-term care or nursing home facility resident or employee, member of an emergency response team, or other occupation with high risk of exposure to SARS-CoV-2, and those working outside the home in customer facing occupations (e.g. waiter, cashier or store clerk, public transportation or taxi driver)
* Positive serum pregnancy test during Screening and/or positive urine pregnancy test on Day 1
* Breastfeeding during any period of study participation
* Occupational or household exposure to children \<5 years of age or to immunocompromised persons
* Receipt of or scheduled to receive any other SARS-CoV-2 vaccine prior to Day 1. Once dosed with MV-014-212, subjects should not receive an authorized or approved COVID-19 vaccine until after the Day 57 visit (single-dose subjects) or the Day 92 visit (two-dose subjects)
* Any medical disease or condition that, in the opinion of the PI, precludes study participation. This includes acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Community Acquired Pneumonia (CABP)

This is a study of safety and effectiveness of ceftaroline fosamil in children with Complicated Community-acquired Pneumonia receiving antibiotic therapy in the hospital.

To evaluate safety, effectiveness, pharmacokinetics and tolerance of ceftaroline fosamil in pediatric subjects ages 2 months to \< 18 years who are initially hospitalized with Complicated Community Acquired Bacterial Pneumonia (CABP) at high risk of infection due to methicillin-resistant Staphylococcus aureus (MRSA)

Eligibility Criteria:
Inclusion Criteria:

* Presence of CABP warranting 3 days of initial hospitalization
* Confirmed presence of indicators of complicated CABP

Exclusion Criteria:

* Hypersensitivity or allergic reaction to vancomycin or any β-lactam antimicrobial
* Confirmed or suspected infection with a pathogen known to be resistant to IV study drugs or known infection at baseline with a sole atypical organism
* Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pneumonia
* Non-infectious causes of pulmonary infiltrates
ACT-ED: Accessibility and Feasibility of an Acceptance and Commitment Therapy (ACT)-Based Eating Disorder Prevention Program

The goal of this clinical trial is to investigate the accessibility and feasibility of an online group prevention program developed for women at risk for eating disorders. Also, to conduct a preliminary analysis of treatment efficacy. The main questions it aims to answer are:

Does ACT-ED an acceptable intervention for women at risk for eating disorders? Does intervention result in reduced eating pathology?

Participants will:

Join the online, 4-session ACT-based group program Fill the measures at Pre-test, post-test and follow-up assessment


Eligibility Criteria:
Inclusion Criteria:

* Being a woman aged 18 years or older
* Exhibiting disordered eating behaviors (EDE-Q score ≥ 3.03)
* Experiencing body dissatisfaction (BSQ-34 score ≥ 110)

Exclusion Criteria:

* Current or past diagnosis/treatment for an eating disorder
* Currently receiving psychotherapy
* Currently receiving psychiatric medication (not excluded if there has been no change in treatment in the last 6 months)
* Having chronic psychiatric disorders (e.g. psychosis)
* Having a substance addiction
Efficacy of Tranexamic Acid in Foot and Ankle Surgeries

Epidemiology of foot and ankle surgeries that present to the hospitals in the US are often underestimated. However there has been growing emphasis on identification of these injuries and practice patterns.

Approximately 20% of all foot and ankle fractures are open. Excellent operative field without measurable bleeding remain prerequisite of most orthopedic procedures. Increase blood loss can increase the risk of infection, hematoma formation and wound complications. Presence of blood in synovium not only has direct corrosive effects but also causes increased intra capsular pressure leading to capsular fibrosis culminating as ankyloses.

Tourniquets are employed to optimize surgical field visualization thereby limiting operative duration and improving technical precision. There are several unwanted effects that can arise from use of tourniquet like neurapraxia, vascular injury, post operative swelling etc. Hence there is a growing interest in achieving the same operative goals without the use of tourniquet.

Antifibrinolytics come to one's rescue to achieve a blood sparing effect. Its efficacy in reducing intra operative and post operative blood loss is well documented in cardiac surgery, hip and knee replacement surgery and spinal surgery. Tranexamic acid is a synthetic antifibrinolytic drug that competitively blocks the lysine-binding sites of plasminogen, plasmin and tissue plasminogen activator, thereby delaying fibrinolysis and blood clot degradation. It has been effectively used as IV, oral, topical as well as intra articular dosing. The effects of IV administration lasts 8-17 hours after the initial dose. Orthopedic surgeons have incorporated TXA into multiple elective surgeries as a means of reducing blood loss and transfusion requirements. Reduced bleeding translates to decreased incidence of wound hematoma and other complications.

Effectiveness of Tranexamic acid(TXA) is unknown in foot and ankle surgeries. The aim of this study is to not only evaluate effectiveness of intravenous TXA in reducing post operative blood loss during foot and ankle surgeries but also if it modulates to reduced wound complications and reduced narcotic consumption.

Eligibility Criteria:
Inclusion Criteria:

* ASA (American Society of Anesthesiology) class I-IV
* age 8-75.

Exclusion Criteria:

* ASA class V
* morbid obesity
* patient refusal
* patients with known coagulopathy disorder
* renal insufficiency
* hepatic dysfunction
* serious cardiac disease
* an allergy to TXA or receiving antiplatelet and /or anticoagulant drugs will be excluded.
Anticholinergic Burden - Treatment Optimization

There is increasing evidence that medications with anticholinergic effects may adversely affect cognitive function. Older adults are particularly sensitive to anticholinergic effects because of changes in pharmacokinetics and pharmacodynamics. The cumulative effect of taking one or more medicines with anticholinergic properties is referred to as anticholinergic burden. To estimate the anticholinergic burden, Boustani et al. published the Anticholinergic Cognitive Burden scale (2008). The objective of this study is to measure the association between the use of medications with anticholinergic properties (identified by the ACB scale) and cognitive performance. Anticholinergic use and cognitive performance will be measured at baseline and 6-months follow-up.


Eligibility Criteria:
Inclusion Criteria:

* 50 years and older
Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder

A study to evaluate the efficacy and safety of two atypical antipsychotics vs. placebo in patients with an acute exacerbation of either schizophrenia or schizoaffective disorder

This study was intended to compare the efficacy and safety of risperidone, quetiapine, and placebo in the treatment of patients with acute exacerbations of schizophrenia or schizoaffective disorder. The primary tested hypothesis was a comparison of the efficacy of risperidone and quetiapine (active combined group) to placebo. Other a priori hypotheses tested included comparison of the onset of antipsychotic effect of risperidone to quetiapine and placebo, and to evaluate the efficacy, safety, and cost of risperidone compared with quetiapine in the treatment of subjects with an acute exacerbation of schizophrenia or schizoaffective disorder.

During the first phase of the study (15 days), patients randomized to risperidone were titrated from 1 mg to 4 mg or from 1 mg to 6 mg per day, depending on body weight. Patients randomized to quetiapine were titrated from 50 mg to 400 mg or from 50 mg to 600 mg per day, depending on body weight. Based on investigators determination of patient clinical response, patients in the quetiapine group could be titrated to a maximum of 600 mg or 800 mg per day depending on body weight.

During the second phase of the study (days 15 - 42), patients continue to take the dose of study medication taken in the first phase, but additional psychotropic medication could be added as clinically necessary to control symptoms in patients who remained sufficiently symptomatic (defined as a certain minimum value on a clinical global severity scale.)

Eligibility Criteria:
Current diagnosis of an acute exacerbation of either schizophrenia or schizoaffective disorder
Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia

Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of patients suffer from oncological or dermatological diseases. The present study is based on: evidence that retinoids are involved in neurodevelopment ("the retinoid dysregulation hypothesis"); an assumption that the combined effect of antipsychotic agents and bexarotene will have a beneficial effect on schizophrenia patients; and the positive findings from our pilot open-label clinical trial (ClinicalTrials.gov Identifier: NCT00141947). However, clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.

Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75 mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of 90 schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 6 weeks of treatment. A battery of research instruments will be used for assessment of psychopathology, side effects, general functioning and quality of life. In addition, cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count will be monitored at baseline and during the study

Recruiting was beginning on November 2008

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years, male or female
2. DSM-IV criteria for schizophrenia, or schizoaffective disorder.
3. Ability and willingness to sign informed consent for participation in the study
4. Stable blood parameters including adequate hematologic function, defined as WBC ≥ 4.300/μL, absolute neutrophil count ≥3.000/μL (\> 50%), and platelet count ≥ 180,000/μL; normal coagulation parameters; bilirubin ≤1.5 times the upper limit of normal (ULN); AST/ALT ≤ 2.5 × ULN; and serum creatinine ≤1.5 mg/dL.
5. Only patients who had a normal baseline fasting triglyceride (FTG) level will be entered into the study; triglycerides may be normalized before study entry with use of an antilipemic agent.

Exclusion Criteria:

1. Lipid abnormalities. Fasting triglyceride normal (normalization with an antilipemic allowed prior to study entry).
2. Leucopenia or neutropenia. Hematopoietic: Hemoglobin at least 12.5 g/dL; WBC\< 4300/μL; Absolute neutrophil count \< 3000/μL; Platelet count \< 155,000/μL
3. Evidence of organic brain damage, mental retardation, alcohol or drug abuse
4. Impairment of renal function
5. Hepatic dysfunction
6. A history of pancreatitis
7. Thyroid axis alterations
8. Suicide attempt in past year.
9. Cataracts.
10. Systemic treatment with more than 15,000 IU of vitamin A daily.
11. Patients with a known hypersensitivity to bexarotene or other components of the product.
12. Pregnant women or a woman who intends to become pregnant.
A Real-world Study of Nitric Oxide Generator and Delivery System

The study is aimed to observe the efficacy and safety of Nitric Oxide Generator and Delivery System in Pulmonary Hypertension of Newborn in real clinical settings.


Eligibility Criteria:
Inclusion Criteria:

1. Clinically considered to benefit from inhaled nitric oxide (iNO) and decided to use Nitric Oxide Generator and Delivery System by clinicians
2. Admitted to the Department of Neonatology at the hospital, gender unlimited
3. Diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support
4. Documented Oxygenation index (OI) ≥8 prior to the treatment
5. Signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study

Exclusion Criteria:

1. Proven risks of nitric oxide contraindication
2. Undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation
3. Other circumstances that investigators believe unsuitable for enrollment
Prospective, Randomized Controlled Study to Evaluate the Effect of Artificial Intelligence Assisted Optical Diagnosis of Advanced Adenomas

This study is a clinical validation of our developed a computer-aided optical dignosis of advanced adenoma using non-magnified NBI image. This study is a randomized clinical trial comparing endoscopists' optical recognition of advanced adenoma for sending to histological examination with our computer-aided system. The hypothesis of the study is that the developed computer-aided system increases the percent of sending actual advanced adenoma Intelligence Assisted Optical Diagnosis of Advanced Adenomas

Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. However, it should be noted this policy could only be applied in diminutive polys considering high proposition of advanced adenomas in polyps more than 5 mm. In addition, optical diagnosis criteria of advanced adenomas have not been validated for finding advanced adenomas among adenoma polyps. If as many as advanced adenomas as possible could be differentiated from non-advanced adenomas and be further sent for histological examination, this policy could be generalized to small polyps.

Considering this situation, the investigators tried to develop computer-aided optical dignosis of advanced adenoma using non-magnified NBI image with preliminary, satisfied results. In this study, the investigators next validate the investigators' developed computer-aided system for detecting advanced adenomas by comparing endoscopists' optical detection of advanced adenomas with or without the investigators' computer-aided system.

Eligibility Criteria:
Inclusion Criteria:

* Endoscopists with NBI experience

Exclusion Criteria:

* Endoscopists without colonoscopy and NBI experience