cyrilzakka/clinical-trials huggingface dataset:
Clinical Comparison of Restorative Materials

Composite resin materials are the first treatment choice in direct restorations due to their good mechanical properties, excellent esthetic properties, conservative preparation, and successful clinical performance. However, resin-based composite materials in deep cavities are more likely to irritate the pulp tissue due to insufficient polymerization and residual monomer release. Therefore, glass ionomer-based restorative materials can be used more successfully in deep cavities. In addition, the hardening mechanisms of high-viscosity glass ionomer cement are the same as those of conventional glass ionomer cement, and their wear resistance, surface hardness, compression, and bending strength are increased. No clinical studies evaluate the performance of different restorative materials in deep cavities. This clinical study aims to evaluate the clinical performance of high-viscosity glass ionomer, bulk-fill composite, and conventional composite in deep cavities.

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in deep cavities.

The treated patients were called back for controls after one week, six months, and twelve months. Restorations were evaluated clinically according to modified FDI criteria (marginal discoloration, color match, anatomical form, fracture and retention, marginal adaptation, contact point, post-operative sensitivity, secondary caries and periodontal response).

Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 12-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using Wilcoxon Signed rank test (p \< 0.05).

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy patients aged 18 and over
* Patients with good oral hygiene.
* Vital teeth are to be included in the study.
* The presence of an antagonist and a contact tooth for the tooth to be restored.
* Teeth with deep caries lesions or radiographically reaching ¾ of the dentin but with a hard dentin region between the caries and the pulp according to ESE (European Society of Endodontology) criteria.

Exclusion Criteria:

* Patients with a history of bruxism and periodontal disease
* Patients under 18 years of age
* Spontaneous pain in the tooth to be restored
* Intense carious lesion reaching the entire thickness of the dentin according to ESE (European Society of Endodontology) criteria
* Observation of mechanical perforation during caries cleaning
* Patients suspected of pregnancy or pregnant
Ocular Biomarkers for Successful Premium Trifocal Intra-ocular Lenses Implantation

The purpose of this study is to identify ocular biomarkers that can predict the success of phacoemulsification with bilateral AT LISA try 839MP (Carl Zeiss Meditec AG) implantation to achieve satisfactory post-post-operativly spectacle-free vision. Social, biometric and patient reported outcomes will be evaluated.

Pre-operatively all patients were submitted to a comprehensive ophthalmic history and examination including, corneal topography, and aberrometry (Pentacam), biometry (IOLMaster 700, Carl Zeiss Meditec AG, Jena, Germany), specular microscopy (CEM 539, Nidek Co Ltd.), and macular and papillary Optical Coherence Tomography (Cirrus 4000 Hd OCT, Carl Zeiss Meditec AG).

All surgeries were performed by the same surgeon done by standard phacoemulsification with in-the-bag IOL placement. Patients had both eyes operated within a week.

Patients were assessed at day 1, 6, and month 3 after surgery. Six months post-operatively, refraction and slit-lamp examination was performed, and patients asked to complete the patient reported outcome questionnaire that evaluates visual satisfaction, spectacle independence and dysphoptsia like-symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 45 years old with clinical identified bilateral cataracts
* Patients that want to have good vision most of the time without glasses at all distances
* Highest limit of mesopic pupil of 6 mm
* Corneal total higher-order aberration (HOA) ≤ 0.5 μm
* Angle kappa ≤ 0.58 mm
* Absence of cornea ectasia diagnostic criteria.

Exclusion Criteria:

* Patients with moderate or severe dry eye syndrome
* Ocular comorbidities such as corneal, retinal or optic nerve disease
* Previous ocular surgeries
* Patients with unreal post-surgical visual expectations
* Patients with known mild cognitive impairment or dementia.
Risk Factors Associated With Binge Drinking Behaviors Among College Students

The purpose of this study is to specify the psychological, cognitive, neuro-functional and genetic profile associated with binge drinker behaviors among young adults. Results will help identifying more precisely vulnerability factors associated with this pattern of alcohol consumption and guiding prevention efforts.

Binge drinking behavior is characterised by speed of drinking on a particular occasion, frequency of drunkenness during the most recent six month period, and the percentage of times getting drunk when drinking. The prevalence of weekly binge drinking among European Union drinkers in 2009 was reported to be 28% of the student population, and 33% among all young people aged 15-24. The consequences of this behavior are multiple and often dramatic, they include: academic failure, violent acts, rape, domestic or road accidents. The study aims to identify vulnerability factors associated with binge drinking. The protocol explores the psychological (personality), neuropsychological (executive functions, memory), genetic (snp polymorphisms) and neuro-anatomical (fMRI) patterns associated with binge drinking behavior.

Eligibility Criteria:
Inclusion criteria :

* Males or females
* Right-handed
* Aged 18-25 years
* Native French speaker, able to read French and complete study evaluations
* Caucasian
* Able to provide informed written and verbal consent

Exclusion criteria

* A significant general medical illness, including neurological disorders, mental retardation or head trauma
* Depression, bipolar disorder, schizophrenia or schizoaffective disorder diagnostic according to DSM-IV
* Handling of psychotropics substances
* A sensorial impairment (visual and/or hearing)
* Women who are pregnant
* Contraindication to the use of MRI (pacemaker, metal in their body)
A Pivotal Study to Evaluate the Safety and Effectiveness of RMT Medical Technology's SafeFlo® Vena Cava Filter

To determine the safety and effectiveness of the SafeFlo filter for permanent protection against pulmonary emboli. All patients will be selected to receive the filter according to the stated inclusion / exclusion criteria after consultation between the attending physician and interventional radiologist. Patients with a permanent implantation will be followed for up to 6 months. Clinical success will be defined as no occurrences of any of the following events: recurrent pulmonary embolism, IVC occlusion or filter embolization. The proportion of permanent filter patients considered to be a clinical success will be the primary efficacy parameter.


Eligibility Criteria:
Inclusion Criteria:

* Traditional indications for vena cava filter in patients with established DVT or PE, including (40):

  * Patients with proven Pulmonary Embolus (PE) or Deep Vein Thrombosis (DVT) and one or more of the following:

    1. Contraindication to anticoagulation
    2. Complication of anticoagulation
    3. Failure of anticoagulation

       * Recurrent PE despite adequate anticoagulation therapy
       * Inability to achieve adequate anticoagulation
    4. Poor compliance with anticoagulation medications
* Extended indications for vena cava filter placement in patients with established DVT or PE, including the following (31, 40):

  * Large free-floating thrombus in the iliac vein or IVC;
  * Following massive PE in which recurrent emboli may prove fatal;
  * During/after surgical or transcatheter embolectomy;
  * Filter placement in high-risk trauma and orthopedic patients:
* High risk trauma or orthopedic patients who cannot receive anticoagulation because of increased bleeding risk, and have one or more of the following injury patterns (31, 40):

  1. Severe closed head injury (GCS \< 8);
  2. Incomplete spinal cord injury with para or quadriplegia;
  3. Complex pelvic fractures with associated long-bone fractures;
  4. Multiple long bone fractures.
* Patients undergoing long-term immobilization (e.g., ICU or Surgical oncology)

Exclusion Criteria:

* All patients under 18 years of age.
* All patients undergoing emergency procedures.
* All patients with abnormal IVC anatomy or pathology of the IVC such as thrombosis or tumor which prevent safe filter implantation.
* All patients with an IVC diameter which precludes oversizing of the filter platform.
* All patients with active infection / bacteremia.
* All patients with sensitivity to contrast media.
* Uncorrectable severe coagulopathy (e.g., patients with liver or multisystem failure).
Premature Coronary Atherosclerosis in Scleroderma

The purpose of this trial is to study the proportion of scleroderma patients who suffer from asymptomatic coronary atherosclerosis compared to healthy controls.

Coronary calcium scores will be obtained from a group of patients with scleroderma and a group of controls. Comparison of the calcium scores will be made.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years.
2. Fulfillment of the American College of Rheumatology (ACR) criteria for the classification of scleroderma.
Acute Effect of Motor-Cognitive Training

Participants will complete a functional MRI to evaluate brain activation, functional connectivity, and behavioral performance immediately before and after a training program (approximately 30 minutes). The training program will comprise of integrate neuromuscular (agility, dynamic postural stability, shuffling, rapid acceleration/deceleration, plyometrics, lateral shuffle, and core stability) and cognitive (reaction time, processing speed, task switching, decision-making, and working memory) challenges.


Eligibility Criteria:
Inclusion Criteria:

* Physically active

Exclusion Criteria:

* Injury to the muscle or bone (upper extremity, lower extremity, or back) within the past 3 months
* Had musculoskeletal surgery or fracture (required open reduction internal fixation or within the last 12 months)
* Had a concussion or mild head injury within the last year
* Have been diagnosed with any kind of neurological, vestibular, or visual disturbance that impairs mobility
* Currently taking medications that affect the central nervous system
* Pregnant or suspicions of being pregnant
* Have metal fragments, pins, plates, or clips, shrapnel, body piercings that cannot be removed, have surgical implants or orthodontics that cannot be removed
* Have claustrophobia
* Have a history of cognitive impairment
Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose

The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

Topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. These bacteria serve as potential sources for post-operative infection. One commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. Studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the Zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic Vigamox, which does not include this preservative.

Comparison: The effect of Zymar antibiotic eye drops on conjunctival cultures compared to the effect of Vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 25 years of age or older
* Informed consent
* Likely to complete the entire course of the study

Exclusion Criteria:

* Contraindications or known sensitivity to any component of the study medications
* A subject on oral or topical antibiotics
* A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
* Monocular subjects
* Contact lens wearers
* Subjects who regularly take eyedrops other than preservative free artificial tears
* A subject with an eye infection
Gait Training With Executive Functions Tasks in Subjects With Parkinson´s Disease: A Study Protocol

The aim of this study is the development and implementation of a new protocol of a physical therapy training, based on a gait training associated with executive tasks, for treatment of individuals with Parkinson's Disease.

The hypothesis is that this group of patients who will carry out training of this study protocol will show improvement in measured parameters (functionality of gait and cognitive ability), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.

The aim of this study is the development and implementation of a new protocol of physical therapy training, based on a gait training associated with executive tasks for treatment of individuals with Parkinson's Disease.

The proposed motor training consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and after this, 30 minutes of gait training in a dual-task condition, associated with distracting tasks that require handling of the main executive functions.

It will be an open label study, non randomized, where 30 patients with PD in stages 1 to 3 on Hoehn \& Yahr scale will participate in the study, to be held in Brazil Parkinson Association. The training will consist of 10 sessions, two times per week for five weeks.

The executive tasks concomitant with gait training cover the following executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.

The main outcome measures are: (1) Dynamic Gait Index (DGI), (2) Montreal Cognitive Assessment (MoCA), (3) Trail Making Test A and B, (4) Unified Parkinson's Disease Rating Scale (UPDRS) and (5) Falls Efficacy Scale (FES).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Idiopathic PD performed by a neurologist specialist in movement disorders;
* In use of dopaminergic medication;
* Disease severity of 1 to 3 according to Hoehn \& Yahr scale;
* Absence of other neurological disorders or co-morbidities that may affect gait;
* Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
* Vision and hearing adequate or corrected to normal;
* Ability to walk independently;
* Absence of prolonged off state;
* Age 50 to 85 years.

Exclusion Criteria:

* Biomechanical alterations (other pathologies) that could compromise the completion of training;
* Presence of depression, detected by the Geriatric Depression Scale (GDS-15);
* Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during gait training;
* Any changes in drug treatment for PD.
Fibricheck Detection cApabilities for Atrial Fibrillation

Evaluation of accuracy of the FibriCheck Mobile Application on various smartphone devices, compared to the reference diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* At least 22 years old;
* Capable of independently performing FibriCheck recordings (researcher-observed);
* Cardiology patients, hospitalized/in-clinic or consulting the cardiac outpatient clinic, with or without a diagnosis of atrial fibrillation.

Exclusion Criteria:

* Individuals with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can influence the natural heart rhythm;
* Individuals enrolled in another clinical trial;
* Individuals with physical or medical characteristics that prevent them from successfully taking a measurement e.g. extreme callus (i.e., rough or thickened area of skin fingertip), tremor, cognitive impairment, Parkinson's disease;
* Pregnant and/or nursing women.
A Study of the Natural Course of SURF1 Deficiency

The purpose of the study is to prospectively and systematically collect standardized clinical information, to describe important features of the disease course of SURF1 deficiency. These include but are not limited to symptomatology, clinical course, and risk factors for severe disease and complications.

Participant eligibility for the study will be determined during a screening period lasting up to 45 days. In-clinic follow visits will occur over several days every 6 months for 2 years from baseline. Thereafter, annual telephone follow-up contact will be conducted for 2 additional years. Thus, the active study duration for each participant will be up to approximately 2 years and the total duration per participant will be approximately 4 years.

The study will be conducted in the United States and select sites outside the United States based on incidence data.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent/assent provided by the participant based on participant's cognitive ability as determined by Principal Investigator (PI), and/or participant's parent(s) or legally authorized representative(s).
* Participant is \< 18 years of age at time of initial informed consent.
* Displays one or more clinical features consistent with SURF1 deficiency, including but not limited to, hypotonia, motor delays, motor regression, failure to thrive, language delays, and/or language regression.
* Genetic diagnosis of SURF1 pathogenic or likely pathogenic mutation(s), either compound heterozygous or homozygous mutations. If variants are of uncertain significance (VUS), verify documentation of cytochrome c oxidase (COX) activity deficiency.
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.

Exclusion Criteria:

* Any known genetic abnormality (other than SURF1 deficiency), including but not limited to a chromosomal aberration or molecularly known or clinically suspected progressive neurometabolic disorder or dementia, that confounds the clinical phenotype.
* The presence of significant non-SURF1-related central nervous system (CNS) impairment/behavioral disturbances that would confound the scientific rigor or interpretation of results of the study or a known history of perinatal asphyxia, kernicterus, carbon monoxide or methanol intoxication.
* Current participation in a therapeutic study or participation in a therapeutic study within 30 days prior to enrollment in the present study.
* Prior or current treatment with gene or stem cell therapy.
* Any condition that, in the opinion of the Site Investigator, could put the participant at undue risk and/or would ultimately prevent the completion of study procedures.
How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?

Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.

Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.

The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.

Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must be over the age of 18 years of age
* must be fluent in English
* have adequate vision to see a computer screen from 12-18 inches, fine motor skills to press a key on a computer keyboard and hearing to hear directions and questions provided by the researcher
* Individuals must also be able to read words and phrases

Exclusion Criteria:

* Pregnancy
* history of seizures
* neurologic injury including concussion/head injury or stroke or other neurologic conditions
* History of documented learning disabilities and/or ADHD
* Metal implants in the body (excluding dental fillings), psoriasis or eczema affecting the scalp.
Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis

The primary goal of the study is to compare different methods for pulse wave measurement and analysis which are cuffless and contactless. The novel measurement tools will be compared to cuff-based reference methods.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* male or female sex
* signed informed consent.

Exclusion Criteria:

* acute sickness which influences hemodynamic parameters
* arm circumference is below or above the limits for the blood pressure of the reference method (i.e. below 20 or above 40 cm)