cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear

The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an IRB-approved Informed Consent Form;
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
* Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
* Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
* History of refractive surgery or plan to have refractive surgery during the study;
* Ocular or intraocular surgery within the previous 12 months or planned during the study;
* Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
* Any previous or current wear of MYDAY;
* Habitually wearing monovision or multifocal lenses during the last 3 months;
* Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
* Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
* Other protocol-defined exclusion criteria may apply.
The MR-Linac Technical Feasibility Protocol

Radiation therapy is predominantly based on a Computed Tomography (CT) scan obtained during the treatment planning phase. During the course of radiotherapy, however, both the tumor and organs at risk (OAR) are variable in position, shape and size between fractions, and during beam delivery within one treatment fraction. Around the clinical target volume (CTV) a safety margin (Planning Target Volume, PTV) is created to account for these geometric uncertainties to ensure that the tumor receives the prescribed dose.

Direct integration of imaging at the linear accelerator enables daily monitoring of patient positioning, tumor position, and alterations in patient anatomy. Image guided radiotherapy (IGRT) enables the detection and immediate correction of such deviations and increases the precision of delivery.

Adaptive radiotherapy has become an important strategy for serially modifying dose distributions in a manner that can substantially reduce OAR dose and subsequent toxicity, while maintaining adequate target coverage. Current adaptive protocols rely upon a standard CT-based workflow and (cone-beam) CT-based image guidance.

Magnetic Resonance Imaging (MRI) has superior soft-tissue contrast over CT and seems a very promising modality to integrate in the radiation treatment process, facilitating better visualization of the tumor and OAR during treatment.

The proposed protocol aims to determine feasibility of multiple new techniques and software for MR-guided adaptive radiation therapy. For each proposed technique feasibility has to be determined individually. A secondary aim is to prospectively collect data from cohorts of patients treated at the MRL and report on acute toxicity.

By including multiple parallel cohorts, the protocol will accelerate the technical development of MR-guided adaptive radiotherapy and the evidence-based introduction of the MRL into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patient, age ≥ 18 years, treated with radiation therapy on the MRL.
* WHO performance 0-2.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Contra-indications for an MRI examination.
* Patient is pregnant.
* Claustrophobia.
* Patients \>140 kg and/or a body width \> 60 cm.
* Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation.
Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment

Evaluation of oral midazolam to improve children's behavior and reduces the stress and anxiety during dental treatment

This study was initially planned to investigate three paediatric sedation regimens that also included the following arms:

* oral midazolam + oral ketamine + inhaled sevoflurane
* oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS registry was called PedSed-III and included the aforementioned arms.

However, there was a long delay in fund release from the funding agency (State of Goias Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013, resources were released in November 2013.

We could not wait for funding release because this study was part of the MS dissertation of the principal investigator that was supposed to be concluded in the first semester of 2013. Then we decided to develop a less robust study, including only two arms: oral midazolam versus oral placebo. The other variables of the study did not change. We finished this two-arms study and have the final results for that comparison.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2 to 5 years old, American Society of Anesthesiologists (ASA) I or II, healthy, with no cognitive impairment, presenting with early childhood caries

Exclusion Criteria:

* Children presenting with at least one of the following:
* airway obstruction and/or oral breathing;
* recent use of systemic corticosteroids
* needing less than two dental restorations;
* previous dental sedation.
Acoustic Reflection Method and Work of Breathing

Upper airway obstruction (UAO) is very common in children. Presently, the importance of the UAO is evaluated by the physician during an endoscopic evaluation under general anaesthesia.

The aim of the study is to evaluate two new techniques to quantify the importance of the UAO in children; the acoustic reflection method and the measurement of the work of breathing.

80 children will be included in this monocentric, prospective, open labelled study.

The following evaluations will be performed the day prior to the endoscopic evaluation :1) calculation of a clinical score based on the diurnal and nocturnal respiratory and nutritional tolerance of the UAO, 2) evaluation of the importance and the localisation of the UAO assessed by the acoustic reflection method, 3) measurement of the work of breathing, 4) recording of nocturnal gas exchange during at least 6 hours by s single monitor (Sentec™) which measures pulse oximetry (SaO2) and transcutaneous carbon dioxide (PtcCO2), and evaluation of sleep quality by actigraphy (recording of patient's movements by an Actiwatch™).

All the patients will be re-assessed after 3 months. If no treatment is required, a second clinical evaluation with an acoustic reflection examination will be performed. If a surgical treatment or a noninvasive positive pressure ventilation will be necessary, a second complete evaluation will be performed with an endoscopic examination, the calculation of the clinical score, an acoustic reflection examination, the measurement of the work of breathing, and the recording of the nocturnal gas exchange and sleep quality. This second endoscopic examination will be performed only for medical purpose and not for research only.

The study will last 24 months, comprising 21 months for the inclusion of the patients and 3 months for the analysis of the data.

Eligibility Criteria:
Inclusion Criteria:

* children aged 0 to 15 years old,
* in a stable state,
* presenting an UAO which requires an endoscopic evaluation under general anaesthesia
* signed informed consent
* affiliation to french health benefits

Exclusion Criteria:

* UAO due solely to a hypertrophy of the adenoids and/or the tonsils,
* patients with a tracheostomy or a non operated cleft palate
DAPSONE GEL7.5%Versus Trichloroacetic Acid 20% ON ACNE VULGARIS

Acne vulgaris, a chronic inﬂammatory skin disorder, is one of the most prevalent diseases that eﬀects more than 80% of the population worldwide . A variety of factors such as genetics, hormones, infections, as well as environmental factors have been identiﬁed as the causes of acne development . Acne usually generates as a result of blockage in the pilosebaceous unit (including hair follicle, hair shaft, and sebaceous gland) due to the over-produced sebum by sebaceous gland, which further triggers the excessive proliferation of the bacterium Propionibacterium acnes (P. Acnes).

Chemical peeling can target the pathogenic factors recognized in acne and treat present primary and secondary lesions, it also improves the pigmentary changes seen with acne, and hastes the time taken to repair skin to normal. Trichloroacetic acid (TCA), salicylic acid (SA), and azelaic acid (AA) have proved efficacy in the treatment of acne as a result of their exfoliative and keratolytic properties .

The mechanism of TCA peel in the treatment of acne vulgaris is due to its ability to diminish corneocyte cohesion and keratinocyte plugging, thus helping in comedolytic action. In addition, application of TCA to the skin causes precipitation of proteins and coagulative necrosis of epidermal cells, leading to removal of damaged skin and its replacement by normal tissue.

Dapsone is a "4,40-diamino diphenyl sulfone" compound and an aniline derivative from synthetic sulphones.. Sulphonamides were first used in humans as antimicrobial agents to treat streptococcal infections. Dapsone derived from sulphonamides was first used in the treatment of leprosy in 1940 . Subsequently, it was used in the treatment of bullous dermatoses, especially dermatitis herpetiformis, and in the treatment of non-infectious inflammatory dermatoses, especially neutrophilic dermatoses . Today, Dapsone treatment is among the treatment options for many dermatological diseases.

Dapsone carries both bacteriostatic and anti-inflammatory properties. Its antimicrobial effect stems from its sulfonamide-like ability to inhibit the synthesis of dihydrofolic acid .

Additionally, dapsone has multiple anti-inflammatory properties. It inhibits the production of reactive oxygen species directly and reversibly inhibits the myeloperoxidase enzyme thus decreasing hypochlorous acid formation.

further more topical dapsone has been used with different concentration in treating acne vulgaris: both dapsone gel 7.5% and dapsone gel 5%has been used and found to be safe and effective

Eligibility Criteria:
Inclusion Criteria:

* Both males and females will be included.
* Patients older than 12 years of age.
* Patients with mild and moderate AV.
* Patients had not received any topical or systemic treatment for AV during the previous 2 weeks

Exclusion Criteria:

* Severe acne.
* Patients under treatment with contraceptive pills or any kind of systemic or topic acne medication (isotretinoin, antibiotics, topical products).
* History of hypertrophic/keloid scar formation.
* Pregnancy, breast feeding.
* Recurrent herpes infection.
Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies

The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.

This study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. Participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a Diabetes Navigator. Participants in the intervention group will receive assistance from a Diabetes Navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. The investigators will compare the group receiving Diabetes Navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 5 to 75 years.
* Diagnosis of type 1 diabetes
* Patient of Johns Hopkins Medicine adult or pediatric diabetes clinics
* Not using or not optimally using diabetes technology.
* Planned Diabetes technology intensification by diabetes provider.
* If already on diabetes technology - must be using the specific device for a minimum of 14 days.

Exclusion Criteria:

* Optimally using Diabetes Technology
* Pregnancy or lactation or planned pregnancy in the next 12 months.
* Other types of diabetes (type 2 diabetes, Maturity Onset Diabetes in Youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes)
* Active participant of any other research study that may interfere with diabetes management.
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)

The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).

A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.

Eligibility Criteria:
Inclusion Criteria:

* Proliferative Diabetic Retinopathy
* Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400)
* Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment

Exclusion Criteria:

* Proliferative vitreoretinopathy in study eye
* Clinically significant macular edema (CSME) in the study eye
* Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye
* Uncontrolled glaucoma in either eye
* Other protocol-specified conditions
Interest of Auriculotherapy in the Treatment of Xerostomia

The aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old;
* Complain about xerostomia after cervical irradiation in the context of ENT cancer;
* End of radiotherapy\> 3 months
* Covered by a national healthcare insurance
* Consent form signed.

Non inclusion Criteria:

* Pregnant or breastfeeding women;
* Local counterindication to auriculotherapy;
* With anticoagulant treatment;
* History or existing of hemophilia;
* Valvular prosthesis;
* Ear's pavilion infection;
* Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
* Having started in the 48 hours preceding the first auriculotherapy session, any new management of xerostomia and likely to interfere with the study (specific medication and/or complementary therapeutic management);
* Difficulty to comply with the treatment, questionnaires or study protocol;
* Being deprived of liberty or under guardianship.
The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women

The benefits of weight-loss programs on mood state and cognitive and motor behavior remain unclear and are largely limited to those of calorie restriction (CR) or physical exercise alone. Our aim was to investigate the effect of a combined CR and aerobic exercise program on mood state, cognition-related brain activity, and cognitive and motor behavior in overweight and obese women. Twenty-six overweight or obese women were randomized to either a control group (no intervention) or an experimental group (aerobic exercise + 12.5% energy-intake reduction). Brain-derived neurotrophic factor (BDNF) levels, mood, prefrontal cortex activity, cognitive performance, and learning of a speed-accuracy task were evaluated before and 6 months after the beginning of the program. Confusion and depression increased in the control group (P \< 0.05), whereas tension decreased in the experimental group (P \< 0.05). BDNF level and learning of a speed-accuracy task remained unchanged. Although PFC activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P \< 0.05). An improvement in reaction time during the speed-accuracy task was observed (P \< 0.05). In conclusion, a 6-month combined CR and aerobic exercise intervention improved the psychosocial mental state of overweight and obese women. Although it improved motor planning during the speed-accuracy task, it had little impact on cognition and no effect on brain activity and learning of the speed-accuracy task.


Eligibility Criteria:
Inclusion Criteria:

* gender: female;
* body mass index (BMI) greater than 25 kg/m2;
* exhibiting weight stability (body weight change \<2 kg) for at least 2 months prior to enrollment;
* sedentary lifestyle (regular exercise 1 h/week).

Exclusion Criteria:

* undergoing lactation;
* pregnant or postmenopausal;
* type 2 diabetes;
* cardiovascular disease.
Examination of Circumferential Reduction

The rationale for the selection of Outcome Measures is the compliance with FDA regulations as pertain to medical devices with a moderate level of risk of hazard leading to harm of the patient; firstly, the safety of the device in achieving the desired effect of its intended use when operated in the intended manner; and secondly, the effectiveness of the device in achieving its desired effect of its intended use in accordance with its proposed label and labeling. The rationale for the selection of the primary outcome measure is to satisfy the question of safety and effectiveness of the use of red-light exposure to reduce the circumference of overweight patients with a statistically significant Routine Use population size. Given that the Routine Use Data Analysis is open label and therefore not blinded, there is no need for a control group nor additional cohorts for varying levels of exposure and corresponding safety and/or effectiveness.

In the 1960s, the concept of using light energy for a variety of health maintenance goals and overcoming a number of dermatological conditions began in earnest to receive the attention of NASA researchers as a means of providing desired clinical outcomes to astronauts while in the confines of a space capsule over long periods of time. The research was well funded and supported by the U.S. government, and confirmed the value of light emitting diode (LED) low-level light therapy (LLLT), in particular red light from the 635nm frequency, for producing a variety of healthful effects within the dermis. The ability to achieve a reduction in the dimensions of exposed liposomes using red light is intended to be confirmed by analyzing the clinical data from a minimum of one hundred patients who were exposed to the 635 nm frequency for 30 minutes by use of the subject device (Contour Light) during routine use to confirm that the device is safe and effective for its intended application. Please see the following clinical articles, appended in section 10.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females ages 18 and above
* Generally good health

Exclusion Criteria:

* Pregnancy
* Active cancer within the past year
* Pacemaker
* Diminished ability to void waste (liver and/or kidney function impairment)
* Photosensitivity (generally and/or from medication)
Effects of Inspiratory Muscle Training in Children With Cerebral Palsy

Even if cerebral palsy not directly effect respiratory system, impairment of nervous and muscle systems, because of the brain damage, may cause respiratory functions impairment. In literature, it has been showed that children with cerebral palsy have decreased respiratory muscle strength and associated with trunk control, quality of life and respiratory functions. But, there is no study in literature that aims to increase respiratory muscle strength in these children. Hence, the aim of this study is to investigate effects of inspiratory muscle training on respiratory functions, trunk control, activities of daily living, functional exercise capacity and quality of life in children with cerebral palsy.

A convenience of children with hemiparetic and diplegia CP, 7-14 years, is going to recruited from Gazi University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation. Patients will randomly allocate to either a treatment group or control group. The treatment group will receive inspiratory muscle training at 30-40% of maximal mouth pressure, the control group will receive sham inspiratory muscle training at a fixed work load, 5% of maximal mouth pressure. Groups are going to train for a total of 30 min/d, 7 days/week, for 6 weeks. Before and after treatment, every each of patients pulmonary function test will be evaluated with using spirometry, respiratory muscle strength using with electronic mouth pressure device, trunk control with using trunk control measurement scale, activities of daily living using with Pediatric Evaluation of Disability Inventory (PEDI), functional exercise capacity usin with six minute walk test (6MWT) and quality of life using with Cerebral Palsy Quality of Life Questionnaire (CPQOL).

Eligibility Criteria:
Inclusion Criteria:

* Aged 7-14 years
* Diagnosed to spastic cerebral palsy
* Gross Motor Function Classification System levels I or II.
* Have no earlier interventions in the form of orthopaedic surgery or injection with botulinum toxin type A in the 6 month prior to baseline assessments
* Child are able to demonstrate sufficient co-operation and cognitive understanding participating

Exclusion Criteria:

* Active medical condition impairment (pneumonia etc.)
* Do not accommodate the study
* Do not want to attempt the study