Kornimate/medical-research-clean huggingface dataset:
clinical study of oral endosseous titanium implants in edentulous subjects

Conditions: Ectodermal Dysplasia; Jaw, Edentulous

Summary: the amendment to clinical protocol 86-d-0015, clinical study of oral endosseous titanium implants in edentulous subjects, and patients with ectodermal dysplasia is to allow the investigators to determine: (1) if placement of endosseous titanium implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) the final position of the implant, the ability to fabricate prosthesis. (3) body image, diet and perceived ease of chewing selected foods. selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with ectodermal dysplasia. at least 16 permanent teeth must be congenitally missing. a total of 30 patients will be included. a consent to participate in this study will be obtained from each patient: 18 \& older - consent signed by patient 13-17 years - consent signed by parent, assent signed by patient 7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study

the amendment to clinical protocol 86-d-0015, clinical study of oral endosseous titanium implants in edentulous subjects, and patients with ectodermal dysplasia is to allow the investigators to determine: (1) if placement of endosseous titanium implants in pre-adolescent patients (age 7 to 10) will influence the growth and development of the craniomandibular complex. (2) the final position of the implant, the ability to fabricate prosthesis. (3) body image, diet and perceived ease of chewing selected foods. selection of patients for participation in the study will be based on the number of congenitally missing teeth associated with ectodermal dysplasia. at least 16 permanent teeth must be congenitally missing. a total of 30 patients will be included. a consent to participate in this study will be obtained from each patient: 18 \& older - consent signed by patient 13-17 years - consent signed by parent, assent signed by patient 7-10 years - consent by parent, assent signed by child if capable of understanding or note on chart describing procedure used to obtain the child's assent to the study

Eligibility criteria:
individuals with a need for replacement maxillary and mandibular complete dentures.

Keywords: ectodermal dysplasia edentulous endosseous implants mandibular atrophy oral titanium
metabolic abnormalities, lifestyle and diet pattern in heart failure

Conditions: Heart Failure; Metabolic Disease

Summary: metabolic abnormalities (e.g., hypertension, diabetes mellitus, dyslipidemia, and obesity) and unhealthy lifestyle behaviors (e.g., smoking and drinking habits, sedentary behavior, sleep disorder and physical inactivity) and unhealthy diet (e.g., high sugar and high fat) are major risk factors for cardiovascular diseases mobility and mortality. the investigators sought to estimate the impact of metabolic abnormalities, lifestyle behavior and diet pattern on prognosis of heart failure. this study planned to consecutively enroll 1,500 participants with heart failure with reduced ejection fraction and heart failure with mid-range ejection fraction fulfilling the inclusion criteria. each heart failure survivors will be followed up for 5 years. information on metabolic diseases, lifestyle and diet pattern were obtained through standardized questionnaire. the major adverse cardiac events will be identified by reviewing pertinent medical records and discharge lists from the hospitals, or official death certificates collected at local death registration centers, or directly contacting participants' family. the cox proportional hazard model will be used to assess the association between metabolic risk factors and lifestyle and diet habits and health outcomes in heart failure patients.


Eligibility criteria:
inclusion criteria: 1. aged 14 years or older; 2. typical symptoms of heart failure according to the framingham criteria; 3. left ventricular ejection fraction (lvef) \<50%, demonstrated by echocardiography or cardiac magnetic resonance, which include either patients with mid-range ef (hfmef) or with reduced ef (hfref) with relevant structural and functional cardiac changes and/or elevated n-terminal pro-brain b-type natriuretic peptide (pro-bnp) (e.g., ≥400 pg/ml). exclusion criteria: 1. age \<14 years or ≥90 years; 2. pregnancy; 3. cancer with a life expectancy of less than one year; 4. participation in other trials; 5. endocarditis, pericardial diseases, or congenital heart diseases; 6. heart failure secondary to non-cardiac diseases (e.g., pulmonary heart disease, infection, infiltration, metabolic derangements, severe anemia, sepsis, and arteriovenous fistula); 7. lack of informed consent; 8. refusal of the drug treatment or intervention recommended by the guidelines.
an efficacy, safety, and tolerability study of vrdn-003 in participants with active thyroid eye disease (ted)

Conditions: Thyroid Eye Disease

Summary: this is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, vrdn-003, in participants with active thyroid eye disease (ted).

this is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with active ted. the key objectives of this study are to determine if vrdn-003 is efficacious, safe and tolerable when administered as a series of subcutaneous/sc injections given every 4 weeks or every 8 weeks compared to placebo in participants with active ted. participants who do not have a meaningful response at week 24 (irrespective of the initial treatment arm) may be eligible to receive additional subcutaneous injections of vrdn-003.

Eligibility criteria:
key inclusion criteria: * must have moderate to severe active ted with documented evidence of ocular symptoms or signs that began within 15 months prior to screening * must have a clinical activity score (cas) of ≥ 3 on the 7-item scale for the study eye * must agree to use highly effective contraception as specified in the protocol * female ted participants must have a negative serum pregnancy test at screening key exclusion criteria: * must not have received prior treatment with another anti-igf-1r therapy * must not have received systemic corticosteroids or steroid eye drops for any condition, including ted, or selenium within 2 weeks prior to first dose * must not have received other immunosuppressive drugs for any condition, including ted, or any other therapy for ted within 12 weeks prior to first dose. * must not have received an investigational agent for any condition, including ted, within 8 weeks or longer duration (depending on the type of investigational agent) prior to first dose * must not have received radioactive iodine (rai) treatment within 8 weeks prior to first dose * must not have had previous orbital irradiation or decompression surgery for ted to the study eye's orbit * must not have a pre-existing ophthalmic condition in the study eye which in the study doctor's opinion, would interfere with interpretation of study results * must not have abnormal hearing test before first dose. must also not have a history of ear conditions considered significant by study doctor * must not have a history of inflammatory bowel disease * female ted participants who must not be pregnant or breastfeeding note: there are additional eligibility criteria for participants who do not have a meaningful response at week 24 (irrespective of initial treatment arm) who may receive additional injections of vrdn-003. these are described in the protocol.

Keywords: ted thyroid eye disease graves thyroid-associated ophthalmopathy dysthyroid ophthalmopathy graves eye disease graves orbitopathy myopathic ophthalmopathy congestive ophthalmopathy edematous ophthalmopathy infiltrative ophthalmopathy
visual performance of pseudophakic patient with different intraocular lenses

Conditions: Cataract; Lens Diseases; Eye Diseases

Summary: this retrospective study comprised patients with cataract, corneal astigmatism, and motivation for spectacle independence. in all cases, a multifocal and monofocal intraocular lens was been implanted in the capsular bag. three months postoperatively, distance, intermediate, and near visual acuities; spherical equivalent; residual refractive astigmatism; defocus curve; and contrast sensitivity was evaluated. a patient-satisfaction and visual phenomena questionnaire was also been administered.

postoperative evaluation was performed at 3 months. the uncorrected and corrected distance visual acuity were assessed using the 100% contrast early treatment diabetic retinopathy study chart, uncorrected intermediate visual acuity at 70 cm, and uncorrected near visual acuity at 40 cm; a binocular defocus curve was constructed using the etdrs chart at 4 m and adding to the patient's manifest refraction +2.50 to -5.00 d sphere in 0.50 increments. the cylinder axis of the intraocular lens (iol) was measured at the slitlamp using the beam protractor after full mydriasis. the mean of the absolute values of degrees the intraocular lens was off axis was determined. contrast sensitivity was measured using the csv-1000 hgt instrument (vectorvision, inc.), which presents a translucent chart divided into 4 cycles with spatial frequencies of 3, 6, 12 and 18 cycles per degree. the background illumination of the translucent chart does not depend on room lighting. all measurements were obtained under mesopic (5 cd/m2) and photopic (85 cd/m2) conditions. the examinations were performed unilaterally at a distance of 2.5 m with best-corrected visual acuity (bcva) and an undilated pupil. all measurements were performed under the same conditions. patient satisfaction and quality of life were assessed by a simple questionnaire. patients were interviewed 3 months postoperative. patients were asked about visual disturbances, visual lifestyle activities, spectacle use, and satisfaction with the procedure.

Eligibility criteria:
inclusion criteria: cataract any race either gender diagnosis of cataracts both eyes pre-existing physical conditions that could skew visual results, such as diabetes, retinal detachment, macular degeneration, or cancer subjects must have \> 1.00 diopter of astigmatism exclusion criteria: central endothelial cell count less than 2000 cells/mm2 glaucoma or intraocular pressure greater than 21 mmhg amblyopia retinal abnormalities diabetes mellitus steroid or immunosuppressive treatment connective tissue diseases

Keywords: cataract vision intraocular lens multifocal monofocal
to evaluate the efficacy and safety of an defocus lens in slowing the progression of myopia

Conditions: Myopia, Progressive

Summary: to confirm the efficacy of dims lenses in controlling myopia progression, we planned a prospective, single-centre, randomised, double-blind, controlled, non-inferiority clinical study.

prior to the trial, subjects signed an informed consent form, screened and qualified subjects were enrolled, and subjects received framed spectacles for correction of myopic refractive error in both eyes, and were fitted with framed spectacles by the investigator according to the standard fitting procedure specified in this protocol. subjects were randomized to trial group a (strong high order aberration group) and trial group b (medium high order aberration group) and control group (hoya miyosmart). the index of effectiveness in this clinical trial was to assess the effectiveness of the test group of lenses in slowing the rate of myopia progression by examining the subject's objective optometric values after ciliary muscle paralysis. the basic examination of this clinical trial included slit lamp examination, eye axis examination, fundus examination, corneal topography, best-corrected visual acuity, binocular visual function, refractive status and best-corrected visual acuity after ciliary muscle paralysis, and intraocular pressure measurements, etc. the spectacle fitting was also recorded, as well as the subjective feeling of the subjects when wearing the lenses. each subject was followed up for 12 months, and the efficacy and safety of the test product for delaying the progression of myopia was evaluated by the investigator at 1 week ± 1 day (telephone follow-up), 1 month ± 15 days (telephone follow-up), 3 months ± 15 days, 6 months ± 15 days, and 12 months ± 30 days after wearing the lenses. during the course of this clinical trial, the lenses were replaced due to loss, breakage, change in refraction or poor vision with the lenses, etc., after evaluation by the investigator, and the changes were recorded.

Eligibility criteria:
inclusion criteria: * the subjects had spherical re of -1.00 to -6.00 d, astigmatism ≤ 1.50 d, anisometropia ≤ 1.50 d * the best corrected visual acuity in the left and right eyes subjective optometry is greater than or equal to 1.0 exclusion criteria: * candidate subjects were excluded from the study if they had strabismus, ocular limitations, or systemic abnormalities affecting vision and ocular motility

Keywords: myopia axial length defocus
use of binaural beats for colonoscopy

Conditions: Pain

Summary: investigators verify the effectiveness of "binaural beats" to reduce pain during colonoscopy .

colonoscopy is a disturbing and painful procedure, so whenever possible it is performed in sedation. although the use of sedative drugs is effective in relieving anxiety and pain such drugs can cause significant side-effects. this study examines the effect of binaural beats stimulation on pain perception during colonscopy. binaural beats is a simple technique, described for the first time since by gerald oster , that include the presentation of two acoustic stimuli with similar frequencies through the two channels of stereo headphones. the interference of their waves which occurs at the level of the central nervous system, produces a composite signal with a frequency resulting from the difference of the two original frequencies. for example if you give an acoustic stimulus of 100 hz to an ear and simultaneously administering another acoustic stimulation of 104 hz to the opposite ,ear the person who listens to these stimuli will perceive a "binaural beat" of 4 hz caused by the difference between the two frequencies. these binaural beats are of interest because they have been thought to cause hemispheric synchronization and influence the eeg frequency like light stimulation . binaural beats have already been used in humans undergoing outpatient surgery in urogynecological and have been shown to help increase patient comfort by reducing the state of anxiety and pain without interfering negatively with postoperative functional recovery . in this study the investigators evaluate the use of binaural beat in outpatients to undergo colonoscopy to reduce pain . a total of 100 patients divided into two groups, 50 treatment and 50 control will be considered. both patient groups will be invited to wear headphones regardless of whether they have been randomized to binaural beats with white noise or white noise only to ensure blindness of participation the headphones will be worn ten minutes before and throughout the procedure. pain will be measured by vas scale and satisfaction by likert scale after the procedure in both groups. blood pressure and heart rate will be monitored before, during, and after the procedure.

Eligibility criteria:
inclusion criteria: * patients scheduled for outpatient colonoscopy * valid consent expression to the study participation * good collaboration in activities provided by the study exclusion criteria: * insufficient degree of collaboration * abnormal hearing * denial of informed consent to participate in the study * previous colon resection surgery

Keywords: binaural beats colonscopy
trauma bpe prolonged exposure therapy for injured individuals admitted to a level i trauma center

Conditions: Traumatic Injury; PTSD; Posttraumatic Stress Disorder

Summary: the purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (ptsd) and a number of other concerns following injury.

this is a prospective randomized controlled trial examining the efficacy of brief prolonged exposure therapy (brief pe) delivered to individuals admitted to a level i trauma center to reduce ptsd symptoms. the overall goal of this project is to test a brief pe (three 60-minute sessions) to reduce psychological distress after injury and to mitigate long-term post-injury distress including ptsd as well as secondary health outcomes (including depression, general anxiety, pain, and quality of life) at 1, 3, and 6 months from baseline. the intervention group (brief pe) will be compared to standard clinical care with treatment as usual (tau).

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 75 years old. * admitted to baylor university medical center at dallas (bumc), baylor scott \& white medical center at temple (bswmc), or froedtert hospital and the medical college of wisconsin (fh/mcw) level 1 trauma center exclusion criteria: * patients in police custody * patients not fluent in english * patients with severe cognitive impairment * patients who are acutely suicidal * patients with active psychosis

Keywords: ptsd traumatic injury posttraumatic stress disorder
investigating the effect of nasal high flow oxygen therapy on regional lung function

Conditions: Chronic Obstructive Pulmonary Disease; Nasal High Flow; Dynamic Volumetric Computed Tomography

Summary: this study aims to assess the effect of nasal high flow oxygen therapy on regional function measured by volumetric computed tomography, in patients with chronic obstructive pulmonary disease.

nasal high flow (nhf) is a non-invasive breathing therapy that is based on the delivery of heated and humidified air at flow rates that exceed peak inspiratory flow, via a large-caliber nasal cannula. it delivers a fraction of inspired oxygen (fio2) from 21% to 100%, with a flow rate up to 60 l·min-1. the therapy is used for a variety of disease conditions including chronic obstructive pulmonary disease (copd). patients with copd frequently manifest flow limitation during resting tidal breathing, through dynamic compression of the airways, which is attributed to a loss of parenchymal tethering of the airways. in patients with severe copd and respiratory failure, improved oxygenation and ventilation may reduce mortality. there are limited clinical data available in adult applications of nhf and on the effectiveness of nhf in patients with stable moderate or severe copd. the mechanisms through which nhf affects the respiratory system are still being investigated. two of the proposed mechanisms of action of nhf therapy are the generation of 3-5 cmh20 positive airway pressure during expiration and washout of the nasopharyngeal dead space. positive airway pressure has been shown to improve oxygenation, ventilation-perfusion matching and respiratory rates, while nasopharyngeal washout reduces the anatomical dead space and thereby improves alveolar ventilation. our working hypothesis is that positive nasopharyngeal pressure generated by nhf particularly during expiration can help maintain small peripheral airways patent, thereby reducing the amount of gas trapping. gas trapping can be quantified based on densitometric analysis of registered computerized tomography images obtained at high and low lung volumes.

Eligibility criteria:
inclusion criteria: * stable, moderate to severe copd, defined as follows: moderate: fev1/fvc \< 0.7 or lower limit of normal, and 30 \< fev1 ≤ 60 percent predicted; severe: fev1/fvc \< 0.7 or lower limit of normal, and fev1 ≤ 30 percent predicted * indication for ct imaging as part of routine workup. * written informed consent signed exclusion criteria: * acute disease condition such as infection, respiratory or cardiac failure * persons referred to in articles l1151-5 to l1151-8 and l1122-1-2 of the french public health code: declared pregnant, parturient or lactating, persons deprived of their liberty by judicial or administrative decision, minors, adults who are legally protected or unable to express consent, etc. * evolving neoplastic disease * patient without social security health care coverage * subject in an exclusion period from another study * any contraindication to nhf such as nasal or upper airway bleeding, secretion, tumor, recent surgery; cervical, nasal or skull fracture.
epidemiology study on neonatal seizure

Conditions: Seizures

Summary: a multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. eeg will used to record the change of brain electric activity and diagnose. other data also will be collected since first seizure until confirmed diagnosis.

this study is designed to describe the incidence of newborn with uncontrolled seizures. seizures can be associated with any high-risk factors during perinatal stage and diagnosed by abnormal electrical activity in the brain. in this study researchers will use electroencephalography (eeg) to determine and monitor newborn with uncontrolled or suspected seizures. eeg works by measuring electrical activity in different areas of the brain. the eeg allows researchers to examine changes in the eeg along with the clinical features of seizures as they occur. in addition to monitoring electrical activity of the brain, researchers will collect demographic, medical history, family, perinatal stage, birth, growth, feeding condition by medical records and questionnaire. these information will allow researchers to learn more about what high-risk factors influence the incidence of neonatal seizure in china.

Eligibility criteria:
inclusion criteria: * age from 0\~28 days; * clinical diagnosed with seizure; * eeg diagnosed with seizure; * parents who consent to their participation in the study; exclusion criteria: * parents who will not comply to the needs and the design process.