Kornimate/medical-research-clean huggingface dataset:
peek prostheses in the all-on-4 concept using zygomatic implants for full-arch rehabilitation.

Conditions: Prosthesis Survival

Summary: the goal of this study is to evaluate the outcome of a poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the all-on-4 hybrid concept (standard and zygomatic implants) after one year of follow-up. the main question it aims to answer is: - what is the survival outcome of the full-arch implant-supported poly-ether-ether-ketone - acrylic resin prosthesis? the participants already rehabilitated with dental implants will receive a poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (peek) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the all-on-4 concept it is necessary to further extend the evaluation to the full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. to test this, the study design to be used will be a single-centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. the sample of this study consists in 10 patients consecutively treated. the cohort will be evaluated after 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the oral health impact profile ohip-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

Eligibility criteria:
inclusion criteria: * subjects who, in the opinion of the investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups. * subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained. exclusion criteria: * female subjects who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes. * subjects with any condition that would compromise their participation and follow-up in this clinical study. * subjects who are currently enrolled in a clinical study.

Keywords: prosthesis, dental implants, zygomatic implants, peek
effect of macrolide antibiotics on airway inflammation in people with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: chronic obstructive pulmonary disease (copd) is a chronic lung disease. azithromycin, an antibiotic, may be beneficial at reducing the symptoms and severity of the disease. this study will analyze previously collected study data to evaluate the anti-inflammatory properties of azithromycin and determine how azithromycin affects the frequency and severity of copd exacerbations.

copd is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. the most common cause is cigarette smoking, but breathing in other types of lung irritants, including pollution, dust, and chemicals, over a long period of time may also contribute to copd. it is the fourth leading cause of death in the united states. symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. some bacterial infections may worsen copd exacerbations. current studies are examining if the macrolide antibiotic azithromycin may be beneficial at reducing the frequency and/or severity of copd exacerbations. azithromycin also has anti-inflammatory properties that may reduce the severity of copd exacerbations by inhibiting the matrix metalloprotease (mmp)-catalyzed breakdown of collagen and the subsequent generation of proline-glycine-proline (pgp), a substance produced in response to collagen breakdown. an increase in pgp levels may indicate an increase in inflammation, which can worsen copd symptoms. nhlbi's copd network macrolide study includes people with copd who were randomly assigned to receive either azithromycin or placebo for 1 year. for this current study, researchers will examine the macrolide participants' previously collected blood samples, sputum samples, and study data, including information on copd exacerbations and azithromycin effects. the purpose of this study is to examine the anti-inflammatory properties of azithromycin in people with copd.

Eligibility criteria:
inclusion criteria: * participating in the copd network macrolide study * clinical diagnosis of at least moderate copd * cigarette consumption of 10 pack years or more exclusion criteria: * diagnosis of asthma * predicted life expectancy of less than 3 years * history of hypersensitivity to macrolide antibiotics * long-term kidney insufficiency * long-term liver insufficiency * prolonged qt interval * use of medications that may prolong the qt interval

Keywords: chronic obstructive pulmonary disease copd exacerbation macrolide
a national registry on chinese patients with cystic fibrosis

Conditions: Pulmonary Function

Summary: cystic fibrosis (cf) is a rare autosomal recessive disease involving multiple organs, especially the lungs and digestive organs. it is most commonly seen in caucasians. only a few chinese cf patients have been described in literature, taking into account the large population of china. the main objectives of this study are to accurately evaluate the prevalence of cf, the status of disease, the diagnosis and treatment, the quality of care, and the health related outcomes in china.


Eligibility criteria:
inclusion criteria: fulfilled who clinical diagnostic criteria for cf; was in a stable phase with no respiratory infections for nearly 4 weeks; subjects (or their guardians) signed informed consent. exclusion criteria: patients with other bronchiectasis who did not meet the inclusion criteria; those with severe cardiac or renal disease
body composition in infants with klinefelter syndrome and effects of testosterone treatment

Conditions: Klinefelter Syndrome

Summary: this research study in infant males with klinefelter syndrome (47,xxy) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. the investigators know that older boys and men with klinefelter syndrome often have more fat compared to muscle than adults without klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. the investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with klinefelter syndrome.


Eligibility criteria:
inclusion criteria: * male infants with 47,xxy karyotype exclusion criteria: * gestational age at birth \<36 weeks * birth weight \ 95% for gestational age * history of thrombosis in a first degree relative * exposure to androgen therapy outside of the study protocol.

Keywords: body composition klinefelter syndrome xxy sex chromosome variation sex chromsome aneuploidy
evaluating and improving functional driving vision of patients with astigmatism: phase 3

Conditions: Astigmatism

Summary: it is a common clinical practice to leave small amounts of astigmatism uncorrected in contact lens wearers. therefore, some drivers who have astigmatism and wear contact lenses may experience blur while driving. the purpose of this study is to determine if correcting small amounts of astigmatism with contact lenses will improve driving safety.

the purpose of this randomized control trial is to compare visual performance and simulated driving performance of adults with astigmatism when wearing 1\*day acuvue® moist for astigmatism (toric), 1\*day acuvue® moist (spherical control), and 1\*day acuvue® moist (placebo) contact lenses. adult subjects with nearsightedness and astigmatism will wear three types of soft contact lenses (placebo, spherical and toric in randomized order). each subject will read letters on standard eye charts and complete vision and driving tests in a driving simulator. subjects will repeat these tests with each lens type. analyses will include an anova to look for a main effect of lens condition, and separate contrasts to compare toric vs. spherical, toric vs. placebo, and spherical vs. placebo lenses. investigating the lenses under simulated driving conditions, which involve eye movement demands, will lend insight into the potential advantages of toric over spherical contact lenses for driving safety.

Eligibility criteria:
inclusion criteria: * adult licensed driver * ages 18-39 years * corrected vision of 20/40 or better in each eye * astigmatism between 0.75 and 1.75 diopters in each eye * nearsightedness between 0 and -9 diopters in each eye * no active eye infection * no defective peripheral vision * no bifocal correction * routinely wears toric contact lenses (more than 4 times per week) * routinely drives a car (more than 4 times per week) * no history of motion, sea, or big screen (e.g. imax) sickness, and no persistent simulation adaptation syndrome exclusion criteria: * corrected vision worse than 20/40 in either eye * no astigmatism in either eye * active eye infection * defective peripheral vision * wears bifocals * wears contact lenses less than 4 times per week * drives infrequently (less than 4 times per week)

Keywords: astigmatism, contact lens, driving
n-acetylcysteine treatment of alcohol use disorder in veterans with tbi

Conditions: Traumatic Brain Injury (TBI); Hazardous and Harmful Alcohol Use

Summary: the goal of the project is to improve the care of veterans with mild traumatic brain injury (mtbi) and unhealthy alcohol use.

this is a pilot controlled clinical trial that aims to assess the efficacy of n-acetylcysteine (nac) to reduce alcohol use and improve brain injury symptoms in veterans with mtbi who consume alcohol at hazardous or harmful levels.

Eligibility criteria:
inclusion criteria: 1. male and female veterans 2. ages 18-65 (inclusive) 3. a history of mtbi as defined by american congress of rehabilitation medicine (acrm), in the chronic, stable phase of recovery (\>6 months from injury). 4. current (past month \[30 days\]) hazardous or harmful alcohol use: hazardous use is drinking that meets niaaa criteria: current (past 30 day) weekly drinking, consisting of an average of 15 standard drinks/week for men or 8 standard drinks/week for women. harmful use is drinking behavior that meets dsm-5 criteria mild aud. 5. participants must express a desire to reduce or stop alcohol use. 6. female subjects that must have a negative urine pregnancy test and must be either postmenopausal one year or practicing an effective birth control method. exclusion criteria: 1. unstable psychotic or bipolar disorders, dementia, or other psychiatric disorders judged to be unstable in the clinical judgment of the pi or study physician. 2. clinically significant unstable medical conditions, in the clinical judgment of the pi or study physician. 3. female patients who are pregnant or nursing. 4. concurrent participation in another alcohol treatment study, or in any research study involving medications. 5. requiring acute medical detoxification from alcohol based on a score of 12 or more on the clinical institute withdrawal assessment of alcohol scale (ciwa-ad). 6. nac use in the past week prior to study entry. 7. use of aud treatment medications (disulfiram, naltrexone, or acamprosate) within the past week. 8. participants who are legally mandated to participate in an alcohol treatment program. 9. participants who have had a suicide attempt in the past 3 months or suicidal ideation, with intent, in the 30 days prior to enrollment. 10. participants who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the nac package insert. 11. participants with known hypersensitivity to acetylcysteine

Keywords: tbi hazardous and harmful alcohol use veterans co-occurring disorders pharmacotherapy
alternative measurements of cough pressure and effects of epidural anaesthesia on cough pressure

Conditions: Respiratory Physiology

Summary: pressure generated by cough is an expression of expiratory muscle strength. cough pressure (pcough) is usually measured with gastric and/or esophageal catheters, but these are often either inconvenient or uncomfortable for the patient. the aim of this study was to evaluate whether central venous, vesical or rectal catheters could be useful to measure cough pressures as alternative sites to standard esophageal and gastric balloons.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 75 years and scheduled for colon cancer surgery were recruited. * informed consent signed. exclusion criteria: rectal surgery, advanced cancer, abdominal wall disorders, respiratory or neuromuscular illness, body mass index \> 30, chronic pain, pregnancy and inability to cough adequately.
hydromorphone and c-section

Conditions: Postoperative Pain

Summary: this study will investigate the dose of hydromorphone which will relieve the pain of women following a cesarean section when delivered directly in the area around the spinal cord (i.e., intrathecal injection). the primary objective is to determine the dose of intrathecal hydromorphone that results in a pain score of less than 3 out of 10 12 hours after intrathecal injection in 50% of women. secondary objectives include determining the average amount of time patients obtain pain relief after injection. other secondary objectives include determining the frequency and severity of side-effects associated with intrathecal administration of hydromorphone, including: bradycardia, hypotension, respiratory depression, apnea, pruritus, rash, nausea, vomiting, and drowsiness. thirty women admitted to labor and delivery for planned cesarean section desiring will be consented for the study. the starting dose of intrathecal hydromorphone will be 6 mcg. the up-and-down sequential allocation method of statistical analysis will be used, meaning that each subsequent dose will be dependent upon the result obtained from the prior dose - ergo, if the initial subject has pain relief, the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone. after the intrathecal injection is given, patients will undergo their cesarean section. the patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire. the patient's medical record will be reviewed to determine when she first requested supplemental pain medication. a pain score of less than three will be a positive result. a pain score of three or greater will be a negative result. blood pressure, heart rate, arterial oxygen saturation, 5 and 10 minute apgar scores, and any side effects will also be assessed.


Eligibility criteria:
inclusion criteria: * healthy women undergoing cesarean section exclusion criteria: * any comorbidities other than obesity, hypertension, fetal anomalies
denheart - self-reported health and quality of life at hospital discharge from a heart centre in denmark

Conditions: All Conditions Treated at the Heart Centres

Summary: the objective of this study is to describe: 1) differences in perceived health at hospital discharge between diagnostic groups and in-hospital predicting factors. 2) perceived health at hospital discharge as a predictor of morbidity and mortality after 1 and 3 years. 3) the association between perceived health, sick leave and health care utilization. the five heart centres in denmark diagnose and treat about 50.000 patients with different diagnoses every year and offer both invasive and non-invasive treatment. perceived health status is measured by self-reported health, quality of life, anxiety and depression and symptoms. knowledge about perceived health status can help to guide inpatient practise and outpatient follow-up. furthermore, it can be used to evaluate differences between diagnostic groups, regional differences and predicting factors for perceived health status at hospital discharge and long term morbidity and mortality. also economic analysis of healthcare utilisation and work ability status are possible. five danish heart centres (rigshospitalet, gentofte hospital, odense university hospital, aarhus university hospital and aalborg university hospital) are all including patients from april 2013 to april 2014. all patients discharged or transferred from one of the heart centres are potential participants in the study. patients are unselected and consecutively included at hospital discharge. included patients will be asked to complete and return a questionnaire before they leave the hospital. the following questionnaires will be used to measure the perceived health status of the patients at hospital discharge: sf-12, hospital anxiety and depression scale, eq-5d, brief illness perception questionnaire, heartqol and edmonton symptom assessment scale. furthermore 14 ancillary about health and health behaviour are included in the questionnaire. this amounts to a total of 62 items in the questionnaire. the denheart study data collection, database development and reporting of primary outcomes are funded by the five participating heart centres in denmark. further funding for registry data, analyses and reporting will be applied for in external funds.


Eligibility criteria:
inclusion criteria: * hospitalized at one of the five heart centres * able to fill out the questionnaire exclusion criteria: * \<18 years * no danish cpr number * for ethical reasons unconscious patients are also excluded.
cross-reactive immunity elicited by oral and parenteral typhoid vaccines

Conditions: Healthy

Summary: in a recent controlled study, the investigators explored cross-reactive immune responses against different salmonella spp. in healthy volunteers immunized with either the oral (vivotif® ) or parenteral (typherix®) typhoid vaccines (isrctn68125331). in the present study immune responses will be studied in a group receiving both of these vaccines and in the previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization).

many salmonella spp causing gastroenteritis share o antigen serotypes with salmonella enteritidis subsp. enterica serovar typhi (s.typhi) and could therefore be in 'reach' of the protective efficacy of the oral live typhoid fever vaccine vivotif®. some of these salmonellae are common causes of diarrhoea in travellers (0-30% of travellers diarrhea depending on the area). in a recent controlled study, the investigators showed that a cross-reactive immune response is elicited against different salmonella spp. in healthy volunteers immunized with either the oral (vivotif® ) or parenteral (typherix®) typhoid vaccines (isrctn68125331). in the present study immune responses will be studied in a group receiving both of these vaccines and in previously immunized volunteers after booster immunization (same groups receive same vaccines 2-4 years after primary immunization; groups: vivotif / typherix / vivotif + typherix). the results are compared to those obtained after primary immunization.

Eligibility criteria:
inclusion criteria: 1. male or female subjects aged ≥18 to ≤65 years 2. general good health as established by medical history and physical examination 3. written informed consent 4. females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. abstinence is acceptable. 5. available for all visits scheduled in this study. exclusion criteria: 1. primary groups: vaccination against typhoid fever within 5 years before dosing. 2. history of clinical typhoid fever, clinical paratyphoid a or b fever. 3. immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study 4. current intake of antibiotics or end of antibiotic therapy \<8 days before first imp administration 5. chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational vaccine; oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 6. acute or chronic clinically significant gastrointestinal disease

Keywords: vivotif typherix salmonella typhi non-typhoid salmonella salmonella paratyphi enzyme-linked immunospot assay plasmablast
implementation of a consensus-based discharge protocol for preterm infants with lung disease

Conditions: Bronchopulmonary Dysplasia

Summary: the researchers have worked to create consensus recommendations among national efforts to help with the transition and coordination of care for preterm infants with lung disease around discharge from the neonatal intensive care unit to home. this study looks to evaluate implementation of the recommendations at boston children's hospital and referring nicu's (beth israel deaconess medical center and brigham and women's hospital). specifically, the research team will be looking at follow-up rates, healthcare utilization, and parental satisfaction/feedback with implementation of these guidelines.

premature infants with bronchopulmonary dysplasia (bpd) have complex care needs around discharge. bpd affects up to 40% of former preterm infants born at \<28 weeks gestation, with about 10,000 new cases of bpd in the united states every year. healthcare utilization in this population in the first two years of life is high, with increased hospitalizations, visits, and medication usage. coordinated follow-up programs may help improve outcomes and reduce rates of hospitalization in this population. however, guidelines do not exist to identify which infants discharging from the nicu should be targeted for specialty follow-up for their respiratory disease, the time frame and format that this should occur, and which evaluations should be performed routinely around discharge. this will be an implementation study, measuring outcomes 3 months prior and 3 months after enactment of a discharge bundle for preterm infants with bpd at local nicus (brigham and women's hospital, beth israel deaconess medical center) who will be followed by boston children's hospital.

Eligibility criteria:
inclusion criteria: * preterm infants born \<32 weeks with at least mild bpd, defined as 28 days of respiratory support after birth. * efforts will be made to include a mix of infants with mild, moderate, and severe bpd, including infants discharged on oxygen. exclusion criteria: * discharge to a location other than home. * infants with other congenital disease (cardiac, genetic, neurological) thought to contribute significantly to their respiratory disease.

Keywords: bronchopulmonary dysplasia nicu discharge