Kornimate/medical-research-clean huggingface dataset:
a comparison of safety and efficacy of cefdinir oral suspension versus azithromycin in pediatric subjects with acute otitis media

Conditions: Acute Otitis Media

Summary: to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (day 1) then 5 mg/kg/day (days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with aom.


Eligibility criteria:
inclusion criteria: * clinical diagnosis, documented by medical history and physical examination, is aom i 1 week. * clinical symptoms include \>=1 of the following: otalgia (earache or pain), this may be expressed as ear pulling or nabbing; ear fullness; decreased hearing, this may be based on reports from parents or legally authorized representatives; discharge from the external auditory canal (following acute perforation of the tympanic membrane). * at least two (2) of the following signs are present in at least one ear: full or bulging or perforated tympanic membrane, which may be erythematous (note - since hyperemia may be present in a febrile or crying child, a red tympanic membrane alone is insufficient for the diagnosis of aom); loss of tympanic membrane landmarks (opacity of the tympanic membrane); abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind the tympanic membrane and edema of the tympanic membrane. have evidence of middle ear fluid demonstrated by acoustic reflect tympanometry (ear check) showing values of 3, 4 or 5. * generally in good health based on medical history, vital signs, physical exam, and historical laboratory results. * subject must be a suitable candidate for oral antibiotic therapy. exclusion criteria: * previous enrollment in this study. * enrollment in any other investigational study using unapproved products or unapproved doses; in the previous four weeks prior to study start. * hypersensitivity reactions to cefdinir, other cephalosporins, azithromycin, other macrolide and azalide antibiotics, and/or sensitivity to multiple allergens. * presence of tympanostorny tubes or otitis externa at evaluation 1. * systemic treatment with any anti-infective agent within 14 days prior to evaluation 1 or during the study. * treatment with a long-acting injectable antimicrobial agent (e.g., penicillin g benzathine) within 4 weeks prior to study drug administration. * concomitant infection that requires additional antimicrobial therapy. * evidence of chronic, suppurative otitis media. * evidence of perforation of the tympanic membrane \> 24 hours. * evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media. * immunocompromised subject (e.g., neutropenic subjects). * presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response. * any expectation that treatment with probenecid will be expected during the study drug administration period. * known significant renal or hepatic impairment.
hemochromatosis--genetic prevalence and penetrance

Conditions: Blood Disease; Hemochromatosis

Summary: to examine the cost effectiveness of hereditary hemochromatosis (hh) screening in primary care.

background: hereditary hemochromatosis (hh) is the most common inherited disorder among caucasians with an estimated frequency as high as 8 per 1000. affected individuals absorb excessive amounts of dietary iron and develop progressive accumulation of tissue iron stores with consequent organ dysfunction including hepatic cirrhosis, diabetes mellitus, congestive heart failure, arthropathy and impotence. early diagnosis and institution of phlebotomy treatments will prevent disease manifestations and normalize life expectancy. in 1996, hfe, the gene for hhc was mapped on the short arm of chromosome 6 (6p21.3). hh is therefore a natural target for the development of a routine screening strategy. design narrative: the investigators have demonstrated the favorable cost-effectiveness ratio of adopting a screening strategy for hh and have screened 16,031 primary care patients using serum transferrin saturation (ts) levels to confirm the prevalence of undiagnosed hh in this setting and to demonstrate the feasibility of screening. the recent description of hfe gene mutations in individuals with hh has made genetic testing for hh possible and may increase the attractiveness of general screening. however, several important questions about genetic prevalence and penetrance remain to be addressed before such a recommendation can be made. the large screened sample provides a unique opportunity to address several of these important issues. first, they will obtain population-based estimates of the prevalence of hfe gene mutations. second, they will determine the sensitivity of serum ts testing for detecting these mutations. third, the comparison of genotype and phenotype will allow them to draw useful inferences about disease penetrance. the results will enable them to propose an optimal screening strategy for hh and to determine the place of genetic testing in the diagnostic algorithm. this strategy may vary depending on age, sex and race. the answers to these questions will enable them to determine with greater confidence the relative effectiveness of a screening strategy for hh and will clarify for primary care practitioners which of their patients should be screened for this disorder. these questions have recently been identified as a priority by the centers for disease control and prevention and by the national heart, lung, and blood institute.

Eligibility criteria:
no eligibility criteria
dose escalation study of vinpocetine in healthy volunteers

Conditions: Fetal Alcohol Spectrum Disorders

Summary: the objective of this study is to determine whether vinpocetine is safe when taken at higher doses.

the planned study seeks to provide preliminary data to assess the benefits and safety for vinpocetine to address cognitive problems in two groups of patients. one group are patients with epilepsy in whom cognitive problems are common, but there is currently no specific treatment available. vinpocetine has been shown to improve memory in animals and also has anticonvulsant activity. the other group are people who suffer cognitive/behavioral problems from fetal exposure to alcohol or anticonvulsant drugs. in animals, vinpocetine has been shown to mitigate these deficits. we propose to extend our prior preliminary studies by conducting a phase i study in healthy volunteers, a phase i study in adolescents with cognitive impairments from fetal alcohol exposure, then phase ii studies in patients with epilepsy and in adolescents/adults with cognitive impairments from fetal alcohol or antiseizure medication (e.g., valproate) exposure. the proposed investigations are guided by prior pk and pd studies in animals and humans. they are designed to provide data on the dosages needed to provide levels comparable to effective animal studies and provide data on the potential efficacy and safety of vinpocetine in improving cognition in order to direct more definitive randomized trials in the future. specific aim: to determine the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop data on pharmacokinetic response curve for vinpocetine effects.

Eligibility criteria:
inclusion criteria: 1. healthy adults 18-40 years old. 2. proficient english. 3. use of appropriate contraception if woman of childbearing potential. exclusion criteria: 1. major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression). 2. those who score \>18 overall on the bdi-ii or \>0 for item #9 (suicidal thoughts) at screening. 3. use of centrally active medications. 4. history of allergy to vinpocetine. 5. iq\<80. 6. bmi≥30. 7. pregnancy or lactation.

Keywords: cognition vinpocetine
effectiveness of catheter reminder and evaluation program

Conditions: All Hospitalized Patients; With and Without Catheter

Summary: the investigators will conduct a cluster randomized controlled trial to evaluate the efficacy of catheter reminder and evaluation program (care) in reducing the duration of catheter use and the number of infection relating to catheter use.


Eligibility criteria:
inclusion criteria: * all hospitalized adults in 6 general medical wards at siriraj hospital * with or without catheter exclusion criteria: * none
study of fluoxetine in patients with depersonalization disorder

Conditions: Depersonalization Disorder

Summary: the purpose of this study is to: 1) determine the effects of fluoxetine in the treatment of depersonalization disorder, 2) assess the durability of treatment response in these patients, 3) assess the improvement in psychiatric disability in these patients, and 4) assess the effects of comorbid axis i disorders (depression, social phobia, panic/anxiety, obsessive-compulsive disorder) and axis ii personality disorders on treatment outcome in these patients.

in this trial, participants will be randomly assigned to receive either fluoxetine or placebo. treatment will consists of two phases (acute treatment and maintenance). in the acute treatment phase, participants will receive fluoxetine or placebo daily for 12 weeks. participants will be followed every 2 weeks. in the maintenance phase, participants showing significant improvement after 12 weeks may continue treatment for an additional 6 months. in this phase, participants are followed every 4 weeks. participants who do not improve during the acute treatment phase may receive open fluoxetine, or another appropriate medication, for 3 months.

Eligibility criteria:
inclusioin criteria: * meets dsm-iv criteria for depersonalization disorder in the last month exclusion criteria: * prior or concurrent bio- or chemotherapy or * use of any of the following within 2 weeks prior to study entry: antipsychotics, anticonvulsants, stimulants, barbiturates, lithium, benzodiazepines, or antidepressants * use of mao inhibitors or investigational drugs within 4 weeks prior to study entry * history of fluoxetine use at a dose of 10 mg or more for at least 6 weeks duration * hematologic, hepatic, renal, cardiovascular, pulmonary, metabolic, endocrine, systemic, or gastrointestinal disease * history of mental disorders * current substance abuse * current eating disorder * current clinically unstable suicidal ideation * unstable medical illness * clinically unstable * clinically important abnormalities in lab tests or physical exams * history of seizure disorders or abnormal electroencephalogram * hypersensitivity or severe side effects to fluoxetine * pregnancy or breast-feeding. women of child-bearing potential must use effective contraception

Keywords: depersonalization disorder neurologic and psychiatric disorders rare disease
clinical trial of clinical efficiency and safety of ergoferon in treatment of influenza

Conditions: Influenza

Summary: the purpose of this study is: * to assess clinical efficiency of ergoferon for treatment of influenza * to assess safety of ergoferon for treatment of influenza * to compare efficiency of ergoferon and tamiflu for treatment of influenza


Eligibility criteria:
inclusion criteria: 1. patients of both sexes aged from 18 to 60 inclusively. 2. patients with body temperature \>37,8°c at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity. 3. diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by quickvue immunological test). 4. the possibility to start therapy within 24 hours after the onset of the first influenza symptoms. 5. signed informed consent form for participation in the study. exclusion criteria: 1. patients aged below 18 years and above 60 years. 2. suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides). 3. vaccination against influenza prior to epidemic season onset. 4. medical history of polyvalent allergy. 5. allergy/ intolerance to any of the components of medications used in the treatment. 6. exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial. 7. chronic renal insufficiency. 8. intake of medicines listed in the section "prohibited concomitant treatment" for 15 days prior to the inclusion in the trial. 9. pregnancy, breast feeding, unwillingness to keeping to contraception method during the study. 10. drug addiction, alcohol usage in the amount over 2 units of alcohol per day. 11. patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines. 12. participation in other clinical trials in the course of 1 month prior to the inclusion in the trial. 13. the patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. the immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted. 14. the patient works for ooo "npf "materia medica holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
pharmacokinetic interaction between maraviroc and fosamprenavir/ritonavir in healthy subjects

Conditions: Healthy

Summary: this is will be an open-label, fixed-sequence, multiple dose crossover study in 2 cohorts of 14 healthy male and/or female subjects, to estimate the effect of maraviroc on the pharmacokinetics of amprenavir and ritonavir and fosamprenavir/ritonavir on the pharmacokinetics of maraviroc.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * total body weight \>45 kg (99 lbs). exclusion criteria: * history of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor) within 6 months of screening. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * known hypersensitivity or history of allergy to sulfonamides.

Keywords: maraviroc fosamprenavir drug interaction pharmacokinetics hiv aids ccr5 protease inhibitor
incidence of short sublingual frenulum in newborns at the hospital nostra senyora de meritxell.

Conditions: Ankyloglossia

Summary: the aim of the study was to analyze the incidence of short sublingual frenulum in newborns of the hospital nostra senyora de meritxell of the principat of andorra.

thus, the objective of this study was to determine the incidence of ag in newborns of the hospital nostra senyora de meritxell of the principat of andorra, as well as the relationship with auxological data, associated malformations or diseases and hereditary component of the newborn. a random sample of 2167 individuals is enough to estimate, with a confidence of 95% and an accuracy of +/- 1 percentage units, a population percentage that is projected to be around 6%. the percentage of replenishment required is projected to be 0%. with this sample, it will be sufficient to estimate the children who have ankyloglossia, the % of relatives who also have it (a population percentage that is projected to be around 25%). confidential and anonymous collection of data from patients' medical records for a period of 2 years and 8 months, and write them down in a database to finally correlate them and see if there is any association with the parameters studied.

Eligibility criteria:
inclusion criteria: - the inclusion criteria are patients born from july 2018 to february 2021 (both inclusive) and of both genders. exclusion criteria: * the exclusion criteria are all those who were born abroad and who after 24 hours go to the hospital of andorra, those urgently transferred to other foreign centers after birth, as well as those who present medical records with lack of information.
painless subconjunctival antibiotic and antifungal injection in corneal ulcer patients

Conditions: Corneal Ulcer

Summary: the propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.


Eligibility criteria:
inclusion criteria: * the corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features. 1. corneal epithelial defect with stromal infiltration 2. reaction in anterior chamber 3. positive for bacteria or fungus * the patients have to receive subconjunctival antibiotic injection twice at least. * the patients must be informed consent. exclusion criteria: * the patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs. * the patients who administered nsaids or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection. * unable to cooperate with the treatment. * pregnant women

Keywords: corneal ulcer painless subconjunctival injection antibiotics antifungal lidocaine
conservative surgery with or without axillary lymphnode removal in treating women with t1n0 breast cancer

Conditions: Female Breast Neoplasms; Carcinoma, Ductal, Breast

Summary: rationale axillary surgery is still fundamental part of breast cancer (bc) management for adjuvant treatment planning. purpose randomized phase iii trial to compare the effectiveness of surgical therapy with or without axillary dissection following conservative treatment in women with stage i breast cancer. to determine the possibility to avoid axillary surgery in patients with early breast cancer, finding an alternative method to define the need of adjuvant treatment without compromising long-term disease control.

objectives: to compare the efficacy of conservative surgery, with or without axillary lymphnode removal (quadrantectomy with axillary dissection (quad) vs. quadrantectomy alone (qu)) followed by adjuvant treatment. to plan no adjuvant therapy vs. adjuvant therapy (ea+cmf+tam regimen) based on a biological panel of the primary tumor in the qu group (defined as good panel (gp) ( er+, and up to one unfavourable features (g3, her2+++, laminin receptor+) or bad panel (bp)(er-, or er+ and more than one unfavourable features), whereas in quad group based on good factor ( n-, er+ and gi-ii disease (gf)) or bad factor ( n+ or giii or er- disease (bf)). to determine the relationship between the biological variables (hormone receptor status, grading, laminin receptor, and c-erbb2) and the clinical outcome of the disease in these patients. outline this is a randomized unicenter study. patients are randomized to 1 o 2 treatment arms. arm 1: patients undergo conservative surgery with axillary lymphnodes removal arm 2: patients undergo conservative surgery without axillary lymphnodes removal post-operative adjuvant strategy was previously described. patients are followed every 4 months for the first two years, every 6 months for the following two years, and then annually thereafter. project accrual 600 patients will be accrued for this study over 4 years eligibility ages eligible for study: 18-65 years genders eligible for study: female

Eligibility criteria:
inclusion criteria: * women with t1n0m0 invasive breast cancer * 18-65 years exclusion criteria: * bilateral breast cancer * no other prior or concurrent malignancy except basal cell carcinoma

Keywords: breast cancer axillary dissection
lifestyle intervention treatment for patients with mild obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild osa.

obstructive sleep apnea (osa) is one of the most common sleep disturbances, and it has been estimated that one out of five adults has at least some degree of sleep related breathing disturbances. obstructive sleep apnea affects mostly the middle-aged work force, and causes a negative impact on public health by increasing both morbidity and mortality. obesity is related to many diseases including diabetes, cardiovascular diseases, and metabolic syndrome,and obesity is also considered as the most important risk factor for osa.considering the prevalence of mild osa, and the beneficial effects of even a slight weight loss on both the severity of osa and the likelihood of developing osa, lifestyle intervention including weight reduction represents a viable option for the treatment of patients with mild osa.however, although included in the clinical guidelines, there is a definite lack of well executed studies on the effect of weight reduction upon osa. accordingly, we are conducting a randomized study on the effects of lifestyle intervention in the most prevalent subgroup of osa patients, overweight patients with mild osa. the study is an on-going prospective, randomized, parallel group trial. the main objective of the study is to determine whether a supervised lifestyle intervention including individualized dietary counseling could be a curative treatment for patients with mild osa.

Eligibility criteria:
inclusion criteria: * age 18-65 years * apnea-hypopnea index 5-15 * bmi 28-40

Keywords: sleep apnea lifestyle intervention cardiovascular