Kornimate/medical-research-clean huggingface dataset:
evaluation of the acceptability and efficacy of 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream

Conditions: Vulvovaginal Atrophy

Summary: evaluation of the acceptability and efficacy of 10 micrograms of estradiol vaginal tablets vs promestriene vaginal cream in postmenopausal women aged 45 years or older, with one or more moderate to severe symptoms of vulvovaginal atrophy (dryness, dyspareunia, soreness or irritation).


Eligibility criteria:
inclusion criteria: * postmenopausal women aged 45 years or older. women will be considered postmenopausal with more than 12 months since last menstrual period * women who have read and signed the informed consent form * women with an intact uterus * one or more vaginal symptoms (dryness, soreness, irritation, dyspareunia) rated as moderate to severe. symptoms are moderate if the patient needs a treatment and feels discomfort. symptoms are severe if the patient needs a treatment, and feels such a degree of discomfort that this could severely impact the subject's daily activities. * blood estradiol concentration of 30 pg/ml or less . exclusion criteria: * women who have not signed the informed consent form * women who had a known or suspected history of breast carcinoma * estrogen dependent neoplasia. women with a known, past or suspected estrogen-dependent malignant tumours such as endometrial or ovarian cancer * positive or suspicious mammogram results * any systemic malignant disease * hormone therapy treatment (sex hormones or vaginal treatments or steroids) in the last three months * women who had abnormal vaginal bleeding or uterine bleeding of unknown cause * vaginal infection requiring treatment * previous or current venous thromboembolism (deep venous thrombosis, pulmonary embolism) untreated endometrial hyperplasia known thrombophilic disorders (e.g. protein c, protein s, or antithrombin deficiency) active or previous arterial thromboembolic disease (e.g. angina, myocardial infarction) acute liver disease, or history of liver disease as long as liver function tests have failed to return to normal known hypersensitivity to the active substances or to any of the excipients porphyria * any serious disease or chronic condition that could interfere with study compliance * history of thrombolytic disorders * use of vaginal contraceptives (diu, vaginal ring...) * participation in another clinical trial in the last three months.

Keywords: vaginal dryness vaginal soreness vaginal irritation dyspareunia
positron emission tomography imaging of brain reorganisation of the central auditory cortex in asymetrical profound deaf patient with a cochlear implantation.

Conditions: Profound Hearing Impairment

Summary: our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss. subjects with asymmetric hearing loss treated with a cochlear implant and a control group of normal hearing subjects will perform two tests for binaural integration (speech recognition in noise and spatial localization) and two tasks of non-linguistic sounds perception.

cochlear implantation is the most efficient method to restore hearing in deaf patients. however, about 2/3 of patients have some residual hearing and these patients usually combine two types of auditory information (electrical and acoustical). it is important to know how the brain is processing during two distinct stimulations and how it is related to the auditory level of performance. patients and controls will undergo a positron emission tomography scan brain imaging session during a simplified voice/non-voice discrimination task. for each tasks and brain imaging sessions, patients will be stimulated either with the non-implanted ear (acoustical stimulation), the cochlear implant (electrical stimulation) and using both modalities in a binaural condition.

Eligibility criteria:
inclusion criteria: * cochlear implantation\>3 months * signature of informed consent * affiliation to social service. exclusion criteria: * associated neurological disorder * protected subjects * epilepsy episodes * psychotropic medication * pregnancy

Keywords: cochlear implantation deafness auditory cortex auditory plasticity tinnitus
a multi-center, evaluation of the onset and duration of action of ac-170 0.24% compared to vehicle

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the onset and duration of action of ac-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (cac) model.


Eligibility criteria:
inclusion criteria: * positive bilateral conjunctival allergen challenge (cac) reaction exclusion criteria: * known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study
cholesterol self-testing in patients post acute coronary syndrome

Conditions: Acute Coronary Syndrome; Prevention; LDL Hyperlipoproteinemia; Therapeutic Adherence

Summary: the pharmacological reduction of ldl-c lowers cardiovascular risk and is therefore a priority in cardiovascular secondary prevention. the achievement of ldl-c target levels in germany, europe, and worldwide is inadequate, despite a wide array of lipid-lowering medications. only a small proportion of post-myocardial infarction patients reach their ldl-c target range within a year. there is a significant need for new strategies to improve ldl-c target achievement and thereby reduce the occurrence of secondary cardiovascular events. the aim of the study is to establish a basis for improving prevention by achieving the target ldl level effectively and quickly in patients with high and very high cardiovascular risk profiles.

in this randomized study, the investigators aim to investigate whether additional self-monitoring of cholesterol values by patients leads to more effective ldl reduction and quicker achievement of the target ldl range versus usual care. this study systematically and prospectively examines the benefits of self-monitoring and control of cholesterol levels for the first time. the patients in the intervention arm will receive a device for self-measurement of cholesterol values and will be trained in its use. these patients will independently measure their cholesterol levels monthly using capillary blood tests and report the results to the study physicians, who will then adjust the therapy accordingly. the control arm is treated according to local standards, which includes control of the cholesterol values twice a year at the visit in out-patient clinic. patients in both study arms will be followed up for at least 12 months.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patients with acute coronary syndrome in the last 6 months and not having reached the ldl target value * signed informed consent exclusion criteria: * persons unable to understand the study * persons unable or unwilling to perform self-measurements * persons unable or unwilling to undergo additional cholesterol-lowering therapy to reach the ldl target * pre-menopausal women without contraception * use of experimental drugs or investigational products within 30 days prior to screening * employees or contractors of the institution conducting the study or family members of the principal investigator, co-investigator, or financial supporter

Keywords: acute coronary syndrome dyslipidemia statin lipid lowering therapy cardiovascular disease
korean practice patterns for screening pca(prostate cancer)

Conditions: Neoplasms, Prostate; Prostate Cancer; Benign Prostatic Hyperplasia

Summary: this is to investigate korean urologist's practice patterns for screening prostate cancer according to psa level.

this is to investigate korean urologist's practice patterns for screening prostate cancer according to psa level.

Eligibility criteria:
inclusion criteria: * male with psa more than 2.5ng/ml from 1 jan 2008 to 31 dec 2008 exclusion criteria: * age less than 40 at psa screening * history of drug use which can affect level of psa within 6months before psa screening * subject who participate any other clinical trial

Keywords: serum prostate specific antigen
metabolic syndrome risk factor in igt: stop-niddm trial

Conditions: Metabolic Syndrome

Summary: the aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (mets) on the incidence of diabetes in people with impaired glucose tolerance (igt) and to assess the effect of acarbose by mets status. double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. mets by atp iii definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (ifg).


Eligibility criteria:
inclusion criteria: * high risk population * age 40 to 70 yrs. * bmi \> 25 and \ 5.5 mmol/l and \< 7.8 mmol/l; igt in oggt exclusion criteria: * known type 2 diabetes * drug intake affecting glucose tolerance * any cardiovascular events within the last 6 months

Keywords: prevention, type 2 diabetes, metabolic syndrome, acarbose treatment
effect of stellate ganglion block on meniere's disease

Conditions: Vertigo; Meniere Disease

Summary: stellate ganglion block (sgb) has been the alternative treatment of meniere's disease for years. however, objective evidence of the effect of sgb was still lack. the investigators conducted a randomized controlled study to examine the immediate effects of sgb in sp/ap of electrocochleography (ecog).

ten patients were randomly assigned to receive stellate ganglion block. these ten patients made up the experimental group. another ten patients in the control group were assigned to receiving one dosage of oral medications: 0.25mg of erispan@ (fludiazine) , 25mg cephadol@ (diphenidol), and 200mg kentons@ (tocopherol nicotinate).

Eligibility criteria:
inclusion criteria: * patients diagnosed with unilateral meniere's disease, according to the criteria of the american academy of otolaryngology-head and neck surgery, aao-hns (1995) exclusion criteria: * patients with coagulopathy, * arrhythmia, * myocardial ischemia, * glaucoma, * pregnant, * chronic otitis media or externa, and * past history of middle or inner ear surgery were excluded.

Keywords: stellate ganglion block. meniere's disease. electrocochleography. vertigo. hearing impairment.
assessment of intellectual abilities for subjects with velopharyngeal incompetence and their impact on speech intelligibility

Conditions: Velopharyngeal Incompetence Due to Cleft Palate

Summary: to assess effect of intelligence on speech production on subjects with velopharyngeal incompetence search if there is any relation between congenital velopharyngeal incompetence and decrease iq of patients

speech production is a complex process by which thoughts are generated into spoken utterances. production involves the selection of appropriate words and the appropriate form of those words from the lexicon and morphology, and the organization of those words through the syntax. then, the phonetic properties of the words are retrieved and the sentence is uttered through the articulations associated with those phonetic properties. the term intelligibility refers to 'speech clarity' or the proportion of a speaker's output that a listener can readily understand. velopharyngeal incompetence (vpi) refers to any situation in which an individual is unable to completely close the nasal airway during speech. the velopharyngeal mechanism is comprised of a complex group of structures that act in unison to control airflow through the nose and mouth by elevation of the soft palate and constriction of both the lateral and posterior pharyngeal walls. any disruption in this mechanism may result in abnormal, poorly intelligible speech. vpi can manifest as hypernasality, nasal emission, decreased vocal intensity, and/or facial grimacing. intellectual ability refers to the skills required to think critically, see connections between disciplines and problem solve in new or changing situations. memory, creative problem solving and vocabulary also contribute to the level of an individual's intellectual ability. orofacial clefts (ofcs) are frequently occurring human birth defects that have a complex, multifactorial etiology. though structural orofacial defects are often surgically corrected during infancy and early childhood, ofc patient cohorts are at high risk for neurobehavioral problems including learning disability, impaired language function, psychosocial adjustment issues, and persistently reduced academic achievement.

Eligibility criteria:
inclusion criteria: * children with cleft lip and palate primary or secondary repaired * velopharyngeal incompetence due to any cause especially short palate and deep pharynx * children above 3 years exclusion criteria: * hearing impairment * neurological disease * adhd

Keywords: iq speech vpi
alfuzosin xl lower urinary tract symptoms efficacy and sexuality study

Conditions: Prostatic Diseases

Summary: to assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (xatral xl) in patients with lower urinary tract symptoms (luts) suggestive of benign prostatic hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * ambulatory patients suffering from lower urinary tract symptoms suggestive of bph. exclusion criteria: * patients requiring bph surgery immediately or within the 12 following months: * acute renal obstruction * chronic renal obstruction * chronic renal failure from bph * bladder stone * recurrent urinary tract infection * other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size) * hematuria from bph * patients whose urinary symptoms are satisfactorily controlled on other bph medication ( alpha-blockers or 5 alpha-reductase) * patients previously not improved by an alpha1-blocker treatment * known hypersensitivity to alfuzosin * history of postural hypotension or syncope * combination with other alpha1-blockers * hepatic enzyme (sgot or/and sgpt ) \> 1.5 upper normal limit * unstable angina pectoris * severe concomitant condition threatening life. * patients who had failed treatment with finasteride (proscar) * patients with neuropathic bladder. * patients with history of previous surgery for bph * patients with high risk for prostate cancer based on the clinical judgement of the investigator the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a decentralized clinical trial to promote evidence-based care for underserved patients with neurofibromatosis 1

Conditions: Neurofibromatosis 1

Summary: the goal of this fully decentralized, randomized controlled trial is to compare the efficacy of two educational interventions for individuals with neurofibromatosis 1 (nf1). the primary objective of the study is to determine which intervention leads to higher rates of evidenced-based health screenings for nf1 patients in primary care settings. adults with nf1 and parents/guardians of children with nf1 from across the u.s. who do not go to a specialized nf clinic and who have an upcoming annual wellness visits (e.g. an annual physical, a well-child visit, etc.) scheduled with a primary care provider (pcp) are eligible to enroll in the study. to see if you might be eligible, fill out a prescreening survey here: https://redcap.link/mynfguide

background: the majority of individuals with neurofibromatosis 1 (nf1) in the united states lack access to specialized nf1 clinics and consequently don't receive care aligned with national recommendations. to address this gap in care, researchers are evaluating two interventions to determine which one helps people get recommended nf1-related health screenings at their annual wellness visit with a primary care provider. methods: participants (adult patients or parents) who enroll in the study will complete baseline survey assessments online before their pcp visit and then be randomized to one of two groups. both groups will be given letters, one for themselves and one for their clinician, that describe nf1 care recommendations. after attending their annual wellness visit, all participants will be asked to complete an online follow-up survey. a small subsample of participants will also be asked to do a virtual qualitative interview. no visits to massachusetts general hospital are required for this study.

Eligibility criteria:
adult inclusion criteria: * currently lives in the united states (including puerto rico and other united states territories) * has a clinical diagnosis of neurofibromatosis 1 * does not attend an nf clinic within the children's tumor foundation nf clinic network * has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent * speaks english or spanish parent/guardian of a child with nf1 inclusion criteria: * currently lives in the united states (including puerto rico and other united states territories) * cares for a child (age \<18 years) with a clinical diagnosis of neurofibromatosis 1 * does not attend an nf clinic within the children's tumor foundation nf clinic network * their child has an in-person, well-person visit with a primary care provider scheduled within 3 months of their consent * speaks english or spanish exclusion criteria: * only one person per household may participate in the study * unwilling or unable to give informed consent

Keywords: neurofibromatosis nf1 guideline healthcare pcp parent pediatric primary care annual care physical exam well-child
restricted reporting for positive urine cultures

Conditions: Bacteriuria; Urinary Tract Infection

Summary: asymptomatic bacteriuria (ab) is a condition in which bacteria are detected in urine culture without urinary symptoms. the inappropriate use of antibiotic treatment for ab selects bacterial flora to express resistance mutations. reducing inappropriate antibiotic use for ab is difficult, since the microbiology laboratory cannot distinguish patients with ab. the investigators study will use a restricted laboratory report requesting the physician to call the laboratory for culture results. the restricted report may reduce the rate of inappropriate treatment of ab.

positive urine cultures during the study period will be randomized to restricted microbiology laboratory reporting or standard microbiology laboratory reporting. physician or patient consent will not be collected. patient records will be assessed by the investigator to determine if patients have ab or urinary tract infection. physician antibiotic treatment decision in both groups will be collected.

Eligibility criteria:
inclusion criteria: * positive urine culture from inpatients at health sciences centre or st. clare's mercy hospital or outpatients during study period. exclusion criteria: * pregnancy, * antibiotic treatment at the time of urine collection, * collection from an indwelling catheter, * admission to long term care facility.
a randomized, double blind study to compare the effects of olmesartan medoxomil versus placebo in patients with established atherosclerosis

Conditions: Atherosclerosis

Summary: the purpose of this study is to determine the efficacy of treatment with olmesartan medoxomil, an angiotensin receptor blocker, compared to placebo on the blood levels of surrogate markers of vascular inflammation for atherosclerotic disease. patients will be randomized to receive either olmesartan medoxomil or placebo for one year.


Eligibility criteria:
inclusion criteria: * males or females age less than or equal to 18 * tee-defined grade iii or iv atherosclerotic disease of the thoracic aorta documented within the previous 90 days, or established atherosclerotic disease of the lower extremities as demonstrated by: * a history of lower extremity peripheral vascular surgery for obstructive atherosclerotic disease, or * a history of lower extremity peripheral arterial angioplasty for obstructive atherosclerotic disease, or * a history of lower extremity amputation secondary to atherosclerotic disease, or * an abi \<0.90 within the previous 90 days, or * a history of claudication in patients with documented coronary artery disease (i.e., history of myocardial infarction, coronary revascularization, or coronary angiography demonstrating at least one obstructive coronary lesion with a 50% or greater stenosis). exclusion criteria: * women of childbearing age who do not agree to utilize protocol approved contraceptive methods. * average pre-dose sbp \< 100 or dbp \< 60. * patients with any serious disorder including cardiovascular (ventricular arrhythmias, valvular disease or implantable defibrillator), renal, pulmonary, hepatic, gastrointestinal, endocrine/metabolic (excluding patients with controlled diabetes mellitus), hematologic/oncologic (including an active malignancy other than basal cell carcinoma or non-metastatic prostate cancer), neurologic, and psychiatric diseases. * patients with a history of mi, ptca, cabg, heart failure, cva or tia within the last 30 days.
new onset of arrhythmia after patent foramen ovale (pfo) closure

Conditions: Cardiovascular Diseases

Summary: embolic stroke of undetermined source (esus) accounts for approximately 25% of all ischemic strokes, with patent foramen ovale (pfo) considered a major mechanism behind esus. when specific anatomic criteria are met, transcatheter pfo occlusion is regarded as the gold standard for secondary stroke prevention. however, previous studies have shown that percutaneous pfo closure may increase the risk of new-onset atrial fibrillation and atrial flutter (af), arrhythmias that elevate the risk of embolic stroke. this raises concerns about performing pfo closure. indeed, the most common clinically significant complication after catheter-based pfo closure is af. available data indicates that af typically occurs in the early period following occluder implantation, with peak incidence around the 14th day post-closure, followed by a decline after the 45th day. although af is considered the most frequent adverse complication after percutaneous pfo occlusion, its incidence remains relatively low, ranging from 3% to 7.4%, depending on the method used for arrhythmia screening, though this remains unclear. in this study, investigators will prospectively monitor patients who have experienced esus and are indicated for pfo closure. they will be screened for the occurrence of af following percutaneous pfo closure using a 3-week ecg holter monitor (from day 7 to day 28 post-closure) and again 1 week (one year post-closure) after the procedure. the study aims to determine the true incidence of new-onset af following catheter-based pfo occlusion and to identify the risk factors associated with its development.


Eligibility criteria:
inclusion criteria: * indication for percutaneous closure of patent foramen ovale due to stroke, confirmed through an interdisciplinary meeting between cardiologists and neurologists, in accordance with current guidelines. * age \> 18 years. * written informed consent. exclusion criteria: * patients with a known history of atrial fibrillation, atrial flutter, or atrial tachycardia.