Kornimate/medical-research-clean huggingface dataset:
a study on concentrations of 16448 in blood and the safety of this compound in healthy males with premature ejaculation

Conditions: Premature Ejaculation

Summary: 16448 is being investigated for the treatment of primary premature ejaculation (pe) using a novel mode of action. there are no approved therapies for premature ejaculation, and novel therapies are needed for this syndrome. 16448 has been shown to increase ejaculatory latency in the pca rat model of premature ejaculation. a novel instrument, the sexual assessment monitor (sam), will be used to measure ejaculatory latency time in this study. this device, which measures elt under standard conditions, has been shown to provide a more reliable measure of ejaculatory latency compared to the use of a stopwatch during sexual intercourse


Eligibility criteria:
inclusion criteria: * body weight \>50kg * body mass index (bmi): 19-30 * healthy men with long term (at least 6 months) symptoms of pe * erectile dysfunction - (patients should have ef(erectile function) domain of iief(international index of erectile function questionnaire \>26 or normal) * no history of reduced sexual desire * no history of significant psychiatric illness or currently active significant medical illness * no ssri's(selective serotonin reuptake inhibitors) use within the last 4 months * no history of diabetes, renal or hepatic disease * no significant injuries to the head or spinal cord i.e. history of head injury, spinal cord injuries, and conditions such as multiple sclerosis. exclusion criteria: * previous or current use of any pde-5(phosphodiesterase type 5) inhibitors for the treatment of erectile dysfunction * subject receiving treatment in the last 6 months for depression, psychiatric disorders, mood disorders, schizophrenia, substance abuse or anxiety disorders * subject is taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (or related drugs), mono-amine oxidase inhibitors or ß-blockers * subject has received or is continuing to receive any treatment for pe (e.g. local anaesthetic spray, or intra-cavernosal injection) in the four weeks prior to the study start * subject has a history of other clinically significant organic diseases e.g. uncontrolled hypertension, ischemic heart

Keywords: premature ejaculation (pe) ejaculatory latency time (elt)
edoxaban versus edoxaban with antiplatelet agent in patients with atrial fibrillation and chronic stable coronary artery disease

Conditions: Atrial Fibrillation; Coronary Artery Disease; Stable Angina; Stable Chronic Angina

Summary: this study evaluates the efficacy and safety of edoxaban with the combination of edoxaban and antiplatelet in patients with stable cad (coronary artery stenosis ≥50% on medical treatment or revascularized stable cad \[≥ 12 months for acute coronary syndrome and ≥ 6 months after stable cad\]) and high-risk atrial fibrillation (cha2ds2-vasc score ≥2).


Eligibility criteria:
inclusion criteria 1. a subject was ≥ 18 years of age 2. patients with nonvalvular atrial fibrillation with high embolic risk (cha2ds2-vasc score ≥2) 3. patients with stable coronary artery disease * anatomically confirmed coronary artery disease (with ≥50% stenosis of major epicardial coronary artery documented by cardiac catheterization or coronary computed tomographic angiography) on medical therapy alone. * revascularized coronary artery disease (either percutaneous coronary intervention or coronary bypass surgery) whom the last revascularization should be performed ≥12 months before study enrollment for the acute coronary syndrome and ≥6 months for stable angina pectoris. exclusion criteria 1. patients with thrombocytopenia 2. high risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time) 3. prior history of intracranial haemorrhage 4. mechanical prosthetic valve or moderate to severe mitral stenosis 5. the risk of bleeding increased due to the following reasons; * i. history of gastrointestinal ulcers within 1 month * ii. malignant tumor with high risk of bleeding * iii. brain or spinal cord injury within 1 month * iv. history of intracranial or intracerebral hemorrhage within 12 months * v. esophageal varices * vi. spinal cord vascular abnormalities or intracerebral vascular abnormalities * vii. active bleeding * viii. hemoglobin level \<7.0 g/dl or platelet count ≤ 50,000 / mm3 * ix. history of major surgery within 1 month 6. uncontrolled severe hypertension 7. hemodynamically unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy 8. history of hypersensitivity to edoxaban, aspirin, or clopidogrel 9. genetic problem with galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 10. planned percutaneous coronary intervention or coronary bypass surgery was planned within 1 year after randomization 11. liver cirrhosis or liver dysfunction (ast or alt \> x3 of normal range or coagulation abnormality) 12. estimated crcl by cockcroft-gault equation\<15 ml/min 13. life expectancy less than 12 months 14. the subject was unable to provide written informed consent or participate in long-term follow-up 15. pregnant and/or lactating women 16. patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Keywords: edoxaban antiplatelet anticoagulant
airway collapse in patients with mounier-kuhn syndrome: titration with positive pressure to reduce collapse

Conditions: Mounier-Kuhn Syndrome

Summary: mounier-kuhn syndrome (mks), or congenital tracheobronchiomegaly, is an entity characterized by dilation of the trachea and bronchi, associated with respiratory infections.the main signs and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and wheezing.some of these symptoms are believed to be due to excessive collapse of the intra-thoracic trachea and bronchi, resulting in airways obstruction of more than 50% . the purpose of this study is to identify and reduce tracheal collapse.

mounier-kuhn syndrome (mks), or congenital tracheobronchiomegaly, is an entity characterized by dilation of the trachea and bronchi, associated with respiratory infections. the prevalence among patients with respiratory symptoms is 0.4 to 1.6%. its histological features include the atrophy or absence of longitudinal elastic fibers and smooth muscle cells of the airways, responsible for the structural alterations found, such as tracheobronchiomegaly, the presence of inter cartilaginous diverticula, bulging and dilation of the walls of the trachea and bronchi. the main signs and symptoms are cough, bulging and purulent expectoration, digital clubbing, dyspnoea, and wheezing and wheezing accompanied by recurrent respiratory infection. there may be association with other comorbidities such as gastroesophageal reflux disease, chronic obstructive pulmonary disease, bronchiectasis and obstructive sleep apnea / hypopnea syndrome (osas). some of these symptoms are believed to be due to the tracheobronchial disease present in some patients, defined by excessive collapse of the intrathoracic trachea and bronchi resulting in airways obstruction of more than 50%. the main clinical impact is obstruction to expiratory airflow, with consequent air entrapment, reduction of cough and bronchial hygiene effectiveness, facilitating recurrent respiratory infections. because it is a rare morbidity and little studied, the specific therapy is not consensual, and the main interventions are extrapolated from other pathologies. the use of non invasive mechanical ventilation (nimv) with continuous positive airway pressure (cpap) is reported as an option for treatment, however, there are no randomized studies proving its efficacy. the purpose of this study is to identify and reduce tracheal collapse and bronchi of smk carriers with the use of positive pressure (cpap-niv) and to analyse their repercussion in the small airways.

Eligibility criteria:
inclusion criteria: * has mounier-khun syndrome * accept and signed informed consent form exclusion criteria: * other morbidity avoiding study procedures

Keywords: tracheal bronchial tracheobronchiomegaly collapse obstructive sleep apnea syndrome computer tomography impedance tomography
effectiveness of lower maintenance dose of ticagrelor early after myocardial infarction (electra) pilot study

Conditions: Myocardial Infarction

Summary: the electra pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet inhibition in stable patients who recently underwent acute myocardial infarction and were treated with percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * diagnosis of acute st-segment elevation myocardial infarction or acute non-st-segment elevation myocardial infarction according to the third universal definition of myocardial infarction * index event treatment with percutaneous coronary intervention * male or non-pregnant female, aged 18-80 years old exclusion criteria: * contraindications for ticagrelor * further coronary revascularization planned during the first 45 days after myocardial infarction * indications for chronic treatment with oral anticoagulant or low-molecular-weight heparin * active bleeding * history of intracranial hemorrhage * recent gastrointestinal bleeding (within 30 days) * history of coagulation disorders * history of moderate or severe hepatic impairment * history of major surgery or severe trauma (within 3 months) * active neoplastic disease * patient requiring dialysis * chronic inflammatory disease * current therapy with strong cyp3a inhibitors or strong cyp3a inducers

Keywords: platelet reactivity ticagrelor myocardial infarction pharmacodynamics antiplatelet therapy
treatment effectiveness among psoriasis patients treated with cosentyx (secukinumab)

Conditions: Psoriasis

Summary: this was a retrospective cohort study utilizing data from modernizing medicine data services' (mmds) electronic medical records (emr)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes.

this was a retrospective cohort study utilizing data from modernizing medicine data services' (mmds) electronic medical records (emr)-based dermatology database to evaluate secukinumab patient characteristics, treatment patterns, and outcomes. psoriasis (pso) patients initiating secukinumab were identified and indexed to the first secukinumab use using the most recent data at study initiation (data period: march 1, 2018 to august 31, 2019) and with a subsequent data refresh (data period: march 1, 2017 - july 31, 2020).

Eligibility criteria:
inclusion criteria: * ≥1 orders/administrations for secukinumab within the index window (march 1, 2018 to august 31,2019 for the base analysis; march 1, 2018 to january 31, 2020 for the refresh analysis). the date of the first order or administration was be the index date * patients in the mmds database with a diagnosis of pso on or prior to the 1st secukinumab order/administration * ≥18 years of age as of the index date * to ensure capturing continuous patient activities in the emr dataset, patients must have at least one more visit (any visit regardless of diagnosis) in addition to the index visit within the first 6 months after secukinumab initiation * patients must have at least one visit (any visit regardless of diagnosis) within the 12 months pre-index period exclusion criteria: * evidence of secukinumab use in the 12-month pre-index period * data quality issues (missing age, gender, prescription order information)
efficacy and safety evaluation of jet floss ex after 8-week application

Conditions: Bleeding on Probing; Plaque; Gingival Index

Summary: this was a single center, comparison among treatments, 8-week study of the efficacy and safety of jet floss ex. totally 72 eligible subjects were recruited in this study and randomly divided into 2 groups. during wash out phase (7 days before the study), subjects used distributed manual toothbrush and toothpaste every morning and evening to replace their own products. after that, subjects screened by dentist to ensure met the inclusion criteria. during treatment phase, for group1 (treatment group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used the test product (jet floss ex) twice a day. for group2 (control group), subjects continued to use distributed manual toothbrush and toothpaste every morning and evening, and add used auxiliary product (interdental brush) twice a day. during the study, any other oral care products and non-emergency oral treatment were not allowed. test objective:to evaluate the efficacy and safety of test product by means of intraoral exams of bop, pd, mgi, rmnpi, hard and soft tissues exams and selfassessment.


Eligibility criteria:
inclusion criteria: * chinese men or women aged 18-60 years old; * in general good health at the time of the study; * possess a minimum of 20 scorable teeth; * each quadrant has ≥4 inter tooth gaps that can be inserted by interdental brush； * rmnpi≥0.6; * bop≥50%; * mgi≥1.75; * pd≤5 mm; * there were no diseases that will affect the test results; * willing and able to participate as evidenced by signing of informed consent; * willing to comply with all study protocol requirements. exclusion criteria: * intending to get pregnant, pregnant, lactating or within 6 months of delivery; * those who have known allergies against oral care product or have severe oral disease; * simultaneous participating in another oral study; * have any fixed facial orthodontic appliances or removable partial dentures; * severe presence of tartar or stain which will affect the test; * others whose participation in the study is determined inappropriate by the dentist.

Keywords: gingival index bleeding on probing plaque
subsyndromal delirium in intensive care unit

Conditions: Delirium

Summary: subsyndromal delirium (ssd) is a condition characterized by a less severe cognitive impairment in comparison to delirium. to date there is no published consensus on ssd definitions and has been commonly reported as an intermediate stage between delirium and normal mental states. ssd encompasses some of the delirium symptoms, and has been diagnosed with intensive care delirium screening checklist scale (icdsc) and confusion assessment method-icu (cam-icu). the objective of this study is to identify subsyndromal delirium prevalence, the association between ssd and clinical outcomes and understanding the relationship between ssd and conversion to delirium. the relevance of this study is understanding of subsyndromal delirium in icu, namely the importance of early presentations of acute brain dysfunction in the patients outcome.

subsynd is a prospective, observational, multicenter clinical study, involving 400 patients in intensive care units, to assess subsyndromal delirium. a systematic screening for delirium and subsyndromal delirium (ssd) is done with intensive care delirium screening checklist (icdsc) and confusion assessment method-icu (cam-icu). scales are applied once per day until icu discharge or for up to 14 days of being in icu. the investigators access three different groups of patients: non-delirium, delirium and subsyndromal delirium. it is intended that either icdsc or cam-icu, paired with a richmond agitation and sedation scale (rass) be administered once per day (i.e. with first assessment in the morning). all patients with abnormal cam-icu or icdsc features, beside the underlying cause of delirium and ssd are included. in addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see case report form (crf)).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. admission in intensive care unit exclusion criteria: 1. primary neurological diagnosis, with glasgow coma scale (gcs) \<14 on icu admission or in previous days; 2. blindness or deafness; 3. aphasia; 4. inability to communicate in the native language of the country where the study is enrolled; 5. death during the first 24 hours; 6. limitation of therapeutic efforts in the intensive care unit admission; 7. refusal to participate; 8. previous diagnosis of dementia or psychiatric illness; 9. readmission in icu;

Keywords: delirium subsyndromal delirium intensive care unit
use of nudges to enhance enrollment in critical care research

Conditions: Critical Illness

Summary: difficulties enrolling patients in randomized clinical trials (rcts) have long been recognized as a major barrier to successful evaluation of medical interventions. this is particularly problematic among intensive care unit (icu) trials, of which more than one-third do not reach target enrollment. under-enrollment and selective enrollment reduce rcts' abilities to answer the research questions, thereby degrading the trials' scientific value and ethics. current evidence suggests that financial incentives can ethically increase study enrollment, but this approach can pose large up-front costs to researchers. however, several nonmonetary behavioral interventions, or nudges, may offer novel and easily scalable approaches to increase enrollment in rcts. the investigation team propose a 2-arm rct in 10 icus at penn to test the relative effectiveness of nudges on enrollment rates. investigators hypothesize that a bundle of nudges during recruitment will increase enrollment rates compared to usual recruitment procedures will increase enrollment. investigators will enroll 182 critically ill patients' surrogate decision makers(participants) to engage in recruitment procedures for a simulated rct comparing two mechanical ventilation weaning protocols among mechanically ventilated patients. investigators will also measure participants' assessment of risk of the simulated trial after the informed consent process. this work will provide the first empirical evidence regarding the efficacy of inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future clinical trials.


Eligibility criteria:
inclusion criteria: surrogate decision-makers of patients who are: 1. patient and surrogate is 18 years of age or older 2. surrogate is english-proficient 3. patient is mechanically ventilated 4. patient is admitted to participating icu exclusion criteria: surrogate decision-makers of patients who are: 1. patient is receiving comfort care only 2. patient has anticipated extubation in the next 24 hours. 3. patient with tracheostomy. 4. bedside clinician declines patient participation. 5. surrogate decision maker not available to approach prior to patient being extubated.

Keywords: critical illness mechanical ventilation economics, behavioral surrogate decision maker
second-line irinotecan and capecitabine versus irinotecan for gemcitabine and cisplatin refractory biliary tract cancer

Conditions: Biliary Tract Neoplasms

Summary: this study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin * age 18 years or older * measurable reference cancer site(s) confirmed with computed tomography (ct) or magnetic resonance imaging (mri) * karnofsky performance status (kps) of at least 70% * adequate renal function, adequate hepatic function, adequate bone marrow function exclusion criteria: * the presence of any severe concomitant disease that could interrupt the planned treatment * intractable pain * hypersensitivity to study drugs * serious cardiovascular disease * if female, pregnancy or breastfeeding
multi-component intervention to improve health outcomes and quality of life among rural older adults living with hiv

Conditions: HIV

Summary: engagement in hiv medical care and adherence to hiv medications are both essential in improving health outcomes among people living with hiv (plh), but plh living in rural areas-who suffer higher mortality rates than their urban counterparts-can confront multiple barriers to care engagement and adherence, especially as they face the logistical, medical, and social challenges associated with aging. this project will pilot test four intervention components designed to improve care engagement and medication adherence to determine their impact on health outcomes and quality of life among rural, older plh. the four intervention components, adapted from evidence-based interventions and delivered remotely, are: (1) counselor-facilitated peer social support, (2) hiv stigma reduction, (3) strengths-based case management, and (4) individually-tailored technology use optimization. the investigators hypothesize that components will be acceptable to participants, will be feasible to administer remotely, and will show preliminary impact on (1) the proportion of participants that have viral suppression and (2) health-related quality of life. results from this study will provide us with tools to improve health outcomes for rural older people living with hiv.


Eligibility criteria:
inclusion criteria: * age 50 years or greater * living in a zip code classified as a "small and isolated small rural town" area by rural-urban commuting area codes (rucas), and/or in a county classified as rural based on rucas, and/or in a county with a score of .4 or higher on the index of relative rurality (irr) * living in alabama, arkansas, georgia, kentucky, mississippi, missouri, oklahoma, south carolina, or tennessee * living with hiv * indicates willingness to participate in support groups * indicates willingness to self-collect a dried blood spot sample * has a telephone at home * able to provide informed consent exclusion criteria: * not meeting eligibility criteria described above