Kornimate/medical-research-clean huggingface dataset:
patient specific optimized therapy (psot)

Conditions: Data Collection

Summary: data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (ep) intervention in order to develop a patient specific optimized therapy (psot) to improve specific patient's arrhythmia treatment for atrial flutter.

prospective, single-center, non-randomized, open label, single arm study. consented subjects who are scheduled to undergo ablation due to atrial flutter will be enrolled in the study. data will be collected from all subjects during the ablation procedure and post procedure for a period of 3 months. kodex - epd™ system will be used in all procedures during treatment of cardiac arrhythmias. anonymized data will be stored in an epd database and will be used to train and test predictors for personalized optimized therapy. data will be collected on paper and/or electronic forms and saved in the epd database. advanced data analysis will be used to map patient specific demographics, history, current ailment, intervention to patient outcome. the technology to be utilized will help develop a method to identify the personalized treatment for a given patient (defined by: patient's demographic, history, current ailment and intervention information to achieve optimal outcome). data will be anonymized by removing patient protected health information, only initials will be used. the data will be integrated to an epd data base and will be used to train and test predictors for personalized optimized therapy.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age. * subject signed a written informed consent form to participate in the study, prior to any study related procedures. * subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. * a female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days. * subject is deemed amenable to therapeutic ablation for atrial flutter. exclusion criteria: * any planned surgical or endovascular intervention within 30 days before or after the index procedure. * subject is enrolled in another drug or device study protocol that has not reached its primary endpoint. * patient had experienced previous stroke (tia or cva). * thrombi detected in the heart. * known marked valvar insufficiency. * life expectancy less than 12 months. * known severe renal insufficiency.
nasopharyngeal airway in obese patients undergoing painless gastroenteroscopy compared with transnasopharyngeal airway

Conditions: Complication; Patient Satisfaction

Summary: painless endoscopy is a popular endoscopic diagnosis and treatment method at present, and propofol combined with fentanyl general intravenous anesthesia has been widely used in painless endoscopic diagnosis and treatment.however, the combined application of the two has an obvious respiratory center inhibition effect, leading to the decrease of blood oxygen saturation in patients, especially obese patients, more prone to blood oxygen plunge, even threatening life.due to the potential risk of upper airway obstruction in some obese patients, intraoperative hypoventilation may occur during painless colonoscopy due to the influence of sedative and analgesic drugs, thus causing hypoxia in patients. in addition, the anatomical and pathological changes of obese patients themselves make hypoxia tolerance poor and airway establishment difficult, which may endanger the safety of patients.currently, supracloglottic ventilation devices that have little impact on patients and are easy to accept are often used clinically to complete short daytime operations. the most common is the application of oropharyngeal ventilation to solve upper airway obstruction , however, oropharyngeal ventilation is inconvenient to use in gastroenteroscopy and treatment, while nasopharyngeal ventilation is suitable. however, based on the experience of observers,although the nasopharyngeal airway can play a good role in the unobtrusived airway, the incidence of nasopharyngeal hemorrhage is high, and the comfort of patients is poor. therefore, the researchers considered to directly insert the nasopharyngeal airway into the pharyngeal cavity next to the oral pad through the mouth, so as to achieve the effect of unobtrusived airway and increase the local oxygen concentration, and the idea of this experiment came from this.

the purpose of this trial is to reduce complications, ensure safety during gastroenteroscopy and improve postoperative satisfaction of patients.according to the preliminary experimental results, the nasopharyngeal airway inserted by the oral pad is more convenient than the traditional operation, and the incidence of postoperative bleeding and pharyngeal pain is lower.the pros and cons of these two methods will be fully informed when the informed consent is signed with the patients at the early stage of the trial, so that the patients can voluntarily choose the implantation method.

Eligibility criteria:
inclusion criteria asa1-2; bmi≥28; age 18-65years old exclusion criteria pregnancy； history of allergies to propofol； history of alcohol abuse; psychiatric or neurological disorders; speech and communication disorders; auditory or visual impairments that may affect quality assessment of recovery; prior memory or cognitive impairment
fulvestrant 500mg in patients with advanced breast cancer

Conditions: Metastatic Breast Cancer

Summary: fulvestrant 500mg in patients with advanced breast cancer

a multicenter, prospective study real-world to evaluate the safety profile and effectiveness in chinese patients who received fulvestrant 500mg as first-line endocrine treatment for advanced breast cancer

Eligibility criteria:
inclusion criteria: 1. chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received fulvestant 500mg treatment as determined by treating physician. ovarian suppression in premenopausal women is permitted, including ovarian ablation and lhrha. 2. histologically confirmed positive oestrogen receptor status (er positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters. 3. prior endocrine therapy for advanced disease was not permitted. 4. the prescription of the fulvestant is clearly separated from the decision to include the subject in the nis, and is part of normal medical practice. the recruitment of the patient to the study should be within 1 month of the first fulvestant injection. 5. provision of subject informed consent. exclusion criteria: 1. if participating in any controlled clinical trial, the subject cannot take part in this study. 2. her2 overexpression or gene amplification, ie, immunohistochemistry (ihc) 3+ or fluorescence in situ hybridisation (fish)+, where appropriate. 3. pervious regimen of endocrine therapy for advanced disease. 4. more than one regimen of chemotherapy for advanced disease. 5. pregnancy and lactation. 6. severe hepatic impairment.
a comparison of prostaglandin e2 (pge2) inhibition of acuvail(ketorolac 0.45%), xibrom (bromfenac 0.09%)and nevanac (nepafenac)in patients undergoing phacoemulsification

Conditions: Cataracts

Summary: approximately 126 subjects scheduled to undergo cataract surgery by phacoemulsification, will be randomized in an even allocation (1:1:1) to either acuvail, xibrom or nevanac. subjects will be instructed to begin dosing the study medication in the operative eye the day before surgery and continue dosing on the day of surgery. beginning one hour before surgery 1 drop of study medication will be instilled by operating room staff approximately every 15 minutes for a total of 3 doses. at the designated time a paracentesis will be performed at the start of the cataract procedure and at least 0.15cc of aqueous humor will be collected. the sample will be immediately stored on dry ice and shipped to a laboratory for analysis.


Eligibility criteria:
inclusion criteria: * subjects must be 18 years of age or older * scheduled for cataract surgery by phacoemulsification * subjects must be willing to comply with all study requirements and be willing to give informed consent exclusion criteria: * any subject that has a history of uveitis or active iritis * subject can have o previous eye surgery with the exception of refractive surgery but not within 6 month * no ocular use of prostaglandins within 2 weeks of surgery * use of oral, injectable or topical ophthalmic steroids, nsaids of immunosuppressants within 14 days prior to surgery * contraindications to nonsteroidal anti-inflammatory drugs (nsaids) * active ocular infection
study to investigate safety and efficacy of sildenafil in the newborns with persistent pulmonary hypertension (pphn)

Conditions: PPHN; Persistent Pulmonary Hypertension of the Newborn; Hypoxic Respiratory Failure

Summary: sildenafil is efficacious in newborns with persistent pulmonary hypertension and its use will reduce the need for inhaled nitric oxide.

letter to investigator dated 18 june 2012 that study was to be terminated. study terminated due to evolved and widespread use of standard of care, relevance of study questioned. no safety reasons or issues.

Eligibility criteria:
inclusion criteria: * 72 hours of age; and \> or = to 34 weeks gestational age. * persistent pulmonary hypertension of the newborn or hypoxic respiratory failure associated with: 1. idiopathic pphn or 2. meconium aspiration syndrome or 3. sepsis or 4. pneumonia * oxygenation index (oi) \>15 and \<60 calculated exclusion criteria: * patients already receiving inhaled nitric oxide (ino) on referral. * prior or immediate need for full cardio pulmonary resuscitation or extracorporeal membrane oxygenation (ecmo). * life threatening or lethal congenital anomaly. * large left to right intracardiac or ductal shunting (diagnosed from echocardiogram on admission to gosh). * clinically significant active seizures as per clinical judgment. * bleeding diathesis as per clinical judgment

Keywords: pphn neonates sildanefil iv
study to evaluate your super's moon balance and its impact on premenstrual syndrome

Conditions: PMS; Menstrual Discomfort; Menstrual Pain

Summary: this is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common pms and menstrual symptoms, as well as health-related biomarkers.

it is hypothesized that the dietary supplement marketed as "your super moon balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of pms and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. further, the ability of the supplement to reduce biomarkers of inflammation (crp) and stress (cortisol), and promote sleep, will be evaluated.

Eligibility criteria:
inclusion criteria: * individuals with a regular menstruation * age 18-40 * moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other pms-related symptoms * must be in generally good health - no unstable, uncontrolled health condition * bmi under 35 * self-reported sleep-issues * willingness to refrain from ibuprofen or naproxen sodium (such as advil, aleve, motrin or midol) during each period (pill bleed) during the study * agree to not change their diet significantly during the duration of the study * agree to not change the intensity of their workouts for the duration of the study * must get their period regularly exclusion criteria: * severe chronic conditions, including oncological and psychiatric disorders * known to have any severe allergic reactions * currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study * participants unwilling to follow the study protocol * have used a similar product (ingredients) in the 6 weeks prior to the study
serotype distribution of streptococcus pneumoniae that causes invasive diseases at children and adults in turkey

Conditions: Pneumococcal Diseases

Summary: the aim of this study is to specify the serotype distribution of streptococcus pneumoniae that causes invasive diseases at children and adults in turkey.

non-interventional observational study descriptive analysis will be conducted.

Eligibility criteria:
inclusion criteria: serotype distribution and antibiotic sensitivity of pneumococcal isolates that causes invasive pneumococcal diseases which are obtained from the blood, csf, and/or all other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, bal) of the adults of 18 years of age or older with children that are younger than 18 years old at these centers and laboratories will be defined. exclusion criteria: isolation of any other microorganism than pneumococcus at the same sample.

Keywords: serotype distribution streptococcus pneumoniae pneumonia
decreasing the temporal window in individuals with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: in the absence of sufficient monetary resources, individuals must attend to immediate, minimum needs (e.g., food, shelter). this constricts one's temporal window and engenders neglect of the future. in observational studies, scarcity is associated with higher rates of delay discounting. additionally, socioeconomic status is inversely associated with alcohol use disorder and related problems. experimentally, scarcity shortens attention, impedes cognitive function, and increases delay discounting in multiple populations. moreover, scarcity increases demand for fast foods in the obese and increases craving for alcohol in problem drinkers. these data suggest that economic scarcity worsens both components of reinforcer pathology (delay discounting and alcohol overvaluation), thus increasing vulnerability to alcohol use disorder. however, studies investigating the effects of scarcity on alcohol demand discounting rate have been limited. the purpose of aim 1b is to examine effects of decreasing the temporal window and its concomitant effects on alcohol valuation (demand, and craving) and delay discounting.

participants will be randomly assigned to experimental or control groups, balanced by discounting rates and sex. we plan to have 112 participants complete the study, based on our power analysis. participants will complete two online sessions. during the first session, they will complete the baseline assessments. during the second session, they will complete the same assessments after being exposed to the scarcity or control narratives (both in audio format). the assessment will include delay discounting and demand tasks, and measures of alcohol craving. participants will also complete assessments of their stress and mood response to the narrative intervention, using the stress appraisal measure (sam) and panas for two purposes. that is, 1) to monitor participant safety, 2) to measure the mediating ability of affect on changes in the temporal window.

Eligibility criteria:
inclusion criteria: * high-risk or harmful drinking (audit\>15) * 21 years of age or older * desire to quit or cut down on their drinking, but do not have proximate plans to enroll in treatment for aud during the study period exclusion criteria: * having a current unmanaged psychotic disorder * reporting current pregnancy or lactation * having dementia

Keywords: delay discounting behavioral economic demand scarcity narrative alcohol craving
exploratory study of personalized mrna vaccine in patients with refractory rhabdomyosarcoma

Conditions: Rhabdomyosarcoma

Summary: an exploratory study on the use of mrna tumor vaccines in the treatment of refractory rhabdomyosarcoma


Eligibility criteria:
inclusion criteria: 1. diagnosed with rhabdomyosarcoma confirmed by pathological or molecular testing; 2. age ≥ 6 years; 3. no known effective treatment available or no treatment proven to prolong survival with an acceptable quality of life; 4. expected survival time greater than 6 months; 5. ecog performance status score of 0-1; - exclusion criteria: * 1.history of or concurrent with other untreated malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer; 2.history of or current active autoimmune diseases. 3.has uncontrolled cardiovascular diseases.
superinfection and hyperinflammatory phenotype in covid-19 (coronavirus disease 2019) pneumonia patients

Conditions: COVID-19 Pneumonia; Superinfection Lung

Summary: patients suffering from covid-19 (coronavirus disease 2019) pneumonia are prone to bacterial and mycotic superinfection. according to existing evidence, the prevalence of superinfection is about 8% to 14% (95% ci 5-26%). however, the percentage of patients treated for superinfection is as high as 80%. there can be multiple reasons for this difference.

the inflammatory markers, such as c-reactive protein (crp), procalcitonin (pct), presepsin (psp), interleukin-6 (il-6) frequently used as diagnostic tools in covid-19 (coronavirus disease 2019), are usually increased in these patients. this increase is a result of activation of systemic inflammatory cascade, part of covid-19 pathophysiologic pathway. this can escalate to state known as covid-19 associated hyperinflamation (cov-hi). in addition, current diagnostic tools for diagnosing hap/vap (hospital-acquired pneumonia and ventilator-associated pneumonia) are often limited in patients with covid-19 pneumonia. the current method of choice for superinfection diagnosing is bal (bronchoalveolar lavage). the cov-hi phenotype (cov-hi: crp \> 150 mg/l, or doubling within 24 h from greater than 50 mg/l, or ferritin concentration \> 1500 ug/l) is associated with significantly worse course of illness and higher mortality rates. these inflammatory markers may be used preferentially as prognostication tools, not bacterial superinfection markers. the intention of this project is to investigate the role of currently used inflammatory biomarkers. or eventually, to discover new parameters associated with superinfection proven by bal.

Eligibility criteria:
inclusion criteria: 1. admission on icu 2. age more than 18 years 3. covid-19 pneumonia criteria fulfilled exclusion criteria: none -

Keywords: covid-19 superinfection inflammatory markers
proactive counselling towards follow-ups in newborn hearing screening

Conditions: Hearing Loss; Newborn Morbidity

Summary: the study aims to investigate if proactive parental educating and counselling can minimize loss to follow-ups of parents whose infant fail newborn hearing screening.


Eligibility criteria:
inclusion criteria: * the parents whose infants do not pass hearing screening exclusion criteria: * the parents whose infants have illnesses and are not ready for hearing screening * the parents who decide to migrate to other areas
ventilation with supraglottic airway devices

Conditions: Laryngeal Masks Comparison

Summary: airo-q self pressurized airway device with blocker will be compared with proseal lma in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.


Eligibility criteria:
inclusion criteria: * adult female patients asa i\&ii. * age: 18-55 years old. * bmi\< 35. * undergoing elective surgeries. exclusion criteria: * patients with history of upper respiratory tract infections and obstructive sleep apnea. * patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia. * patients with coagulation disorders. * patients with el-ganzouri airway score ≥ 5 will.
utility of sputum induction and novel technologies to improve tb diagnosis in a high hiv prevalence primary care setting

Conditions: Tuberculosis

Summary: this study will investigate the benefit of using sputum induction for tb diagnosis in a primary care clinic for adult tb suspects that are either unable to produce a sputum sample (sputum scarce) or on initial diagnostic work-up have 2 negative sputum smear samples (who standard for frontline tb diagnosis). the investigators hypothesize that acquiring an induced sputum sample for smear microscopy and liquid tb culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce tb patients in a primary care clinic in a resource-limited high tb hiv prevalent setting.

tuberculosis is on the increase in africa. a key area of weakness in tb control efforts is the inability to make a rapid diagnosis. this is, in part, due to the inability to obtain representative biological samples and the non-availability of cheap, effective, rapid and field-friendly diagnostic tools. indeed, in hiv positive patients, where the sensitivity of sputum smear is as low as 20%, culture results take several weeks and a significant proportion of patients do not expectorate sputum. sputum induction for the diagnosis of tb has been evaluated in several studies, has been shown to have a good yield, feasibility and safety when performed correctly, and with diagnostic comparability to bronchoscopy. few studies have evaluated the performance of induced sputum outside of the hospital environment and the tolerability, yield and performance outcome of sputum induction in a primary care facility has yet to be evaluated. the objective of this study is two-fold. we seek to evaluate, through a randomized controlled trial, the feasibility, performance outcomes and impact on time-to-diagnosis and -treatment of sputum induction, in a high hiv prevalence primary care setting, for the diagnosis of smear negative/ sputum scarce tb. we hypothesize that acquiring an induced sputum sample for smear microscopy and liquid tb culture will decrease time-to-diagnosis and time-to-treatment initiation in smear negative/sputum scarce tb patients in a primary care clinic in a resource-limited high tb hiv prevalent setting. we will also evaluate the potential incremental benefit of novel technologies to improve the rapidity and diagnostic yield using induced sputum samples (xpert mtb/rif assay, microscopic observation drug susceptibility testing (mods) and the genotype mtb drplus line probe assay).

Eligibility criteria:
inclusion criteria: 1. 2x smear negative or sputum scarce tb suspects 2. primary care patient (not referred by doctor) 3. adult patients (\>18 years) 4. able to provide informed consent exclusion criteria: 1. not meeting inclusion criteria 2. \<18 years 3. unable to provide informed consent

Keywords: tuberculosis diagnosis sputum induction primary care