Kornimate/medical-research-clean huggingface dataset:
diagnostic test of choice for helps syndrome

Conditions: HELPS Syndrome

Summary: our team recently described a new medical condition called helps (hemi-laryngo-pharyngeal-spasm) syndrome(1). helps syndrome is a condition caused by a blood vessel pinching the nerve rootlets of the vagus nerve (xth cranial nerve). it is similar to the well recognized hemifacial spasm syndrome but the nerve involved is the vagus instead of the facial nerve. as a result, the symptoms are episodic throat contractions and cough. the throat contractions become stronger and more frequent over the years and can lead to a terrifying inability to breath. patients may end up intubated in the emergency department or with a tracheostomy because of inability to breath during a severe episode. some but not all of our patients can tell which side of their throat (left or right) contracts during a choking episode. in between these choking episodes, patients feel normal. a surgical cure for these patients is microvascular decompression of the xth nerve.

the treatment of helps syndrome begins with the correct diagnosis. some patients are able to localize the side of their symptoms in helps syndrome while others are unable to. the purpose of this study is to prospectively study which of the following is the diagnostic test of choice for patients who are unable to localize their helps: 1. ciss mri sequences, 2. interictal laryngoscopy, and 3. unilateral and contralateral botox injections separated 3-months apart. both neuroradiologist and otolaryngologist will be blinded to the outcome of surgery and be asked "based on your diagnostic test, which side do you believe we should perform mvd surgery?"

Eligibility criteria:
inclusion criteria: * patients diagnosed with helps as described in our initial publication (honey et al. 2016) * patients unable to localize the side of their helps syndrome exclusion criteria: - unable to provide informed consent

Keywords: microvascular decompression, xth nerve
antibiotic selection using next generation sequencing vs urine culture

Conditions: Kidney Stone; Renal Stone; Infection, Bacterial

Summary: this is a randomized controlled clinical study evaluating the use of next-generation sequencing (ngs) to improve antibiotic prescribing before ureteroscopy or percutaneous nephrolithotomy.

ngs will be performed on voided urine collected as routine care approximately 30 days prior to surgery. results will be presented to infectious disease pharmacist within 48-72 hours to help select the most appropriate antibiotics, and independently as part of routine care, surgeons will choose the antibiotic that they would use in each case, while the infectious disease pharmacists would select their optimum choice. approximately 220 subjects will be randomly assigned in a 1:1 ratio to receive either ngs antibiotic recommendation or standard of care (soc) prophylaxis prescribed treatment. subjects assigned to standard of care will have urine cultures sent for analysis, and the physician will choose antibiotics based on results as per usual practice. subjects assigned to the ngs group, in addition to routine urine culture results, will have ngs urine culture results sent to an investigational drrug (id) pharmacist, and recommendations will be shared with the physician to determine the antibiotic selection. the physician will ultimately decide the appropriate antibiotics to prescribe. approximately 7-14 days after surgery, the research staff will conduct a telephone call to ask about any post-operative infections, complications, and any additional antibiotics that were prescribed.

Eligibility criteria:
inclusion criteria: * patients planning to undergo kidney or bladder stone removal surgery using endoscopy including ureteroscopy and percutaneous nephrolithotomy or any other transurethral procedure * age 18 or older * able to give informed consent exclusion criteria: * unwilling or unable to provide informed consent * age \< 18 * does not meet inclusion criteria
evaluation of a novel method of contrast volume quantification - avert plus

Conditions: Extravasation of Contrast Media

Summary: purpose: to evaluate the accuracy of the avert plus to monitor contrast volume used during angiographic procedures. research design: the avert plus is an fda 510k cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. this will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.

thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. the avert plus is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. for each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. at the same time, the net volume delivered to the patient will also be recorded from the avert plus console. for each injection, these two sets of variables will be compared to determine accuracy of the avert plus to quantify net contrast volume used.

Eligibility criteria:
inclusion criteria: * subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate. exclusion criteria: * none
tranylcypromine treatment of bipolar depression

Conditions: Bipolar Disorder I or II

Summary: this study seeks to investigate whether tranylcypromine (parnate®) might be an effective treatment of bipolar depression. new treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. this study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.


Eligibility criteria:
inclusion criteria: 1. history of bipolar i, ii 2. currently depressed (major depressive episode or depression nos) 3. physically healthy or physically stable (i.e.,no changes in medical interventions in past three months or likely for the next three months) 4. on stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer. 5. prior adequate trial on at least one antidepressant. 6. able to follow a tyramine-free diet 7. must speak english exclusion criteria: 1. current psychosis 2. past psychosis not occurring during an episode of mania or depression 3. prior nonremission to tranylcypromine 60 mg/d (or greater) 4. currently taking effective medication precluded while taking a monoamine oxidase inhibitor (e.g., a psychostimulant or a serotonin re-uptake inhibitor) 5. current (last six months) drug or alcohol abuse or dependence 6. significant suicide risk 7. significant cardiovascular risk

Keywords: major depressive episode depression nos bipolar disorder bipolar disorder i bipolar disorder ii bipolar depression major depression
pain and anxiety during local block

Conditions: Anesthesia, Local; Pain; Anxiety

Summary: introduction: currently, there is no scientific evidence about pain in the anesthetic blockage of the first finger according to the application method. however, clinical evidence has valued the use of carpule, due to the low pain it generates in the patient to the application of anesthetic. most studies on anesthesia and pain, especially with the use of carpule and distracting methods, belong to the field of dentistry. objectives: it is intended to determine the pain after an anesthetic block in h of frost in the first finger with different application methods, such as syringe and carpule. as secondary objectives, it is intended to establish the difference in pain according to the sex and age of the patients. methodology: experimental, transverse and random clinical trial type analytical study, in which a sample of 200 individuals will be selected, 100 per group, which would require digital anesthesia of the first finger and that would fulfill the inclusion criteria. result: after the completion of the study conclusions: after the completion of the study


Eligibility criteria:
inclusion criteria: * subjects over 18 years of age * both sexes * participants must present nail pathology that requires surgical intervention. exclusion criteria: * systemic degenerative * neuromuscular diseases * pregnant or likely to be pregnant
dartmouth middle meningeal embolization trial (dammet)

Conditions: Chronic Subdural Hematoma; Subdural Hematoma

Summary: chronic subdural hematomas (csdh) are one form of bleeding in the head. they are one of the most common diseases encountered by neurosurgeons across the country. the csdh can push on the brain and produce symptoms that include seizures, weakness, loss of sensation, and confusion. many of these csdh produce repetitive bleeding. treatment has largely consisted of surgical drainage of hematoma (also known as a blood clot) through either a small hole in the skull or open surgery. however, it is common for the csdh to reappear despite these procedures. a recent study has shown a treatment failure rate of 27% and a need for additional surgery at 19%. a new approach to treatment of csdh blocks the blood supply to the tissue that produces the repeated bleeding. catheters are used to gain access to the middle meningeal artery (mma), an artery that supplies the coverings of the brain. the artery is blocked using small particles or glue in a process called embolization. a recent pilot study of 72 patients who underwent mma embolization showed a much lower rate of repeated bleeding. based on these results, it is thought that this procedure holds promise in reducing the number of csdh that require one or more operations. the goal of this study is to systematically examine if blocking the blood supply to the tissue responsible for repeated bleeding helps the csdh resolve and improves patient outcomes.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * have radiographic imaging showing a csdh \> 7mm in maximal thickness encompassing \> 50% of the convexity (non-focal). * capable of giving consent for the procedure or have an acceptable surrogate capable of giving consent on the subject's behalf exclusion criteria: * the csdh is secondary to an underlying vascular malformation, tumor, cyst, spontaneous cerebrospinal fluid hypotension or previous craniotomy * life expectancy \< 6 months * vascular anatomy that puts the patient at high risk for adverse events (e.g. critical carotid stenosis, abnormal external-internal carotid circulation) * incapable of being reasonably expected to be able to attend follow-up appointments at dartmouth-hitchcock medical center * vulnerable patients including homeless patients, incarcerated patients and mentally ill patients without appropriate medical decision-making proxy that the physician believes are incapable of appropriately assessing the risks of the procedure

Keywords: subdural hematoma chronic subdural hematoma intracranial hemorrhage
migraine manager (r01)

Conditions: Migraine; Migraine Disorders

Summary: the objective of this trial is to test whether an online tailored intervention, migraine manager, is efficacious in improving headache outcomes compared to an attention control intervention in adolescents with migraines. we will conduct a randomized clinical trial to compare a sample of 80 youth (ages 11 to 17) with migraine receiving the online tailored adherence intervention to 80 youth in an attention control group. we will test whether adherence to healthy habit (hydration, regular meals, exercise, sleep) recommendations serves as a mechanism for improved headache outcomes. clinically meaningful outcomes will be assessed by reliable, valid, and sensitive measures. the primary outcome (i.e., number of headache days) will be assessed via online daily diary pre- and post-intervention, with additional follow-up at 3, 6, 9, and 12 months. secondary outcomes include health-related quality of life and migraine disability.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of migraine using current international classification of headache disorders criteria (ichd-3) for migraine with or without aura * frequency of 8 or more headaches per month * access to the internet whether public (e.g., library) or private (e.g., home, personal) * english fluency for patient and caregiver exclusion criteria: * patients with a diagnosis of pervasive developmental disorder as determined by medical chart review * patients with a diagnosis of or serious mental illness (e.g., psychotic disorder) as determined by medical chart review

Keywords: migraine
the impact of immunostimulating nutrition on the outcome of surgery

Conditions: Gastric Cancer; Pancreatic Cancer

Summary: the aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. the study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.

all patients qualified between june 2001 and december 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. additional eligibility criteria included: age between 18 and 80 years, karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (american society of anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. the study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. the secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay. after completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. the following groups were generated: standard enteral nutrition (sen), immunostimulating enteral nutrition (imen), standard parenteral nutrition (spn), and immunostimulating parenteral nutrition (impn). the study was carried out following the international ethical recommendations stated in the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * resectable gastric or pancreatic cancer * age between 18 and 80 years, * karnofsky performance status score of 80 or more, * adequate organ function exclusion criteria: * unresectable gastric or pancreatic cancer * patients requiring preoperative nutritional support, * disseminated tumors, * serious comorbidities (american society of anesthesiologists risk class of 4 or 5), * renal or liver failure were excluded

Keywords: immunonutrition enteral nutrition parenteral nutrition surgery
study to evaluate the safety and efficacy of csb-001 ophthalmic solution 0.1% in subjects with corneal scars

Conditions: Corneal Scar

Summary: this study will enroll subjects with recently formed corneal scars that resulted from a corneal insult presenting and diagnosed within the past approximately 30 days and not less than approximately 7 days. all subjects will be assigned to csb-001 investigational treatment on day 1. all subjects will dose with csb-001 four times daily or three times daily starting on day 1 and continue until day 14. subjects with a resolved scar at day 7 will discontinue dosing and return to the clinic on day 14. subjects will return on days 21, 28, 56, and month 3 for safety and efficacy assessments.


Eligibility criteria:
inclusion criteria: * centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in the greatest diameter and with a portion of the scar within approximately 3.5 mm of the optical center of the cornea assessed at screening and confirmed at baseline, and subject reports ability to detect any effect of scar on any element of vision. * eye with a recent corneal insult approximately ≤30 days and ≥7 days from the screening visit. * corneal insult includes but is not limited to mechanical / chemical / thermal injury, bacterial keratitis, prk, and contact lens related ulcer. * eye with observed rate of epithelialization that in the investigator's opinion does not demonstrate clinical characteristics of a slow healing (persistent defect) cornea. * subjects must have the ability and willingness to comply with study procedures. exclusion criteria: * corneal scar that encompasses more than approximately 50% of the depth of the remaining stroma as guided by asoct image at the screening visit. * maximum scar diameter greater than approximately 5 mm without prior approval by the sponsor based on screening visit images. * no portion of the scar is within the approximate 3.5 mm of the optical center of the cornea based on screening visit images. * any active ocular infection in the opinion of the investigator (bacterial, viral, fungal, or protozoal) at the screening or day 1 visits. subjects with an active bacterial infection at the screening or day 1 visit in the opinion of the investigator may be rescheduled to reassess the status of the infection and continue in the study if infection is deemed not active. * ocular surgery planned during the study treatment period. * presence or history of any ocular or systemic disorder, condition or procedure that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the investigator to be incompatible with the study visit schedule or conduct. note: other inclusion/exclusion criteria apply.
efficacy and safety of bg2109 in subjects with heavy menstrual bleeding associated with uterine fibroids.

Conditions: Uterine Fibroids; Heavy Menstrual Bleeding

Summary: the primary objective of this study is to demonstrate the superior efficacy versus placebo of bg2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

the study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of bg2109 alone and in combination with add-back therapy (estradiol 1 mg / norethindrone acetate 0.5 mg) for the treatment of uterine fibroids in china.

Eligibility criteria:
key inclusion criteria: 1. subject is an 18 years and older premenopausal woman. 2. subject's body mass index ≥ 18 kg/m2. 3. subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound. 4. subject's menstrual cycles is between 21 days and 35 days in the last 3 months. 5. subject has clinical manifestations of heavy menstrual bleeding. 6. subject's menstrual blood loss \>80ml for at least 2 menstrual periods assessed at screening using the alkaline hematin method. key exclusion criteria: 1. the subject is pregnant or breast-feeding or is planning a pregnancy within the duration of the treatment period of the study. 2. the subject has a history of uterus surgery that would interfere with the study. 3. the subject's condition is so severe that she will require surgery within 6 months. 4. the subject have had or are currently suffering from any estrogen- dependent malignancy. 5. the subject has a significant risk of osteoporosis, or have a known history of osteoporosis or other metabolic bone disease.
dissecting the mechanism of dna methylation on the invasiveness of pituitary tumors.

Conditions: Pituitary Tumors

Summary: dna methylation is one of the important ways of protein post-translational modification.pituitary adenoma (pa) is a benign neuroendocrine tumor that originates from adenohypophysial 45 cells, and accounts for 10%-20% of all primary intracranial tumors. however some pas can present with high invasiveness and irregular growth, which tend to compresses the optic chiasm and third ventricle, encase the internal carotid artery, and affect hormone secretion from the pituitary gland and hypothalamus. in this study we focus on the mechanism of dna methylation on the invasiveness of pituitary tumors.


Eligibility criteria:
inclusion criteria: * 1) histologically confirmed pas, 2) non-function pituitary adenomas exclusion criteria: * 1) associated with other tumors or serious underlying diseases, 2) the medical records were not complete, or the follow-up data were missing.
ceftolozane-tazobactam for the treatment of respiratory infections due to extensively drug-resistant pseudomonas aeruginosa among critically ill patients: a retrospective study.

Conditions: Ventilator Associated Pneumonia; Antibiotic Resistant Infection

Summary: the aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of icu dependent nosocomial respiratory tract infections due to extensively drug resistant pseudomonas aeruginosa. different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of colomycin.

ceftolozane-tazobactam (c/t) is a novel type of beta-lactam/beta-lactamase inhibitor antibiotics targeting nosocomial infections caused by gram-negative bacteria. in recent years, ceftolozane-tazobactam was prescribed for treating complicated urinary tract infections (cuti) and complicated intraabdominal infections (ciai). following the results of aspect-np trial in 2019, it was approved as a therapeutic option in nosocomial pneumonia including hospital-acquired pneumonia (hap) and ventilator-associated pneumonia (vap). the drug shows an excellent activity against esbl-producing enterobacterales and multidrug-resistant (mdr) and extensively drug-resistant (xdr) strains of pseudomonas aeruginosa. the latter is widely recognized as a common pathogen of nosocomial respiratory tract infections. there is still a need for observations of clinical experiences to better define the risk-benefit profile of ceftolozane-tazobactam. the aim of this study is to report our experience with ceftolozane-tazobactam and to evaluate its safety and efficacy in the treatment of icu dependent nosocomial respiratory tract infections due to extensively drug resistant pseudomonas aeruginosa. different dosing regimes of ceftalozane-tazobactam is evaluated and compared to the standard therapy of colomycin.

Eligibility criteria:
inclusion criteria: * hospital-acquired pneumonia caused by extensively drug-resistant pseudomonas aeruginosa * ≥ 72 hours of targeted antibiotic therapy against pseudomonas aeruginosa with either colomycin or ceftolozane-tazobactam exclusion criteria: * participation in an interventional trial aiming nosocomial infections * treatment was not with the intent to cure the infection