Kornimate/medical-research-clean huggingface dataset:
a two comparator, controlled phase 3 study in patients with and without evaporative dry eye

Conditions: Dry Eye Syndromes

Summary: omega 3 (om3) tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by allergan. it is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (ede) and those without (non-ede). it would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in ede and non-ede patients


Eligibility criteria:
inclusion criteria: * able to read and comprehend english and give informed consent as demonstrated by signing a record of informed consent; * over 18 years of age; * not wearing contact lenses in the past 3 months before enrolling * willing to use eye drops and comply with the study visit schedule as directed by the investigator; * habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye; * at the screening visit (day -14), patients must have ocular surface disease index (osdi) score \>18 (0 to 100 scale). at baseline (day 1) visits, patients must have osdi score \> 12 to continue in the study. * tbut≤10sec in at least 1 eye at screening visit and baseline visit * corneal sodium fluorescein staining score ≥ 1 and \<4 (oxford scheme) at screening and baseline visit. exclusion criteria: * schirmer test (with anesthesia) ≤ 2 mm in either eye at screening * patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the screening visit. patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the screening visit; * any active anterior segment disease excluding blepharitis; * any systemic disease that may affect ocular health e.g. graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus; * history of epilepsy or migraines exacerbated by flashing, strobe-like lights; * rigid or soft contact lens wearer, including orthokeratology; * history of eye surgery within 6 months prior to enrolment in the study; * previous corneal refractive surgery
phase ii study to evaluate the safety and efficacy of prostatic artery embolization

Conditions: Prostate Carcinoma; Benign Prostatic Hyperplasia

Summary: this is a phase ii prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo prostatic artery embolization (pae) prior to treatment. pae will be administered by interventional radiology. patients will be seen for follow-up at 6 weeks and 12 weeks following pae after which they will start definitive radiotherapy. after completion of radiotherapy the patient will be seen at 12 weeks


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. gleason grade groups 1 and 2) who are eligible for and who select xrt as their cancer management method. * ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy. * ability to understand and the willingness to sign a written informed consent document * prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans * american urologic association (aua) or international prostate symptom score (ipss) score ≥ 15 * normal organ and marrow function as defined in protocol exclusion criteria: * patients with gleason grade group 1 or 2 pca who select active surveillance as their cancer management method. * receiving androgen deprivation therapy (adt) * patients with unfavorable intermediate (gleason grade group 3) or high risk localized pca (gleason grade groups 4 and 5) * receiving any investigational agents for the explicit purpose of prostatic size reduction * inability to receive prostatic artery embolization (pae) within 6-12 weeks of definitive radiation therapy * active urinary tract infection (uti) * history of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the pae; patient cannot be medicated against allergic reaction prior to pae. * active cystolithiasis or prostatitis * inability to have multi-parametric magnetic resonance imaging (mpmri) * prior transurethral resection of the prostate (turp) within 2 years * prostate size greater than or equal to150 grams * vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment.
trial of nano-hydroxyapatite-containing toothpastes for relief of dentin hypersensitivity

Conditions: Dentin Sensitivity

Summary: subjects will be enrolled into 3 balanced groups each using a different strength toothpaste. dental hypersensitivity (dhs) will be assessed at study start, midway and study end.

this study is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group clinical trial. the three groups will be randomly assigned to use one of three test toothpastes having an identical base formulation but containing respectively either 0% nano-hydroxyapatite (hap) (placebo), 15% nano-hap or 5% kno3 (positive control). all dental examinations for data collection will be conducted by the same clinical examiner.

Eligibility criteria:
inclusion criteria: * males or females between the age of 20 and 80 years, of any socio-economic status * diagnosed as having dhs, i.e. having at least one sensitive tooth with demonstrated cervical erosion/abrasion or gingival recession * showing a sensitivity response to both tactile and cold air stimulus delivered by a yeaple probe and a one-second blast of cold air respectively * patients must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions * patients must be able to read, comprehend, and sign the informed consent form * the teeth and sites to be tested should be on the buccal/labial surfaces of incisors, canines, premolars or molars where the affected sites are accessible * teeth selected for testing should have a plaque index of ≤ 2 exclusion criteria: * the sensitive tooth is associated with concomitant oral pain due to any other condition such as soft-tissue lesions, tooth-ache ascribable to dental caries, tooth fracture, or cracked tooth syndrome, or pain due to other surgical procedures or injuries. * the sensitive tooth is associated with a periodontal abscess as diagnosed from an x-ray or clinical examination of the tooth * the sensitive tooth is associated with mobility \>1 * the sensitive tooth is associated with gum pain from gingivitis, occlusal trauma, thermal or chemical burns * patients having pain from periodontal-related causes but not dhs * previous professional desensitizing treatment * patients using medication which could interfere with the perception of pain * medical histories marked by chronic use of anti-inflammatory agents, daily analgesics, anticonvulsants, antihistamines, antidepressants, sedatives and/or other psychotropic drugs * pregnancy or breastfeeding * allergies and idiosyncratic responses to toothpaste ingredients * eating disorders or conditions associated with vomiting * systemic conditions that are etiologic or predisposing to dhs * excessive dietary or environmental exposure to acids * the sensitive tooth was restored in the preceding three months * the sensitive tooth is an abutment tooth for fixed or removable prostheses * the sensitive tooth has extensive restoration or restorations extending into the test area * patients below 20 years or above 80 years of age * smokers
effect of body position and probe position on the localization of breast mass

Conditions: Breast Diseases

Summary: the purpose of this study is to demonstrate that bvn g-1000 can precisely and consistently measure the position of female breast lesions regardless of patient rotation and probe angle during ultrasound examination.

the proposed research consists of quantitatively detecting and reporting the effect of body rotation and ultrasound probe position on the breast on the position of breast lesions relative to the breast nipple and body orientation planes, required for positional annotations, in female subjects at one study visit. measurements will be manually and automatically recorded by two ultrasound operators with each image and will be compared among these conditions to detect effects of probe position and probe orientation and patient's body position relative to the exam table. the manual and automated measurements will be compared to determine the differences between the data obtained using the two different methods.

Eligibility criteria:
inclusion criteria: 1. female 2. 21-70 years of age 3. known palpable or non-palpable benign or probably benign breast mass or masses, less than 2 cm in maximum diameter and at least 4 cm away from the nipple, from a previous ultrasound examination exclusion criteria: 1. women with cardiac pacemaker or portable defibrillator 2. women with known breast cancer or suspicious lesions 3. pregnant and lactating women 4. women who have breast implant(s) 5. women who have had prior breast surgical intervention not including breast needle biopsy, in the same breast with the qualifying target mass. 6. women with the target finding to be mapped within a distance of 4 cm from patient's nipple. 7. women with multiple similar qualifying targets in close proximity (less than 4 cm between targets). 8. women with history of allergy to medical-grade adhesive tape or ultrasound gel 9. women whose weight is over 250 pounds

Keywords: female breast lesion ultrasound examination
comparison of mri and cedm to evaluate treatment response before surgery

Conditions: Breast Cancer

Summary: the purpose of this study is to compare the diagnostic accuracy of breast magnetic resonance imaging (mri) and contrast enhanced digital mammography (cedm) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (nat).


Eligibility criteria:
inclusion criteria: * any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-nat breast mri and mammogram * surgery (mastectomy or bct) planned within 60 days of the mri exclusion criteria: * women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level \> 1.3 or egfr ≥45) * known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the mri is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy * pregnant women * male patients * presence of non mr compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make mri a contraindication * known or suspected renal impairment. requirements for gfr prior to mri as determined by local site standard practice * women who have already had their standard of care post-nat mammogram and/or breast mri

Keywords: mastectomy breast mri contrast enhanced mammography cedm 17-045
apricot-l: study to evaluate efficacy and safety of apricoxib with erlotinib in patients with non-small cell lung cancer

Conditions: Recurrent Non Small Cell Lung Cancer

Summary: this study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of cox-2 and egfr pathways in patients with up-regulated cox-2 expression in tumor will have a clinical benefit compared with erlotinib alone.


Eligibility criteria:
inclusion criteria: * pathologically determined stage iv nsclc including stage iiib (pleural effusion) * failed at least one prior platinum-based chemotherapy for stage iiib or stage iv nsclc. patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible. * measurable disease by recist * greater than or equal to 18 years of age * ecog ps of 0 or 1 exclusion criteria: * radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment * evidence of nyha class iii or greater cardiac disease * history of mi, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months * known hiv infection or aids * symptomatic cns metastases * pregnant or nursing women * hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other nsaids. * history of upper gi bleeding, ulceration, or perforation * prior history of cox-2 inhibitor therapy for the treatment of metastatic nsclc * previous anti-egfr kinase therapy
transversus abdominis plane blocks for infants and children for postoperative pain control

Conditions: Postoperative Pain

Summary: after undergoing hernia surgery, hydrocelectomy or lower abdominal surgery, a child may experience some amount of pain in the post-operative period. as part of the anesthesia technique, the investigators routinely provide a nerve block done on the abdominal wall that will provide pain relief for at least 10 hours postoperatively. this is referred to as a tap block. the purpose of this study is to determine if the nerve block performed with local anesthetic solution using a regular concentration solution vs. a diluted solution may offer different durations of pain relief.

children undergoing groin surgery or abdominal surgery under general anesthesia are offered pain relief postoperatively using regional anesthesia techniques including a central block like a caudal block, or peripheral nerve blocks including ultrasound guided ilioinguinal nerve block or transversus abdominis plane (tap) block. the tap block, a peripheral block of the thoraco-lumbar nerve roots as they exit between the internal oblique and the transversus abdominis muscle can be easily visualized using ultrasound guidance. the tap block has been used for analgesia following major surgeries including lower abdominal surgeries and in newborn infants following major abdominal procedures including colostomy placement.1 the purpose of this study is to determine if two different concentrations of bupivacaine delivered at a total dose of 1 ml/kg offer similar or altered analgesia, i.e., does the concentration of the anesthetic matter more than the volume of local anesthetic while performing a tap block in children undergoing groin surgery. parents and the investigators will be blinded to the solution used for the tap block. the solution will be drawn up by an investigator who is not a participant in the patient's care in a sterile fashion.

Eligibility criteria:
inclusion criteria: * children under 8 years of age presenting for hernia repair, hydrocelectomy or lower abdominal surgery * estimated operative time approximately 3 hours * american society of anesthesiologists classification asa i or ii * parental consent to be included in the study exclusion criteria: * any contraindications to local anesthesia but not limited to 1. local infection of the abdominal wall. 2. allergy to amide local anesthetics 3. history of significant cardiac disease or uncontrolled seizures. 4. allergy to rescue analgesia including acetaminophen and or hydromorphone. 5. neonates under 28 days. * inability for the family to complete the postoperative questionnaire

Keywords: regional anesthesia children postoperative pain relief
clinical effect of botulinum toxin type a in treatment of spasticity

Conditions: Spasticity; Brain Injuries; Spinal Cord Injuries; Multiple Sclerosis

Summary: spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex. the treatment goal of spasticity is medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity. local treatments such as botulinum toxin type a, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. as stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (bethoux et al., 2015). in particular, botulinum toxin type a (bont-a) is considered the gold standard treatment for focal spasticity, showing a level a evidence for spasticity reduction in upper- and lower-limb spasticity (simpson et al., 2016). however, current evidence is mainly focused on post-stroke spasticity (franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (sci), traumatic brain injury (tbi), or multiple sclerosis (ms). interestingly, spasticity is a major concern for the rehabilitation of these patients. the aim of this observational study is the evaluation of the clinical efficacy of bont-a in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as sci, tbi, and ms.


Eligibility criteria:
inclusion criteria: * age \>18 years * spasticity as a consequence of traumatic brain injury, spinal cord injury or ms (documented by clinical records) * muscle tone graded at least 1+ on the modified ashworth scale in the relevant joints of the affected limb(s), which requires medical intervention * bont naïve or pre-treated with any bont product. if previously treated with any bont, at least a 4 months interval between last injection and inclusion exclusion criteria: * presence of fixed contractures or bony deformities in the affected limb * changes in any oral antispastic medications or specific physiotherapy regimen \<4m before study entry or during the study. * other neurological or orthopaedic conditions involving the affected limbs. * sensitivity to bont-a or to its excipients * other contraindications as given in the local smpc for bont-a
efficacy long-term dietary nitrate consumption to plasma nitrite conversion

Conditions: Cardiovascular Diseases in Old Age

Summary: the objective of this study was to determine the chronic effects of beetroot juice supplementation on the acute (90-minute post nitrate consumption) efficacy of converting dietary nitrate to plasma nitrate and plasma nitrite in healthy middle-to-older aged adults. the investigators were also interested in determining the effect of this intervention on fasting levels of plasma nitrate and nitrite over time. furthermore, the number of participants classified as "non-responders" was determined based on increases in plasma nitrite achieved using tolerable volumes of beetroot juice by other studies.


Eligibility criteria:
inclusion criteria: * middle and older (40-80 year-old) men and women * body mass index between 18.5 - 30.0 kg/m2 * able to provide own transportation to study testing visits * able to consume study beverages * able to speak and read english exclusion criteria: * tobacco user (smoke or chew), including e-cigarettes * known conditions of: diabetes mellitus (type 1 or 2), atrophic gastritis, hypo- or hyperthyroidism, gout, history of kidney stones, history of hypotension, cardiovascular disease, chronic obstructive pulmonary disease, inflammatory bowel diseases, impaired liver or kidney function * current or recent (last 3 months) treatment for cancer * current use of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, medication for hypothyroidism, antacid and heartburn medications

Keywords: beetroot juice dietary nitrate plasma nitrite
study of azasite versus vigamox in the tears of healthy volunteers

Conditions: Bacterial Infections; Eye Infections

Summary: the purpose of this study is to evaluate the drug concentrations of azasite compared to vigamox in tears of healthy volunteers


Eligibility criteria:
inclusion criteria: * have visual acuity, using corrective lenses (no contact lenses) if necessary, in both eyes of at least +0.7 as assessed by early treatment of diabetic retinopathy study. * have normal lid anatomy. exclusion criteria: * have an abnormal biomicroscopy or ophthalmoscopy exam. * have a diagnosis of dry eye disease or have experienced any of the dry eye symptoms (photophobia, foreign body sensation, itching, burning, pain, dry or grittiness) in the past thirty days. * have used artificial tears in the past thirty days. * have a diagnosis of on-going ocular infection or lid margin inflammation. * have ever had penetrating ocular surface or intraocular surgery. * have a known hypersensitivity to azithromycin, or any macrolide antibiotic or to any of the ingredients in azasite. * have had a known hypersensitivity to vigamox or any fluoroquinolone antibiotics or to any of the ingredients in vigamox. * have had corneal or lid abnormalities. * have glaucoma, or intra ocular pressure of 22 mm hg or greater in one or both eyes. * have any ocular pathology with the exception of cataracts. * have a serious systemic disease or uncontrolled medical condition. * have experienced symptoms of viral or allergic conjunctivitis in the past 30 days. * have a history of liver or kidney disease resulting in persisting dysfunction.
mechanisms of open and hidden placebo in stroke recovery

Conditions: Stroke; Hemiparesis

Summary: this trial aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects thus providing a novel mechanism to explain placebo effects that can be used to ultimately enhance stroke rehabilitation therapies.

placebo effect leads to significant effects on brain excitability and connectivity, ultimately influencing clinical outcomes, including motor learning in stroke. this trial will provide critical mechanistic data to improve the understanding of placebo in stroke clinical trials, as to solve methodological and ethical dilemma in research designs, and to improve its clinical outcomes. it aims to investigate whether placebo in isolation (open and hidden) has a specific neural signature in stroke subjects. for this purpose, the investigators plan to recruit 56 chronic stroke participants, that will be randomized using blocked randomization in a 2:2:2:1 proportion to one of the following groups, respectively: 1) open placebo (op) alone (16 subjects); 2) sham rtms alone (16 subjects); 3) no intervention (16 subjects); or 4) active rtms alone (8 subjects). all four groups will undergo 2 weeks of daily intervention visits (10 sessions).

Eligibility criteria:
inclusion criteria: 1. adults with hemiparesis due to chronic stroke 2. stroke duration of 6 months or more 3. fugl-meyer scale upper extremity motor assessment score of \> 11 and ≤ 56 4. pre-stroke disability (defined as a score of \< 3 on the modified rankin scale) 5. age 18 or older exclusion criteria: 1. stroke of anterior cerebral artery territory with prefrontal lesion and stroke-related decreased eeg power in the prefrontal cortex 2. unable to understand instructions 3. tms contraindications: electronic hardware in close contact to the discharging coil such as cochlear implant, internal pulse generator or medical pump 4. concurrent unstable medical conditions 5. a score of 24 or higher on the hamilton depression rating scale (hdrs) 6. joint or paretic extremity pain likely to interfere with assessments 7. pregnancy

Keywords: stroke placebo