Kornimate/medical-research-clean huggingface dataset:
frameless stereotactic radiosurgery for intact brain metastases

Conditions: Brain Metastases

Summary: this is a randomized study to determine if not treating planning target volume (ptv) margins during radiation therapy worsens progression free survival rates in patients with brain metastases.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) with an ecog performance status 0-2 and a life expectancy of 3 months or more. * histologically confirmed systemic malignancy with gadolinium contrast-enhanced mri scan demonstrating 1-5 intraparenchymal brain metastases. * well-circumscribed, measureable intraparenchymal brain lesion(s) with maximum tumor diameter ≤3.0 cm. if multiple lesions are present, the other(s) must not exceed 3.0 cm in maximum diameter. at least one lesion must be ≥1.0 cm in maximum diameter and ≥0.5 cm in a perpendicular diameter to be considered measurable disease. * negative urine or serum pregnancy test done ≤ 14 days prior to ct simulation, for women of child-bearing potential only. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * diagnosis of germ cell tumor, small cell carcinoma or hematologic malignancy. * metastases in the brain stem, midbrain, pons, medulla, or within 7 mm of the optic apparatus (optic nerves, chiasm and optic tracts). * diagnosis of leptomeningeal disease. * prior cranial radiotherapy within 90 days of trial enrollment or prior srs at any time to any lesion to be treated on protocol * chemotherapy (including oral agents and targeted agents) or immunotherapy given within 14 days of srs. hormonal therapy is permitted. for her2+ breast cancer patients, anti-her2 therapy cannot be given within 14 days of srs. patients who are scheduled to receive trastuzumab emtansine after srs cannot be enrolled. * contraindications to gadolinium contrast-enhanced mri (eg, non-compatible pacemaker, egfr\<30, gadolinium allergy).

Keywords: brain metastases stereotactic radiosurgery
cute (chronic urticaria treatment evaluation)

Conditions: Chronic Idiopathic Urticaria

Summary: a study to compare the clinical efficacy and safety of levocetirizine vs. desloratadine in patients suffering from chronic idiopathic urticaria (ciu) measured by the mean pruritus severity score over the first week of treatment


Eligibility criteria:
inclusion criteria: - at visit 1: clinical history of chronic idiopathic urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause - at visit 2 (after a baseline period of at least 3 days): patient with adequate signs of ciu, both in terms of symptoms and severity. exclusion criteria: - any condition that would interfere with the evaluation of the therapeutic response.

Keywords: chronic idiopathic urticaria cute levocetirizine xyzal®
investigational drug versus an approved drug in patients with osteoarthritis (0663-061)(completed)

Conditions: Osteoarthritis

Summary: the purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.

the duration of treatment is 12 months.

Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief exclusion criteria: * known allergies to the study drugs

Keywords: arcoxia
evaluation of cold sore treatments on ultra violet (uv) induced cold sores

Conditions: Oral Herpes Simplex

Summary: the purpose of this study is to determine if a new drug treatment is effective to block the development of a cold sore lesion following ultra violet (uv) exposure.

this was a multi-center, randomized, evaluator and subject-blind, placebo controlled study design the objective of this study was to evaluate the ability of the test articles to block the development of a cold sore lesion from progressing beyond the prodromal stage following a uv-induced process. the primary efficacy endpoint of this study was to determine if a recurrent oral herpes episode initiated with prodromal symptoms was aborted before progressing to a lesion (vesicle) via assessing lesion stages by a trained evaluator. the secondary efficacy endpoints included: a) subject self-assessments and b) test article weights and diaries to track treatment compliance.

Eligibility criteria:
inclusion criteria: * clinical history of recurrent cold sores averaging 2 or more episodes per year * uv exposure is known to cause a cold sore outbreak exclusion criteria: * history of abnormal reactions to sunlight * used antiviral therapy directly prior to entering study * any other condition which in the opinion of the investigator may affect the results or place the subject at undue risk.

Keywords: herpes labialis herpes simplex herpes ultra violet (uv) induced
modified anterior palatoplasty in obstructive sleep apnea syndrome

Conditions: Obstructive Sleep Apnea

Summary: the aim of this study is to evaluate the effectiveness of barbed suture modification of anterior palatoplasty in the treatment of patients with retropalatal mild to moderate obstructive sleep apnea syndrome (osas).

a prospective analytic study will be conducted on a total number of 20 patients presented with mild to moderate obstructive sleep apnea for whom barbed suture modified anterior palatoplasty will be performed. surgical steps * procedure will be performed under general anesthesia * bilateral tonsillectomy will be performed. * then, the inferior portion between upper 2/3 and inferior 1/3 of palatopharyngeus muscle will be partially released * then, a rectangular shaped strip of mucosa and the underlying submucosa will be removed at the center of the soft palate consisting of 0.5-0.7 mm in length and with width corresponding to the tonsillar fossae distance. * then,the stripped area will be sutured by single resorbable polydioxanone barbed bidirectional size 0 monofilament suture by introducing one needle at the center point of the wound then will be passed laterally within the palate, turning around pterygomandibular raphe till it comes out at the most superior part of the raphe at one side the thread will be pulled until it hangs at the central transition zone which is a free zone present between the two directions of the thread. * then, again the needle will be passed back through the tonsillectomy bed and then this suture will be suspended around the raphe again; a gentle traction is then applied on the thread only and no knots are taken.t * the opposite side will be done by the same way. * finally, each thread will be come out at the raphe of the same side, for locking of the stitches and looseness prevention; a superficial stitch in the opposite direction is taken, and then the thread is cut while bushing the tissue downward for more traction.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate obstructive sleep apnea syndrome. * patients diagnosed with mild (ahi 5 to15) and moderate (ahi 16 to 30) osas with only retropalatal collapses * patients who are noncompliant with continuous positive airway pressure (cpap). exclusion criteria: * patients diagnosed with sever osas (ahi more than 30) * the main site of obstruction at retrolingual level or multilevel obstruction. * contraindication of surgery (e.g. cardiovascular problems and bleeding tendency). * patients with significant craniofacial anomalies affecting airway. * patients with bmi\>40 kg/m2. * patients unfit for general anesthesia. * history of previous velopharyngeal or lingual surgeries.

Keywords: obstructive sleep apnea barbed suture anterior palatoplasty
early pancreatic stent placement for preventing pep

Conditions: Cholangiopancreatography, Endoscopic Rretrograde; Post-ERCP Pancreatitis

Summary: our aim is to compare early versus late pancreatic stent placement in preventing pep among patients with naive papilla. the evl trial will provide essential answers regarding the optimal timing of prophylactic pancreatic stent placement in pep prevention.all patients with difficult biliary cannulation undergoing endoscopic retrograde cholangiopancreatography (ercp) with pancreatic guidewire-assisted technique for biliary access will be told about the opportunity to participate in evl research. in total, 768 patients will be randomly assigned (1:1) to two arms: (1) early pancreatic stent placement (epsp) (a pancreatic stent will be placed immediately after endoscopic retrograde cholangiography (erc) or endoscopic sphincterotomy (est)) and (2) late pancreatic stent placement (lpsp) (a pancreatic stent will be placed after all completion of therapeutic biliary procedures, e.g. biliary stone removal or drainage).the primary outcome is the rate and severity of pep. the secondary outcomes are hyperamylasemia, the rate of stenting success, and other ercp-related adverse events (aes).

patients with challenging biliary access using pancreatic guidewire-assisted method will be enrolled in the study. recruitment will take place among individuals referred to the four participating centers for therapeutic biliary procedures. after obtaining signed consent forms, participants who meet all the inclusion criteria and have no exclusion criteria will be randomly grouped (with a 1:1 ratio) into epsp and lpsp

Eligibility criteria:
inclusion criteria: participants who fulfill all the below criteria will be enrolled: 1. with naive papilla; 2. over 18 years; 3. undergoing ercp with pancreatic guidewire-assisted technique for biliary access; 4. providing a signed, written informed consent. exclusion criteria: participants who meet any of the following criteria will be excluded: 1. unreachable main papillae; 2. surgically altered gastrointestinal anatomy; 3. concurrent acute pancreatitis; 4. biliary cannulation over pancreatic duct stent after precut sphincterotomy or wire-guided method (native early attribute); 5. failed biliary cannulation; 6. severe active cardiopulmonary disease; 7. breastfeeding or pregnancy; 8. ampullary tumour.

Keywords: cholangiopancreatography, endoscopic rretrograde pancreatic stent post-ercp pancreatitis
radiation therapy in treating patients with stage i or stage ii prostate cancer

Conditions: Prostate Cancer

Summary: rationale: radiation therapy uses high energy x-rays to damage tumor cells. purpose: randomized phase iii trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage i or stage ii prostate cancer.

objectives: i. determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20% increase in the proportion of stage i/ii prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy. ii. determine whether high-dose radiotherapy produces a 33% reduction in the cumulative incidence of a rising psa (second hormone failure) following hormone therapy given at the time of first psa/clinical failure when compared with conventional-dose radiotherapy. iv. assess the relative rectal, bladder, and sexual morbidity of conformal photon doses of 70.2 and 79.2 gy in these patients. v. collect, in a prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients. outline: randomized study. arm i: radiotherapy. boost to the prostate using high-let protons followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using conformal photons with energies greater than 6 mv. conventional dose. arm ii: radiotherapy. as in arm i. high dose. projected accrual: there will be 390 patients accrued into this study over 3 years. an additional 3.5 years will be required for follow-up.

Eligibility criteria:
disease characteristics: histologically confirmed adenocarcinoma of the prostate primary tumor confined to prostate tnm clinical stages t1b-c or t2a-b no t1a no t1b-c tumor with gleason grade 1-2/5 no gleason grade 1-2/5 and psa less than 4 ng/ml nodes negative on imaging (nx) or by surgical sampling (n0) psa no greater than 15 ng/ml treatment must begin within 28 days after randomization patient characteristics: age: any age performance status: karnofsky 70%-100% life expectancy: greater than 10 years other: no major medical or psychiatric illness that precludes protocol entry no prior or concurrent second malignancy within 5 years except basal cell skin cancer prior concurrent therapy: no prior treatment for prostate cancer

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer
comparison of drug eluting balloon and drug eluting stent

Conditions: Coronary Artery Disease; Stable Angina; Unstable Angina; NSTEMI

Summary: the purpose of this study is to evaluate the safety and efficacy of drug-eluting balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (deb first).

a recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis. we think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.

Eligibility criteria:
inclusion criteria: * de novo lesion * 2.5mm =\< reference diameter =\< 4mm * lesion length =\< 28mm * type a, b1/b2 lesion exclusion criteria: * st-segment elevation mi * reference diameter \ 4mm * bifurcation lesion * type c lesion * history of ami or stroke within 1 year f. chronic renal disease (cr \> 2mg/dl)

Keywords: drug eluting balloon bare metal stent drug eluting stent coronary artery disease
study of plozasiran (aro-apoc3) in adults with severe hypertriglyceridemia

Conditions: Severe Hypertriglyceridemia

Summary: this phase 3 study will evaluate the safety and efficacy of plozasiran injection (aro-apoc3) in adult participants with severe hypertriglyceridemia (shtg). after providing informed consent eligible participants will be randomized to receive 4 doses (once every 3 months) of plozasiran or placebo, and be evaluated for efficacy and safety. after month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension under a separate protocol.


Eligibility criteria:
inclusion criteria: * established diagnosis of severe hypertriglyceridemia (shtg) and prior documented evidence (medical history) of fasting tg levels of ≥ 500 mg/dl (≥5.65mmol/l) * mean fasting tg level ≥500 mg/dl (≥5.65 mmol/l) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period * fasting low density lipoprotein-cholesterol (ldl-c) ≤130 mg/dl (≤3.37 mmol/l) at screening * screening hba1c ≤8.5% * willing to follow diet counseling and maintain a stable low-fat diet * must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the investigator) exclusion criteria: * use of any hepatocyte-targeted small interfering ribonucleic acid (sirna) that targets lipids and/or triglycerides within 365 days before day 1 (except inclisiran, which is permitted). administration of investigational drug and inclisiran must be separated by at least 4 weeks * use of any other hepatocyte-targeted sirna or antisense oligonucleotide molecule within 60 days or within 5-half-lives before day 1 based on plasma pharmacokinetics (pk), whichever is longer * known diagnosis of familial chylomicronemia syndrome (fcs) (type 1 hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes * acute pancreatitis within 4 weeks prior to screening * body mass index \>45kg/m\^2 note: additional inclusion/exclusion criteria may apply per protocol
treatment of depression with quetiapine

Conditions: Major Depression With Psychotic Features

Summary: the purpose of this study is to examine the mood stabilizing and antipsychotic properties of quetiapine in the treatment of depression by comparing subjects who were randomly assigned to either quetiapine monotherapy, quetiapine and citalopram; or haloperidol and citalopram. we hypothesize that quetiapine monotherapy would have similar effects to the combination of a first generation antipsychotic plus an antidepressant for the treatment of a major depressive episode with psychosis.

thus, current practice for treating psychotic depression is to combine an antidepressant with an antipsychotic. however, there are limitations to this approach. the rate of response is still lower than in other forms of major depression (janicak et al., 2001). the rate of noncompliance is higher in this group; and the incidence of adverse effects related to the antipsychotic is increased (janicak et al., 2001). as a result, studies have examined alternative treatments. the present study proposes to examine quetiapine's antipsychotic and mood stabilizing properties for the treatment of a major depressive disorder with psychotic features subjects will be randomized to either quetipine monotherapy, quetiapine and citalopram; or haloperidol and citalopram.

Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 18 to 75 years. * a structured clinical interview for the dsm-iv (scid) derived diagnosis of major depression with psychosis, single or recurrent episode (unipolar or bipolar). * subjects may have an anxiety disorder or an additional mood disorder such as dysthymia. * baseline 24-item hamilton depression rating scale (hdrs) score of greater than or equal to 21. * a baseline positive and negative syndrome scale (panss) score of greater than or equal to 4 on at least one of the 4 psychosis items. * women of childbearing potential must agree to practice a medically accepted means of contraception. * length of current episode no longer than 3 months. exclusion criteria: * pregnant or lactating women * women of child-bearing age who refuse a pregnancy test or who refuse to use a contraceptive technique when sexually active. * persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; substance dependence disorder in the last 6 months; substance abuse in the last 6 months or a dementing disorder are excluded. * persons with serious, unstable medical illnesses. * subjects who have been intolerant or nonresponsive to adequate trials of quetiapine, haloperidol and/or citalopram. * subjects who have received an injectable decanoate medication within 1 half life of the medication (i.e, 4 weeks for haloperidol or 2 weeks for fluphenazine). * subjects who have received fluoxetine within 4 weeks prior to randomization. * subjects who have received aripiprazole within 2 weeks prior to randomization. * subjects who have been treated with ect within the last 6 months.

Keywords: depression psychosis
persistent low back and pelvic pain 3-6 months post partum

Conditions: Pelvic Girdle Pain Post Partum; Low Back Pain Post Partum

Summary: the purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. the females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. they will then divide the females into hanne alberts 5 subgroups of pelvic pain. the females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.

the study is a follow up study to "prevalence of low back pain and pelvic pain in the pregnant population in stavanger".

Eligibility criteria:
inclusion criteria: * low back and\\or pelvic girdle pain during pregnancy * fluent understanding of spoken and written norwegian exclusion criteria: * hospitalisation due to pain or complications post partum

Keywords: low back pain pelvic pain pelvic girdle pain post partum
evaluation and optimization of pb127 myocardial perfusion echocardiography on ultrasound systems

Conditions: Coronary Artery Disease; Healthy

Summary: the purpose of this clinical trial is to evaluate various commercially available ultrasound systems and to identify imaging parameters to be used with these systems (along with the contrast agent pb127) as well as to further evaluate the safety of pb127.


Eligibility criteria:
inclusion criteria: 1. men and women 1. normal volunteers (18 30 years old), with no history of cad 2. patients (≥ 18 years old) with known or suspected cad, scheduled for or undergone clinically indicated coronary angiography within 28 days prior to or following study day 1 exclusion criteria: 1. unable to provide written informed consent 2. women who are pregnant or lactating 3. known hypersensitivity or known contraindication to: 1. dipyridamole 2. ultrasound contrast agents (including pb127 and excipients) 3. blood, blood products, albumin, egg whites, or protein 4. use of caffeine or xanthine containing products within the 24 hours prior to pb127 administration on study day 1 5. previous exposure to pb127 6. inadequate echocardiographic windows 7. heart transplant 8. known right to left shunt, including atrial septal defect 9. history of cabg 10. current uncontrolled ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter 11. pacemaker or defibrillator 12. unstable angina grade ccs class iv severity with ongoing symptoms and/or ongoing infusion of iv nitroglycerin 13. second degree or greater heart block 14. hypertension (spb \>200 and/or dbp \>110 mmhg on two consecutive readings within 1 hour prior to pb127 administration) 15. hypotension (spb \<90 mmhg on two consecutive readings within 1 hour prior to pb127 administration) 16. severe aortic stenosis (\>100 mmhg peak transvalvar gradient or \<0.6 cm2 estimated valve area) 17. pulmonary edema within the 7 days prior to study day 1 18. resting oxygen saturation of less than 90% 19. q wave mi within the 7 days prior to study day 1 20. ptca within the 28 days prior to study day 1 21. chronic obstructive pulmonary disease or bronchospastic airway disease which, in the opinion of the investigator, is significant enough to contraindicate dipyridamole 22. known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of \>50 mmhg 23. liver disease, characterized by or including one or more of the following 1. elevated total bilirubin \>upper limit of normal 2. currently elevated hepatic enzymes \>3x upper limit of normal 24. medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions

Keywords: coronary artery disease echocardiogram contrast perfusion ultrasound normal volunteers