Kornimate/medical-research-clean huggingface dataset:
sirolimus-eluting stent versus standard stent in diabetic

Conditions: Coronary Artery Disease

Summary: the purpose of this study was to determine whether sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to bare metal stent in diabetic patients with de novo coronary artery stenosis.


Eligibility criteria:
inclusion criteria: * diabetic either non-insulin or insulin-dependent (according to world health organization report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography) exclusion criteria: * impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia * stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (\> 2 mm) that should be treated during the procedure * left ventricle ejection fraction \< 25% * prior treatment with intracoronary brachytherapy or other drug eluting stent at target site * restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent st elevation \< 72 hours and/or cpk twice the upper normal limit * non-st elevation acute coronary syndromes with cpk twice the upper normal limit * severe hepatic or renal disease (creatinin clearance \< 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy \< 1 year
efficacy and safety of am-301 on allergic symptoms of perennial allergic rhinitis sufferers

Conditions: Perennial Allergic Rhinitis; Rhinitis, Allergic

Summary: alleviation of allergic symptoms induced by house dust mites when using the medical device am-301. this clinical investigation explored the efficacy and safety of am-301 when used to reduce symptoms of house dust mite sufferers. the primary objective was to compare the efficacy of am-301 device between treated and non-treated subjects in the treatment of perennial allergic rhinitis (par).

this was a randomized, open-label, 3-period crossover study. the total study duration was approximately 65 days and consisted of 2 screening visits and 3 treatment visits (total 5 visits) followed by a telephone call. patients with hdm allergy as assessed by their medical history and a positive skin prick test for dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase. at least 7 days after the second screening visit, the treatment visits started. eligible subjects were randomized to one of the six treatment sequences (abc, bca, cab, acb, bac, cba) at an equal ratio. the treatments were applied 10 minutes before the challenge at visit 3, 4 and 5: * treatment a: one spray am-301 (0.14 ml) per nostril, * treatment b: two sprays am-301 (0.28 ml) per nostril (at two defined spray angles in order to obtain a broader coverage of the nasal mucosa), * treatment c: no treatment. the cross-over design allowed treatment c to be used as internal control. between the three treatment visits in the chamber there was a 7±2 days wash-out period.

Eligibility criteria:
main inclusion criteria: * body mass index between 18.0 and 32.0 kg/m2 inclusive. * history of perennial allergic rhinitis to house dust mite for more than 1 year. * positive skin prick test (spt) for dermatophagoides pteronyssinus (der p) allergen at screening or within 12 months prior to the screening visit. main exclusion criteria: * any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study. * use of any medication considered to have an influence on the outcome of the study during the eec session, at the discretion of the investigator and/or designee. * recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, that might interfere with study results as determined by the investigator and/or designee.

Keywords: allergic rhinitis symptoms runny nose itchy nose
osteopathic sympathetic harmonization and depression

Conditions: Osteopathic Manipulative Treatment

Summary: depression appears to be resistant to the available pharmacological treatments. autonomic responses accompanied by any psychological stress are sympathetic nervous system (sns) and neuroendocrine responses are formed by hypothalamus-pituitary-adrenal (hpa) axis. the purpose of this study is; assessment of effectiveness of osteopathic approach on sympathetic nervous system and hpa axis in adolescents with depression.

depression diagnosed and volunteer to participate 39 cases who between the ages of 15-21 included. all participants were recruited and randomly assigned into two groups, the osteopathy group (og) and the placebo group (pg). stimulation on the sympathetic truncus and prevertebral ganglia were performed in the og group. the stimulation of the pg group was performed with a lighter touch and a shorter duration in similar areas. each participant was filled in the demographic data form, beck depression scale and state and trait anxiety inventory (stai form - 1 and form - 2) before the application. emotional state visual analog scale and stai form - 1 was filled and blood pressure and pulse measurement were made and saliva sample was taken before application, immediately after application and 20 minutes after application.

Eligibility criteria:
inclusion criteria: * to be diagnosed with clinical depression by a psychiatrist according to the diagnostic and statistical manual of mental disorders (dsm-5) criteria * volunteering to participate in the study exclusion criteria: * fever over 38.5 * acute injury or infection * rib fracture * cardiac arrhythmia * using drugs that affect cortisol levels (oral contraceptives, hormonal drugs, antidepressants, antipsychotics etc.) * being pregnant, premenstrual or in the menstrual period for female participants

Keywords: depression sympathetic nervous system cortisol
confounder-corrected quantitative mri biomarker of hepatic iron content

Conditions: Iron Overload; Hemochromatosis; Hemosiderosis

Summary: the purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected r-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.

this multi-center, multi-vendor study will validate a rapid magnetic resonance-based confounder-corrected r2\* mapping method as a quantitative imaging biomarker of liver iron concentration (lic). excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. measurement of lic is critical for detection and staging of iron overload, and for monitoring iron-reducing chelator therapies that are expensive and have side effects. magnetic resonance imaging (mri) is a widely available, accessible, and safe technology, and it is very sensitive to the presence of iron in tissue. translation of an mri biomarker of liver iron concentration into broad clinical use requires that it is clinically feasible, precise, robust to changes in scan parameters, calibrated to a validated reference standard of lic, and is reproducible across sites and manufacturers. there are currently no available mri methods that meet these requirements. r2\*-mri holds the greatest promise to meet these requirements. r2\* mapping can be performed very rapidly with whole-liver 3d coverage in a single 20s breath-hold. protocol modification approved to include additional liver susceptibility measurements for approximately 10 participants (already enrolled at the uw) via recently acquired superconducting quantum interference device (squid). the completion of this additional imaging will depend upon the successful set up and installation of this device. per a protocol amendment approved on 10/11/21, the investigators are re-opening the study and increasing enrollment for control subjects. up to 20 control subjects (changed from 5) will be enrolled.

Eligibility criteria:
inclusion criteria: * know or suspected iron overload * minimum age: stanford- 8years , university of wisconsin - 10 years, john hopkins follow- 10 years, university of texas-southwestern - 18 years exclusion criteria: * contraindication to magnetic resonance imaging

Keywords: mri iron overload
changes in renal papillary density after hydration therapy in calcium stone formers

Conditions: Urolithiasis

Summary: patients with recurrent calcium oxalate stones undergoing endourological procedures for renal stones at our institution from june 2013 to june 2014 were considered eligible for enrolment. enrolled patients underwent a baseline unenhanced ct scan before the urological procedure; after endoscopic removal of their stones, the patients were instructed to drink at least 2 l/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°c \<200 mg/l) for at least 12 months. finally, the patients underwent a follow-up unenhanced ct scan during hydration regimen.


Eligibility criteria:
inclusion criteria: * patients undergoing endourological procedures for renal stones * recurrent stone disease * calcium oxalate stones (\>50% of the stone made of calcium oxalate) exclusion criteria: * systemic conditions causing stones (hyperparathyroidism, intestinal malabsorption, renal tubular acidosis) * non-calcium oxalate stones
use of sb424323 with aspirin in non-valvular atrial fibrillation in patients at a low or intermediate risk for stroke

Conditions: Fibrillation, Atrial; Atrial Fibrillation

Summary: this study will allow determination of the pharmacokinetic and pharmacodynamics of sb424323 in a relevant population. the data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.

a randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of sb424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

Eligibility criteria:
inclusion criteria: * patients with non valvular atrial fibrillation and any of the following: * \</= 60 years old with no heart disease. * 60 years old with heart disease but no risk factors. * \>/=60 years old and \</=75 years old with no risk factors and no heart disease. * must be able to take aspirin. exclusion criteria: * previous heart attack or stroke. * history of high blood pressure, diabetes or a prior blood clot. * liver or kidney disease. * need for anti-thrombotic or anti-platelet drugs. * need for cardiovascular medicines.

Keywords: non valvular atrial fibrillation stroke aspirin
study of olaparib (lynparza™) versus enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer (profound study)

Conditions: Metastatic Castration-resistant Prostate Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.

this is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mcrpc) who have failed prior treatment with a new hormonal agent (nha) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (hrr) pathway. subjects will be divided into two cohorts based on hrr gene mutation status. approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.

Eligibility criteria:
inclusion criteria 1. histologically confirmed diagnosis of prostate cancer. 2. documented evidence of metastatic castration resistant prostate cancer (mcrpc). 3. subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or crpc . 4. ongoing therapy with lhrh analog or bilateral orchiectomy. 5. radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy). 6. qualifying hrr mutation in tumor tissue. exclusion criteria 1. any previous treatment with parp inhibitor, including olaparib. 2. subjects who have any previous treatment with dna-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization. 3. other malignancy (including mds and mgus) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years. 4. subjects with known brain metastases.

Keywords: metastatic castration-resistant prostate cancer (mcrpc) homologous recombination repair (hrr)
opioid free management after ureteroscopy

Conditions: Kidney Stone

Summary: the purpose of this research study is to compare how well two medications work to control post-operative pain.

this will be a randomized double blinded control trial with subjects randomized to either opioid group (norco 5-325 milligram) or a non-opioid group (ibuprofen 400 milligram). subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. subjects eligible for the study will have a discussion with the study team member about treatment options. subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. the ureteroscopy will be performed using standard of care instruments and techniques. no changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. post operatively; investigators plan to discharge all subjects home from the recovery unit. all subjects will be seen one week after surgery for follow up, questioner filling and stent removal.

Eligibility criteria:
inclusion criteria: * ureteroscopy performed for renal stones * age over 18 years * two kidneys exclusion criteria: * solitary kidney * poor kidney function (gfr\<30) * allergy to either ibuprofen or norco * pelvic kidney

Keywords: ureteroscopy opioid non-opioid stent placement nephrolithiasis
storage of bile from routine procedures to study risk factors

Conditions: Gallbladder Cancer; Cholangiocarcinoma; Biliary Tract Cancer

Summary: the purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.

the specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. the development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.

Eligibility criteria:
inclusion criteria: * presenting to iu for treatment of biliary tract disease; age greater than or equal to 18 exclusion criteria: * problems other than biliary tract disease

Keywords: storage bile biomarkers biliary malignancies
impact of new immunological diagnosis tests of latent tuberculosis before anti tnf therapy

Conditions: Tuberculosis

Summary: tuberculosis is a current infection during anti tnf therapy. after infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have latent tuberculosis infection (ltbi) wich can reactivate later. in order to prevent this tuberculosis reactivation, ltbi diagnosis screening is preconised in patients who need anti tnf therapy. this diagnosis is made till now by the tuberculin skin test (tst) but this test is not specific of tb. new blood tests (qftb-g and t-spot.tb) specific to mtb infection are now available. the primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of ltbi in patients before anti tbf therapy

detailed description : principal outcome: therapeutic impact of the use of new tests for diagnosis of ltbi in patients before anti tbf therapy secondary outcomes : * medico-economic impact of replacement of tst by qftb-g and t-spot.tb tests in ltbi screening in patients before anti tnf therapy. * concordance of qftb-g and t-spot.tb tests results with tst * concordance between qftb-g and t-spot.tb tests and evaluation of indetermined tests. * concordance of qftb-g and t-spot.tb tests results with patient disease. * concordance of qftb-g and t-spot.tb tests results with tst in patients with ltbi determinated by clinical or radiological observation * impact of geographical, disease and treatment in patients with ltbi determinated by clinical or radiological observation * identify the original characteristic and maximal impact therapeutic of qftb-g and t-spot.tb test analysed criteria : * therapeutic impact * patients percentage with different therapeutic outcome based on usual recommendations medico-economic * medico-economic impact :impact of both tests as early and late cost - efficacy statistic : * primary criteria : percentage of patients for whom therapeutic would have been changed by qftb-g and t-spot.tb tests results compared to usual diagnosis strategy. * secondary criteria : concordance of qftb-g and t-spot.tb tests with tst concordance between both qftb-g and t-spot.tb tests . 400 patients timing : inclusions : 1 years

Eligibility criteria:
inclusion criteria: * 18 years old * patient with rheumatoid arthritis or ankylosing spondylitis or crohn's disease * patient without anti tnf treatment and who need one by infliximab, adalimumab or etanercept * consent signed * patient with social right * patient who have been examined exclusion criteria: * pregnancy and breast feeding

Keywords: anti tnf therapy tuberculosis tuberculin test qftb-g t-spot.tb need anti tnf therapy
treatment of hyperuricemia with rasburicase in patients with acute lymphoblastic leukemia or high grade lymphoma

Conditions: Adult Acute Lymphocytic Leukemia; High-grade Lymphoma

Summary: in this study the efficacy and tolerability of two approaches to treat and prevent hyperuricemia is tested in patients with acute lymphoblastic leukemia or high-grade lymphoma with high risk of tumor lysis syndrome. both arms are compared by randomisation. in one arm patients receive during pre-phase chemotherapy conventional prophylaxis with allopurinol whereas in the other arm rasburicase is used.


Eligibility criteria:
inclusion criteria: * patients of the gmall b-all/nhl-study 2002 * patients of the gmall-study 07/2003 * patients of the gmall-study elderly 1/2003 which fulfill the following criteria: * bulky disease (\> 7.5 cm) * high ldh (\> 2 x unl) * uric acid \>8 mg/dl/ \>475µmol/l at diagnosis * leukocytes \> 30 000/µl exclusion criteria: * exclusion criteria of the gmall b-all/nhl study 2002 or the gmall-study 07/2003 or gmall-elderly 1/2003 and: * asthma or severe, live-threatening atopic allergy in history * hypersensitivity against uric acid * glucose-6-phosphate-dehydrogenase deficiency * pretreatment with rasburicase or urikozyme™
day-case versus inpatient laparoscopic supracervical hysterectomy

Conditions: Hysterectomy

Summary: the purpose of this study is to determine if women subjected to laparoscopic supracervical hysterectomy in a day-case setting would be less satisfied with the length of hospital stay when compared with women who had an overnight stay following their surgical procedure. the null hypothesis was that there was no difference in satisfaction with length of hospital stay.

objective: to determine whether women having day-case laparoscopic supracervical hysterectomy (lsh) are as satisfied with the length of stay in hospital as women who stay overnight following the procedure. design: randomised controlled trial (rct). setting: ulleval university hospital, oslo, norway. population: 49 women scheduled for lsh were enrolled and 45 patients completed the study (22 in the inpatient group and 23 in the day-case group). methods: women were randomised to either day-case care or overnight hospital stay following a routine supracervical hysterectomy. the primary outcome measure was satisfaction with the length of stay in the hospital (measured on a 10-point visual analogue scale) and secondary measures were health-related quality of life (measured using the euroqol eq5d), anxiety (measured using the state-trait anxiety inventory for adults (stai) and general questions about their experiences of having the operation. readmissions, prolonged hospitalisations, complications and any contact with a health professional after discharge were also recorded. measures were taken on the day of surgery (postoperatively), and on days 1, 2, 4 and 7 following surgery. the data were analysed based on an intention to treat.

Eligibility criteria:
inclusion criteria:. * women requiring a hysterectomy for benign conditions exclusion criteria: * previous history of cervical dysplasia, an abnormal smear test within the last two to three years, * abnormal histology or cytology at endometrial sampling, * a history of endometriosis, * advanced endometriosis diagnosed intra-operatively, * previous major abdominal or pelvic surgery (patients with previous caesarean section were considered as eligible), * a mental disorder or somatic disease that would interfere with a normal recovery pattern such as substance dependence disorder, * psychosis, or american society of anaesthesiologists (asa) rating 3 and 4 patients, and * inability to understand and execute oral and written norwegian language. * women were also excluded from the study if they did not have an adult carer (a relative or a friend) staying with them during the first night after discharge; or they were living or staying at a hotel more than an hour's drive from the hospital; and if they did not have access to a telephone.

Keywords: hysterectomy laparoscopy day-case surgery quality of life ambulatory surgical procedures