Kornimate/medical-research-clean huggingface dataset:
thrombus aspiration in thrombus containing culprit lesions in non-st-elevation myocardial infarction (tatort-nstemi)

Conditions: Non-ST-elevation Myocardial Infarction

Summary: whereas thrombus aspiration in patients with st-elevation myocardial infarction (stemi) is recommended by current guidelines, there are insufficient data to unequivocally support thrombectomy in patients with non-stemi (nstemi). the thrombus aspiration in thrombus containing culprit lesions in non-st-elevation myocardial infarction (tatort-nstemi) trial is a 400 patient, prospective, controlled, multicenter, randomized, open-label trial. the hypothesis is that under the background of early revascularization, adjunctive thrombectomy in comparison to conventional percutaneous coronary intervention (pci) alone leads to less microvascular obstruction (mo) assessed by cardiac magnetic resonance imaging (cmr) in patients with nstemi. patients will be randomized in a 1:1 fashion to one of the two treatment arms. the primary endpoint is the extent of mo assessed by cmr. secondary endpoints include infarct size and myocardial salvage assessed by cmr, enzymatic infarct size as well as angiographic parameters, such as thrombolysis in myocardial infarction-flow post-pci and myocardial blush grade. furthermore, clinical endpoints including death, myocardial reinfarction, target vessel revascularization and new congestive heart failure will be recorded at 6 and 12 months. safety will be assessed by bleeding and stroke. in summary, the tatort-nstemi trial has been designed to test the hypothesis that thrombectomy will improve myocardial perfusion in patients with nstemi and relevant thrombus burden in the culprit vessel reperfused by early pci.


Eligibility criteria:
inclusion criteria: * ischemic symptoms such as angina pectoris \>20 minutes * occurrence of last symptoms \<72 h before randomization * cardiac troponin t or i levels above the 99th percentile * culprit lesion containing thrombus (timi-thrombus grade 2-5 within the lesion) and intended early pci exclusion criteria: * cardiogenic shock * stemi * no identifiable culprit lesion or a timi-thrombus grade \<2 * coronary morphology ineligible for thrombectomy (e.g. very tortuous vessels, severe calcification) * indication for acute bypass surgery * age \ 90 years * contraindications for treatment with heparin, aspirin or thienopyridines * pregnancy * current participation in another clinical study * co-morbidity with limited life expectancy \<6 months * contraindications to cmr at study entry

Keywords: non-st-elevation myocardial infarction thrombectomy magnetic resonance imaging microvascular obstruction
laboratory assessment of pilairo q cpap mask performance and ease of use.

Conditions: Obstructive Sleep Apnea

Summary: participants will undergo a normal sleep study. they will be randomised to use either a fph pilairo q nasal pillow cpap mask, or another mask. the sleep technician will record leak and pressure data, and complete questionnaires regarding satisfaction and ease of use at the end of the night. it is hypothesised that the pilairo q mask will be superior to other standard masks for cpap therapy in terms of ease of use, satisfaction and overall titration experience.

participants will be recruited from patients who visit the sleep lab for cpap titration. only eligible participants, that provide written informed consent, will be enrolled into the investigation only those participants whom are previously diagnosed with an ahi \>5 can be approached and enrolled into the study. once the consent form has been signed, participants will be randomly assigned to receive either pilairo or any other standard care nasal/nasal pillows mask for their cpap titration. a randomisation log will be provided by fph. the titration session will take place as per the lab's routine practice. throughout the night the sleep technician will record in the crf the absolute leak value for the mask every 10 minutes. at the end of the session the sleep technician will complete a questionnaire in relation to the titration experience for that participant/mask. the data will be collected in the crf that fph staff will provide to the site.

Eligibility criteria:
inclusion criteria: * ahi equal or greater than 15 from the diagnostic night. * equal or greater than 18 years of age exclusion criteria: * inability to give informed consent. * history of intolerance to cpap. * anatomical or physiological conditions making cpap therapy appropriate (for example a deviated septum)
an evaluation of an oral antidiabetic agent for the treatment of type 2 diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this study is to determine if an investigational drug is safe and efficacious for poorly controlled type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes for at least 3 months. * diabetes managed with diet and exercise alone or with either metformin or sulfonylurea alone as an adjunct to diet and exercise. * diabetes therapy must be unchanged for at least 3 months prior to screening. * females must be of non-childbearing potential (surgically sterilized or at least 1 year post-menopausal, as defined by cessation of menses). female patients who are not surgically sterilized and who are less than or equal to 45 years should have their post-menopausal status confirmed by fsh greater that 30ng/ml at screening. exclusion criteria: * current use of insulin or any antidiabetic agent other than a sulfonylurea agent or metformin. * current use of metformin or a sulfonylurea agent in combination. * history of liver disease. * history of unstable angina (as defined by the braunwald system), myocardial infarction, or a coronary revascularization procedure within the past 6 months. * currently suspected carcinoma or history of carcinoma in the last 5 years, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.

Keywords: type 2 diabetes
comparing covered self-expandable metallic stent (sems) above/across the sphincter of oddi

Conditions: Cancer of Bile Duct; Pancreatic Cancer

Summary: the purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of oddi, in malignant bile duct obstruction.


Eligibility criteria:
inclusion criteria: * inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or cbd, \>= 18 years old * bile duct or gallbladder cancer invading cbd or distal chd * pancreatic cancer with mid or distal cbd invasion * cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of vater. * first attempt of endoscopic biliary metallic stenting * negative history of biliary tract surgery * life expectancy at least longer than 4 months (karnofsky score \>60%) exclusion criteria: * ampullary cancer * klatskin tumor * combined intrahepatic bile duct cancer * patient with hemobilia * previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 fr within 14 days

Keywords: cbd hbd cancer of bile duct pancreatic cancer
comparison of subconjuctival versus topical bevacizumab as adjunct therapy to trabeculectomy

Conditions: Complications of Treatment; Progression

Summary: bevacizumab is an anti vascular endothelial growth factor(anti-vegf) substance that is known to reduce neovascularization and fibrovascular proliferation in inflammatory conditions, including post-operative inflammation. it has shown efficacy in numerous ocular conditions(off-label), that includes age related macular degeneration, proliferative diabetic retinopathy, neovascular glaucoma and corneal neovascularization. it is being explored as an option for preventing recurrence of pterygium and as an adjunct to improving outcomes of trabeculectomy. there is a debate as to the mode and duration of bevacizumab administration for trabeculectomy. this study aims to compare a single subconjunctival dose of bevacizumab with topical therapy over one month in terms of outcomes of trabeculectomy surgery, non-progression of field loss and stable intraocular pressure(iop) control.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * progression * failure to reach target iop * non compliant exclusion criteria: * resurgery * systemic contraindication to bevacizumab * all other forms of glaucoma

Keywords: trabeculectomy bevacizumab anti-vegf efficacy
the thoracic peri-operative integrative surgical care evaluation trial - stage iii

Conditions: Lung Cancer; Gastric Cancer; Esophageal Cancer

Summary: despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. these issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (hrqol). on a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. too many clinical trials focus on single agent therapies, rather than broad multi-faceted individualized and integrative care interventions that are used in real world settings. the thoracic poise project has the overarching goal of improving care for thoracic cancer patients by impacting hrqol, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery.


Eligibility criteria:
inclusion criteria • adults eligible for complete resection of lung, gastric or esophageal cancer exclusion criteria * small cell, carcinoid, or gastrointestinal stromal (gist) tumours * any wedge resections of lung cancer * history of cancer with active treatment in the last 3 years (not including superficial bladder cancer or non-melanoma skin cancer) * patients currently receiving care guided by an nd or who have previously seen an nd in the last 3 months * pregnant or breastfeeding women\* * any reason which, in the opinion of the principal investigator (or delegate), would prevent the subject from participating in the study * use of an investigational drug or participation in an investigational study within 30 days prior to starting the study

Keywords: natural health products thoracic cancer surgery integrative care nutrition physical activity psychological health
different modalities interventions post supracondylar humeral fracture in pediatrics

Conditions: Supracondylar Humeral Fracture in Pediatric

Summary: the aim of the study is comparing the effects of lllt and pemft on range of motion of elbow and radioulnar joint ,pain ,muscles strength of upper limb and hand function in children with post-operative type ii and iii supracondylar humeral fracture.

intervention study describe the effects of low level laser and pulsed electromagnetic field in children with supracondylar humeral fracture . all children will be randomly classified by envelope method into two study groups of equal number. study group a and study group b. both groups will receive designed physical therapy program, 20 minutes, 3 times per week for six weeks in addition to study group a will receive lllt, 5 minutes and study group b will receive the same physical therapy program, in addition to pemf, 20 minutes.

Eligibility criteria:
inclusion criteria: 1. age ranges from 6 to 10 years of both genders. 2. all subjects have unilateral extension type ii and iii supracondylar humeral fracture requiring closed reduction and percutaneous pinning (crpp). 3. the study will be start immediately after removal the splint. 4. children clinically and medically stable. 5. children able to follow verbal commands. 6. children sample will represent those children who enrolled in schools and other not yet. - exclusion criteria: the patients will be excluded if they have one of the following criteria; 1. previous soft tissue injury at the same affected side of fracture. 2. presence of associated fractures on the ipsilateral or contralateral upper limb. 3. active infection near the fracture site. 4. children with congenital or acquired skeletal deformities in the upper limbs. 5. children with neurological deficits such as convulsions, involuntary movements, receiving muscle relaxants. -

Keywords: schf- low level laser- pulsed electromagnetic field.
probiotics to promote intestinal health

Conditions: Communicable Diseases; Infection; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions

Summary: the purpose of this study is to evaluate the effectiveness of bacteria called lactobacillus gg, a probiotic, in preventing the growth of resistant bacteria in the digestive tract in patients on broad spectrum antimicrobials.


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years old * admission to the non-icu medical and surgical wards * on broad spectrum antimicrobials with an anticipated length of stay of \>48 hours exclusion criteria: * pregnancy * non english speaking * expected to die within 7 days * unable or unwilling to consent * hiv infection with a cd4 count \<200 * neutropenia with an absolute neutrophil count less than 500 cells/ml (or expected to drop to less than 500) * clinically significant diarrhea or history of c. difficile infection in the last 3 months * history of vre colonization and/or infection in the last year * transplant recipients

Keywords: probiotics
comparison of wash wipes and standard care in the prevention of incontinence-associated dermatitis in elderly

Conditions: Irritant Contact Dermatitis Due to Incontinence; Diaper Rash; Pressure Ulcer; Incontinence-associated Dermatitis

Summary: incontinence is a widespread problem in all health care setting. one of the main complications of incontinence is inflammation of the skin in the genital and anal region, also known as incontinence-associated dermatitis (iad). iad is a known risk factor of pressure ulcer development. prevalence figures of iad vary between 5.6% and 50%. the primary aim of this study is to compare the effectiveness of a 3-in-1 genital wipe versus standard care (traditional water and soap) for the prevention of iad. the second aim is to perform a health economic evaluation of the 3-in-1 genital wipe versus standard care, and third to compare the cost of a 2-in-1 total body wash wipe versus standard care for total body wash. other outcomes are the comfort and tolerance of both the nurses and participants. in this randomized controlled trial, performed in 13 long-term care settings, the participants will undergo a 30 day study period. in the experimental intervention, the participants will be washed with body wash wipes and genital wipes. in the control group, the subjects will receive traditional care. iad as well as pressure ulcer prevalence will be monitored. subjective and objective time measurements will be performed.


Eligibility criteria:
inclusion criteria: * urinary incontinence, fecal incontinence or double incontinence * depending on help for washing * free of skin damage (without signs of pressure ulcers or iad such as skin breakdown or redness) exclusion criteria: * not incontinent or minor incontinent (e.g. stress incontinence) * urinary or fecal catheter * use of incontinence wipes in the uro-genital area two weeks prior to the start of the study * the use of a skin barrier product in the uro-genital area two weeks prior to screening * presence of a bacterial/fungal infection in the uro-genital area

Keywords: elderly long-term care
does coenzyme q 10 supplementation reduce muscle pain caused by statins? (cholesterol lowering medications)

Conditions: Statin Induced Myalgia

Summary: the purpose of this study is to determine whether coenzyme q 10 supplementation will decrease the rate of muscle pain in patients with previous statin related muscle pain.


Eligibility criteria:
inclusion criteria: * patients treated for hyperlipidemia with a hmg-coa reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms exclusion criteria: * patients with other identifiable cause of myopathy. patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.

Keywords: coenzyme q 10 statin myalgia
umbilical or adult donor red blood cells in extremely low gestational age neonates and retinopathy of prematurity (born)

Conditions: Retinopathy of Prematurity

Summary: extremely low gestational age neonates (elgan, i.e., born before 28 gestation weeks) are among the most heavily transfused pediatric patients. in this clinical setting, repeated red blood cell (rbc) transfusions independently predict a poor outcome, with a higher risk for mortality and morbidity. recent studies from our own and other groups highlighted a close association between low levels of fetal hemoglobin (hbf) and severity of retinopathy of prematurity (rop) and bronchopulmonary dysplasia (bpd), two disabilities that frequently complicate preterm birth. this association is not surprising, considering that 1) preterm neonates have a highly immature antioxidant reserve and both rop and bpd rely on the oxidative damage as underlying mechanism; 2) in comparison with hba, hbf is endowed with higher oxygen affinity, greater redox potential, higher tetrameric stability, and higher ability to generate unbound nitric oxide, all functions potentially protective in presence of an oxidative challenge; 3) in normal prenatal life, developing organ and tissues are exposed exclusively to hbf until last weeks of gestation; 4) in preterm neonates, the switch of the synthesis from hbf to hba occurs around their due date, i.e., several weeks after the premature birth; 5) when preterm neonates receive transfusions, their tissues are abruptly exposed to high levels of hba. we have recently run a pilot trial demonstrating as a proof-of-concept that transfusing cord blood red blood cell concentrates (cb-rbc) effectively prevents or restrains the hbf loss consequent to adult donor standard transfusions (a-rbc). this study explores the hypothesis that transfusing cb-rbcs instead of a-rbc may lower the incidence of severe rop in elgans needing transfusions.


Eligibility criteria:
inclusion criteria: * gestational age (ga) at birth between 24+0 and 27+6 weeks * signed informed consent of parents. exclusion criteria: one or more of the following: * maternal-fetal immunization * hydrops fetalis * major congenital malformations associated or not with genetic syndromes * previous transfusions * hemorrhage at birth * congenital infections * health care team deeming it inappropriate to approach the infant's family for informed consent.
granulocyte-colony stimulating factors or antibiotics for primary prophylaxis for febrile neutropenia

Conditions: Early Stage Breast Cancer

Summary: taxotere-cyclophosphamide (tc) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. tc chemotherapy can cause febrile neutropenia (fn) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. to reduce the risk of chemotherapy-induced fn,tc is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (g-csf). however, there are considerable cost differences between these strategies; subcutaneous daily g-csf costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100. the investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. this feasibility study (react-tc nct02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing g-csf with ciprofloxacin. this study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer * planned tc chemotherapy * ≥19 years of age * able to provide verbal consent exclusion criteria: * contraindication to either ciprofloxacin or g-csf
the registry study to compare the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries

Conditions: Coronary Artery Disease; Total Occlusion of Coronary Artery

Summary: the aim of this study is to find strategy for treatment through comparing the cardiopulmonary exercise test parameters before and after cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.


Eligibility criteria:
inclusion criteria: * age 19 and more * chronic total occlusion of coronary artery disease * cardiac rehabilitation exclusion criteria: * not applicable

Keywords: cardiopulmonary exercise test chronic total occlusion cardiac rehabilitation
evaluation of intensive parent-child interaction therapy"

Conditions: Behavior Problem; Parenting

Summary: the purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of parent-child interaction therapy (i-pcit; 5 days/week over the course of 2 weeks) versus a more traditional weekly pcit format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (ebp).

the purpose to the current study was to examine the comparative efficacy of a more condensed intensive version of parent-child interaction therapy (i-pcit; 5 days/week over the course of 2 weeks) versus a more traditional weekly pcit format (1 day/week over the course of 10 weeks) in treating early childhood externalizing behavior problems (ebp). using a randomized trial design, 60 young children (m child age = 4.33 years; range 2-6.92; 65% male; 85% latinx) with elevated levels of ebp and their mothers were assigned to either i-pcit (n = 30) or traditional pcit (n = 30). families completed pre-treatment and post-treatment assessments as well as a follow-up assessment 6-9 months following treatment completion. across all assessments, mothers completed measures of child behavior, discipline practices, and parenting stress. observational data on child behavior and parenting was also collected during three 5-minute standard situations that vary in the degree of parental control (child-led play, parent-led play, \& clean-up).

Eligibility criteria:
inclusion criteria: * children had to be between 2 and 7 years of age * mothers had to rate their children above the clinically significant range (t-score \> 60) on a measure of child ebp (eyberg child behavior inventory; eyberg \& pincus, 1999), * be willing to come to treatment every day (monday - friday) during a two-week period, * both mother and child had to be able to speak and understand english. exclusion criteria: * an intellectual disability (full scale iq \< 70 based on the wppsi-iv; wechsler, 2012), * a previous autism spectrum disorder diagnosis, * the inability of parents to attend sessions daily.