Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study to evaluate denosumab compared with zoledronic acid in postmenopausal women with osteoporosis

Conditions: Post Menopausal Osteoporosis

Summary: this study will compare the effectiveness of denosumab treatment every 6 months with once yearly zoledronic acid treatment on bone mineral density (bmd) at various skeletal sites.


Eligibility criteria:
inclusion criteria: * ambulatory postmenopausal women. * age 55 years or older * subject has provided informed consent prior to any study specific procedures * received oral bisphosphonate therapy for osteoporosis at least 2 years prior to screening visit * screening bmd (g/cm²) values at the lumbar spine, total hip or femoral neck values of equal to or less than those listed in the protocol. * at least 2 lumbar vertebrae and one hip must be evaluable by dual energy x-ray absorptiometry (dxa) at the screening visit exclusion criteria: * received other osteoporosis treatment or bone active treatment * evidence of history of any of the following: * hyperthyroidism (stable on antithyroid therapy is allowed) * hypothyroidism (stable on thyroid replacement therapy is allowed) * hypo- or hyperparathyroidism * hypo- or hypercalcemia based on the central laboratory reference ranges * recent tooth extraction (within 6 months of screening visit) * paget disease of bone (subject report or chart review) * other bone diseases which affect bone metabolism (eg, osteopetrosis, osteogenesis imperfecta) (chart review) * abnormalities of the following per central laboratory reference ranges: * vitamin d deficiency (25\[oh\] vitamin d level \< 20 ng/ml), repletion will be allowed and subjects may be re-screened * hypercalcemia * elevated transaminases ≥ 2.0 x upper limits of normal (uln) * history of any solid organ or bone marrow transplant * malignancy (except nonmelanoma skin cancers, cervical or breast ductal carcinoma in situ) within the last 5 years * known intolerance to calcium or vitamin d supplements * self-reported alcohol or drug abuse within 12 months prior to screening * currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) * history or evidence of any other clinically significant disorder, condition or disease that in the opinion of the investigator or amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
characteristics of patients with type 2 diabetes mellitus (cvd-rndr)

Conditions: Type 2 Diabetes

Summary: this observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (t2dm) who were initiating use or treatment with sodium-glucose co-transporter-2 (sglt-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on national russian diabetes registry data.


Eligibility criteria:
inclusion criteria are: * new user receiving or dispensed prescription of sglt-2 inhibitor medication or other gld treatments oral as well as injectable, including fixed-dose combination (fdc) products containing these medication groups; * t2dm diagnosis on or prior to the index year; * ≥ 18 years old at index year. exclusion criteria are: * patients with a t1dm diagnosis on or prior to index year and only insulin use in the year prior to index; * patients with a gestational diabetes in the index year or 1 year prior to index.
trial to evaluate the efficacy and safety of a combination therapy of candesartan and amlodipine versus candesartan monotherapy in hypertensive patients inadequately controlled by candesartan monotherapy

Conditions: Hypertension

Summary: a phase 3 trial to evaluate the efficacy and safety of a combination therapy of candesartan and amlodipine versus candesartan monotherapy in hypertensive patients inadequately controlled by candesartan monotherapy


Eligibility criteria:
inclusion criteria: * age of 19 or above * inadequately controlled essential hypertension at screening 1. drug naive or didn't take antihypertensive drug within 2 weeks prior to visit 1 * mean sitdbp ≥ 95mmhg on target arm 2. taking antihypertensive drug but not controlled * mean sitdbp ≥ 90mmhg on target arm * inadequately controlled after 4 weeks of candesartan 16mg monotherapy * mean sitdbp at visit 2 ≥ 90mmhg on target arm * ability to provide written informed consent exclusion criteria: * the change of mean sitdbp ≥ 10mmhg or mean sitsbp ≥ 20mmhg on target arm at visit 1 * mean sitdbp ≥ 120mmhg or mean sitsbp ≥ 200mmhg on target arm at visit 1 and visit 2 * known to suspected stage 2 hypertension(aortic coarctation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) * patient with congestive heart failure(nyha class iii, iv) * patient with unstable angina pectoris, myocardial infarction, valvular heart disease, arrhythmia(treatment required) within 3 months * history of stroke, cerebral hemorrhage within 6 months * type i diabetes mellitus, type ii diabetes mellitus with hba1c \> 8.5% * history of severe or malignant retinopathy * ast/alt \> unl\*3, serum creatinine \> unl\*1.5, k \> 5.5meq/l * patient with acute or chronic inflammatory(treatment required) status * patient who need to take antihypertensive drug besides investigational products * patient must be treated with medications prohibited for concomitant use during the study period * history of angioedema related to ace inhibitor or angiotensin ii receptor blockers * hypersensitive to candesartan/amlodipine * patient who are dependent on drugs or alcohol within 6 months * history of disability to drug adme, active inflammatory bowel syndrome within 12months, impaired pancreatic function, gi bleeding, obstructions of urinary tract * patients treated with other investigational product within 30 days at first time taking the investigational product * women with pregnant, breast-feeding * history of malignant tumor within 5 years * not eligible to participate for the study at the discretion of investigator

Keywords: hypertension
stenting and angioplasty with protection in patients at high risk for endarterectomy (sapphire)

Conditions: Carotid Artery Disease

Summary: the primary objective of this study is to compare the safety and effectiveness of the cordis nitinol carotid stent and delivery systems (5.5 f and 7 f) with the angioguard xp distal protective device to cea in the treatment of carotid artery disease in patients at increased risk for surgery.


Eligibility criteria:
inclusion criteria: 1. the patient must be \> 18 years of age. 2. the patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as: * one or more tias, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or * one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis \>50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, or the patient must have a \>80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms. 3. to be entered into the study, the patient must have one or more of the following conditions: * congestive heart failure (class iii/iv) and/or known severe left ventricular dysfunction lvef \< 30% * open heart surgery within six weeks * recent mi (\>24 hours and \<4 weeks) * unstable angina (ccs class iii/iv) * synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization * age greater than 80 years as a single risk factor. exclusion criteria: 1. the patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours. 2. the patient has an intracranial mass lesion (i.e., abscess, tumor, or infection). 3. the reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm by quantitative analysis. see instructions for use, for proper stent sizing. the exception to this would be with a lesion having \>95% stenosis where the true diameter of the distal vessel can not be determined such as the case with a string sign or distal vessel collapse. in this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm. 4. the patient has known peripheral vascular, supra-aortic or internal carotid artery tortuosity which preclude the use of catheter-based techniques if so randomized. 5. the patient has any intracranial aneurysm (\> 9 mm).
varithena versus endothermal ablation of the great saphenous vein (veritas)

Conditions: Varicose Veins

Summary: the purpose of this study is to observe insights into the benefits of varithena compared to endothermal ablation (eta) in the treatment of the great saphenous vein.

to collect comparative evidence on patient reported outcomes of varithena compared to eta when used to treat the incompetent great saphenous vein (gsv). eta will include either radiofrequency ablation or endovenous laser ablation according to the site's standard practice. to provide long term (1-year, 2-year, and 3-year) outcomes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * primary gsv incompetence, defined as reflux \> 0.5 seconds on duplex ultrasound in a single limb (note the contralateral limb can have varicosities or svi if intervention is not required within 3 months i.e. asymptomatic) * failed conservative therapy (compression, diet, exercise, leg elevation) * ceap clinical condition classification c2 - c6 * vein diameter 5-10mm, inclusive * gsv treatable length \> 10cm * superficial venous disease manifest by clinical symptoms (rvcss ≥ 4) * able to comprehend and sign an informed consent document and complete written study questionnaires * willing and able to return for scheduled follow-up visits (7-days, 3-months, 6-months, 12-months, 24-months, and 36-months post-procedure) * willingness to comply with post-treatment compression protocol exclusion criteria: * allergy to polidocanol, xylocaine, or epinephrine * deep vein thrombosis or pulmonary embolism within 3 months prior to randomization or hypercoagulable disorder * post thrombotic deep vein disease above the calf veins * pregnancy or lactating (within 30 days of randomization) * symptomatic peripheral arterial disease or ankle-brachial pressure index (abpi) \< 0.8 * previous treatment to targeted incompetent gsv or previous superficial thrombophlebitis in targeted gsv * previous venous intervention in affected limb in past 3 months * local aneurysmal gsv segments * inability to walk unaided * inability to wear post-procedure compression bandaging and stockings * patients with clinically significant reflux of the small saphenous vein (ssv) or anterior accessory saphenous vein (aasv) * in the clinical judgement of the investigator, patient who will require ipsilateral deep venous intervention within 3 months following randomized treatment * in the clinical judgement of the investigator, patient who will require contralateral venous intervention (superficial or deep) within 3 months following randomized treatment * patient on therapeutic anticoagulants * active malignancy * life expectancy \< 2 years * documented covid-19 infection currently or within 2 months prior to randomization * enrollment in another clinical trial that could confound the endpoint within 3 months prior to screening or within 3 months following enrollment

Keywords: great saphenous vein incompetence
a study of tirzepatide (ly3298176) versus insulin degludec in participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. the study will last about 67 weeks and may include up to 22 visits.


Eligibility criteria:
inclusion criteria: * participants must: * have been diagnosed with type 2 diabetes mellitus (t2dm) * have hba1c between ≥7.0% and ≤10.5% * be on stable treatment with unchanged dose of metformin or metformin plus an sglt-2 inhibitor for at least 3 months before screening * be of stable weight (± 5%) for at least 3 months before screening * have a bmi ≥25 kilograms per meter squared (kg/m2) at screening exclusion criteria: * participants must not: * have type 1 diabetes mellitus * have had chronic or acute pancreatitis any time prior to study entry * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss * have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (alt) enzyme level \>3.0 times the upper limit of normal (uln) for the reference range, as determined by the central laboratory. participants with nonalcoholic fatty liver disease (nafld) are eligible for participation in this trial only if their alt level is ≤3.0 the uln for the reference range * have an estimated glomerular filtration rate \<45 ml/minute/1.73 m2 (or lower than the country specific threshold for using the protocol required dose of metformin per local label) * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2 * have been taking any other diabetes medicines other than metformin, or metformin plus an sglt-2 inhibitor during the last 3 months * have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Keywords: t2dm
prehabilitation to overcome the stress of surgery: the role of nutrition in enhancing postoperative functional capacity

Conditions: Colorectal Cancer

Summary: to determine the impact of nutritional supplementation with whey protein on postoperative functional capacity in patients undergoing colorectal surgery for cancer.it is hypothesized that, compared with a control group receiving nutrition counselling only, patients receiving nutritional counselling along with preoperative and postoperative nutritional supplements will have a significantly improved change in functional walking capacity from baseline to 8 weeks after surgery.

the aims of this research project are the following: 1. determine to what extent a nutritional prehabilitation regimen, which includes whey protein, initiated before surgery and continued after surgery, optimizes the recovery of functional walking capacity following colorectal resection for cancer. 2. to understand further which measures of immediate surgical recovery are sensitive to prehabilitation interventions, and predict change in later outcome measures.

Eligibility criteria:
inclusion criteria: * +18 years of age * referred electively for resection of malignant, non metastasized, colorectal lesions * french or english speaking exclusion criteria: * asa class 4-5 * co-morbid medical, physical and mental conditions (e.g.dementia, disabling orthopedic and neuromuscular disease, psychosis) * cardiac abnormalities * severe end-organ disease such as cardiac failure (new york heart association classes i-iv), copd, renal failure (creatinine \> 1.5 mg/dl, and hepatic failure alt and ast \>50% over the normal range) * sepsis * morbid obesity (bmi \>40) * anemia (hematocrit \< 30 %, haemoglobin \<10g/dl, albumin \< 25mg/dl).

Keywords: cancer colon rectum surgery
tid 1000 mg mesalazine versus tid 2x500 mg mesalazine in active ulcerative colitis (uc)

Conditions: Active Ulcerative Colitis

Summary: the purpose of the trial is to proof whether tid 1000 mg mesalazine is non-inferior to tid 2x 500 mg mesalazine in the treatment of patients with acute ulcerative colitis


Eligibility criteria:
inclusion criteria: * signed informed consent * men or women aged 18 to 75 years * active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology exclusion criteria: * crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis) * toxic megacolon * screening stool positive for germs causing bowel disease * malabsorption syndromes * celiac disease * other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhoea or gastrointestinal bleeding
outcomes following omission of daily routine chest radiographs following pulmonary resection

Conditions: Lung Cancer; Lung Diseases; Lung Cancer, Nonsmall Cell; Surgery; Lung Adenocarcinoma

Summary: currently, it is the standard of care practice to perform daily routine cxr when a chest tube is in situ following pulmonary resection. however, previous research as well as experience of thoracic surgeons suggested this kind of management has poor diagnostic and therapeutic value. eliminating daily routine cxr for adult patients having undergone pulmonary surgery might decrease the frequency of radiation exposure and hospitalization costs per patient without increasing reintervention rates, length of hospital stays, readmission rates or any adverse events.


Eligibility criteria:
inclusion criteria: * adult males or females who plan to receive vats pulmonary resections confined to lobectomies, segmentectomies and wedge resections. * willingness to adhere to randomized treatment. * ability to answer self- and interviewer- administered questions in english * understand and sign a written informed consent form in english exclusion criteria: * previous thoracic surgery history in the same side. * exploration, biopsy, lung volume reduction surgeries (lvrs), bilobectomies, sleeve resections or pneumonectomies performed.
the effect of different wound dressing on prevention of pressure ınjury related to nimv mask

Conditions: Pressure Injury

Summary: this study is aimed to examine the effect of different wound dressings on the prevention of pressure injury in the face area related to noninvasive mechanical ventilation mask. the study was completed out with 102 patients who were followed up in chest diseases and thoracic surgery hospital between october 2019 and august 2020 and met the inclusion criteria of the study. in the study, hydrocellular and hydrocolloid wound dressing was applied to the pressure areas under the mask of noninvasive mechanical ventilation in the intervention groups, while the routine treatment process was followed in the control group. wound dressings were obtained from hartmann. study data were collected with the "individual characteristics form" and "pressure injury rating scale".

in the hospital where the study was conducted, patients with respiratory failure receive nimv treatment with an oro-nasal mask. in the study, hydrocolloid and hydrocellular wound dressings were placed on the pressure areas under the mask of the patients in the intervention group. nimv treatment was applied to the face area of the patients in the control group with an oronasal mask without using any barrier cover. the pressure areas of the patients in the intervention and control groups were evaluated with the pressure injury scale before and after the nimv treatment. follow-up was carried out twice a day for 7 days.

Eligibility criteria:
inclusion criteria: * over 18 years, receiving nimv therapy for at least 6 hours a day, on the first day of hospitalization and followed up for at least 7 days, receiving nimv treatment with an oro-nasal mask, tolerant of mask, exclusion criteria: * patients with pre-treatment pressure injuries in the facial area, patients with diabetes mellitus, patients with mental or psychological problems

Keywords: noninvasive mechanical ventilation pressure injury wound dressing
bleeding, cardio- and cerebrovascular complications in head and neck surgery

Conditions: Head and Neck Cancer

Summary: in this retrospective registry trial, the investigators sought to assess the incidence and predictors of cardiovascular and cerebrovascular complications as well as their derivatives (acute coronary syndrome, decompensated heart failure, an episode of atrial fibrillation requiring cardiologist consultation, stroke, pulmonary embolism and venous thromboembolism) in cohort of patients undergoing head and neck surgery.

inclusion criteria consisted of all the consecutive patients (n=456) diagnosed with head and neck cancer at turku university hospital between 1999 and 2008. patients receiving palliative procedures were also included. patients whose treatment had started in other institute or whose treatment was not finished in the investigators institute and patients with primary diagnosis of skin cancer were excluded from this study. all head and neck surgery operations (n=591) were assessed. information was collected by the first author of this article from referral letters, patient files, anesthesiology reports, intensive care unit reports, laboratory database, radiology database, electrocardiograms and pathology reports. death was certificated from national authority for collecting and compiling statistics on various fields of society and economy.

Eligibility criteria:
inclusion criteria: * patients diagnosed with head and neck cancer in turku university hospital between 1999-2008 exclusion criteria: * skin cancer, treatment started in other institute or not finished in our institute