Kornimate/medical-research-clean huggingface dataset:
hematological disorder in patients with angiodysplasia

Conditions: Angiodysplasia; Hematological Disease

Summary: the study aim will be to assess the association between git angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia.

angiodysplasia is a vascular gi tract abnormality tortous thin walled blood vessels seen in mucosa and submucosa highly prone to rupture resulting in git bleeding and hematological disorders ,impaired coagulation profile and anemia are main changes in angiodysplasia . (an overview of angiodysplasia: management and patient prospects,grainne holleran et al. expert rev gastroenterol hepatol. 2018 sep.) gastrointestinal angiodysplasia is a major cause of recurrent bleeding. haemostatic abnormalities have been implicated in the haemorrhage from these common vascular lesions but their precise contribution remains to be established. (gastrointestinal angiodysplasiag dodda et al. j assoc acad minor phys. 1997) angiodyplasia and aortic stenosis are both conditions that are highly prevalent in elderly people and can often co-exist. recent studies suggest that this association is related to subtle alterations in plasma coagulation factors . the von willebrand factor is the strongest link between aortic stenosis and bleeding associated with gastrointestinal angiodysplasia. with an aging population, the disease burden of aortic stenosis and its association with angiodysplasia of the bowel makes this an incredibly under-diagnosed yet important condition. this association when dealing with elderly patients presenting either with unexplained anemia, gastrointestinal bleeding or with aortic stenosis should be considered. a high index of suspicion and appropriate diagnostic techniques followed by appropriate and prompt treatment could be life-saving. (heyde syndrome complicated by essential thrombocythemia: a case report) chronic hematologic diseases increase the fragility of blood cell components, leading to the progressive destruction of blood cells at the site of aortic stenosis . in this process, further destruction of large multimers of von willebrand factor may lead to coagulation disorders and gastrointestinal bleeding, such as heyde syndrome.

Eligibility criteria:
inclusion criteria: * adults (above 18 years) and elderly * both genders * admitted to git unit with manifestations of git angiodysplasia diagnosed by upper endoscopy and colonoscopy. * bleeding git symptoms exclusion criteria: * other causes ofgit bleeding * bleeding git ulcers * hematological disorder causing bleeding tendency ex hemophilia
drain-less abdominally based breast reconstruction using lysine-derived urethane adhesive

Conditions: Breast Cancer

Summary: drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. however, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry. this proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. by eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

objectives: 1. establish the safety of a lysine-derived urethane adhesive (tissuglu, cohera medical) in patients undergoing autologous abdominal-based breast reconstruction. this will be assessed via analyzing complication profiles of patients post-operatively. the primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group). 2. determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. this will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks. study design: patients will be randomized to one of three arms: 1) traditional closed-suction drains, 2) tissuglu with closed-suction drains and 3) tissuglu without closed-suction drains.

Eligibility criteria:
inclusion criteria: * patients undergoing abdominally-based breast reconstruction * both unilateral or bilateral reconstruction is allowed * both delayed or immediate reconstruction is allowed exclusion criteria: * diabetes * bmi\>30 * active smokers.

Keywords: a-br abdominal-based breast reconstruction seroma
kynex versus refresh plus study in subject with dry eye

Conditions: Dry Eye

Summary: the effect of kynex versus refresh plus in subjects with mild to moderate dry eye.


Eligibility criteria:
inclusion criteria: * 20 years of age or older, of any race and either sex. * able to understand and sign an informed consent that has been approved by an institutional review board. * criteria for the diagnosis must include the following two characteristics at visit 1 (day 1): * subjects' assessment of dry eye status (answer of at least "some of the time" to the question, "how often have your eyes felt dry enough to want to use eye drops?" * sodium fluorescein (nafl) corneal staining score sum of ≥3 in either eye (nei scoring system). * able and willing to follow study instructions. exclusion criteria: * subjects who meet any of the following criteria will be excluded from this study: * history or evidence of ocular or intraocular surgery in either eye within the past three months. * history of intolerance or hypersensitivity to any component of the study medications. * history or evidence of epithelial herpes simplex keratitis (dendrictic keratitis); vaccine, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye. * use of topical ocular medications during the study period. * subjects using systemic medications that may contribute to dry eye (e.g. cold and allergy medications, tricyclic antidepressants, hormone replacement therapies) may not be enrolled in the study unless they have been on a stable dosing regimen for a minimum of 30 days prior to visit 1. in addition, the dosing regimen must remain stable throughout the study. * presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article. * subjects unwilling to discontinue contact lens wear during the study period. contact lens wear must have been discontinued at least one week prior to visit 1. * current punctal occlusion of any type (e.g. collagen plugs, silicone plugs). * enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals. * participation in any investigational drug or device study within 30 days of entering this study.

Keywords: sodium hyaluronate, kynex, carboxymethylcellulose sodium refresh plus dry eye cornea staining tbut
active breaks in people with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.

an open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. interstitial glucose concentrations (fgm), insulin dose and physical activity/ postural transitions (activpal) will be monitored throughout. to improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.

Eligibility criteria:
inclusion criteria: * t1d diagnosis more than 3 years ago * sedentary (\> 10h per waking day sedentary (sitting or lying) * using insulin therapy with multiple daily injections or insulin pump * aged 18-66 (uk retirement age) * use of abbot freestyle libre 2 fgm (\>6 weeks to avoid potential lifestyle changes as a result of sensor use) exclusion criteria: * engaged in structured planned exercise (e.g. running, cycling, gym, or sports) * pregnancy or planning to become pregnant * \<6 months postpartum or stopped breastfeeding \<1 month before recruitment * existing cerebrovascular or cardiovascular disease * significant history of hyperglycaemia (hba1c \>85 mmol/mol) * history of severe hypoglycaemia requiring third party assistance within the last 3 months
randomized study comparing periodic acceleration versus static position in cerebrovascular stroke patients

Conditions: Cerebrovascular Stroke

Summary: stroke is one of the leading causes of death and disability worldwide. more than 85% of strokes are due to blood vessel occlusion resulting in partial destruction of the brain parenchyma. current protocols try to re-establish blood circulation as soon as possible through chemical and/or mechanical interventions but new strategies are needed. periodic acceleration (pgz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). application of pgz in an animal model of stroke resulted in a dramatic reduction of associated brain damage. this trial will investigate whether stroke patients exposed to pgz experiment significantly higher recovery than patients that remained static during their treatment.

periodic acceleration (pgz) is a non-invasive method consisting in the application of a rocking movement to the patient that ultimately will induce the release of beneficial chemicals from the vascular endothelium (the cells lining the inside of the blood vessels). application of pgz in an animal model of stroke resulted in a dramatic reduction of associated brain damage. this trial will investigate whether stroke patients exposed to pgz experiment significantly higher recovery than patients that remained static during their treatment.

Eligibility criteria:
inclusion criteria: * a signed informed consent form must be obtained prior to recruitment * patients with symptoms of acute ischemic stroke * less than 12 hours from initiation of the stroke * age: 18 years or older * capable of following the protocol exclusion criteria: * pregnant or lactating women, and women that do not follow a contraceptive plan and may become pregnant * less than 18 years of age * more than 12 hours from the initiation of the stroke or when the initiation time is unknown. * hemorrhagic stroke * candidates to receive thrombolytic treatment * spine traumatism or other conditions that may be aggravated by pgz * patients that cannot be properly followed because of phycological, social, familiar, or geographical reasons.

Keywords: stroke periodic acceleration endothelium release ischemic penumbra shear stress adrenomedullin
eliquis regulatory post marketing surveillance

Conditions: NonValvular Atrial Fibrillation

Summary: the primary objective of this study is to examine the safety profile of eliquis in korean nonvalvular atrial fibrillation patients.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * patients ≥19 years of age * adult patients who are diagnosed with nonvalvular atrial fibrillation and are initiating eliquis anticoagulation therapy for risk reduction of stroke and systemic embolism * patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study exclusion criteria: * receiving eliquis treatment for an indication that is not approved in korea * contraindicated for the use of eliquis as described in the korean label
staging laparoscopy to assess lymph node involvement in advanced gastric cancer

Conditions: Gastric Cancer; Lymph Node Metastasis

Summary: staging laparscopy to assess lymph node involvement in advanced gastric cancer (pola) study aims to investigate the safety and feasibility of icg-guided sn retrieval in gc patients undergoing multimodal treatment. the pretreatment clinical variables potentially associated with the procedure will also be analyzed. to the best of our knowledge, the current study is the first to evaluate the role of icg in sn biopsy in advanced gc patients undergoing multimodal treatment.

comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction, particularly in advanced gc. recent data on the sentinel node (sn) concept in early gc has shown favorable results regarding ln detection rate and clinical status determination. staging laparoscopy (sl) with lavage cytology provides an additional value to the clinical staging of gc, particularly in detecting occult peritoneal disease. the role of indocyanine green (icg) guided sn mapping in gc confirmed its technical feasibility. icg can be safely used to identify sn, determine the surgical resection line, improve the ln harvest, and reduce noncompliance in patients undergoing d2 lymphadenectomy. the majority of the studies focused on the aspect of the increase in ln harvest. at the same time, no data exist regarding its potential role in gc nodal staging. to the best of our knowledge, the current study is the first to evaluate the role of icg in sn biopsy in advanced gc patients undergoing multimodal treatment.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma) 3. stage ii - iii disease (ct2-4a, n0-3, m0) based on the pretreatment ct and 8th edition of tnm classification 4. qualification for sl by the decision of the multidisciplinary tumor board 5. written informed consent for endoscopy and sl exclusion criteria: 1. early gc (ct1n0-3m0) scheduled for endoscopic treatment by the multidisciplinary tumor board 2. previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection 3. distant metastasis (cm1) clinically apparent in pretreatment abdominal/pelvic ct 4. technical inability to perform endoscopic icg injection or icg injection beyond the submucosa 5. visual inability to identify the sn during sl 6. positive cytology (cyt+) after sl 7. other malignancies 8. history of allergy to iodine agents

Keywords: gastric cancer icg staging laparoscopy
a study of diabetic patients with de novo native coronary artery lesions

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to assess the safety and effectiveness of the cypher sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated bx velocity balloon-expandable stent in patients with manifest diabetes mellitus. both stents are mounted on the raptorâ rapid exchange stent delivery system.

this is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the cypher sirolimus-eluting stent as compared to the uncoated bx velocity balloon-expandable stent in patients with manifest diabetes mellitus. patients with de novo native coronary artery lesions \ =2.5mm and \<=3.5mm in diameter (by visual estimate) will be included in the study. a total of 190 patients will be entered and randomly allocated to the cyphertm sirolimus-eluting stent or the uncoated bx velocity balloon-expandable stent at a 1:1 ratio. patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month). it is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.

Eligibility criteria:
inclusion criteria: * diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b i-ii) or patients with documented silent ischemia; * manifest diabetes mellitus, proven by fasting glucose (12 h) \> 127 mg/dl or oral glucose challenge: \>= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin; * treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. if more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended; * target vessel diameter at the lesion site is \>= 2.5mm and \<= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width); * target lesion is \<= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length); * target lesion diameter stenosis is \> 50% and \<100% (visual estimate); exclusion criteria: none
a phase 2b study of du-176b, prevention of venous thromboembolism in patients after total hip arthroplasty

Conditions: Venous Thromboembolism; Thromboembolism; Thrombosis; Embolism and Thrombosis; Deep Vein Thrombosis; Arthroplasty, Replacement, Hip

Summary: the objective of this study is to compare the efficacy, safety of du-176b 30mg or du-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.


Eligibility criteria:
inclusion criteria: 1. patients undergoing unilateral total hip arthroplasty 2. patients who are 20-84 years olds exclusion criteria: 1. subjects with risks of hemorrhage 2. subjects with thromboembolic risks 3. subjects who weigh less than 40 kg 4. subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Keywords: prevention venous thromboembolism edoxaban anticoagulants
treatment of cik for patients with refractory non-hodgkin lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: the purpose of this study is to study the safety and efficacy of chemotherapy usage followed by cik transfusion in refractory and/or chemoresistant lymphomas.

autologous cytokine-induced killer (cik) cells transfusion(\>2\*10\^9 cells count) within 2 weeks after regular chemotherapy every 3 months.

Eligibility criteria:
inclusion criteria: * diagnosed as non-hodgkin lymphoma with negative effect of regular chemotherapy, and need further therapy exclusion criteria: * patients refuse the therapy or have no tolerance for the therapy
pharmacokinetics of bibb 515 bs and effect of food after oral administration in healthy subjects

Conditions: Healthy

Summary: to assess the effect of a breakfast (40 g fat) on single dose pharmacokinetics of a 2.5 mg bibb 515 dose in capsules as well as the tolerability of bibb 515 bs capsules


Eligibility criteria:
inclusion criteria: * healthy male caucasian subjects as determined by results of screening * written informed consent in accordance with good clinical practice (gcp) and local legislation * age ≥ 18 and ≤ 50 years * broca ≥ - 20 % and ≤ + 20 % exclusion criteria: * any finding of the medical examination (including blood pressure, pulse rate and ecg) deviating from normal and of clinical relevance * gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * surgery of gastrointestinal tract (except appendectomy) * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurologic disorders * history of orthostatic hypotension, fainting spells or blackouts * chronic or relevant acute infections * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * intake of drugs with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial) * use of any drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial) * participation in another trial with an investigational drug (≤ 2 months prior to administration or during the trial) * smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * inability to refrain from smoking on study days * alcohol abuse (\> 60 g/day) * drug abuse * blood donation \> 100 ml (≤ 4 weeks prior to administration or during the trial) * excessive physical activities (≤ 10 days prior to administration or during the trial) * any laboratory value outside the reference range of clinical relevance
eis-12656 as single agent and in combination in patients with specified solid tumors

Conditions: Advanced Solid Tumor; Homologous Recombination Deficiency; HRR Deficiency

Summary: this trial investigates a new drug, eis-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. the trial consists of a dose escalation part (phase 1) and a dose expansion part (phase 2).

the trial is a phase 1/2, open label, uncontrolled trial to investigate the safety and preliminary efficacy of eis-12656 alone or in combination with a parpi or t-dxd in patients with specified advanced or metastatic solid tumors with homologous recombination deficient (hrd) mutations. in the phase 1 dose escalation phase participants will receive ascending doses of eis-12656 to evaluate the safety and tolerability and to determine an effective and safe dose for the phase 2 part. in the phase 2 dose expansion phase participants will either receive eis-12656 monotherapy at the recommended phase 2 dose (rp2d) (module 1) or eis-12656 in combination with a parpi or t-dxd (modules 2 and 3). the objective is to evaluate the safety and tolerability and anti-tumor activity of eis-12656 alone or in combination.

Eligibility criteria:
inclusion criteria: * recurrent locally advanced or metastatic solid tumors * homologous recombination deficient mutations * progressed on at least on prior line of treatment or intolerant to additional effective standard therapy * measurable disease (recist 1.1 criteria) * adequate organ and bone marrow function * ecog performance status 0 or 1 * life expectancy \> 3 months exclusion criteria: * history or evidence of any clinically relevant gastrointestinal disease * radiation therapy within ≤2 weeks * significant cardiovascular disease * uncontrolled, active, symptomatic brain metastases