Kornimate/medical-research-clean huggingface dataset:
the atlantis trial

Conditions: Chronic Venous Hypertension Due to Deep Vein Thrombosis; Venous Reflux

Summary: the purpose of this study is to test whether addition of aquatic exercise to conventional treatment helps reduce the adverse outcomes of chronic venous insufficiency including cvi resulting from venous thrombosis.

post-thrombotic syndrome (pts) develops in approximately 25-60% of patients with acute lower extremity deep venous thrombosis (dvt) depending on severity, chronicity, anatomic level of involvement and efficacy of anticoagulation.the frequency increases with occlusive iliac venous thrombosis. pts results in significant morbidity and a staggering toll on health careresources . pts is reduced by early percutaneous endovenous intervention and administration of new oral anticoagulants. there are conflicting results on the efficacy of exercise . in general, exercise has been useful in activation of the muscle pump and improvement of symptoms. there are no data about exercise in a swimming pool. both walking in water or swimming reduce the effect of joint contact and therefore pain which is particularly useful in patients with arthritis or heavyweight. furthermore with less effect of gravity, absorption of dependent edema would be faster. dry skin becomes hydrated and the chlorine of water can exert antiseptic properties. there are no data on the role of aquatic activity in the reduction of measures of venous insufficiency.the purpose of this study is to assess whether encouragement of patients to perform aquatic activity in addition to baseline treatment would positively impact chronic venous insufficiency.

Eligibility criteria:
inclusion criteria: age\>18 years; a villalta score of ˃5 or a modified venous clinical severity score (vcss) of ˃5 plus ongoing symptoms of ˃3 months despite receiving conservative management (minimum of 2 of the following: compression stockings, leg elevation, physical activity on land and use of non-steroidal anti-inflammatory drugs where appropriate, for the preceding 3 months). exclusion criteria consisted of unwillingness or inability to use or no access to a swimming pool; open ulceration; planned intervention for arterial or superficial venous reflux, deep venous thrombosis (dvt), venous stenosis, pelvic congestion syndrome, within the first 3 months of enrolment; or using a swimming pool on a regular basis.

Keywords: post thrombotic syndrome chronic venous insufficiency
nausea and pain prophylaxis during thyroid surgery

Conditions: Thyroid Diseases; Parathyroid Diseases

Summary: postoperative pain and nausea may diminish a patient's wellbeing, and may also delay rehabilitation, as well as increase the total cost of care and treatment. opioids are effective drugs for treatment of pain, but with the disadvantage of side effects such as somnolence and nausea. the benefits of various types of non-opioid analgesic in reducing patients' postoperative need for opioids have been well-documented. one non-opioid prophylaxis documented for various surgery is short-term treatment with corticosteroids. the optimal dose of corticosteroids for peroperative nausea and pain prophylaxis is not well-documented. in our study we will attempt to determine whether the aforementioned benefits of corticosteroids are valid for a group of patients undergoing thyroid surgery. hypothesis: single-dose treatment with dexamethasone provides a better analgesic effect and/or reduced use of opioids than placebo in patients undergoing elective throid surgery. higher dose of dexamethasone provide better and/or longer-lasting analgesic effects without influencing the side effect profile.


Eligibility criteria:
inclusion criteria: * inpatients scheduled for elective thyroid surgery and parathyroid surgery under general anesthesia. * informed consent exclusion criteria: * patients who use steroids * patients who use antiemetics * patients who use opioid analgesics * body weight \> 100 kg * bmi \> 35
hla-a*0201 restricted peptide vaccine therapy with gemcitabine with gemcitabine in patient pancreatic cancer (phase1)

Conditions: Pancreatic Cancer

Summary: the purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating hla-a\*0201 restricted patient with non-resectable pancreatic cancer.

the prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. it has been required development of new treatment modalities. immunotherapy is one of the encouraging modalities for cancer patients. the investigators have to assess its toxicities and immune responsiveness.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer * measurable disease by ct scan * ecog performance status 0-2 * life expectancy \> 3 months * laboratory values as follows: 2,000/mm3 \ 75,000/mm3, total bilirubin \<1.5 mg/dl, asparate transaminase \<150iu/l, alanine transaminase \< 150 iu/l, creatinine \< 3.0mg/dl * hla-a\*0201 * able and willing to give valid written infromed consent exclusion criteria: * pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) * breast-feeder * active or uncontrolled infection * prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks * serious or uncured wound * active or uncontrolled other malignancy * steroids or immunosuppressing agent dependent status * interstitial pneumonia * ileus * decision of unsuitableness by principal investigator or physician-in-charge

Keywords: pancreatic cancer peptide vaccine vegfr gemcitabine
prehabilitation in elective colorectal resection: a pilot study (prehab)

Conditions: Colorectal Cancer

Summary: this is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.

operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. for some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. as part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. it is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.

Eligibility criteria:
inclusion criteria: * adult patient * scheduled to undergo a colorectal resection as part of treatment for colorectal cancer. * english speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits. exclusion criteria: * geographic inaccessibility * unwilling to provide consent

Keywords: prehabilitation colorectal surgery
study utilizing rilonacept in gout exacerbations

Conditions: Acute Gout Flare

Summary: this purpose of this clinical research was to determine the efficacy and safety of an experimental drug called rilonacept in participants with an acute gout attack. participants participated in this study for 30 days. rilonacept alone was being compared with indomethacin alone and the combination of rilonacept plus indomethacin in treating acute gout flares.


Eligibility criteria:
inclusion criteria: 1. male or female 18 - 70 years of age 2. previously met the preliminary criteria of ara for the classification of the acute arthritis of primary gout 3. presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity 4. must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint 5. current presentation of acute gout flare in 3 joints or less exclusion criteria: 1. treatment with any non-steroidal anti-inflammatory drug (nsaids) or opiates within 48 hours prior to baseline assessments. treatment with long-acting nsaids within 1 month prior to baseline visit. treatment with naproxen, meloxicam, nabumetone, celecoxib and indomethacin sr within 5 days prior to baseline visit. 2. treatment with oral analgesics within 6 hours before baseline assessments. treatment with topical analgesics within 12 hours before baseline assessments 3. history of nsaid intolerance 4. participants with history of chronic, gouty arthritis

Keywords: metabolism, inborn errors allopurinol metabolic diseases genetic diseases, inborn musculoskeletal diseases joint diseases arthritis rheumatic diseases metabolic disorder purine-pyrimidine metabolism, inborn errors gout flare
radiation therapy in treating patients with brain cancer

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for patients with anaplastic astrocytomas. purpose: randomized phase iii trial to study the effectiveness of radiation therapy in treating patients with anaplastic astrocytomas.

objectives: i. compare the disease-free interval and survival in patients with supratentorial malignant brain gliomas randomized to radiotherapy alone vs. radiotherapy plus radiosensitization with mitolactol (dbd) followed by dbd and carmustine. outline: randomized study. group i: radiotherapy. external-beam cranial irradiation with megavoltage equipment. group ii: radiotherapy with radiosensitization followed by maintenance chemotherapy. radiotherapy as in group i; with mitolactol, dbd, nsc-104800; followed by dbd; carmustine, bcnu, nsc-409962. projected accrual: a total of 212 patients will be entered over more than 3 years.

Eligibility criteria:
disease characteristics: histologically confirmed anaplastic astrocytoma standard maximum resection or stereotactic biopsy required within 4 weeks prior to therapy patient characteristics: age: over 16 performance status: ecog/zubrod/who 0-2 life expectancy: at least 8 weeks hematopoietic: wbc greater than 4,000 platelets greater than 100,000 hematocrit greater than 30% hepatic: bilirubin less than 2 mg/dl renal: creatinine less than 1.5 mg/dl creatinine clearance greater than 70 ml/min bun less than 40 mg/dl other: no major medical illness prior concurrent therapy: no anticancer drugs between surgery and protocol treatment no steroids after 10 days following surgery (may be resumed occasionally during radiotherapy)

Keywords: adult anaplastic astrocytoma
comparison of biphasic insulin aspart 30 individually adjusted by the subject and the trial physician, both combined with metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial was conducted in asia, europe and south america. the aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (biasp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (hba1c).


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes for a minimum of 12 months prior to visit 1 (screening) * currently treated with a basal insulin analogue for at least 3 months prior to visit 1 (screening) * stable treatment (no change in dose or regimen) with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) ± additional oad treatment. the metformin treatment must have been stable for at least 2 months prior to visit 1 (screening) * hba1c higher or equal to 7.0% and below or equal to 10.0% (one re-test within one week of screening visit was allowed. the last sample was to be conclusive) * body mass index (bmi) below or equal to 40.0 kg/m\^2 * able and willing to eat at least 2 main meals each day during the trial * able and willing to adhere to the protocol including compliance with performance of self measured plasma glucose (smpg), injection regimen and titrating themselves according to the protocol * experience in performing self measured plasma glucose (smpg) exclusion criteria: * treatment with any thiazolidinedione (tzd) and glucagon-like peptide-1 (glp-1) receptor agonists or pramlintide within the last 3 months prior to visit 1 (screening) * impaired hepatic function defined as alanine aminotransferase (alat) above or equal to 2.5 times upper referenced limit (one re-test within one week of screening visit was allowed. the last sample was to be conclusive) * impaired kidney function with serum creatinine above or equal to 133 micromol/l (1.5 mg/dl) for males and above or equal to 124 micromol/l (1.4 mg/dl) for females (one re-test within one week of screening visit was allowed. the last sample was to be conclusive) * cardiac problems or uncontrolled treated/untreated severe hypertension (defined as systolic blood pressure higher or equal to 180 mmhg and/or diastolic blood pressure higher or equal to 100 mmhg) * previous use of pre-mixed insulin products (pre-mixed insulin analogues or pre-mixed human preparations) or bolus insulin. previous use of pre-mixed or bolus insulin products was allowed only in case of hospitalisation or a severe condition requiring intermittent use of pre-mixed or bolus insulin products for less than 14 consecutive days, but not during the last 3 months prior to screening visit (visit 1)
barriers to adherence to asthma controller meds in low income urban minority adolescents

Conditions: Asthma

Summary: poor adherence to appropriate asthma medications is an important risk factor contributing to high asthma morbidity and mortality in urban african american adolescents. as part of the adept (adolescent disease empowerment and persistency technology) for asthma pilot 2 study, a focus group was developed specifically to explore existing barriers to adherence among inner city african american adolescent asthmatics.


Eligibility criteria:
inclusion criteria: * 12-18 years of age * self identify as african american * have persistent asthma * read at a minimum fourth grade reading level * be on a prescribed daily inhaled corticosteroid medication for asthma exclusion criteria: * candidate refusal or presence of other co-morbidities
determining the utility of a behavioral intervention in chronic migraine

Conditions: Migraine; Headache; Migraine Disorders; Chronic Migraine; Lifestyle Factors; Headache Disorders

Summary: this proposal will involve a pilot study to evaluate the feasibility, acceptability, and outcomes of a lifestyle behavior protocol in managing chronic migraine. additionally, the proposal will investigate biomolecules that are uniquely involved in chronic migraine patients who respond to the protocol. successful completion of this proposal will inform the design of a future full-scale behavioral clinical trial to control chronic migraine.


Eligibility criteria:
inclusion criteria: * have chronic migraine for a minimum of 1-year * aged 18 years and older exclusion criteria: * other headache disorders including secondary headache disorders * children younger than 18 years old * current pregnancy

Keywords: migraine disorders headache lifestyle
everolimus-eluting(promus-element) vs. biolimus a9-eluting(nobori) stents for long-coronary lesions

Conditions: Coronary Artery Disease

Summary: this randomized study is a multi-center, randomized, study to compare the efficacy of biolimus a9-eluting stent (nobori) vs. everolimus-eluting stent (promus element) for long coronary lesions.

following angiography, patients with significant diameter stenosis \>50% and lesion length(\> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for long-des v trial inclusion and exclusion criteria will be randomized 1:1 to a) nobori and b) promus-element stent by the stratified randomization method.

Eligibility criteria:
inclusion criteria: * the patient must be at least 18 years of age. * significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (\>=28mm) * patients with silent ischemia, stable or unstable angina pectoris, ad non-st-elevation myocardial infarction * the patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: * any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus. * an elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment. * acute st-segment-elevation mi or cardiogenic shock * terminal illness with life expectancy \<1 year * patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. * in-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel isr is permitted) patients with ef\<30%. * serum creatinine level \>=3.0mg/dl or dependence on dialysis. * patients with left main stem stenosis (\>50% by visual estimate).

Keywords: coronary disease stent
use of continuous glucose monitoring combined with ambulatory glucose profiles to characterize glycemic control

Conditions: Type 2 Diabetes

Summary: obtain continuous glucose monitoring (cgm) data from individuals taking exenatide lar, sitagliptin, or pioglitazone. the cgm measurements collected will help determine the characteristics of glucose control prior to treatment and during treatment.


Eligibility criteria:
inclusion criteria: * 18 years or older * type 2 diabetes * a1c 7.1 - 11 * bmi 25 - 45 * stable weight for 3 months before screening * fasting glucose \< 280 at screening * stable dose of metformin for at least 2 months before screening * not being treated with or on a stable dose of hormone replacement therapy, oral contraceptives, anti-hypertensive agents, lipid lowering agents, thyroid replacement therapy, anti-depressants, drugs known to affect body weight * male or female, non-lactating, non-pregnant and willing to use birth control * lab values that are not clinically significant at screening * physical exam and ecg that are not clinically significant at screening * able to read, understand, and sign consent form exclusion criteria: * liver disease * renal disease * cardiovascular disease * gastroparesis * cancer within 5 years of screening * macular edema * chronic infections * drug or alcohol abuse * fasting triglycerides \> or = 600 at screening * previous exposure to exenatide lar * has donated blood within 60 days of screening or is planning to donate during the study * has had a major surgery or blood transfusion within 2 months before screening * is currently being treated or is expecting to be treated with byetta, januvia, su, tzd, glp-1 analog, alpha-glucosidase inhibitor, meglitinide, nateglinide, symlin, insulin, systemic corticosteroids, lopid or rifampin * has received an investigational drug within 1 month before screening * has allergies or hypersensitivity to any component of the study drug * has previously had an adverse event related to tzd or januvia * is an immediate family member of the study sight or directly affiliated * is employed by amylin, lilly or alkermes

Keywords: continuous glucose monitoring exenatide once weekly or januvia or actos
effect the glycemic control on cardiac function

Conditions: Cardiac Function; Glycemic Control

Summary: evaluation of the effect of the glycemic control on cardiac function in patients with type 2 diabetes mellitus

type 2 diabetes mellitus (t2dm) is one of the most common metabolic disorders worldwide and its development is primarily caused by a combination of two main factors: defective insulin secretion by pancreatic β-cells and the inability of insulin-sensitive tissues to respond to insulin diabetes mellitus is a chronic, metabolic disease characterized by elevated levels of blood glucose, which leads over time to damage to the heart,vasculature, eyes, kidneys and nerves. over 90% of diabetes mellitus cases are t2dm, a conditionmarked by deficient insulin secretion by pancreatic islet β-cells, tissue insulin resistance (ir) and aninadequate compensatory insulin secretory response . progression of the disease makes insulinsecretion unable to maintain glucose homeostasis, producing hyperglycaemia. t2dm is a multisystem disease with a strong correlation with cvd development t2dm leads to a two- to four-fold increase in the mortality rate of adults from heart disease and is associated with both micro- and macro-vascular complications, the latter consisting of accelerated atherosclerosis leading to severe peripheral vascular disease, premature coronary artery disease (cad) . these factors lead to t2dm being considered a significant risk factor for cvd \]. these include the role of ir in atherosclerosis, vascular function, oxidative stress, hypertension, macrophage accumulation and inflammation factors implicated in cardiovascular risk outcomes from t2dm and the interactions between them. t2dm derived hyperglycemia, hyperinsulinemia and ir causes endothelial dysfunction, diabetic dyslipidemia and inflammation leading to atherosclerosis leading to cvd. in addition, it is well documented that type 2 dm is associated with enhancement of platelet and hemostatic activities clinical trials have shown that intensive glucose control reduces the risk for microvascular complications among patients with type 2 diabetes, but its effect on cvd, including coronary heart disease (chd), and peripheral arterial disease, is uncertain . early data from the ukpds (united kingdom prospective diabetes study) 34 suggested a protective effect of improved glucose control on cvd, cvd deaths, and all-causes mortality poor glycemic control and insulin resistance are associated with deterioration of heart failure and lv dysfunction . however, available data suggest no difference in the risk of worsening heart failure between subjecting patients to intensive glycemic control and standard treatment arms . the relationship between glycated hemoglobin (hba1c) and lvef remains unclear

Eligibility criteria:
inclusion criteria: * type 2 diabetic patients with heart diseases exclusion criteria: * patients with type 1 diabetes mellitus * gestational dm * ckd patients requiring haemodialysis * immune system disorder
itbs in mci and mild ad

Conditions: Mild Cognitive Impairment (MCI); Mild Alzheimer Disease

Summary: this study aims to examine the effects of itbs on cognitive function in individuals with mci or mild ad, with a secondary objective of exploring prefrontal tbs mechanisms for cognitive function and the effect of itbs on bdnf.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of mci (overall clinical dementia rating of 0.5) * clinical diagnosis of mild alzheimer's disease (overall clinical dementia rating of 0.5 or 1) exclusion criteria: * history of stroke * history of uncontrol seizure * history of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality * mental illness * drug abuse

Keywords: rtms itbs mild cognitive impairment mild alzheimer disease