Kornimate/medical-research-clean huggingface dataset:
combined stent insertion and hifu ablation for pancreatic carcinoma with biliary obstruction

Conditions: Pancreatic Carcinoma; Biliary Obstruction

Summary: the purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.

distal malignant biliary obstruction is a common problem in patients with pancreatic carcinoma. in unresectable pancreatic carcinomas, percutaneous stent placement has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of anticancer treatment. venous chemotherapy, transcatheter arterial chemoembolization, or radiotherapy have been used to prolong stent patency and survival after stent insertion for patients with pancreatic carcinoma and biliary obstruction. high-intensity focused ultrasound ablation is a noninvasive and atoxic treatment of malignant tumor using focused ultrasound energy from an extracorporeal source that is targeted within the body resulting in thermally induced necrosis and apoptosis. the purpose of this study is to compare the clinical effectiveness and long-term outcomes between patients with pancreatic carcinoma and biliary obstruction who are treated by stent insertion with or without high-intensity focused ultrasound ablation.

Eligibility criteria:
inclusion criteria: 1. malignant distal biliary obstruction; 2. pathologically diagnosed pancreatic carcinoma; 3. unresectable cases. exclusion criteria: 1. inability to obtain informed consent; 2. eastern cooperative oncology group performance status of 4; 3. life expectancy of 3 months or less; 4. biliary obstruction that was not directly caused by pancreatic carcinoma.
the effect of food (high fat and low fat breakfast) on the pharmacokinetics of regorafenib

Conditions: Dietary Fats; Pharmacokinetics

Summary: an open label, three way crossover study to determine the effect of a high fat breakfast or a low fat breakfast on the pharmacokinetics of a single dose of regorafenib.


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 45 years (inclusive) at the first screening examination * bmi: between 18 and 32 kg / m² exclusion criteria: * regular use of medicines at the time of screening, including prescription medications, herbal supplements and high dose vitamins * sitting systolic bp \> 140 mmhg or diastolic bp \> 90 or \< 60 mmhg * history of hypersensitivity or allergy * history of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
the gos-frail (geriatric oncology supportive care for frail older adults with cancer) study

Conditions: Geriatric Oncology; Supportive Care; Quality of Life

Summary: background cancer is more prevalent in older adults, but most cancer treatment trials have mainly involved young and healthy subjects. among geriatric syndromes, frailty is a significant risk factor for negative outcomes such as treatment delays, discontinuation, and treatment-related side effects, as well as functional decline and poor survival. research has shown that geriatric assessment with appropriate intervention can improve these outcomes, although the impact may be influenced by the inclusion of patients receiving palliative-intent treatment. supportive care focuses on symptom assessment and treatment to enhance treatment tolerance and quality of life. to date, there have been no studies examining the combined benefits of geriatric oncology and supportive care clinics. we conducted a pilot study called geriatric oncology supportive clinic for elderly (gospel), which demonstrated an improved quality of life for older adults with curable cancer. based on these results, we developed an enhanced care model. aim the study gos-frail aims to assess the effect of an integrated geriatric oncology supportive clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy and/or radiotherapy at 1 month. methods the gos-frail study is a multi-centre, open-label, parallel-arm, randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals. 154 adults aged 65 and above, diagnosed with solid organ cancer and planned for curative-intent chemotherapy and/or radiotherapy, and with a clinical frailty scale score of 4 and above, will be recruited. subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material. quality of life questionnaires will be administered at baseline, 2 weeks, and 1, 3, 6, and 12 months from treatment initiation. hypothesis: the gos-frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment.


Eligibility criteria:
inclusion criteria 1. age ≥ 65 2. diagnosis of solid organ cancer 3. plan for curative-intent chemotherapy and/or radiotherapy 4. clinical frailty scale (cfs) score ≥ 4, exclusion criteria: evaluation by geriatric or palliative medicine in the previous 6 months.

Keywords: geriatric oncology supportive care quality of life
efficacy of postoperative adjuvant treatments for hepatocellular carcinoma with portal vein tumor thrombosis

Conditions: Hepatocellular Carcinoma

Summary: the aim of this study is to assess efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hepatocellular carcinoma (hcc) and portal vein tumor thrombosis( pvtt).

hepatocellular carcinoma (hcc) is the sixth most common cancer worldwide and the third major cause of cancer-related death. hcc is characterized by its propensity for portal vein invasion. portal vein tumor thrombosis (pvtt) can be detected macroscopically in the portal vein in 44% to 62.2% of autopsy cases. the natural history of untreated hcc with pvtt is dismal. the median survival of such patients was reported to be 2.7 mouths. non-surgical therapies, such as systemic/regional chemotherapy and transcatheter arterial embolization / transcatheter arterial chemoembolization (tae/tace), are not effective in treating hcc with pvtt. with the improvement of surgical techniques, surgical resection has been reported to achieve promising results. however, the high rate of recurrence and metastasis constitutes one of the most important challenges in improving surgical efficacy for hcc with pvtt. there is rare report about prevention and treatment of postoperative recurrence and metastasis for hcc with macroscopical pvtt patients. we previously found the postoperative portal vein infusion chemotherapy (pvic) and tace benefited pvtt patients, which required further prospective randomized controlled studies with large case number to support our findings. the randomized controlled trial was design to investigate the efficacy of the different adjuvant chemotherapy strategies after hepatectomy and thrombectomy for hcc and pvtt.

Eligibility criteria:
inclusion criteria: 1. age 18 to 75 years 2. hepatocellular carcinoma with portal vein tumor thrombosis in the first branch and/or main trunk of the portal vein confirmed by preoperative radiologic investigations, intraoperative exploration and postoperative pathology. 3. no extrahepatic metastasis 4. no previous management 5. the tumor and pvtt were completely removed confirmed by macroscopy and intraoperative ultrasonography 6. good or moderate hepatic function (child-pugh class a or b) 7. eastern cooperative oncology group (ecog) performance status of 2 or less exclusion criteria: 1. refuse to participate 2. absolute neutrophil count \<1.5\*109/l, hemoglobin \< 80g/l or platelet count \<50 \* 109/l, transaminases greater than 3 times the upper limit of normal, serum creatinine greater than 1.5 times the upper limit of normal, inr greater than 1.5 times of normal, which could not recover after treatment 3. ascites refractory to diuretics 4. variceal bleeding 5. severe diseases of the heart or lung
dietitians helping patients care for diabetes (enhanced)

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims to randomly assign individuals with type 2 diabetes into the enhanced randomized control trial. the study is being conducted by the minneapolis heart institute foundation (mhif) and will have two study sites 1) hutchinson health and 2) new ulm medical center. the study is primarily funded through the academy of nutrition and dietetics (and). the study will examine the impact of a registered dietitian-led, primary care integrated, telemedicine program on diabetes care measures (the 'd5') over one year as compared to usual care. the d5 goals include: blood pressure \<140/90 mmhg, taking a statin as appropriate, a1c \<8%, not using tobacco and taking an aspirin as appropriate.

individuals will be invited to attend a baseline visit where they will have lab work done, anthropometrics (height, weight, waist circumference) and complete a lifestyle assessment. they will formally consent to participation by signing a study consent form. the same measures will be collected after completion of the one year study. study participants will receive two sessions of free lab work, a diabetes education book, and brief coaching with a registered dietitian/certified diabetes educator. in addition, those randomized to the phone coaching will have access to a registered dietitian/certified diabetes educator on a monthly basis for one year of personalized health coaching for free. the intent of this coaching is to help individuals achieve diabetes "optimal" care or meeting all 5 diabetes care measures (blood glucose, blood pressure, tobacco use, statin and aspirin use). this program is designed to complement usual clinic-based primary care, with coaches documenting lab, biometrics and medication adjustments in the ehr, along with documenting phone encounters and communicating directly with patients' pcps as needed. documentation in the ehr uses an order created specifically for the study indicating the patient's research status. lab work required as part of this research study at baseline and 12 months is covered by the study. any lab work and/or medication co-pays or fees outside of the baseline and 12 month study visits are the responsibility of the patient and/or their insurance

Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes 2. individuals who are not meeting 3 or more d5 goals, 3. have had a visit with a provider within the last 2 years exclusion criteria: 1. type 1 diabetes 2. chronic kidney disease (gfr \<30) 3. hiv 4. institutional residence 5. major cognitive or language barrier (as determined by program enrollment staff) 6. other active end-stage disease (e.g., late stage cancer or pulmonary disease) 7. actively receiving cancer treatment 8. pregnant
first in human study of sakurabead for genicular artery embolization to treat pain secondary to knee osteoarthritis

Conditions: Osteoarthritis (OA) of the Knee; Osteoarthritis Knee Pain; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis

Summary: a prospective, single-centre, single-arm, unmasked, first in human study that aims to evaluate the safety and efficacy of sakurabead resorbable microspheres in adult patients suffering from pain secondary to knee osteoarthritis.

to evaluate safety and efficacy of sakurabead for the treatment of pain secondary to knee osteoarthritis. treatment will be performed on up to 15 patients who will be followed up for a period of 6 months.

Eligibility criteria:
inclusion criteria: 1. patient is able and willing to provide written informed consent, and 2. clinical diagnosis of knee oa, and 3. moderate to severe knee pain (vas ≥ 5), and 4. pain refractory to at least 3 months\* of conservative therapies (anti-inflammatory drugs, or physical therapy, or muscle strengthening, or intra-articular injections), and 5. kellgren-lawrence grade 1, 2 or 3 on radiograph of the knee, and 6. age 40 years or older. 7. subject has confirmed evidence of knee oa, defined as an angiographic 'blush' pattern (radiographic) in one or more of the target genicular artery(ies). exclusion criteria: 1. severe knee oa (kellgren-lawrence grade 4) 2. current infection of target joint, or 3. life expectancy less than 24 months, or 4. known advanced atherosclerosis as defined by history of lower extremity or pelvis arterial bypass graft, lower extremity or pelvis arterial stent placement or prior history of vascular claudication, or 5. rheumatoid or known serologic diagnosis of autoimmune arthritis, or 6. prior knee replacement surgery in the target knee, or 7. complete meniscal or cruciate tear that requires surgery, or 8. history of uncorrectable coagulopathy, or 9. prior iodinated contrast reaction resulting in anaphylaxis, or 10. pregnant and/or lactating female, or 11. at the discretion of the principal investigator 12. subject has evidence of arterial occlusion precluding catheterization. 13. subject has occlusion of the genicular arteries.

Keywords: genicular artery embolization gae knee embolization knee oa knee osteoarthritis
ozurdex for combined pseudophakic cystoid macular edema and diabetic macular edema after cataract surgery

Conditions: Pseudophakic Cystoid Macular Edema,; Diabetic Macular Edema

Summary: the purpose of the study is to determine where a sustained steroid delivery system (ozurdex,allergan) is safe and effective to treat cystoid macular edema in diabetic patients after cataract surgery


Eligibility criteria:
inclusion criteria: * diabetic patients who develop cystoid macula edema after cataract surgery (within 4-10 weeks after surgery * visual acuity worse than 20/32 exclusion criteria: * visual acuity worse than 20/200 * moderate or severe glaucoma (as defined as using \>2 topical glaucoma mediations. * use of systemic, periocular or intraocular corticosteroids within 30 days of enrollment

Keywords: pseudophakic cystoid macular edema, diabetic macular edema, irvine gass syndrome, cataract surgery, ozurdex, dexamethasone
prognostic factors in periampullary tumors and cysts

Conditions: Pancreas Cancer; Pancreas Neoplasm; Pancreas Cyst; Pancreatic Fistula; Pancreas Disease; Bile Duct Cancer; Periampullary Cancer; Surgery; Surgery--Complications

Summary: the project aims at analysing prognostic and predictive factors involved in diagnostics and surgical treatment of cysts and tumors in the pancreas and periampullary region using both clinical data and blood and tissue samples for biomarker development and validation.

from november 2021 an onward, study participants will be prospectively enrolled within the observational study. before that, study participants are retrospectively enrolled. the study has a broad perspective including studies on clinical outcomes and prognostics based on patient and tumor characteristics.

Eligibility criteria:
inclusion criteria: * recommended surgery for tumor or cyst in the pancreas or periampullary region * information avalible in electronic journal files * informed consent (or deceased for retrospective part of the study) exclusion criteria: * no informed consent (and still alive at study initiation)
thromboelastographic guide for blood products in cirrhotics

Conditions: Liver Cirrhosis; Coagulation Disorder

Summary: blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. traditional coagulation tests (namely inr and plts count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. notwithstanding they are still used to guide blood products administration before invasive procedures. thromboelastography (teg) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. the aim of this randomized controlled study was to evaluate the efficacy of teg as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.


Eligibility criteria:
inclusion criteria: * histologic or imaging-proven liver cirrhosis of any etiology * inr\>1.8 and/or plts count \<50x103/μl exclusion criteria: * ongoing bleeding * previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel * ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study * presence of sepsis according to acp-sccp criteria * hemodialysis performed within 7 days
imrt plus cisplatin versus conventional radiotherapy plus cisplatin in stage iii-iv hnscc

Conditions: Oral Cancer; Oropharynx Cancer; Hypopharynx Cancer

Summary: this is a multicentric randomized phase iii trial comparing intensity-modulated radiotherapy (75 gy) plus cisplatin versus conventional radiotherapy (70 gy) plus cisplatin in patients with stage iii-iv squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. the main end points are the rate of locoregional control and the rate of xerostomia at 2 years.

this is a multicentric randomized phase iii trial comparing intensity-modulated radiotherapy plus concomitant cisplatin versus conventional radiotherapy plus concomitant cisplatin in patients with stage iii-iv squamous cell carcinoma of oral cavity, oropharynx or hypopharynx. the main end points are the rate of locoregional control and the rate of xerostomia at 2 years. the imrt total dose is 75 gy (50 gy to ptv1 and t0 + 25 gy (10 fractions) to ptv2). the conventional radiotherapy total dose is 70 gy (50 gy to ptv1 + 20 gy (10 fractions) to ptv2). in both arms, the cervical nodes will receive 50 gy (65 gy in case of np) by conventional radiotherapy (imrt is allowed in the irmt arm). in the two arms, patients will receive concomitant cisplatin (100 mg/m² d1, d21, d42).

Eligibility criteria:
inclusion criteria: * squamous cell carcinoma of oral cavity, oropharynx or hypopharynx * stage iii - iv (t1-t4, n0-n2)(uicc 2002) * not resected * indication of radiotherapy to bilateral cervical nodes at dose\>= 50 gy * delineation of target volumes done before randomization * scintigraphy of parotid gland done before radiotherapy start * quality of life questionnaires (eortc-c30 and eortc-h\&n35) filled in by the patient * informed consent signed exclusion criteria: * n3 (uicc 2002) * distant metastasis * contra-indication to concomitant cisplatin * history of cancer within the last 5 years * history of head and neck radiotherapy * administration of drugs for treatment or prophylaxis of xerostomia (pilocarpine, ethyol)

Keywords: oral cancer oropharynx cancer hypopharynx cancer imrt
acupuncture and hypertension

Conditions: Hypertension

Summary: although traditional chinese medicine advocates the use of acupuncture not only to induce analgesia but also to treat essential hypertension, acupuncture's postulated antihypertensive efficacy in humans has not been subjected to rigorous western scientific testing. before advocating acupuncture as an effective complementary/alternative medicine strategy for essential hypertension, it is necessary to demonstrate that the beneficial effects of acupuncture are scientifically robust, long-lasting, and explicable in terms of modern scientific mechanisms. in spontaneously hypertensive rats, acupuncture-like electrical stimulation of thinly myelinated (group iii) somatic afferents activates central endorphin (naloxone-sensitive) pathways that elicit long-lasting decreases in sympathetic nerve activity (sna) and blood pressure. the ability to record sna with microelectrodes in conscious humans provides a new opportunity to test this novel mechanistic hypothesis in patients undergoing electroacupuncture, a modification of the ancient technique that provides a quantifiable and reproducible stimulus to human skeletal muscle afferents. using a randomized, double-blind placebo-controlled design, we will test the following major hypotheses: electroacupuncture produces a long-lasting reduction in sna, thereby providing a safe and effective complementary treatment of human hypertension. given the enormous interest in acupuncture by our lay public, but the paucity of western scientific data about its efficacy in cardiovascular disorders, our studies in normotensive and hypertensive humans should provide a conceptual framework for deciding whether to accept or reject the large body of chinese (and russian) literature advocating acupuncture as a safe and effective treatment of essential hypertension and other cardiovascular disorders (such as heart failure, and myocardial ischemia).


Eligibility criteria:
inclusion criteria: * patients with normal blood pressures or blood pressures over 120/80 up to 165/105
evaluation of immunological reconstitution after haploidentical bone marrow transplantation

Conditions: Lymphoma

Summary: evaluation of immunological reconstitution after haploidentical bmt using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide in patients with poor prognosis lymphoma


Eligibility criteria:
inclusion criteria: * patients with lymphoma (any histology) relapsed after high dose chemotherapy and in partial remission, complete remission or stable disease after the last ct line that * signed informed consent to perform an haploidentical allo-bmt using a nonmyeloablative preparative regimen and post-transplant cyclophosphamide exclusion criteria: none