Kornimate/medical-research-clean huggingface dataset:
coconut sugar lowers blood pressure and arterial stiffness in middle-aged and older adults

Conditions: Aging; Blood Pressure; Arterial Stiffness

Summary: the goal of this intervention is to determine the efficacy of coconut sap powder (csp) to lower arterial stiffness and blood pressure in middle-aged and older adults. participants will be randomized to the csp arm or placebo arm of the study. primary endpoints include: aortic stiffness assessed by carotid-femoral pulse wave velocity, resting brachial and (non-invasive) carotid blood pressure, and carotid stiffness (e.g. beta stiffness index, carotid compliance, elastic modulus, distensibility).


Eligibility criteria:
inclusion criteria: * body mass index 18-35 kg/m2 * brachial blood pressure \<140/90 * nonsmoker * no known clinical disease, or suggestive signs or symptoms of clinical disease * free of alcohol or drug dependence exclusion criteria: * taking any anti-hypertensive, lipid lowering or other cardiovascular altering medications * known allergies to coconut or tree nuts (i.e., cashews, almonds, or pistachios) * engaging in vigorous intensity exercise
the comparisons of one-stage stone removal in mild and moderate cholangitis

Conditions: Cholangitis; Choledocholithiasis

Summary: in expert comment, performing the sphincterotomy for choledocholithiasis with acute cholangitis may increase bleeding and pancreatitis risks (from 2% to 10%). therefore, investigators often perform biliary drainage in acute stage, and arrange 2nd session ercp for stone removal later. however, in the recent study, single-stage endoscopic treatment may be still effective (stone removal rate 90%) and safe for mild to moderate acute cholangitis associated with choledocholithiasis. investigators will carry out a prospective trial to analyze one-stage retrograde endoscopic common bile duct stone removal in mild and moderate cholangitis with choledocholithiasis to determine the safety, successful rate, and complications in these two groups.

investigators will enroll 204 naïve papilla with a body temperature ≥37 °c who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. the method of one-stage: performing the stone removal at the first session of ercp. the pancreas duct stent will be placed for preventing post ercp pancreatitis (pep) if necessary. the indomethacin 100mg anal route will be administered for all patients without allergy history. all participants will receive the empiric antibiotics treatment for cholangitis.

Eligibility criteria:
inclusion criteria: * naïve papilla with a body temperature ≥37 °c who was diagnosed with mild to moderate cholangitis associated with choledocholithiasis. exclusion criteria: * procedural failure requiring an anatomy-modifying procedure, such as a billroth ii subtotal gastrectomy or r-en-y gastrojejunostomy ; * stenosis of the pyloric ring ; * tumor-related obstruction; * failure to locate the papilla ; * active peptic ulcer bleeding ; * intolerance due to inadequate sedation * cbd sludge; * non-naïve papilla in ercp

Keywords: acute cholangitis choledocholithiasis ercp one-stage treatment
vitrectomy retinal oxygenation

Conditions: Diabetic Macular Edema

Summary: vitrectomy is the common treatment for patients with macular edema secondary to epiretinal membrane. recently, in eyes with diabetic macular edema or persistent macular edema following retinal vein occlusion, vitrectomy will be increasingly performed as an additional treatment modality. in eyes with impaired oxygen situation vitrectomy may improve the retinal oxygen saturation. however, little information is available about the oxygenation and the blood flow of the retinal vessels after vitroretinal surgery. hypoxia is a the major trigger of vascular endothelial growth factor (vegf), which is in turn the most important factor for the development of macular edema. it is a major issue to improve the oxygen situation and the blood flow of the retina and there are just a few not satisfactory procedures available to overcome this problem. however, vitrectomy would be an adequate therapy for many of these diseases, and it would be an appreciated side effect of the treatment in almost every case. to investigate the influence of oxygenation and blood flow of the retina on clinical outcomes after a successfully 23 gauge vitrectomy in eyes with epiretinal membrane, persistent macular edema following diabetic retinopathy or retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * male or female, at least 18 years of age. * ophthalmoscopic evidence of epiretinal membrane scheduled for vitrectomy and membrane peeling. * persistent diabetic macular edema * written informed consent * female patients of childbearing potential must have a negative urine pregnancy test. exclusion criteria: * uncontrolled systemic disease * symptoms of a clinically relevant illness in the 3 weeks before the first study day * any ocular condition that in the opinion of the investigator would be a contraindication for the surgical procedure * history of glaucoma, aphakie or presence of anterior chamber intraocular lens, choroidal neovascularisation, significant cataract, any ocular infection, - history of pars plana vitrectomy. * contraindication to pupil dilation. * need for silicon oil or gas after the surgery * advanced diabetic retinopathy with vitreoretinal tear and/or bleeding

Keywords: oxygenation of the retinal vessels vitroretinal surgery
development of a decision aid to facilitate ovarian cancer patient's choices regarding biomarker ca125

Conditions: Ovarian Cancer

Summary: in 2015 the danish health authorities initiated major changes in the national follow-up (fu) program for ovarian cancer patients. the new fu program argues that there is no effect of routine monitoring of tumour marker ca125. now every patient needs to choose if they wish routine measurement of ca 125 to be part of the follow-up program. shared decision making (sdm) can help health professionals develop a more individualized care plan in collaboration with the patient, as stated in the revised national fu program. due to the complexity and challenges within ovarian cancer care, this is an evident area of focus. sdm is defined as an approach in which the clinician and patient go through all phases of the decision-making process together and share the preference for treatment and reach an agreement on treatment choice. clinicians have information about disease, tests and treatments, whereas patients hold information about their life circumstances, goals of life, and preferences for healthcare. sdm thereby offers a way of individualizing recommendations, according to patients' special needs and preferences. sdm has potential to give the patients a higher quality of healthcare by putting the patient in the center of care. decision aids (da) are tools that can provide information and systematically describe the advantages and disadvantages of a specific intervention or monitoring, which can help patients become involved in decision making. using evidence-based da leads to improvement in knowledge, better understanding of screening, prevention and treatment options, and more accurate perception of risks for the patients. all participants fill in a demographic and decisional conflict scale questionnaire at baseline. after having been presented with the decision aid and made a choice as to ca125, the participants will complete the collaborate and decisional conflict scale questionnaire dealing with confidence as to the choice made and the level of shared decision making experienced. six months later the decision regret scale questionnaire is to be completed to reveal any regrets in relation to the ca125 decision. for a preliminary investigation of the applicability of the da, 15-20 patients not eligible for this study will be asked for their opinion.


Eligibility criteria:
inclusion criteria: * patients \>18 years of age * histologically confirmed epithelial ovarian, fallopian tube or serous primary peritoneal cancer * have completed their first line treatment, with complete remission. * manage to read and speak danish exclusion criteria: * have recurrent disease after first line treatment

Keywords: shared decision making follow-up
a single dose study of shr0410 in healthy male participants

Conditions: Acute Pain

Summary: this is a randomized, double-blind, placebo-controlled, single ascending-dose study to investigate the effect of a single intravenous (iv) dose of shr0410 at 6 dose levels (0.5 μg/kg, 1 μg/kg, 2 μg/kg, 5 μg/kg, 10 μg/kg and 20 μg/kg) in healthy participants.

forty eight eligible participants will be enrolled into the 6 dose cohorts. for each cohort, a sentinel group of 2 subjects (1 receiving shr0410 and 1 receiving placebo) will be dosed first (1:1 ratio). if no drug related adverse events occur in the sentinel participants, the remaining 6 subjects in a cohort will be dosed on the next day or later in a 5:1 ratio (5 subjects receiving shr0410 and 1 subject receiving placebo). shr0410 will be diluted in saline and administered as a 15 min constant dose iv infusion at a rate of 20 ml/hr on day 1.

Eligibility criteria:
inclusion criteria: 1. male between the ages of 18 and 45 years, inclusive. 2. body mass index (bmi) of 18.0 to 30.0 kg/m2 and a total body weight of 50 kg to 125kg, inclusive. 3. considered generally healthy upon completion of medical history, physical examination, vital signs, spo2, laboratory parameters, and ecg, as judged by the investigator. exclusion criteria: 1. known sensitivity to any of the components of the investigational product formulation, or any other opioids. 2. evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). 3. any other medical or psychological condition, which in the opinion of the investigator, might create undue risk to the participant or interfere with the participant's ability to comply with the protocol requirements, or to complete the study.
investigation of new intermittent catheter swelling media in healthy volunteers

Conditions: Catheter Site Pain; Catheter Site Discomfort

Summary: investigation of novel swelling media for ce marked intermittent urinary catheters. the study was a randomized, single blinded, cross-over investigation comparing a novel swelling media with a comparator swelling media in 22 adult, healthy, male volunteers.

the cp279 study investigated a novel swelling media for male intermittent urinary catheters. the study was conducted in denmark and was a single-site, randomized, single blinded, cross-over investigation, testing inferiority of a novel catheter swelling media against a comparator swelling media in 22 adult, healthy, male volunteers. each participant was randomized to one of two treatment arms, using a randomization sequence of two (i.e., with two different random options for the order in which the participants tested the two swelling media). the study thus contained two test visits, for which the 22 participants tested the two different swelling media, respectively. there was 4-14 days between the test visits and all catheterizations were performed by trained nurses. due to a visual difference between the products, it was only possible to blind the subjects.

Eligibility criteria:
inclusion criteria: * written informed consent given * minimum 18 years of age and with full legal capacity * male gender * willing to refrain from using analgesics up to 24 hours prior to catheterization visits * negative urine multistix analysis for erythrocytes (microscopic hematuria) * negative urine multistix analysis for leukocytes and nitrite, or if positive, subsequent negative for bacterial growth in urine culture exclusion criteria: * abnormalities, diseases or surgical procedures performed in the lower urinary tract * symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination) * participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or previously participation in this investigation * known hypersensitivity toward any of the investigational device
concurrent chemo-radiotherapy with intensity-modulated radiation therapy (imrt) for limited disease small cell lung cancer (ld-sclc)

Conditions: Stage I-III Small Cell Lung Cancer

Summary: the investigators' group was the first to perform a phase ii trial in patients with limited disease (stage i-iii) small-cell lung carcinoma (sclc) in which only the fluorodeoxyglucose-positron emission tomography (fdg-pet) positive lymph nodes were irradiated. in this trial, only 3% of isolated nodal failures were observed. however, all patients in that study were treated with 3d conformal radiotherapy (3dcrt). at present, imrt techniques have become more standard in lung cancer. because of the lower radiation dose to the lymph nodes outside of the planning target volume (ptv) with imrt, higher incidences of isolated nodal failures may occur. in this trial, the investigators will investigate the patterns of local relapse after imrt with concurrent chemotherapy in patients with stage i-iii sclc.

eligible patients (see below) will receive radiotherapy to the primary tumor and the initially involved mediastinal lymph nodes on fdg-pet scan to a dose of 45gy in 30 fractions in 3 weeks (1.5gy bid). radiotherapy will be delivered concurrently with cisplatin (or in case of a creatinin clearance of \<60ml/min, carboplatin) and etoposide chemotherapy. when after 4 cycles of chemotherapy and concurrent chest radiotherapy, no disease progression is observed and the who performance status is 0-2, pci (prophylactic cranial irradiation) will bee offered to a dose of 25 gy in 10 daily fractions. the radiation doses will be specified according to icru 50. lung density corrections will be applied, as well as all standard qa procedures. technical requirements are the same as in standard practice at maastro clinic.

Eligibility criteria:
inclusion criteria: * histological of cytological proven sclc * uicc stage i-iii, which are amendable for radical local treatment * performance status 0-2 * imrt technique exclusion criteria: * not sclc or mixed sclc and other histologies (e.g. non-small cell carcinoma) * stage iv * performance status 3 or more * no imrt technique

Keywords: radiotherapy sclc
the effect of e-epa on circulating ldl and plasma lipid metabolism

Conditions: Atherosclerosis; Low-density Lipoproteins Aggregation Susceptibility; Low-density Lipoprotein Lipid Composition; Cardiovascular Diseases

Summary: 40-70 healthy volunteers of ages 18 to 65 participate in a e-epa-diet where 3,9 grams of e-epa is added to their normal diet and lifestyles for a month. blood samples will be collected before the study and at weeks 1 and 4 and also, two weeks after finishing the diet. main study focuses are ldl aggregation susceptibility, lipid composition and proteoglycan binding affinity. in addition, important plasma lipid metabolism enzymes and lipid mediated resolvins are measured as well as several baseline characteristics.

four grams of daily e-epa was found to significantly decrease atherosclerotic cardiovascular diseases in the reduce-it study. in the upcoming study the effect of e-epa to low-density lipoprotein (ldl) aggregation susceptibility is measured using dynamic light scattering technique to continuously measure particles size while inducing aggregation. ldl lipid composition is analyzed using electrospray mass spectrometer optimized for lipid measurements. previously is reported that the aggregation susceptibility is affected by the lipid composition which is modifiable (ruuth et. al. eur.h.journal 2018). common disease factors such as total cholesterol, ldl, hdl, triglyserides, apob-100, apoa-i, lp(a) and different modified ldl levels are measured. also, activities of lipid metabolism enzymes like pon-1, lcat, cetp, pltp and lipid mediated resolvins are looked into. objective is to identify changes and possible pathways that are altered by the increase of e-epa and to use the data to possibly explain the health benefits of epa.

Eligibility criteria:
inclusion criteria: * healthy normolipidemic exclusion criteria: * prescription of blood thinner medicine * circulating low-density lipoprotein \> 5mmol/l, triglycerides \>3mmol/l * chronic use of pain medication * fish allergy * pregnancy * breastfeeding

Keywords: atherosclerosis e-epa ldl aggregation susceptibility lipidomics resolvins pon-1 lcat pltp cetp proteglycan binding
compressive single-piece implants for immediate rehabilitation of edentulous maxillectomy patients

Conditions: Patient Satisfaction

Summary: this within-patient study aimed to compare the satisfaction and oral health-related quality of life (ohrqol) of edentulous maxillectomy patients with and without immediately loaded implant-supported obturator prostheses using single-piece compressive implants.

* inclusion criteria: * patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla. * residual alveolar ridge quantity and quality as verified by cone beam computed tomography (cbct), especially in the proposed implant sites. * exclusion criteria: * patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis. * radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6 months) * patients with local inflammation that may cause interference with implant placement. all patients were informed about the detailed treatment plan and received a written informed consent to be signed. ii) preparation of the patient for implant placement: * fabrication of maxillary obturator. * cone beam computed tomography (cbct) was performed for all patients to accurately plan implant location, diameter, and angulation. iii) surgical phase: * surgery was performed under local anaesthesia. * all patients received single-piece compressive implants in the proper positions according to the case demands. * the patients were prescribed systemic antibiotics for one week, anti-inflammatory, analgesic, and mouthwash. iv) prosthetic phase: * necks of placed implants bent up to 15 degrees to be parallel placed. * the maxillary obturator was adjusted on the poured mode, and modified and access holes made above the abutment were finally relined in the patient's mouth at the correct vertical dimension of occlusion to allow for immediate loading protocol. iv) evaluation: * patient satisfaction based on visual analog scale (vas) * oral health impact profile for edentulous patient (ohip-edent) * obturator functioning scale

Eligibility criteria:
inclusion criteria: * patients with a status eligible for implants after partial or total maxillectomy or partial or total loss of the maxilla. * residual alveolar ridge quantity and quality will be verified by cone beam computed tomography (cbct) especially in the proposed implant sites. exclusion criteria: * patients with systemic diseases that interfere with surgical implant procedures e.g., uncontrolled diabetes or osteoporosis. * radiation therapy or chemotherapy to the head and neck area (currently or time interval less than 6-months) * patients with local inflammation that may cause interference with implant placement.

Keywords: vas ohip-edent obturator functioning scale
comparison of effect & safety of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients

Conditions: Coronary Artery Disease (CAD)

Summary: the aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to coronary artery disease (cad) patients who had been treated with a drug-eluting stent before \> 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.


Eligibility criteria:
inclusion criteria: * aged 20 to 80 years * men and women with coronary artery disease who had been treated with drug-eluting stent placement before \> 12 months * patients who had remained in a stable condition with a single antiplatelet agent, aspirin * patients who did not show any sign or symptom of the worsening of their angina within the last six months that required a coronary artery intervention, a coronary artery bypass, or coronary angiography exclusion criteria: * patients who were taking another antiplatelet or anticoagulant drug such as clopidogrel, warfarin, or cilostazol in addition to aspirin, unless they could withdraw from such other drug/s, in which case they could be enrolled in the study after a two-week wash-out period * patients who were suffering from drug abuse or alcohol addiction * hypersensitivity to clopidogrel or aspirin * severe liver disease (alt or ast ≥ 10 times the upper normal limit) * active hemorrhage such as gastro-intestinal ulcer or intracranial hemorrhage * a high risk of bleeding (blood coagulation disorder, uncontrolled severe hypertension, active bleeding, or history of severe bleeding) * pregnant or lactating women * women with childbearing potential who were not using an appropriate contraception method * had medical or mental contra-indications to the study treatment
long term extension study evaluating safety, tolerability and immunogenicity of acc-001 in japanese subjects with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this long term extension study is to assess safety, tolerability and immunogenicity of acc-001 with qs-21 adjuvant in japanese subjects with mild to moderate ad who were randomized in the preceding p2 double blind studies.


Eligibility criteria:
inclusion criteria: * subjects randomized under previous 3134k1-2202-ja (nct00752232) and 3134k1-2206-ja (nct00959192) and met all inclusion criteria and non of the exclusion criteria. * screening brain mri scan is consistent with the diagnosis of ad. * mmse score 10 and above. exclusion criteria: * significant neurological diseases other than ad. * brain mri evidence of vasogenic edema during the preceding studies. * clinically significant illness.