Kornimate/medical-research-clean huggingface dataset:
optimal titration regimen for sbr759 in lowering serum phosphate levels in asian chronic kidney disease patients on hemodialysis

Conditions: Chronic Kidney Disease

Summary: this study will determine the titration regimen for sbr759 compared to sevelamer hcl in lowering serum phosphate levels in asian chronic kidney disease patients on hemodialysis


Eligibility criteria:
inclusion criteria * men or women of at least 18 years old or 20 years old in japan. * stable maintenance of hemodialysis 3 times per week. * controlled serum phosphate if under phosphate-binder therapy. * serum phosphate level \> 6.0 mg/dl (\> 1.9 mmol/l) prior to study treatment initiation. exclusion criteria * peritoneal dialysis or a non-conventional hemodialysis technique . * parathyroidectomy or transplant scheduled during the study. * uncontrolled hyperparathyroidism * history of hemochromatosis or ferritin \> 800 µg/l. * clinically significant gi disorder * unstable medical condition other than chronic kidney disease. * treated with sevelamer hcl monotherapy or sbr759. * treated with oral iron. * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: chronic kidney disease hemodialysis hyperphosphatemia asian patients
capecitabine metronomic chemotherapy plus aromatase inhibitor for postmenopausal hormone receptor positive breast cancer

Conditions: Breast Cancer

Summary: the present study is to determine the adverse effects and clinical efficacy of ai combined with capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with estrogen receptor and/or progestrogen receptor positive.

capecitabine (xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used as first-line and second-line rescue therapy for advanced breast cancer ,third-generation aromatase inhibitors (ai) is the preferred adjuvant endocrine therapy for postmenopausal hormone-sensitive breast cancer. study showed that ai combined with metronomic chemotherapy could improve the objective response and clinical benefit in neoadjuvant therapy.

Eligibility criteria:
inclusion criteria: 1. hormone receptor positive; 2. previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure; 3. patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery. 4. patients with metastatic breast cancer must have evaluable lesions 5. normal laboratory values: 6. informed consent (ethical approval document no. :1112105-1); 7. life expectancy of at least 3 months; 8. postmenopausal or premenopausal with bilateral oophorectomy. exclusion criteria: 1. have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months 2. organ transplant (except for autologous or allogeneic bone marrow transplantation); 3. have evidences of central nerve system metastases or have a history of mental illness that uncontrol; 4. unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity; 5. unwilling or unable to comply with study protocol or unable to meet the follow up; 6. patients who researchers considered were not suitable to participate.

Keywords: breast cancer metronomic chemotherapy aromatase inhibitors
impact of a program of cardiovascular nurse interventions in a valvular haemodynamic unit (process-valve) on quality indicators: a quasi-experimental ambispective study

Conditions: Valvular Heart Disease

Summary: the objective of this study is to evaluate the impact of a program of presurgical and postsurgical nurse interventions (process-valve) on quality indicators of the health of patients undergoing percutaneous valve procedures. (waiting times, patient satisfaction, admission times, hospital readmission, mortality, intrahospital complications and nosocomial infections). design of the study is an ambispective quasi-experimental study. for the control group, data will be collected retrospectively from patients undergoing percutaneous valve procedures who did not receive pre- or postsurgical consultations. the intervention group will comprise those patients who agree to participate in the study and the haemodynamic nurse valve consultation program (process-valve). in addition, the investigators will assess whether a face-to-face postsurgical consultation improved quality indicators compared to postsurgical telephone consultation; for this, a sub-study will be carried out comparing face-to-face or telephone postsurgical follow-up by means of a randomised controlled clinical trial with simple blinding in the intervention group. study area will be at the hemodynamic unit of the hospital de la santa creu i sant pau and the study population are chosen patients for percutaneous valvular intervention who attend the pre-surgical consultation at our center. dependent variable will be the indicators cited in the study aim and the independent variable will be the pre-surgical and post-surgical consultation. in pre-surgical consultation will be done a patient recruitment and will collect sociodemographic and clinical data. at patient will be done an individualized interview with an ad-hoc questionnaire and to collect fragility level of study and level of planned connections. in the subsequent follow-up, all pacients will receive a follow-up visit and collect satisfaction and quality indicators. but this pacients will be randomized to telephone follow-up or face-to-face follow up. sample size has been calculated in 194 to be distributed equally in both groups and the clinical trials groups will be formed by 94 patients in each group the protocol has been modified to an ambispective quasi-experimental study with a subsequent randomization for the type of follow-up (telephone vs face-to-face) due to organizational changes in the participant center.


Eligibility criteria:
inclusion criteria: * patients accepted for heart-team for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation * patients visited in the pre-surgical nursing consultation exclusion criteria: * patients with language barrier * patients undergoing emergency surgery for percutaneous treatment aortic stenosis/insufficiency and mitral or tricuspid regurgitation

Keywords: valvular heart disease nurse consultation health indicators post-surgical follow-up
correlation between modified weakness index and postoperative delirium in elderly patients

Conditions: Frailty

Summary: 1. to study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients 2. can the improved debilitating index predict the delusion after non-cardiac surgery 3. which of the debilitating index are independent risk factors associated with postoperative delusions

early identification of frailty patients is of great clinical significance for preoperative decision making and prognosis assessment. to date, the incidence of postoperative delirium in elderly patients undergoing noncardiac surgery has not been assessed. this study aimed to investigate the relationship between preoperative frailty assessment and the incidence of postoperative delirium after noncardiac surgery. 1. to study whether there is a correlation between weakness and postoperative delusions in elderly non-cardiac surgery patients 2. can the improved debilitating index predict the delusion after non-cardiac surgery 3. which of the debilitating index are independent risk factors associated with postoperative delusions

Eligibility criteria:
inclusion criteria: 1. age ≥ 70 years old; 2. asa: grade ⅰ～ⅳ; 3. signed informed consent； 4. scheduled non-cardiac surgery. exclusion criteria: 1. refuse to participate; 2. expected length of stay \<3 days; 3. the same patient can only be included once, regardless of whether the reason for the second operation is related to the first cause; 4. emergency surgery patients; 5. inability to communicate due to illiteracy, language impairment, severe hearing or visual impairment; 6. central nervous system diseases, including various types of dementia and depression 7. severe renal insufficiency (requiring dialysis treatment); 8. severe liver dysfunction (child-pugh score ≥10); 9. patients who have participated in other relevant clinical studies within 3 months mmse examination has confirmed the existence of cognitive dysfunction: illiteracy ≤17 points, primary school degree ≤20 points, middle school degree (including technical secondary school) ≤22 points, university degree (including junior college) ≤23 points

Keywords: frailty pod
genistein as a possible treatment for alzheimer's disease.

Conditions: Alzheimer's Disease

Summary: genistein is an isoflavone that has antioxidant and neuroprotective effects on alzheimer's disease (ad). a few years ago our group reported that genistein increased pparg (peroxisome proliferator activated receptor gamma) levels. by the way, activation of retinoid x receptor (rxr)-pparg dimer, will make overexpressing apolipoprotein e (apoe), which mediates the degradation of amyloid beta (ab). therefore, we believe that if this phytoestrogen administration increases the availability of the transcription factor, it can increase apoe, and also ab degradation. the main aim of this study is to determinate the effect of 60 mg bid of genistein administration, during 360 days, compared to placebo group, in ad patients.

alzheimer's disease is devastating in terms of personal wellbeing as well as for society. any effort to prevent and/or treat this disease is always sought after. recently, an exciting new possibility was opened by modulating a cellular component called rxr-pparg. a successful experimental treatment for alzheimer's was found by activating rxr. but we previously showed that a component of soya, i.e., genistein, is able to activate the other part of the rxr-pparg molecule, i.e., the pparg moiety. genistein, moreover, does not have the undesirable effect of bexarotene and is a food component. our preliminary results in animals indicate that genistein is effective in the treatment of experimental alzheimer's in mice. epidemiological evidence shows that individuals who live in eastern societies who have a high genistein intake (because they eat a lot of soya) have lower rates of alzheimer's disease. thus we propose a controlled clinical trial to test if administration of the food component genistein is able to prevent or cure, at least partially, alzheimer's disease.

Eligibility criteria:
inclusion criteria: * patients with mild cognitive impairment (mci) compatible with prodromal ad. * mini-mental state examinations (mmse) score between over 24 inclusive. * csf levels of ab, p-tau compatible with ad. * 18 years or older. * must have a study partner who is able and willing to comply with all required study procedures. * willing and able to provide informed consent by either the subject or subject's legal representative. exclusion criteria: * patient who does not meet the inclusion criteria. * thyroid abnormalities with or without treatment. * immune abnormalities in blood analyses. * patient suffers hormone dependent neoplasia. * take a diet rich on isoflavones.

Keywords: treatment genistein alzheimer's disease cerebrospinal fluid amyloid beta
comparison of the efficacy and safety of mirogabalin and duloxetine in chemotherapy-induced peripheral neuropathy in a randomized controlled trial: a quality of life study in cancer survivors

Conditions: CIPN; CIPN - Chemotherapy-Induced Peripheral Neuropathy; CIPN in Adjuvant Breast Cancer Patients; Duloxetine; Mirogabalin

Summary: to conduct a two-arm, parallel, prospective, randomized controlled, open-label trial to compare the efficacy of the novel drug mirogabalin with the conventional treatment duloxetine in reducing pain associated with chemotherapy-induced peripheral neuropathy (cipn). there will be a difference in pain reduction after 4 weeks of treatment between the mirogabalin group and the duloxetine group in patients with chemotherapy-induced peripheral neuropathy (cipn). participants will: * take drug duloxetine or a mirogabalin every day for 4 weeks. * visit the clinic once every 2 weeks for checkups and tests


Eligibility criteria:
inclusion criteria: * cancer survivors aged 19 years or older. * peripheral, symmetrical pain in both feet occurring within 12 weeks of initiating chemotherapy with taxane or platinum agents (or their combination). * patients experiencing at least grade 2 peripheral neuropathy as defined by the nci common terminology criteria for adverse events (ctcae) version 5.0, with an average pain intensity of 4 or higher on the numerical rating scale (nrs) during the past week, following the completion of chemotherapy. * concurrent use of selected analgesics (acetaminophen, nonsteroidal anti-inflammatory drugs \[nsaids\]) is permitted if the following conditions are met: 1. no new analgesics are introduced. 2. current analgesics are not discontinued. 3. the total weekly 24-hour dose of analgesics does not vary by more than 10% during the 2 weeks prior to enrollment. * ongoing treatment for peripheral neuropathy or neuropathic pain must be discontinued at least 7 days before randomization exclusion criteria: * patients with a prior diagnosis of peripheral neuropathy due to diabetes, trauma, alcohol abuse, compression, or other causes, or those with a previously diagnosed central nervous system disorder. (patients with pre-existing diabetes or thyroid disease who had no symptoms of peripheral neuropathy, such as numbness or tingling in the hands or feet, before chemotherapy may be included.) * patients with significant psychiatric disorders, such as severe depression, bipolar disorder, or suicidal ideation. * pregnant or breastfeeding patients. * patients with a history of prior treatment with other neurotoxic chemotherapeutic agents. * patients with renal impairment (creatinine clearance \< 30 ml/min) or hepatic dysfunction. * patients with planned surgical procedures within 4 weeks of enrollment.
ppis and in-hospital morbidity in acute variceal bleeding with chronic liver disease

Conditions: Morbidity

Summary: with this study, the investigators pretend to describe intrahospital morbidity in patients living with cirrhosis (plc) who present to the emergency department with variceal bleeding (vb). this study is a longitudinal, prospective, experimental, analytical single-center clinical trial. the study will be performed in the hospital universitario "jose e. gonzález" de la factultad de medicina, universidad autónoma de nuevo león, monterrey, nuevo león, méxico. the studied population consists of adult-age patients with previous, recent, or new diagnoses of cirrhosis who present to the ed with vh without shock, infection, or acute or chronic disease with a \ 50 points. elimination criteria involve patients who want to discontinue treatment and patients with confounding endoscopic findings (erosive esophagitis, peptic ulcers, duodenal ulcers, gave, and atrophic gastritis). after the endoscopic intervention, the investigators will propose inclusion. after acceptance with informed consent, the investigators will randomize the patients to receive or not receive omeprazole 40 mg iv per day until discharge. the primary outcome will represent several morbidity situations in these patients, including hepatic encephalopathy, intra-hospital infections, re-bleeding, shock, and acute kidney failure. the secondary outcomes include the individual analysis of each component of our compound primary outcome, mortality by day 30, differences when grouping patients by child-pugh stratification, and comparing results in patients receiving omeprazole for more or less than 5 days.


Eligibility criteria:
inclusion criteria * adult * cirrhosis * variceal bleeding with only endoscopic findings consistent with portal hypertension complications * hypovolemic shock and variceal bleeding exclusion criteria: * shock of any type other than hypovolemic. * no cirrhotic patients * patients that have hepatic encephalopathy at admission * hepatorenal syndrome * acute on chronic with clif-c \>50 points * septic patients * spontaneous bacterial peritonitis elimination criteria * voluntary removal of the study * patients with confounding endoscopic findings (erosive esophagitis, peptic ulcers, duodenal ulcers, gave, and atrophic gastritis).

Keywords: proton bomb inhibitors variceal bleeding morbidity
implementation of enhanced recovery after surgery program (eras) in colorectal cancer surgery, a randomized controlled trial

Conditions: Cancer of Colon

Summary: the aim of our study is to determine the effect of implementation of the eras (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.


Eligibility criteria:
inclusion criteria: * age ≤ 60 years, * good nutrition, * no systemic infection and * elective laparoscopic surgery exclusion criteria: * age \>75 years, * malnutrition or an organ system infection * associated with obstruction, bleeding, emergency surgery or other surgical intervention * tumor with extensive metastasis * prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support * previous history of abdominal surgery * patient have previously undergone gastrostomy
prospective köln bonn registry for the extraction of pacmaker and icd leads

Conditions: Infections; Pacemaker, Artificial; Defibrillators, Implantable

Summary: the kobes registry is an all-comers prospective clinical registry of the cooperative köln bonn lead extraction center. all patients undergoing complex lead extraction procedures (i.e. indwelling leads \> 6months) in the hybrid operating room with cardiothoracic standby will be included in the registry. preoperative, intraoperative/procedural and postoperative parameters will be recorded. all patients will be asked to provide written informed consent. data will be pseudonomyzed and entered into a data sheet. data will be monitored by a board and evaluated independently.

the following parameters will be included in the registry preoperative general: * pacemaker / icd indication * ejektionsfraktion * previous cardiac surgery / tavr * specific cardiac disease: ihd, cmp (dcm, hcm, andere), primary electrical disease if icd: * primary / secondary prevention concomitant disease:htn, dm * crf; gfr (ml/min) * if yes: dialysis ? * anticoagulation / antithrombotic therapy: ja/nein indication: * infection (local/systemic), classification * blood culture positive/negative * swab positive * classification * tee: pos/neg * device malfunction * phlebography y/n * vascular access y/n * number of leads and type * uni/bipolar / age / abandoned leads * icd-leads: single-/dual-coil, age / abandoned leads intraoperative: general: * type of anaethesia * tee y/n * safety wire y/n * temporary pacing wire y/n access: * subclavia r/l/bil * femoral: y/n; if yes: planned / bailout: geplant tools * lld: y/n; number * mechanical sheath and type * laser sheath * additional tools: loop-snare / needle-eye snare / rat-tooth result : extraction: complete / partial / failed * procedural success: y/n * infection: procedural / clinial success * safety lead y/n * temporary pacing wire in situ intraoperative complications * vascular injury * pericardial effusion / tamponade * pericardiocentesis * occlusion ballon * thoracotomy * intraoperative catecholamines * death postoperative: * duration * hospital stay * postoperative active system * transvenous / epicardial / capsule/ subcutaneous / extravascular * type of pacemaker * type of icd * wenn ja: transvenös / subkutan postoperative complications: * hematoma / seroma / fistula * further interventions: revision / hematoma/ reinfection

Eligibility criteria:
inclusion criteria: * all patients with a standard indication for lead extraction according to the hrs / ehra guidelines exclusion criteria: * none

Keywords: lead extraction cardiac device infection complication pacemaker implantable cardioverter-defibrillator extraction tools
can dfn-15 terminate migraine with allodynia?

Conditions: Migraine With Aura; Migraine Without Aura; Allodynia

Summary: the majority of migraineurs seeking secondary or tertiary medical care develop cutaneous allodynia during the course of migraine, a sensory abnormality mediated by sensitization of central trigeminovascular neurons in the spinal trigeminal nucleus. triptan therapy can render allodynic migraineurs pain-free within a narrow window of time (20-120 min) that opens with the onset of pain and closes with the establishment of central sensitization. this calls for the development of drugs that can tackle ongoing central sensitization and render allodynic migraineurs pain-free after the window for triptan therapy has expired. there are two main objectives the investigators seek to achieve from this study: to determine whether oral administration of dfn-15 (solution of a cox2 inhibitor, celecoxib) terminates migraine attacks when given to allodynic participants 3 hours after attack onset; and to determine whether mechanical and heat allodynia that develop during acute migraine attacks could be reversed by late (\> 3hrs after attack onset) treatment with dfn-15. participants will be recruited from the headache center and randomized in a double-blinded fashion to receive either the active drug (dfn-15) or placebo in a ratio of 4:1.the participants will be instructed to return to the clinic during a migraine. at the 'during-migraine' visit, which will begin 3 hours after onset of headache, the investigators will document headache intensity, associated symptoms, and mechanical and heat pain threshold (first) before treatment (at 180 min after onset of headache) and (second) at a 120 min after treatment (5 hours after headache onset). based on our prior experience studying migraine patients, the investigators plan to screen 100 patients to achieve 50 participants completing the 2 study visits as planned. the active drug group will consist of 80/100 patients and 20/100 patients will receive the placebo. the study will be terminated as soon as the first 40 participants who received the dfn-15 and first 10 patients who received placebo completed visit 2.


Eligibility criteria:
inclusion criteria: * history of migraine with or without aura for at least 3 years, based on the international classification of headache disorders * two or more migraine attacks per month on average during the year prior to enrollment * ability to give written consent to enrollment exclusion criteria: * fifteen or more headache days per month, on average * aspirin or nsaid induced asthma or allergy * sulfa allergy * any woman who is pregnant or lactacting * history of any of the following: coronary artery bypass surgery, heart attack, angina, stroke, serious gastrointestinal bleeding, peptic ulcer disease, and/or chronic kidney disease * medical conditions requiring the use of diuretics or daily anticoagulants * severe uncontrolled medical problems or medications that may influence measurements