Kornimate/medical-research-clean huggingface dataset:
an international, observational, blinded study to assess the performance of the cordio hearo system

Conditions: Heart Failure

Summary: study design: this is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and upnr of the hearo system.

two periods: run-in period will be a period in which patients will submit daily recordings, baseline creation core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until end-of-study (eos), whichever comes first.

Eligibility criteria:
major inclusion criteria: 1. age 22 or greater 2. diagnosed with symptomatic chronic heart failure \[nyha ii-iva (ambulatory)\] 3. at least one of the following: 1. one adhf hospitalization in the last 12 months 2. one unplanned iv/sc diuretic administration in the last 6 months 3. two unplanned iv/sc diuretic administrations in the last 12 months 4. ntprobnp \>500 pg/ml 4. clinically stable hf according to investigator discretion 5. willing to participate as evidenced by signing the written informed consent. major exclusion criteria: 1. unable to comply with daily use of the app, 2. has had a major cardiovascular event within 3 months prior to enrolment. 3. had a cardiac resynchronization therapy device (crt) implanted or upgrading ≤ 1 month prior to screening visit. 4. has estimated glomerular filtration rate (egfr) \< 30 ml/min/1.73. 5. is likely to undergo heart transplantation/ lvad within 6 months of screening visit. 6. was treated for a significant copd
a post marketing surveillance study on the safety and effectiveness of prucalopride in the treatment of chronic constipation

Conditions: Chronic Constipation

Summary: the purpose of this study is to determine the safety and effectiveness of prucalopride in the treatment of filipino patients with chronic constipation whom prior laxatives fail to provide adequate relief.

this is a 12-week open label (all people know the identity of the intervention), multi-center, prospective (the patients are identified and then followed forward in time for the outcome of the study) observational study assessing the safety and effectiveness of prucalopride among filipino patients with chronic constipation. chronic constipation is a condition in which bowel movements are infrequent or incomplete for a prolonged time. the use of prucalopride should be used in accordance with the approved product label and will follow the normal medical practice of the investigators. patients should take 2 mg prucalopride tablet orally once daily. for elderly patients (\>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given. patients will be asked to fill-up a patient diary daily for 12-weeks to monitor the bowel movement during the study period. all adverse events and concomitant medications taken by the patients during the study will be documented accordingly. patients will be monitored during the 12-week period of observation while the patients are in prucalopride treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic constipation by history and physical examination, including rectal exam * history of chronic constipation not satisfied with laxatives * patient reports, on average, 2 or fewer spontaneous bowel movements (sbms) per week and 1 or more of the following for the last three months: very hard (little balls) and/or hard stools in more than 25% of bowel movements (bms); sensation of incomplete evacuation in more than 25% of bms; straining at defecation in more than 25% of bms; sensation of ano-rectal obstruction or blockade in more than 25% of bms; a need for digital manipulation to facilitate evacuation in more than 25% of bms * females of childbearing potential agree to use highly effective contraceptive methods exclusion criteria: * renal impairment requiring dialysis * secondary chronic constipation and organic gastrointestinal (gi) disorders * intestinal perforation / obstruction due to structural or functional disorder of the gut wall, obstructive ileus, severe inflammatory condition of the intestinal tract such as crohn's disease, ulcerative colitis, toxic megacolon / rectum * hypersensitive to prucalopride or to any of its components * patients receiving concomitant drugs known to cause qtc prolongation * pregnant or lactating

Keywords: chronic constipation prucalopride post marketing surveillance
multi-car t cell therapy in the treatment of multiple myeloma

Conditions: Multiple Myeloma

Summary: the aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous car t cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. another goal of the study is to learn more about the persistence and function of car t cells in the body.

multiple myeloma (mm) is a malignancy of plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (sct). this trial is to test the safety and efficacy of t cells genetically modified to specifically target several mm surface antigens, including bcma, cd38, cd56, cd138 or alternative mm surface antigens, based on a multi-car t cell immunotherapy approach. another goal of the study is to investigate the persistence and function of car t cells in the body after car t cell infusion.

Eligibility criteria:
inclusion criteria: * male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic sct). * complete remission (cr) cannot be achieved after at least 4 prior combination therapy regimens. * mm in cr2 or cr3 and not eligible for allogeneic sct because of age, comorbid diseases, or lack of available donor. * less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \< 1 year). * relapsed after prior autologous or allogenic sct mm patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic sct. * residual disease after primary therapy and not eligible for asct * expected survival \> 12 weeks * creatinine \< 2.5 mg/dl * alt (alanine aminotransferase)/ast (aspartate aminotransferase) \< 3x normal * bilirubin \< 2.0 mg/dl * any relapse after prior sct is eligible regardless of other prior therapy * adequate venous access for apheresis, and no other contraindications for leukapheresis * voluntary informed consent is given exclusion criteria: * pregnant or lactating women * uncontrolled active infection * active hepatitis b or hepatitis c infection * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary. * previous related car-t cell therapy any uncontrolled active medical disorder that would preclude participation * hiv infection

Keywords: multiple myeloma chimeric antigen receptor bcma cd38 cd56 cd138
conserving surgery in inflammatory breast cancer after neoadjuvant chemotherapy

Conditions: Inflammatory Breast Cancer

Summary: inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. the classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast. current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy. in the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response. there are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. this may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.


Eligibility criteria:
inclusion criteria: * patients with inflammatory breast cancer * clinical complete response after neoadjuvant chemiotherapy * targeted tumor * written informed consent exclusion criteria: * metastasis * progression disease * recurrent disease * contraindications to adjuvant radiation therapy

Keywords: inflammatory breast cancer breast conserving surgery radical mastectomy
home-based transcranial direct current stimulation (tdcs) for treatment of attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity

Summary: the investigators are investigating whether home-based tdcs over the course of four weeks can improve adhd symptom severity and improve dysexecutive functioning (cognitive control). further, the investigators are investigating whether there is a dose-dependent response to tdcs.

this mechanistic clinical trial will be the first of its kind to assess the clinical and cognitive efficacy of tdcs, and its relationship to physiological target engagement. it will also provide critical knowledge about tdcs dosing in a therapeutic context (i.e. 30 days of daily tdcs). last, it will assess the feasibility and acceptability of home-based neuromodulation therapies for adhd, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with adhd. an additional goal of the proposed study is to assess the feasibility and acceptability of home-based neuromodulation therapies for adhd, reducing the most significant obstacle for the implementation of devices therapies (i.e. daily visits to the hospital for several weeks) and facilitating access to advanced therapeutics to a large population of patients with adhd.

Eligibility criteria:
inclusion criteria: 1. male and female outpatients 18-65 years of age 2. a diagnosis of add/adhd or meeting the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria. exclusion criteria: 1. contraindication to tdcs: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, vp shunt, pacemakers, pregnancy. 2. active substance dependence (except for tobacco). 3. pregnant or nursing females. 4. inability to participate in testing procedures. 5. premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, parkinson's, ad and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).
use of virtual reality in pain management in pediatric oncology

Conditions: Pediatric Tumor

Summary: dorevi is a monocentric randomized controlled study that will evaluate the efficacy of virtual reality helmets for pain prevention during invasive care on 78 oncologic pediatric patients. two groups of children (between 6 and 11 and between 12 and 18 years old) will be randomized to use helmet plus standard care or standard care alone during invasive procedures (central venous catheter puncture, lumbar puncture, or bone marrow aspiration). the pain intensity will be evaluated using a visual analogic scale during three invasive procedures, and results will be compared between the patients with or without virtual reality.


Eligibility criteria:
inclusion criteria: * patient who tolerates the virtual reality headset * patient followed in pediatric oncology * patient with a diagnosis of benign tumor or cancer * patient who needs to have painful medical procedure during their treatment * patient whose parents have signed the informed consent * patient affiliated with social security or equivalent exclusion criteria: * patient with visual or hearing impairement * patient with epilepsy or other neurological disease * patient with psychiatric disease
stereotactic radiotherapy (sbrt) in patients with locally advanced pancreatic cancer (lapc)

Conditions: Locally Advanced Pancreatic Cancer

Summary: stereotactic radiotherapy (sbrt) in patients with locally advanced pancreatic cancer (lapc). a danish phase ii study.

combination chemotherapy (e.g. folfirinox (5-fluorouracil, irinotecan, oxaliplatin), gem-abraxane, gem-cap, gem-s1) is standard of care in patients with lapc but more and more scientific studies point to the fact that patients without sign of progressive disease (pd) will benefit from additional radiotherapy and especially sbrt. the sample size is based on simon's two stages mini-max design. this design ensures early study termination if there is insufficient effect. a resection rate less than 10% after sbrt is not clinically acceptable. assuming a significance level at 0.1 (α = 0.1) and a power at 90% (β = 0.10) it can be calculated, that 16 patients should be included in the first part of the study. the enrolment will continue until 16 patients have completed sbrt and have been re-evaluated for resection by ct scan (and endoscopic ultrasonography + laparoscopic ultrasound, if available). if 1 or less out of the first 16 consecutive patients are being resected the investigators will reject our hypotheses and close the study after the first stage of accrual. if 2 or more patients are resected, an additional 9 patients will be accrued in the second stage. if at least 4 out of 25 patients are resected, a true resection rate of 30% cannot be excluded, and the investigators will conclude that the treatment is effective enough to continue with future studies. to ensure 25 evaluable patients the investigators will include a total of 30 patients.

Eligibility criteria:
inclusion criteria: * lapc (karolinska type b, c or d1) * cytologically or histologically verified adenocarcinoma/carcinoma * prior combination chemotherapy for 2-6 months (unless contraindicated) and no sign of progressive disease * the patient is medically operable (i.e. no co-morbidity which can preclude anaesthesia or surgery) * world health organization performance status 0-1 * age ≥ 18 years * adequate hepatic function: bilirubin \<3.0 x upper normal limit, international normalized ratio \<1.6, activated partial thromboplastin time \< 1,5 x upper normal limit. patients with obstruction of bile duct or gut must be drained before start of therapy * oral and written informed consent must be obtained prior to registration with planned date of first treatment within 14 days from registration. exclusion criteria: * m1 disease * prior radiotherapy to abdominal cavity * pregnancy or breast-feeding. fertile patients must use adequate contraceptives * severe uncontrolled concomitant illness (e.g. clinically significant cardiac disease or myocardial infarction within 12 months)

Keywords: stereotactic radiotherapy
aminoterminal propeptide of type iii procollagen and severity of coronary artery disease in patients without myocardial infarction

Conditions: Coronary Artery Disease

Summary: background: myocardial fibrosis is a major component in cardiac remodeling in patients with myocardial infarction or hibernation. however, the association of cardiac fibrosis and coronary artery disease (cad) in patients without infarction or hibernation is still unclear. in the present study, we analyzed the relationship between serum concentrations of procollagen propeptides and severity of cad in such patients. patients and methods: forty-six patients (32 men and 14 woman; mean age 64 years) with chest pain and normal left ventricular contractility were enrolled into this study. myocardial infarction was excluded by history and electrocardiograms. all patients received stress thallium-201 single photon emission computed tomography (spect) and analysis of the serum levels of the aminoterminal propeptide of type i and iii procollagen (pinp and piiinp).


Eligibility criteria:
inclusion criteria: * we prospectively studied 46 consecutive patients aged 50 to 75 years (32 men and 14 women; mean age was 64 years) who were referred for chest pain evaluation. exclusion criteria: * mi was excluded by history and electrocardiograms. regional wall motion abnormalities and impaired left ventricular contractility (left ventricular ejection fraction \< 50%) were excluded by routine echocardiography.
sick leave, work disability and quality of life in korean patients with inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: inflammatory bowel diseases (ibd) is a chronic inflammatory condition of the gastrointestinal tract that significantly affects quality of life of patients. several studies have reported that the loss of work productivity is significantly higher than that of the general population due to disease-related symptoms and various factors in patients with inflammatory bowel disease in western countries, but there is few data in korea. therefore, this study is to assess the effect of disease on sick leave, work disability and health related quality of life in korean patients with inflammatory bowel disease by using validated questionnaires.

first, the investigators will estimate the prevalence of work disability in patients with inflammatory bowel disease using the work productivity and activity index (wpai), that have been validated in patients with inflammatory bowel disease. secondary, the predictor of work productivity impairment in patients with inflammatory bowel disease and distribution of type and severity of work disability will be identified. third, the investigators will explore the correlation between the quality of life and psychosocial aspects (anxiety disorder, depression) of patients with inflammatory bowel disease. one year later, the same questionnaire will be surveyed repeatedly in the same participants under usual care to investigate the changes in patient-reported outcome measures.

Eligibility criteria:
inclusion criteria: patients diagnosed with inflammatory bowel disease (crohn's disease and ulcerative colitis) at kyung hee university hospital exclusion criteria: 1. patients who do not agree to fill out the questionnaire. 2. patients who can not fill out the questionnaire themselves. 3. patients who can not understand the questionnaire.

Keywords: work disability quality of life psychosocial distress
comparing ropivacaine and bupivacaine in dtfnb anesthesia in patients undergoing phacoemulsification

Conditions: Cataract Unilateral Pending Extraction; Anesthesia

Summary: deep topical fornix nerve block anaesthesia is now a known form of nerve block for cataract surgeries by phacoemulsification. in this study the investigators intend to compare ropivacaine and bupivacaine in various parameters during phacoemulsification.

prospective, study will be conducted on 100 patients undergoing elective cataract surgery by phacoemulsification under deep topical fornix nerve block at government medical college, haldwani, india. written informed consent to participate in the study will be taken from all the patients. patients will be randomly allocated into two groups, groups b (bupivacaine: n=50) and group r (ropivacaine: n =50). deep topical fornix nerve block (dtfnb) would be performed using two sponges (2x3 mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anesthetizing the conjunctiva with proparacaine local anesthetic drops. the sponges are to be removed after 15-20 minutes. the anesthetic effect will be tested by grasping the limbus with castroviejo 0.12 tissue forceps. no sedative systemic medications will be given to patients perioperatively. all surgeries will be performed by the same surgeon. both patients and surgeon will be blind to which anesthetic agent would be used. a 2.8mm scleral tunnel incision will be made, followed by capsulorhexis. the nucleus would be removed by the stop and chop technique followed by irrigation aspiration of the cortex. foldable acrylic intraocular lens would be implanted in the capsular bag followed by wash of the viscoelastic and hydration of the side ports. a simple pain scoring system will be used during the surgery (0: no pain; 1: discomfort; 2: pain). assessment will be made by verbally asking the patient to score each step of the surgery i.e. scleral tunnel incision, capsulorhexis, hydrodissection, phacoemulsification, irrigation aspiration, intraocular lens implantation and stromal hydration. in case the score being 0 or 1 no intervention will be done. but in cases of score being 2 at any stage of the surgery, an intracameral injection of 1% preservative free lignocaine will be given.

Eligibility criteria:
inclusion criteria: - anaesthesiologists physical status classification system (asa i-ii) to undergo planned cataract surgery by phacoemulsification. exclusion criteria: * younger than 50 years, * had any psychiatric illness (including significant anxiety), * nystagmus, * insufficient pupil dilatation, * very hard cataracts (ns 4-5), * allergy to local anaesthetics, * inability to understand language or * patient refuses the topical anaesthesia technique

Keywords: deep topical fornix nerve block anesthesia ropivacaine bupivacaine anaesthesia eye surgery blocks phacoemulsification
comparison of ticagrelor vs. prasugrel on inflammation, arterial stiffness, endothelial function, and circulating endothelial progenitor cells in diabetic patients with non-st elevation acute coronary syndrome (nste-acs) requiring coronary stenting

Conditions: Acute Coronary Syndrome

Summary: to investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-st elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedures 2. newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70 3. non-st elevation acute coronary syndrome with successful coronary stent implantation (with timi flow grade 3 after the procedure) exclusion criteria: 1. hypersensitivity to ticagrelor, prasugrel or any of the excipients 2. no prior use of either ticagrelor or prasugrel within a month prior to randomization. 3. history of intracranial bleeding at any time 4. active pathologic bleeding 5. hemoglobin a1c \>9% 6. type 1 diabetes 7. decreased serum platelet level (\< 100,000/ul) 8. need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin 9. gastrointestinal bleed within the past 6 months, or major surgery within 30 days 10. renal failure requiring dialysis or anticipated need for dialysis during the course of the study 11. any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study 12. involvement in the planning and/or conduct of the study 13. left ventricular ejection fraction \< 40% 14. hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit) 15. gastrointestinal disorder such as crohn's disease 16. alcohol abuse 17. steroid or hormone replacement therapy 18. serum creatinine \> 2.0 mg/dl. 19. prior history of cva or stroke 20. body weight \< 60 kg 21. life expectancy less than a year 22. known pregnancy, breast-feeding, or intend to become pregnant during the study period

Keywords: diabetic patients with non-st elevation