Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of add on aliskiren in patients with heart failure and renal impairment

Conditions: Heart Failure; Kidney Failure

Summary: the main purpose of this study is to examine the effect of add-on therapy with the direct renin inhibitor aliskiren in comparison to placebo on renal blood flow in patients with heart failure and reduced renal function. * primary outcome measure: change in renal blood flow at 6 months * secondary outcome measures: changes in renal function, n-terminal pro brain natriuretic peptide, left ventricular function, blood pressure and neurohormones

this study is a randomized, double-blind, placebo controlled, parallel group comparison trial, enrolling 100 patients (67 vs. 33) with stable chf. patients will be randomized to aliskiren 300 mg once daily or corresponding placebo for a period of 6 months. efficacy measures will be performed at baseline and at the end of the study. primary efficacy outcome is change in renal blood flow as measured by 131i-hippuran clearance. secondary outcome include change in renal function, neurohormones, left ventricular function and blood pressure. safety assessments include renal function, changes in electrolytes, and blood pressure. patients will be uptitrated to maximum tolerated doses of aliskiren, and safety visits are planned 1 week after initiation and on a 2 month interval afterwards. a total of 8 visits are planned during the entire study period.

Eligibility criteria:
inclusion criteria: * nyha ii-iv heart failure * left ventricular ejection fraction \< 45% * stable heart failure medication * egfr by smdrd formula between 30 and 60 ml/min/1.73m2 exclusion criteria: * known hypersensitivity to study drug or acei * concomitant treatment with both arb and aldosterone receptor antagonist * symptomatic hypotension * acute heart failure * history of stroke, acute coronary syndrome, pci or angioplasty within past 3 months * serum potassium \> 5.2 mmol/l * right heart failure due to severe pulmonary disease * other protocol-defined inclusion/exclusion criteria may apply

Keywords: heart failure renal failure cardiorenal syndrome renin inhibition aliskiren
an educational intervention based on the teach back method on self-care practice among menopausal women

Conditions: Menopause

Summary: this study was conducted to assess the effects of an educational program that had designed based on teach back method in order to improve self-care competency among menopausal women.

in this study 60 menopausal women randomly allocated to intervention group(n=30) and control group(n=30). intervention group participated in an educational program that had designed in four sessions based on teach back method. control group revived no education.

Eligibility criteria:
inclusion criteria: * menopausal women(1-5 years after menopause) * no history of hysterectomy * no history of oophorectomy * literacy for reading and writing exclusion criteria: * no interest for continuing the study * no participating in all educational sessions
effects of whole body vibration in people with chronic stroke

Conditions: Stroke

Summary: the overall aim of the proposed study is to determine whether whole body vibration is beneficial in promoting bone health, physical fitness and neuromotor performance in patients with chronic stroke. subjects in the experimental group will undergo whole body vibration therapy (1 session per day, 3 sessions per week) for 8 weeks. the vibration frequency used in this study will be 30hz. the total duration of exposure to vibration for the experimental group will be 10 minutes. while standing on the vibration platform, patients will be instructed to repeat the following set of light exercises: (1) light squatting,(2) deep squatting, (3) side-to-side weight-shift, (4) forward and backward weight-shift, (5) forward lunge, (6) marching on the spot. the control exercise group, on the other hand, will perform the same exercise program on the platform, but no vibration will be given. the training will be conducted by a qualified personnel with physiotherapy background. the outcome measurement will be performed 4 times: (1) immediately before the commencement of intervention, (2) immediately after termination of treatment, (3) at 1 month after termination of treatment. each subject will be evaluated for bone markers, leg muscle strength, balance, spasticity, and walking ability.


Eligibility criteria:
inclusion criteria: * a diagnosis of stroke more than 6 months * medically stable * able to understand verbal commands * abbreviated mental test score 6 or above * age \>18 * able to stand with or without aids for at least 1.5 minutes exclusion criteria: * neurological conditions other than stroke * significant musculoskeletal conditions (e.g. amputations) * metal implants in the lower extremity * previous fracture of the lower extremity * are currently taking bone resorption inhibitors or were taking the same before stroke. * significant peripheral vascular disease * vestibular disorders * pregnancy * other serious illnesses that preclude the person from participating in the study

Keywords: cerebrovascular accident bone muscle vibration
effect of mizagliflozin on postprandial glucose and insulin in post-bariatric hypoglycemia subjects

Conditions: Postbariatric Hypoglycemia

Summary: this clinical study will examine the safety and tolerability, as well as the effects of orally administered mizagliflozin on post prandial glucose and insulin levels in subjects diagnosed with post-bariatric hypoglycemia (pbh).

this is a phase 2 randomized, sequential crossover single ascending dose study in pbh subjects to determine the effect of two mizagliflozin formulations this study will examine single doses of mizagliflozin in either a liquid or encapsulated formulation. subjects will be randomly assigned to one of two treatment arms. safety, tolerability and pharmacodynamic response to mizagliflozin will be assessed in subjects during a mixed meal tolerance test (mmtt).

Eligibility criteria:
inclusion criteria: * roux-en-y gastric bypass surgery performed \> 6 months prior to enrollment * diagnosis of pbh exclusion criteria: * history of current medical conditions (other than pbh) which may result in hypoglycemia such as insulinoma, adrenal insufficiency, insulin autoimmune hypoglycemia, congenital hyperinsulinemia. * current use of insulin or insulin secretagogues. * history of current dumping syndrome. * history of current fasting hypoglycemia. * pregnancy and/ or lactation: for women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 2 weeks after participating in the study.
study to evaluate the safety, tolerability, pharmacokinetics, and food effect of no-13065 in healthy and obese adult subjects

Conditions: Obesity

Summary: this clinical trial is the first-in-human study of no-13065. the purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of no-13065 in healthy and obese adult subjects.


Eligibility criteria:
inclusion criteria: 1. healthy adult male and/or female (non-childbearing potential only), 19 to 55 years of age 2. continuous non-smoker 3. medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or safety ecgs. 4. women of non-childbearing potential only 5. able to understand and sign a written informed consent form prior to initiation of study procedures. exclusion criteria: 1. subject is mentally or legally incapacitated or has significant emotional problems 2. history or presence of clinically significant medical or psychiatric condition or disease 3. history or presence : familial hyperlipidemia, diabetes, bleeding disorder(s), including relevant familial history, thromboembolic disease, bleeding in the gastrointestinal tract or cns, hepatobillary disease, gilbert's syndrome 4. history or presence of alcohol or drug abuse. 5. has liver function test(s) including alt, ast, ggt, and/or alp or total bilirubin that are \> uln at screening or check-in. 6. positive urine drug or alcohol results.
irreversible electroporation for treatment of solid abdominal tumors

Conditions: Oncology

Summary: irreversible electroporation (ire) is a novel non-thermal ablation modality with promise for revolutionizing the treatment for local solid tumors. with the growing demand for alternative and less invasive treatments for localized tumors, the investigators have seen the development and investigation of several tissue ablation modalities, including radiofrequency ablation (rfa), microwave ablation, and cryoablation. although these modalities have been efficacious, they have some disadvantages owing to their reliance on thermal energy for creating cell death.

irreversible electroporation is novel in that it does not use thermal energy, but electrical energy to produce focused cell death while sparing the normal extracellular matrix, nearby vessels, and structures, while allowing for rapid normal tissue regrowth. unlike thermal ablation modalities, irreversible electroporation does not require significant consideration for dissipation of thermal energy, or heat sink, and has less complications relating to damage of normal soft tissue, eliminating a major cause of treatment failure. irreversible electroporation is a novel minimally invasive tumor/tissue ablation technique that can be used under guidance of ultrasound (us) or computed tomography (ct), without inducing thermal damaging effects, and with preservation of the surrounding vital structures such as vessels, bile ducts, urethra, and nerves which remain intact to function normally, even in locally advanced tumors. the technique depends upon inducing apoptotic non-necrotic cell death in short procedure time. it has the advantage of allowing quick tissue regeneration. irreversible electroporation treatment time is significantly shorter than traditional thermal ablation modalities, usually in few minutes range, and allows for treating considerably larger lesions than thermal ablation modalities.

Eligibility criteria:
inclusion criteria: * patients with unresectable solid abdominal tumors (hepatic, pancreatic, porta hepatis,...). * the mass measures less than 4 cm. * associated with no or oligo metastatic lesions exclusion criteria: * patients with cardiac arrhythmia and pacemaker. * patients unfit for general anesthesia. * the lesion size is larger than 4 cm.
decrease artery occlusion by distal radial arterial cannulation in acs patients

Conditions: Acute Coronary Syndrome; Procedural Complication

Summary: the site of arterial access for coronary angiography and intervention has been the focus of research for decades as it is the source of major complications. transradial access (tra) reduces complications among patients undergoing percutaneous coronary procedures but is reported with the complication of radial artery occlusion (rao) that limits the radial artery for future needs. distal radial access (dtra) has recently gained global popularity as an alternative access route for vascular procedures. among the benefits of dtra are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. this study aims to reveal the feasibility and safety of dtra and routine tra procedures in acute coronary syndrome patients. the primary endpoints are forearm radical occlusion rate and major adverse cardiovascular events (maces) in the two groups, respectively. investigators will also focus on puncture success in diagnostic and interventional cases, rate of one attempt success, access time, procedure time, crossover rate, contrast dose of patients, fluoroscopy time and dose, and healthcare cost of each group.


Eligibility criteria:
inclusion criteria: * presence of a pulse in the snuffbox exclusion criteria: * absence of pulse * ultrasound indication of arterial occlusion or severe calcification * severe forearm artery malformation * patients with severe liver and renal failure, or abnormal coagulation function * established cardiogenic shock * history of previous coronary artery bypass grafting and radial artery use. * raynaud's disease in the medical history

Keywords: distal radial access radial artery occlusion major adverse cardiovascular events
a machine-learning model to predict lymph node metastasis of intrahepatic cholangiocarcinoma

Conditions: Intrahepatic Cholangiocarcinoma; Machine Learning

Summary: the object of this study is to develop a model for prediction of lymph node metastasis among intrahepatic cholangiocarcinoma (icc) patients. intrahepatic cholangiocarcinoma is the second most common kind of primary liver cancer, accounting for approximately 10%-15%. there is a lack of agreement regarding the necessity of performing lymph node dissection (lnd) in patients with icc. currently, the percentage of lnd is below 50%, and the rate of sufficient lnd (≥6) has plummeted to less than 20%. consequently, a large proportion of patients are unable to acquire ln status, which hinders the following systematic treatment strategies after surgery:. therefore, our objective is to construct a ln metastasis model utilizing machine learning techniques, including patients' clinical data and pathology information, with the goal of offering a reference for patients who have not undergone lnd or have had inadequate lnd.


Eligibility criteria:
inclusion criteria: * 1.patients who were confirmed with intrahepatic cholangiocarcinoma 2. curative-intent hepatectomy 3. without concurrent extrahepatic disease exclusion criteria: * 1.patients lacking complete pathology information, 2. patients who didn't get curative resection 3.patients with concurrent extrahepatic disease or had missing follow-up data

Keywords: intrahepatic cholangiocarcinoma machine learning prognosis online calculator
assessment of cognitive functioning before and after treatment with duloxetine

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to study the effect of duloxetine treatment on (1) cognitive functions, the brain mechanisms involved with thinking, reasoning, learning, and remembering; (2) psychosocial functions, how someone interacts with his/her social environment; and (3) the relationship between these two functions, in people who have major depressive disorder, a severe form of depression.

people who have difficulties with concentration and/or cognition as part of their depression will be treated with duloxetine for 12 weeks and their cognitive performance will be assessed before and after treatment using cognitive tests. eligible participants will have eight clinic visits.

Eligibility criteria:
inclusion criteria: * ability and willingness to provide written informed consent * primary diagnosis of major depressive disorder (mdd) * age 18-45 * screening and baseline hamilton rating scale for depression (hrsd) 17-item score greater than or equal to 16 or clinical global impression (cgi) score of at least 4 * subjective report of difficulties with cognition and/or concentration and score of 2 or greater on the inventory for depressive symptomatology (ids-c(30)) item addressing this symptom (#16: concentration and decision making) exclusion criteria: * presence of significant comorbid condition based on laboratory tests, physician information, or evidence at examination * patient report or evidence (based on physical examination or laboratory tests) of existing liver disease * presence of other psychological disorders, including depression due to other comorbid conditions, currently suicidal or high suicide risk, current or past psychotic disorders of any type, bipolar disorder (i, ii, or nos), schizophrenia, or schizoaffective disorder, anorexia, bulimia, obsessive compulsive disorder, alcohol or substance abuse within the last 6 months, or patients with comorbid psychiatric conditions that are relative or absolute contraindications to the use of duloxetine * concomitant pharmacological or psychotherapeutic treatment including but not limited to antidepressants, anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy, cognitive behavioral therapy; current use of other medications that would be contraindicated with duloxetine, as determined by the study doctor * hospitalization for mental illness within the past year * not fluent in spoken and written english * for women, currently pregnant, planning to become pregnant in the next year, or breastfeeding

Keywords: depression major depressive disorder cognitive function psychosocial function
deep inferior epigastric artery flap for breast reconstruction

Conditions: Breast Cancer; Perforator Flap; Anti-Infectives Adverse Reaction; Infections

Summary: background: there is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy. we try to standardize prophylactic antibiotics use during breast reconstruction with deep inferior epigastric perforator flap following mastectomy. methods: this retrospective case series involved 108 patients who underwent immediate breast reconstruction with deep inferior epigastric perforator flap in ditmanson medical foundation chia-yi christian hospital between 2012 and 2019. patients were divided into three groups based on prophylactic antibiotic duration: 1 day, 3 days and \>7 days for patients with drains data were analyzed between january and april, 2021.


Eligibility criteria:
inclusion criteria: * this retrospective study involved 108 patients who underwent immediate diep flap breast reconstruction after unilateral or bilateral mastectomy at the ditmanson medical foundation chia-yi christian hospital between 2012 and 2019. exclusion criteria: * age \< 20 years old.

Keywords: prophylatic antibiotics diep flap
trial to evaluate the effects of naltrexone in nonsuicidal self-injury

Conditions: Nonsuicidal Self-Injury

Summary: the goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

recruiting participants with nonsuicidal self-injurious behavior and randomizing them to the experiment group and the control group at a 1:1 ratio, the test group administers the experiment drug naltrexone along with the general treatment, and the control group provides a placebo. clinical evaluation including the frequency of self-injurious behavior is conducted every two weeks. the investigator and participants will double-blinded. analyze the relationship between changes in clinical symptoms and socio-demographic characteristics, diagnosis, clinical characteristics, and anticipated to discover predictors of treatment effectiveness.

Eligibility criteria:
inclusion criteria: * age: 16 years of age or older * clinical interviews meet dsm-5\&#39;s nonsuicidal self-injury diagnostic criteria * nonsuicidal self-injurious behavior has been observed more than once in the past two months * obsessive compulsive drinking scale general craving item 2 or more points (strong desire) * self-injurious behavior continues even with 4 weeks of general psychiatric treatment for underlying disease * anyone who can independently read and fill out the questionnaire and speak korean * who understand the written consent and voluntarily agree to participate in the study * female participants of childbearing age must be negative on urine pregnancy test at screening exclusion criteria: * currently in psychotic or manic conditions * currently experiencing serious suicidal thoughts * history of substance-related disorders including opioid * do not agree to use very effective contraception from the time of signing the test subject\&#39;s consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements) * severe medical conditions (angina pectoris, myocardial infarction, arrhythmia, any cancer that is not in remission, hypothyroidism, hyperthyroidism, diabetes, hepatitis b, hepatitis c, epilepsy, dementia, hiv infection) * intellectual disability or organic brain damage * difficulty reading and writing korean * taking opioid antagonists (methadone, buprenorphine, etc.) * on an opiate painkiller * currently opiate dependence * acute opiate withdrawal symptoms * naloxone-induced test is positive or the urine test is positive for opiates * have been sensitized to this drug * acute hepatitis, liver failure, severe liver failure * renal disease * hypersensitivity reaction to the main ingredient or other ingredients of this drug * a pregnant woman, a woman who may be pregnant, or a lactating woman * since this drug contains lactose, genetic problems such as galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption, etc * active liver disease
evaluation of radiation exposure and risk factors during coronary angiography

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the radiation exposure in patients undergoing coronary angiography, and to identify reference values for the main radiation doses parameters.

exposure of patients to x-rays during interventional coronary procedures may have deleterious effects, including an increased risk of developing cancer.individual justification for the procedure and its optimization are the cornerstones of dose-reduction for patients.radiation exposure is influenced by a variety of technical and clinical factors.few multicenter data from large populations exist concerning the radiation doses to which patients are exposed during interventional coronary procedures.the aims of this prospective, multicenter survey is to: 1) evaluate the radiation exposure in 4000 patients undergoing coronary angiography by monitoring the parameters of air kema,fluoroscopy dose-area product and total dose-area product; 2) analyze factors associated with variation in radiation dose in everyday clinical practice, such as number of frames, body surface area, sex, age, bmi, arterial approach, fluoroscopy time and so on.

Eligibility criteria:
inclusion criteria: * patients who need to perform coronary angiography exclusion criteria: * contrast medium reactions severe cardiopulmonary insufficiency uncontrolled severe arrhythmia uncorrected kaliopenic, digitalism and acid-base imbalance severe liver and renal dysfunction hemorrhagic disease severe infection disease others who were unwilling to participate the study
safety and efficacy of oral nxc-736 in adult participants with moderate and severe alopecia areata

Conditions: Alopecia Areata

Summary: the purpose of this study is to evaluate the safety and efficacy of nxc-736 monotherapy in participants with severe alopecia areata (aa).


Eligibility criteria:
inclusion criteria: * men or women between ≥19 and ≤65 years of age at the time of informed consent * moderate and severe alopecia areata as assessed by a salt score of 25% ≤ salt \< 95% at screening and day 1/baseline * current episode of hair loss for ≥6 months but \<8 years * stable disease condition (no significant growth of hair) in the last 6 months as assessed by the investigator * willing to keep the same hair style and color (eg, hair products, process, and timing for hair appointments) for the duration of the study exclusion criteria: * participants with the following medical history confirmed during screening: * ohter types of alopecia other than alopecia areata (such as cicatricial/scarring alopecia \[including central centrifugal cicatricial alopecia\], traction alopecia, androgenic alopecia, telogen effluvium, etc.) * active scalp inflammation, scalp infection, scalp psoriasis, or any other scalp condition that may interfere with the salt assessment * previous use of janus kinase (jak) inhibitor (oral or topical), including participation in clinical studies of jak inhibitors