Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate efficacy and safety of aliskiren (150mg & 300mg) administered alone and in combo with valsartan (160mg and 320mg) in patients with high blood pressure

Conditions: Hypertension

Summary: to evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension


Eligibility criteria:
inclusion criteria * patients with essential hypertension * patients who are eligible and able to participate in the study exclusion criteria * severe hypertension * history or evidence of a secondary form of hypertension * history of hypertensive encephalopathy or cerebrovascular accident other protocol-defined exclusion criteria may apply.

Keywords: hypertension, aliskiren
a study to evaluate the drug-drug interactions (ddis) of ibi362 with metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects

Conditions: Overweight Subjects; Obese Subjects

Summary: this trial is conducted in china. the aim of the trial is to investigate the influence of ibi362 on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin, metformin, warfarin, atorvastatin, digoxin in overweight or obese subjects.


Eligibility criteria:
inclusion criteria: * male, age between 18 and 45 years (both inclusive) at the time of signing informed consent * body mass index (bmi) between 24 and 30 kg/m\^2 (both inclusive) and weight≥50kg * the subject has no birth plan and voluntarily takes effective contraceptive measures within 6 months after signing the informed consent form to the last medication exclusion criteria: * cardiovascular, respiratory, hepatic, digestive (including digestive diseases that significantly affect gastric emptying or gastric motility, such as severe gastric spasticity or pyloric stenosis), endocrine (including but not limited to history of thyroid cancer or precancerous lesions), hematological and neurological disorders, or muscle degenerative disorders * drug or alcohol abuse * have dysphagia or any history of gastrointestinal diseases that affect drug absorption. * medical history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. * have a history of acute and chronic pancreatitis or serum amylase and/or lipase ≥ upper limit of normal value (upper limit of normal value, uln) at the time of screening. * those with a history of hypoglycemia. * previous or current mental illness.
a study to assess the efficacy and safety of paricalcitol in the treatment of chronic kidney disease with secondary hyperparathyroidism

Conditions: Secondary Hyperparathyroidism

Summary: the study is being conducted to evaluate the efficacy, and safety of paricalcitol for secondary hyperparathyroidism with stage 3 and stage 4 chronic kidney disease in adults.


Eligibility criteria:
inclusion criteria: 1. under care of physician at least 2 months for ckd 2. not on active vitamin d and calcimimetic therapy for at least 4 weeks prior 3. if taking phosphate binders, on a stable regimen at least 4 weeks prior 4. for entry into pretreatment phase: ipth at least 120 pg/ml gfr of 15-60 ml/min and no dialysis expected for at least 6 months 5. for entry into treatment phase: average of 2 consecutive ipth values of at least 150 pg/ml, taken at least 1 day apart (all values not less than 120 pg/ml) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dl 2 consecutive serum phosphorus levels of not more than 5.2 mg/ml exclusion criteria: 1. subjects who had primary hyperparathyroidism; 2. subjects with a history of acute renal failure; 3. subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms; 4. subjects with a history of unstable angina, grade iii or iv congestive heart failure, and/or clinically meaningful arrhythmia; 5. subjects with serum albumin \< 30g/l, serum hemaoglobin \< 85g/l, or serum transaminase higher than 2.5 times the upper limit of nomal; 6. subjects with a history of malignancy; 7. subjects who plan to undergo surgery during the study period; 8. subjects with a history active granulomatous diseases; 9. subject with a history of alcohol abuse and drug abuse; 10. human immunodeficiency virus antibody (hiv-ab), hepatitis b surface antigen (hbsag), hepatitis c antibody (hcv-ab) or treponema pallidum antibody (tp-ab) are positive; 11. subjects who are allergic to the test drug and its ingredients or excipients; 12. subjects who combined with systemic or systemic diseases that are not suitable for clinical trials; 13. subjects who have participated in clinical trials of other drugs or devices;
prediction of diagnosed covid-19 infection in iuc patients

Conditions: Infection Viral; Coronavirus; ARDS; Pneumonia

Summary: coronavirus 2019 (covid-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. the symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death. currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by pcr. it is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. this will require optimization of care pathways and use of the specific sectors. it is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the covid-19 pcr.


Eligibility criteria:
inclusion criteria: * all patient admitted in icu lille hospital and hospitalized in the unit "emergent biological risk" (reb) before a suspicion of infection with covid-19 * clinical infectious syndrome: fever (\>38°c) or hypothermia ( 36°c), chill, fever at home * a severe respiratory table defined by: * oxygen demand \> 3 l/min in the presence of significant comorbidity (pregnancy, chronic respiratory disease, chronic heart disease, hemopathy, cirrhosis) or \> 6 l/min in the absence of comorbidity * or a respiratory rate \> 30 cycles per minute * the need for mechanical, invasive or non-invasive ventilation * the need for humidified high-flow oxygen therapy exclusion criteria: * patient already included in study for first stay * cirrhosis child c * major surgery in the last 7 days minor patient * patient under guardianship or curatorship * refusal to participate * no social security coverage.

Keywords: critical care biology of infectious agent
the prognostic impact of surufatinib for the treatment of advanced pancreatic ductal adenocarcinoma

Conditions: Pancreatic Cancer

Summary: pancreatic ductal adenocarcinoma (pdac) is a highly aggressive tumor with a poor prognosis, despite the emergence of chemotherapies, unmet medical needs and limited treatment options still exist for patients with metastatic pdac (mpdac). surufatinib is a small-molecule tyrosine kinase inhibitor that targets vascular endothelial growth factor (vegfr) 1, 2, 3, fibroblast growth factor receptor 1 (fgfr1), and colony stimulating factor 1 receptor (csf-1r), and ex vivo experiments have demonstrated its effect on pc models. a retrospective analysis of patients with pdac who underwent surufatinib at zhejiang cancer hospital (hangzhou,china) from july 2022 to july 2023.the database was extracted from the preoperative demographics, blood markers, and surgical pathology information of patients undergoing surufatinib in the investigators' hospital.


Eligibility criteria:
inclusion criteria: (i) were over 18 years old; (ii) had a histological diagnosis of pancreatic adenocarcinoma; (iii) had at least one measurable lesion; (iv) had undergone at least two cycles of surufatinib treatment. exclusion criteria: (i)non-r0 resection; (ii) combined with other malignant tumors.
neural circulatory control and sudep risk.

Conditions: Epilepsy; Seizures

Summary: the investigators believe epilepsy alters the way the body controls blood pressure, heart rate and breathing, and these changes increase the risk of sudden unexpected death in patients with epilepsy (sudep). sudep-7 is a risk scoring tool which may correlate with these changes to the heart and blood vessels. this research study measures those differences which may help identify new markers to help predict those patients at greatest risk in the future.

the investigators overall goals are to determine whether measures of neural-circulatory control during the interictal waking and sleep states, as well as during the ictal/peri-ictal periods, are associated with sudep-7 score risk profiles in refractory epilepsy patients, and to translate these measures into tools for risk-stratification and preventative strategies for sudep.

Eligibility criteria:
inclusion criteria: * adults aged 18-90 * able to consent exclusion criteria: * history of non-epileptic spells/seizures, * children/adolescents under age 18 years * pregnancy * non-compliance with epilepsy monitoring unit safety procedures * unable to consent * history of dysautonomia * chronic obstructive pulmonary disease (copd) * asthma (active requiring therapy) * pulmonary hypertension * known structural heart disease * heart failure * myocardial infarction * stroke * seizures due to traumatic injury * prior surgery for epilepsy * vasculitis * raynaud's * smoking (current or within the last 6 months)

Keywords: sudep sudden cardiac death sudden unexpected death in epilepsy sleep polysomnography autonomic cardiovascular
epilepsy surgery and cognitive outcome

Conditions: Epilepsy, Temporal Lobe

Summary: this study will give important information about long term consequences of temporal lobe epilepsy surgery on cognition (memory, language, concentration etc), psychiatric function and quality of life.

all patients in norway who have undergone temporal lobe epilepsy surgery ten years ago or more, will be invited to participate. two groups will be compared: patients who are younger than 50 years of age vs patients who are older than 50 years of age. the aim of the study is to improve preoperative information to future epilepsy surgery patients, to aid medical personnel (doctors, psychologists) in the selection of patients for surgery, and to improve knowledge of need for long term follow-up and rehabilitation.

Eligibility criteria:
inclusion criteria: * prior temporal lobe epilepsy surgery (10 years ago or more) exclusion criteria: * intelligence quotient (iq) less than 70 * other main language than norwegian

Keywords: epilepsy surgery temporal lobe
integrating bia and egfr for nutritional status in hemodialysis patients

Conditions: Chronic Kidney Disease Requiring Chronic Dialysis

Summary: this study looks at how measurements of body composition from bioelectrical impedance analysis (bia) and estimates of kidney function (egfr) can be applied together to better assess the health of people on hemodialysis. many dialysis patients struggle with malnutrition, muscle loss, and fluid imbalances, but current assessment methods rely on unsophisticated tests and observations. by combining bia and egfr, this study aims to provide a more accurate and non-invasive way to monitor nutrition and overall health, which could lead to better treatment decisions and improved patient outcomes.

the primary objective of the study is to assess the correlation between bioelectrical impedance analysis (bia) derived body composition parameters (e.g.fat mass, fat-free mass, total body water, phase angle) and estimated glomerular filtration rate (egfr) in hemodialysis patients. the study will investigate how bia and egfr can be used together to more effectively monitor nutritional interventions in hemodialysis patients. the study will also assess the prevalence of malnutrition and protein-energy wasting (pew) in the study population using bia and egfr data. hemodialysis patients often suffer from complex nutritional problems due to the interplay between renal function, protein-energy wasting and fluid management. current nutritional assessments in hemodialysis patients are limited, most of which rely on clinical observations or quite basic biochemical tests. a more comprehensive, non-invasive approach is needed to assess both nutritional status and fluid balance. the study will determine whether comparing bia metrics with egfr provides a better picture of a patient's nutritional and renal health, which could then improve patient outcomes and dialysis management. malnutrition, fluid imbalances, and protein-energy wasting (pew) are common in patients undergoing hemodialysis due to chronic kidney disease (ckd) and the effects of dialysis therapy. nutritional status is a critical factor influencing patient outcomes in ckd, but is often under-monitored. traditional methods of assessing renal function, such as estimated glomerular filtration rate (egfr), provide insight into renal health but do not directly measure body composition or nutritional status. bioelectrical impedance analysis (bia), in contrast, provides a detailed picture of body composition, including fat mass, fat-free mass, total body water, and phase angle. the aim of this study is to investigate the relationship between bia-derived markers of nutritional status and egfr to assess their combined utility in assessing nutritional status in hemodialysis patients.

Eligibility criteria:
inclusion criteria: chronic kidney disease hemodialysis for at least 6 months exclusion criteria: pregnancy lactation major second pathology pacemaker recent surgery

Keywords: dialysis bioelectrical impedance nutrition body composition renal impairment
the diagnostic and prognostic role of saa in intrathoracic sarcoidosis

Conditions: Sarcoidosis, Pulmonary

Summary: the goal of this observational study is to elucidate the role of serum amyloid a (saa) in the diagnosis and follow-up of sarcoidosis, including its prognostic value. the main questions it aims to answer are: * whether, at the time of diagnosis, saa is in correlation with other serum markers of granulomatous inflammation, interstitial disease and pulmonary fibrosis, lung function and radiologic characteristics of intrathoracic sarcoidosis, * whether increased serum concentrations of saa at the time of diagnosis act as a prognostic marker of progressive granulomatous inflammation and pulmonary interstitial disease. patients will undergo standard diagnostic procedures for intrathoracic sarcoidosis, according to wasog (world association of sarcoidosis and other granulomatous disorders) criteria. two additional vials of blood will be taken at diagnosis and one vial at follow-up for serum processing and biomarker analysis. healthy blood donors will represent our group of healthy controls.


Eligibility criteria:
inclusion criteria: * above 18 years of age * enrolled immediately after the first diagnostic workup and before any treatment was initiated. exclusion criteria: * individuals with granulomatous disease that could not be unequivocally diagnosed as sarcoidosis were excluded, as well as patients with possible confounding other known systemic inflammatory illnesses, acute infection, patients on immunosuppressive drugs or immunotherapy and patients with active cancer.
the efficacy and safety study of albumin therapy in acute ischemic stroke

Conditions: Cerebral Infarction

Summary: in this clinical study, the efficacy and safety of albumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.

according to the statistics of the cause of death in 2008 by the statistics korea, the stroke was accounted for a large proportion of cause of death among adults, as well as higher mortality, severe sequelae. these stroke in acute phase showed neurological deterioration over 50% of the patients after beginning of treatment and the sequelae resulting in that the nervous tissue was not regenerated is regarded as irreversible changes. the test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of placebo (saline solution (0.9% normal saline)) administered to the control group will be compared to evaluate the efficacy and safety of albumin for the patients with acute ischemic stroke.

Eligibility criteria:
inclusion criteria: * at least 18 years of age less than 75 years old * patients who can be administered albumin within 12hours of onset of acute ischemic stroke * 5 ≤ nihss score \< 15 * patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily exclusion criteria: * medical history of congestive heart failure or patients who are judged congestive heart failure on admission. * patients with cardiac edema or pulmonary edema. * medical history of myocardial infarction within the past six months. * patients who have serious aortic stenosis and mitral valve stenosis. * signs or symptoms of acute mi on admission (serum troponin level ≤0.1 ug/l) * those who had cardiac surgery. * onset of cerebral infarction within the past three months. * before onset of cerebral infarction, patients who were diagnosed as historical mrs ≥ 2. * patients who received treatment of thrombolysis or who planned for treatment of thrombolysis. * acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission. * acute or chronic lung disease requiring supplemental o2 therapy on admission * severe anemia (hb \< 8.0) * severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(\>100/min), and oliguria) * fever, defined as core body temperature\>37.5 ℃ * serum creatinine \> 2.0 mg/dl * history of allergy to albumin. * patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia) * pregnancy * patients who are in life-threatening or stupor coma situation. * evidence of intracranial hemorrhage (intracerebral hematoma (ich), subarachnoid hemorrhage (sah), epidural hemorrhage, acute or chronic subdural hematoma (sdh)) on admission ct or mri scan. * patients who are not the normal, excesses of circulating blood. * haemolytic anemia, anemia due to blood loss. * immunodeficiency disease, immunosuppression. * blood pressure higher than 180/110 mmhg on admission.

Keywords: acute ischemic stroke albumin
efficacy of magnetic imaging colonoscopy applied to beginner endoscopists

Conditions: Colonic Neoplasms

Summary: magnetic endoscopic imaging (scopeguide) is known to be helpful for colonoscope insertion, especially beginner endoscopist. in this trial, study was designed to show the efficacy and safety pertinent to scopeguide use in detail.

colorectal cancer is one of the most commonly diagnosed malignancies worldwide. colorectal cancer screening significantly reduced the incidence and mortality, and colonoscopy is generally recognized as a standard method. among them, magnetic endoscopic imaging (mei, scopeguide, magnetic enhanced instrument, olympus, japan) is a non-radiological imaging instrument that can display the three-dimensional configuration and position of the colonoscope in the abdominal cavity in real time. this study aims to investigate the effectiveness of colonoscopy by measuring the insertion-related index of the colonoscopy according to the scope guide for only beginners of endoscopy.

Eligibility criteria:
inclusion criteria: * age 19-80 * the patient who visit to examine the colonoscopy exclusion criteria: * the patient who has a pacemaker * the patient who has electronic devices in the body * bowel obstruction and bleeding * glomerulus filter rate \< 30 * inflammatory bowel disease, pregnancy * previous history of bowel resection and abdominal surgery * who refuse to write the informed consent * previous history of allergic reaction to sedative drugs and beans, egg * sbp \<80, spo2\<90

Keywords: colonoscopy loop formation scopeguide
safety, efficacy, and pharmacokinetics study of tarceva to treat advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is test the safety of tarceva, find the best dose, and see what effects (good and bad) it has on you and your colorectal cancer. the effects of tarceva will be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without bevacizumab.


Eligibility criteria:
subjects must fulfill all of the following criteria to be eligible for study entry: * signed informed consent * at least 18 years of age * histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum resected or biopsied primary tumors or metastatic site will serve as the basis for histologic confirmation. * measurable disease (defined as at least one dimension \>2 cm \[\>1 cm on spiral ct scans\]) * ecog performance status of 0 or 1 * life expectancy \>3 months * use of an effective means of contraception in men and in women of childbearing potential * ability to comply with study and follow-up procedures
myt1dhero: an mhealth intervention for type 1 diabetes

Conditions: Type1diabetes

Summary: the overall objective of the proposed research is to improve hba1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of t1d. the investigators will test the efficacy of the myt1dhero app against an attention control group. this will allow investigators to better understand the health and psychosocial improvements being made through the app.

this research seeks to realize the potential and test the efficacy of myt1dhero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. the investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. the investigators further seek to decrease family conflict among children with t1d and their parents. in a 12-month rct, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the myt1dhero app. adolescents enrolled in the study will be 10-15 years old, and will have been living with t1d for \ 5 years at the start of the study. the primary outcome will be a change in the participants' hba1c from baseline levels at the start of the study, to levels measured after 12 months.

Eligibility criteria:
inclusion criteria: * the adolescents must: 1. have a t1d diagnosis according to the ada practice guidelines, 2. be 10 to 15 years old, 3. have had a diagnosis of t1d for at least six months, 4. have an hba1c \> 7, 5. have had at least two outpatient visits in the past two years, 6. be treated at spectrum for diabetes, 7. be fluent in english, 8. have a parent/guardian willing to participate, 9. have and be allowed to use a mobile phone for the study, and 10. have permission from their care team to participate. the parent/guardian must: 1. have an adolescent with t1d who is 10 to 15 years old, 2. be fluent in english, and 3. have daily access to email and the internet (for appointment reminders and technical support). exclusion criteria: * for the adolescents include: 1. significant medical conditions other than t1d, 2. being treated for thyroid disorders, celiac disease, or eating disorders, and 3. being in foster care. exclusion criteria for both the adolescents and parents/guardians include: (a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.

Keywords: mhealth adolescent