Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the tolerability and the pharmacokinetics of ckd-348

Conditions: Hypertension and Dyslipidemia

Summary: a phase i clinical trial to evaluate the tolerability and the pharmacokinetics of ckd-348.


Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged ≥ 19 years 2. weight ≥55kg with calculated body mass index (bmi) of 18 to 30 kg/m2 3. those who meet the blood pressure criteria during screening tests: * systolic blood pressure: 90 to 139 mmhg * diastolic blood pressure: 60 to 89 mmhg 4. those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings. 5. those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and 1ecg results at screening. 6. those who agree to contraception during the participation of clinical trial. 7. individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial. exclusion criteria: 1. those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs. 2. those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products. 3. those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month. 4. those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery. 5. those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products. * alcohol: man - 21 glasses/week woman - 14 glasses/week (1 glass: soju 50ml, wine 30ml, or beer 250ml) * smoking: 20 cigarettes/day 6. those who have any history of diabetic mellitus, nephropathy, biliary obstruction, shock, angioedema, cardiac insufficiency, dihydropyridine sensitivity, unstable angina, hypothyroidism. 7. those who have genetic problems such as galactose intolerance, lapp lactose deficiency or glucose-galactose malabsorption. 8. those who are deemed insufficient to participate in this clinical trial by investigators. 9. woman who are pregnant or breastfeeding.
effect of intracameral injection of mydriatic plus anaesthetic combination on corneal endothelial count in phaco

Conditions: Corneal Endothelial Cell Loss; Mydriasis; Cataract

Summary: study evaluates safety of intracameral injection of fydrane (tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary dilatation during phacoemulsification surgery.

in this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification with intraocular lens (iol) implantation, were assigned into 2 groups. 15 eyes (fydrane group) received 0.2ml of fydrane just after the first incision. while 15 eyes (reference group) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. the main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. efficacy was also evaluated by measuring pupil size using surgical caliper at certain timings during surgery: before capsulorhexis and before intraocular lens (iol) implantation, in both groups.

Eligibility criteria:
inclusion criteria: * medium density cataract (nuclear ii to iii) exclusion criteria: * soft or hard density cataract (nuclear i or iv) * history of ocular trauma or previous intraocular surgery * iatrogenic, congenital or traumatic cataract * associated eye disease e.g. pseudoexofoliation syndrome * associated pre-existing corneal endothelial disease e.g. fuchs dystrophy * associated systemic disease that can affect endothelium,

Keywords: corneal endothelial cell count fydrane mixed mydriatic and anaesthetic combination intracameral mydriatic mydriasis phacoemulsification
primary aldosteronism and surgically curable forms in hypertension patients using 11c-metomidate

Conditions: Primary Aldosteronism; Primary Aldosteronism Due to Aldosterone Producing Adenoma

Summary: 10% of patients with hypertension potentially have the treatable condition - primary aldosteronism. primary aldosteronism (pa) is caused by either bilateral adrenal disease (\~40%), managed with lifelong medications; or unilateral disease (\~60%), cured with laparoscopic surgery (adrenalectomy). unfortunately, many patients with curable hypertension remain undiagnosed and consequently develop cardiac disease and strokes. the difficulty with identifying curable unilateral disease is due to adrenal vein sampling (avs): an invasive, and technically-difficult procedure, with inconclusive results in 50% of patients. an alternative novel imaging, 11c-metomidate positron emission tomography-computed tomography (pet-ct), can detect adrenal tumors, and concurrently confirm their over-activity. it is non-invasive, non-operator-dependent, and can identify more patients with curable hypertension. investigators hypothesize that 11c-metomidate pet-ct can accurately identify patients with surgically-curable unilateral adrenal disease among hypertensive asians with primary aldosteronism.

25 patients with confirmed pa who are keen for a surgical cure if unilateral pa is confirmed, will undergo conventional tests, ct, avs, as well as 11c-metomidate pet/ct. results will be reviewed and discussed at a multidisciplinary meeting, and patients with unilateral pa will be offered surgery. patients will be reviewed 6 months post surgery to assess for cure of pa.

Eligibility criteria:
inclusion criteria: • primary aldosteronism, as defined in endocrine society guidelines 2016, with positive confirmatory test (post-salt loading aldosterone \>140pmol/l); or hypokalemia with undetectable renin levels and aldosterone \>550pmol/l. exclusion criteria: * inability to provide written informed consent * \ 70 years * chronic renal failure of stage 3b or greater severity * severe or terminal medical condition(s) * contraindications to isotope scanning or ct scan * contraindication to ingestion of corticosteroids

Keywords: 11-c metomidate pet/ct hypertension adrenalectomy adrenal vein sampling subtyping
remote ischaemic preconditioning in children undergoing cardiac surgery

Conditions: Ischaemic Reperfusion Injury

Summary: surgical correction of congenital heart defects in children requires the utilization of cardiopulmonary bypass, a technique that temporarily substitutes heart and lung functions during surgery. during this process the patient´s circulation is controlled by a bypass machine which provides several functions: 1. controls the patient's blood flow by pumping of blood in the patient's body. 2. controls the correct oxygen levels in the patient's blood. 3. regulates the temperature and fluid level of the blood. this process triggers negative responses in the heart and throughout the whole body, potentially resulting in injury to the heart and other organs such as brain, kidneys and lungs. remote ischaemic preconditioning (ripc) describes a procedure that could potentially reduce the injury to heart muscle during cardiac surgery. the procedure consists of the inflation of a blood pressure cuff on the child's leg for three 5 minute cycles. this process acts by briefly reducing blood flow to the leg muscle, which will then activate the body´s own protective mechanisms and thereby reduce heart injury. several animal studies have been used to help the understanding of the mechanisms behind this process, and trials in human adults have showed optimistic results; however evidence regarding the paediatric population is limited and necessary since children present different basal profiles, risks and requirements. the investigators propose a randomized clinical trial assessing the efficacy of ripc to provide protection against injury to the heart and other organs in children going through cardiac surgery using cpb at the royal hospital for sick children. the research project will have a translational approach, integrating basic molecular mechanisms to clinical outcome. the investigators hope it will allow the understanding and utilisation of the patient´s own protective mechanisms, reducing cpb-related injury and ultimately improving patient outcome.


Eligibility criteria:
inclusion criteria: * children undergoing cardiac surgery for correction of congenital heart defects utilizing cardiopulmonary bypass and cold blood cardioplegia strategy of myocardial protection. * children whose parents understand the child's condition, the purpose of the study and are willing to participate. exclusion criteria: * children whose parents either are unwilling or do not have sufficient understanding of the study. * emergency operations, where there is insufficient time to establish the study protocol. * premature children presenting a corrected gestational age under 35 weeks. * presence of extracardiac abnormalities, apart from cases of down and digeorge syndromes which will be included. * patients with known viral blood infections (e.g. hiv, hepatitis b) or severe congenital infection. * patients with severe preoperative brain injury.
prebiotics and the management of hyperuricemia

Conditions: Subjects With Hyperuricemia

Summary: hyperuricemia is a major risk factor for many chronic diesease. recently, gut mcirobiota has been identified as a novel theraputic target for hyperuricemia. both annimal studies and pilot human trials have demonstrated that administration of prebiotics help delay the progression of hyperuricemia throuh several mechanisms. this trial aims to examine its protective effects and potential mechanisms in clinical trials.

hyperuricemia is a major risk factor for many chronic diseases. recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of hyperuricemia. animal studies have demonstrated that administration of prebiotics help delay the progression of hyperuricemia through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids and hippuric acid. however, whether administration of prebiotics also has a protective effect in subjects with hyperuricemia remain under-explored. moreover, whether the original gut microbiota will influence the protective effect of prebiotics remains largely unknown.

Eligibility criteria:
inclusion criteria: * local residents aged between 18-80 years old; * stable weight (\<5% weight change over the past 3 months); * fsating uric acid \> 420 umol/l for male and \> 360 umol/l for female on two different days; * not taking uric acid lowering drugs or have stopped taking uric acid lowering drugs for over 4 weeks at the time of recruitment; * absence of any diet or medication that might interfere with uric acid metabolims or gut microbiota, especially antibiotics, prebiotics or probiotics at the least 4 weeks before recruitment exclusion criteria: * acute illness or evidence of any acute or chronic inflammatroy of infective diseases; * participation in regular diet program more than 2 times per week in the lastest 3 months prior to recruitment; * mental illness rendering them unable to understand the nature, scope, and possible consequences of the study; * women of childbearing age who are pregant, breast-feeding or preparing for pregnancy; patients who had surgey within the past 6 months or planned surgery during the trial period.
study of nmb drug ejecting balloon for peripheral arteries

Conditions: Peripheral Arterial Disease

Summary: the purpose of this study is to demonstrate the safety and effectiveness of the use of nmb's drug ejecting balloon for the treatment of de novo and restenotic lesions in peripheral arterial disease.


Eligibility criteria:
inclusion criteria: * patients 18 years old or older * patient with lifestyle limiting claudication or rest pain (rutherford- becker scale 2, 3 or 4). * patient with de novo lesion or restenotic lesion ≥70% in the iliac, femoral, popliteal or tibial artery. * the target lesion can be successfully crossed with a guide wire and dilated. * the target lesion is in a native artery of 2.5-10mm in diameter and less than 80 mm in length. * patient is willing to and able to sign a written informed consent and to comply with procedures (e.g., adherence to follow-up visits, including 6 months ct-angiography/mra follow-up). exclusion criteria: * women who are pregnant or breast-feeding and women of childbearing potential who do not use adequate contraception. * previous participation in another study with any investigational drug or device within the past 30 days. * the patient is currently enrolled in another investigational device or drug trial. * severe reaction to contrast agents that cannot be adequately premedicated prior to procedure. * stenosis with corresponding thrombosis treated within 7 days before enrollment. * patient with known contraindications for aspirin or other anticoagulant/antiplatelet therapy. * patient that has co-morbid illness that may result in life expectancy of less than 12 months. * history of haemorrhagic stroke or gastro-intestinal bleeding within 6 months. * patient with major surgery during the 30 days preceding the interventional procedure.
multimodal monitoring study in neuro critical care

Conditions: Subarachnoidal Hemorrhage; Intacranial Hypertension; Acute Trauma Brain Injury

Summary: during the first week after an acute cerebral injury, neurologic clinical exam is often irrelevant, limited by sedation use or spontaneous consciousness disorders. hence, neurological monitoring of brain oxygen consumption, metabolic disorders, electrical activity is used to follow and prevent delayed cerebral injuries. among those instruments, numerous are often described: intra cranial pressure monitoring, brain tissue oxygen pressure monitoring, scalp electroencephalography, continuous electroencephalography and near infrared red spectroscopy (nirs). even if the value of some of those technologies are well known, many remain part of a research domain. here we will not only try to study the correlation between different cerebral autoregulation's index described in the scientific literature but also will we try to identify and describe eeg and cardiorespiratory changes during the first week following brain injury. the objective of this study is to investigate the pathophysiology of acute brain injury and explore potent biomarkers of multimodal monitoring during the first week following acute brain injury.


Eligibility criteria:
inclusion criteria: * - patients hospitalized in neurologic critical care in wertheimer hospital, bron * monitored with the cns moberg® monitoring system exclusion criteria: * - refusal to participate * patients under legal protection
stanford's outcomes research in kids

Conditions: Bacterial, Viral and Other Infectious Agents

Summary: the investigators intend to investigate whether the rise in childhood obesity is caused by the loss of recurrent and chronic infections in modern, industrialized society, beginning in utero and extending through early childhood. the investigators will also examine whether the antimicrobial triclosan, present in numerous cleaning and hygiene products, decreases the incidence of infection within a household.


Eligibility criteria:
inclusion criteria: subjects must meet all of the following inclusion criteria to participate in the study: 1. able to provide written informed consent. 2. able to communicate effectively in verbal english or spanish. 3. willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant. 4. willing to provide consent for review of primary provider medical records regarding, for the mother, medical history and infectious and other conditions during pregnancy, and for the infant, apgar scores, height and weight measurements at birth and over time, infectious and other disease diagnoses and treatment, and vaccination records. exclusion criteria: 1. more than one fetus. 2. high risk pregnancy. 3. intent to move from the bay area within three years after enrollment. 4. history of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness. 5. history of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition. 6. history of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression. 7. a household member who has a compromised immune system 8. other conditions that in the opinion of the pi would make the subject an unacceptable candidate for this study.
an investigational study of a histone deacetylase (hdac) inhibitor plus targretin in cutaneous t-cell lymphoma patients (0683-016)(terminated)

Conditions: Lymphoma

Summary: this is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with targretin in patients with cutaneous t-cell lymphoma in patients who have failed at least one prior systemic therapy.


Eligibility criteria:
inclusion criteria: * women or men greater than or equal to 18 years of age * advanced cutaneous t-cell lymphoma, stage ib or higher including sezary syndrome with progressive, persistent, or recurrent disease * failure of at least one systemic therapy, not including bexarotene (targretin) * eastern cooperative oncology group (ecog) status less than or equal to 2 (measurement to determine your ability to perform daily activities) exclusion criteria: * patient has had investigational treatment in the preceding 30 days * active hepatitis b or c, history of hiv * prior treatment with any hdac inhibitor * patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
cold knife versus monopolar electrosurgery in abdominal incisions

Conditions: Electrosurgery Versus Scalpel

Summary: the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

• study hypothesis: - using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis. type of study: - randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of alzhraa university hospital of faculty of medicine for girls - cairo within 1 year according to sample size. a computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment. participants at morning of the operation will be given information about the study aims and written consent will be taken.

Eligibility criteria:
inclusion criteria: * all patients scheduled for elective gynecological abdominal surgeries for benign diseases * willing to participate in the study. * the participants will receive 2 gm cephalosporines preoperative per hospital policy. exclusion criteria: * history of receiving antibiotics during the preceding 7 days, * chronic medical illness like diabetes, asthma or tuberculosis, * patients have anemia, * surgically scarred tissues, * immuno-compromised patients, * pregnant patients, * patients with pacemaker device, * patients on anticoagulants therapy

Keywords: electrosurgery scalpel abdominal incision
prophylactic or preemptive entecavir in patients with gastric cancer who are inactive hepatitis b carriers

Conditions: Stomach Neoplasms

Summary: there has been no report on whether the patients with gastric cancer who are also inactive hepatitis b carriers should receive prophylactic use or preemptive use of an anti-viral drug entecavir. this open, randomized controlled clinical trial aims to compare the impact of the prophylactic use or preemptive use of an anti-viral drug entecavir on the outcomes of patients with gastric cancer who are also inactive hepatitis b carriers during chemotherapy and the subsequent follow-ups.

patients with gastric cancer who are also inactive hepatitis b carriers are enrolled and randomized into two groups as following. patients in experimental group are treated with entecavir prophylactically in the dose of 0.5mg p.o. every day from the initiation of chemotherapy till 6 months after the end of chemotherapy.patients in active comparator group are only treated with entecavir in the dose of 0.5mg p.o. every day from the time that the dna copies of hepatitis b virus are more than 100 iu/ml till 6 months after the end of chemotherapy.

Eligibility criteria:
inclusion criteria: 1. patients with age between 18 and 75 2. patient with histology-proven gastric adenocarcinoma. 3. patients with eastern cooperative oncology group performance status (ecog) of 0-1 4. patients planned for at least 4 cycles of cytotoxic chemotherapy (either as part of curative therapy or as palliative therapy) 5. patients with at least 6 months' life expectancy from date of recruitment 6. patients with positive hepatitis b surface-antigen (hbsag) 7. patients with normal liver function tests including alanine aminotransferase (alt), aspartate aminotransferase alkaline (ast), phosphatase (alp), gamma glutamyl-transpeptidase (ggt), and bilirubin 8. patients with negative hbv-dna 9. patients with no known history of radiological \&/or histological diagnosis of chronic active hepatitis or cirrhosis of any cause, or history of prior hepatitis b reactivation, or prior chronic therapy for hbv within 6 months 10. patients with no evidence of autoimmune hepatitis, hepatitis c or d virus infection, hiv infection or radiological evidence of liver metastasis 11. adequate bone marrow, hepatic, and renal function within 14 days before recruitment 12. patients who sign the informed consent 13. patients with good compliance during chemotherapy and follow-ups exclusion criteria: 1. patients planned for radiation or radionuclide therapy 2. pregnant female patients 3. patients with a history of psychiatric drugs abuse and can't quit or with a mental disorder 4. patients with immunodeficiency, other congenital or acquired immunodeficiency, or transplantation history 5. according to the investigators' judgment, patients with concomitant disease that seriously harms patients' safety or the completion of study.

Keywords: gastric cancer hepatitis b carrier entecavir