Kornimate/medical-research-clean huggingface dataset:
a first human dose study investigating safety and concentration of study medicine in the blood following once daily oral dosing of nnc0560-0004 in healthy adults.

Conditions: Healthy Volunteers - Liver Diseases

Summary: in this trial, medicine nnc0560-0004 given in capsule form will be compared to placebo in healthy volunteers. participants will either get nnc0560-0004 or placebo. which treatment they get is decided by chance. this is a first in human trial, which means that this is the first time that nnc0560-0004 is given to humans. the study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks. women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.


Eligibility criteria:
key inclusion criteria: 1. female, of non-childbearing potential, or male, both genders aged 18-55 years (both inclusive) at the time of signing informed consent. 2. body mass index (bmi) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening. 3. considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests including inflammatory markers performed during the screening visit, as judged by the investigator 4. cyp2d6 phenotype: 1. for part a and part b: ultra-rapid (from cohort a3 forward and b1 forward), normal or intermediate cyp2d6 function 2. for part c: cyp2d6 poor metaboliser function key exclusion criteria: 1. any disorder/condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 2. known history of histamine intolerance or severe anaphylactic reactions 3. abnormal values at screening for any of the following laboratory parameters * aspartate aminotransferase (ast) greater than upper limit of normal (uln)+10%. * alanine aminotransferase (alt) greater than uln +10%. * bilirubin (except if known gilbert's syndrome) greater than uln +10%. * creatinine greater than uln. a.egfr below 90 ml/min/1.73m\^2 * glycated haemoglobin (hba1c) greater than or equal to 5.7% (39 mmol/mol). 4. cyp2d6 unknown phenotype
identification of microbial dna in maternal plasma after pprom

Conditions: Preterm Rupture of Membranes

Summary: this study evaluates the use of metagenomic next generation sequencing in identifying microbial dna in plasma samples of patients with preterm premature rupture of membranes.

although preterm premature rupture of membranes (pprom) occurs in only 3% of pregnancies, it accounts for 30% of preterm births (ptb) and is associated with serious maternal and neonatal morbidity. an important factor in the underlying pathophysiology of pprom and subsequent ptb is subclinical infection, which promotes a cascade of events that contribute to synthesis of prostaglandins, release of proinflammatory cytokines, infiltration of neutrophils, and activation of metalloproteases. over time, enhanced activity of these infectious and inflammatory pathways contributes to the development of spontaneous labor and/or overt intraamniotic infection (iai). unfortunately, the majority of patients with pprom do not manifest signs and symptoms of infection that are detectable by clinical examination, laboratory evaluation, and traditional microdiagnostic tests, and attempting to predict length of latency period and/or timing of delivery remains a clinical challenge. we propose the use of metagenomic next-generation sequencing (mngs) to identify microbial dna in maternal plasma following pprom. we hypothesize that the presence and abundance of microbial dna is associated with a shorter latency period and that an increase in the abundance of microbial dna precedes delivery.

Eligibility criteria:
inclusion criteria: * for pprom group, preterm premature rupture of membranes between 16 0/7 and 33 6/7 weeks of gestation * for control group, healthy pregnancy with no evidence of preterm premature rupture of membranes or other major complications exclusion criteria: * maternal age \< 18 years * major fetal congenital malformation
correlation between postoperative central corneal thickness and endothelial damage after cataract surgery

Conditions: Cataract; Phacoemulsification

Summary: to study correlation between postoperative corneal edema and endothelial cell loss after cataract surgery by microcoaxial phacoemulsification.

cataract surgery facilitates improved visual acuity through extraction of an opacified lens, followed by intraocular lens implantation. an average adult cornea has 2000 to 2500 cells/mm2, a count that diminishes with age with a rate of attrition of approximately 0.3% to 0.5% per year. long-term postoperative corneal transparency depends on the morphological stability and functional integrity of the corneal endothelium. it is well established that all surgical interventions that require entry into the anterior chamber result in some damage to the corneal endothelium. endothelial cell loss results in cell hypertrophy to maintain continuity, resulting in a change in endothelium cell density and morphology. many studies have assessed the impact of various surgical techniques on endothelial damage and numerous studies have investigated the factors influencing endothelial cell loss after phacoemulsification. the goal of this study is to investigate the correlation of postoperative corneal edema with the reduction of endothelial corneal cell density after phacoemulsification.

Eligibility criteria:
inclusion criteria: * the presence of senile cataract with equivalent grades and a history of visual acuity regression exclusion criteria: * patient with total white cataract * with history of ocular surgery * with other eye diseases (corneal pathology, fuchs dystrophy, uveitis and glaucoma) or systemic diseases (diabetic disorder and dementia)
transvenous approach for the treatment of cerebral arteriovenous malformations

Conditions: Arteriovenous Malformations, Cerebral; Unruptured Brain Arteriovenous Malformation; Ruptured Brain Arteriovenous Malformation

Summary: a new endovascular route for the treatment of brain avms may be possible in some cases: trans-venous embolization (tve). the technique uses microcatheters to navigate to the draining veins of avm, to reach and then fill the avm nidus retrogradely with liquid embolic agents until the lesion is occluded. this technique has the potential to improve on some of the problems with the arterial approach to avm embolization, such as a low overall occlusion rate. however, by occluding the vein first, and filling the lesion with the embolic agent in a retrograde fashion, the method transgresses a widely held dogma in the surgical or endovascular treatment of avms: to preserve the draining vein until all afferent vessels have been occluded. nevertheless, the initial case series have shown promising results, with high occlusion rates, and few technical complications. the method is increasingly used in an increasing number of centers, but there is currently no research protocol to guide the use of this promising but still experimental treatment in a prudent fashion. care trials can be designed to offer such an experimental treatment, taking into account the best medical interests of patients, in the presence of rapidly evolving indications and techniques.


Eligibility criteria:
inclusion criteria: * any patient harboring a brain avm (ruptured or unruptured) in whom tve is considered a promising but yet unproven therapeutic option by the participating clinicians can be submitted to the case selection committee. * patients must be in stable, non-urgent clinical condition, with the acute phase of the avm rupture resolved (where applicable). * case must be approved by the csc. notes on potentially suitable cases: 1. current indications may include (but are not restricted to) brain avms with a small \<3 cm nidus (or small residual nidus), with a single draining vein, and for which curative treatment can be attained with one or at most two treatment sessions. 2. physicians are not required to submit cases prior to any or all treatment; a case can be submitted to the csc for consideration after previous treatments (including previous arterial embolization sessions) have been performed. the timing of the submission of the case will be left to individual operators. previously treated avms (by any other modality: embolization/surgical resection/radiosurgery) are not excluded from tatam. exclusion criteria: * absolute contra-indication to endovascular treatment or anesthesia. * inability to obtain informed consent.

Keywords: brain arteriovenous malformation arteriovenous malformations avm bavm stroke intracranial hemorrhage congenital abnormalities aneurysm vascular malformations cardiovascular abnormalities cardiovascular diseases vascular diseases
levamlodipine maleate or amlodipine besylate for treatment of hypertension: a comparative effectiveness research

Conditions: Primary Hypertension

Summary: the purpose of this study is to determine whether the effectiveness of levamlodipine maleate (xuanning) is noninferior to amlodipine besylate (norvasc) in treatment of hypertension in a chinese primary hypertension population.

it is a multicenter, prospective cohort study with large sample size. it is to evaluate the effect on the incidence of cardiovascular and cerebrovascular endpoint events and blood pressure control in hypertensive patients who use levamlodipine maleate (xuanning) or amlodipine besylate(norvasc).xuanning group and norvasc group will recruit 5000 patients respectively. each site will recruit patients in chronological order；patients who participate will finish the two-year follow up(1,2,3,6,12,18,24 months after recruitment) and relevant data will be recorded. baseline data will be analyzed to evaluate the equilibrium between two or more groups (such as the number of options). logistic regression and propensity scores (ps) would be used to match major indicators of effectiveness and safety indicators using matching method baseline data.

Eligibility criteria:
inclusion criteria: * systolic pressure ≥140mmhg or diastolic pressure ≥90mmhg or receiving antihypertensive drug treatment * patient himself/herself or his/her family member has already signed the informed consent form * patient is fit for use of levamlodipine maleate or amlodipine besylate * age≥45 exclusion criteria: * patient with secondary hypertension * patients who has suffered from myocardial infarction or stroke within the latest 3 months * patients who has obvious intelligence、hearing and limb's activity disability * patients with severe disease, with a life expectancy of less than two years
observational study with neupro® to evaluate the patient´s perception of pain associated with parkinson´s disease

Conditions: Idiopathic Parkinson's Disease

Summary: the primary objective of this study is to evaluate the perception of pain associated with parkinson´s disease in patients who receive neupro® for the first time.


Eligibility criteria:
inclusion criteria: * the decision by the treating physician to treat a patient with neupro® for the first time is made before the patient's participation in this non-interventional study (nis) * a patient data consent form is signed and dated by the patient * male and female patients that suffer from pain associated with idiopathic parkinson's disease according to the physician's assessment * patients have not been treated with rotigotine in the past

Keywords: rotigotine neupro®
effects of bright-light exposure combined with specific exercise training (best) program in patients with cancer

Conditions: Lung Neoplasm; Esophageal Neoplasms

Summary: this study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer.

this study plans to investigate the effectiveness of six-week light exposure combined with an exercise training program on improving sleep-wake rhythm, physical and mental symptoms, quality of life, one-year recurrence rate, and one-year survival rate of patients with lung and esophageal cancer. two groups, parallel, randomly assigned clinical trials, long-term follow-up, repeated measurement (pre-test, 6th week, 12th week, 6th month, 12th month, five times in total), and a design of single center recruitment. the experimental group receiving an intervention comprised six weeks of light exposure combined with exercise training. the active control group receiving six weeks of stretching exercise. with a double-blind study design of participant blind and outcomes assessor blind, subjects were recruited from the thoracic surgery clinic and thoracic surgery ward of a medical center in northern taiwan.

Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed primary lung cancer or esophageal cancer, from the first stage to the third stage. 2. at least 20 years of age. 3. able to communicate in mandarin chinese or taiwanese. 4. literate and free from cognitive disabilities. 5. the attending physician agrees to participate in the study. 6. those who can connect to the internet with mobile devices such as computers, mobile phones, and tablets, or those whose family members can assist in the operation. 7. those with karnofsky performance scale (kps) greater than or equal to 70 points. 8. those who are hospitalized for lung cancer or esophageal cancer lesion resection. exclusion criteria: 1. congestive heart failure. 2. orthopedic diseases of the lower extremities that limit one's walking ability.
effect of collagen matrix graft on palatal fistula formation after cleft palate repair

Conditions: Cleft Lip and Cleft Palate; Cleft Lip, Cleft Alveolus and Cleft Palate; Cleft Palate

Summary: palatal fistulas are a major burden to surgeons and patients in the management of cleft palate. their high rate of occurrence and recurrence makes them particularly challenging even to the highly skilled surgeon. prevention of postoperative palatal fistula is therefore of paramount importance. closure of the nasal mucosa under tension has been proposed as a major cause of palatal fistula formation. however, depending on the presentation of the cleft palate, it may be impossible to achieve surgical closure with minimal tension. till date, there is no universally acceptable method of preventing palatal fistula formation following cleft palate repair. and although the use of pre-surgical appliances such as latham appliance and the use of local and distant tissues to achieve two layer closure have been proposed, the use of a superpositional collagen graft may also be used to achieve closure of the nasal mucosa with minimal or no tension during cleft palate repair. collagen grafts have the added advantage of being more patient friendly compared to the latham appliance which requires an initial surgery for appliance insertion before surgical cleft palate repair. they are also less technique sensitive compared to the use of local and distant tissues. the investigators therefore aim to provide high level scientific evidence of the effectiveness of collagen graft in the prevention of postoperative palatal fistula.


Eligibility criteria:
inclusion criteria: * non-syndromic cleft palate * must be between nine months to two years * must have not previously had cleft palate surgery * must consent to participate in the study exclusion criteria: * all blood dyscrasias * all connective tissue dysfunctions

Keywords: cleft palate palatal fistula collagen graft
assessing diabetes mellitus on cytokine analysis and macular edema following flacs

Conditions: Cystoid Macular Edema; Diabetes Mellitus; Cataract

Summary: the purpose of this study is to assess the effects of diabetes mellitus (dm) on anterior chamber cytokine production and postoperative macular edema in patients undergoing femtosecond laser-assisted cataract surgery (flacs). patients with dm routinely undergo flacs, yet the majority of studies evaluating intraocular inflammation following femtosecond laser treatment have excluded this patient population. importantly, dm alters the inflammatory status of the eye, which may influence the production of inflammatory mediators following femtosecond laser treatment and the development of postoperative macular edema. the results from this study will provide insight into the risks and benefits of flacs in patients with dm.

as discussed above.

Eligibility criteria:
inclusion criteria: * all patients who are scheduled for manual cataract surgery or flacs who have provided informed consent, in accordance with application regulations and guidelines. * only one eye from each participant will be included in the study (the first one to be operated on). exclusion criteria: * intravitreal anti-vegf injection \< 3 months prior to cataract surgery * laser photocoagulation \< 3 months prior to cataract surgery * complications during manual cataract surgery or flacs * current or previous ocular or systemic inflammation * history of rheumatic or immune disease * poor pharmacologic mydriasis * corneal opacities * pseudoexfoliation syndrome * previous ocular surgery or trauma * use of topical or systemic steroids \< 6 months prior to surgery * prostaglandin analog eyedrop therapy * glaucoma * age-related macular degeneration
in children, does using a synera patch decrease pain when injecting propofol at anesthesia induction?

Conditions: Pain on Propofol IV Injection

Summary: the purpose of this study is to evaluate if the synera patch (lidocaine/tetracaine patch), used to numb the skin before iv placement, is effective in reducing pain associated with propofol iv administration when inducing general anesthesia, compared to gebauer's ethyl chloride topical anesthetic skin refrigerant.

commonly, anesthesiologists inject propofol, a sleeping medication, intravenously to induce general anesthesia. propofol injection is associated with pain that can be severe. the investigators also place a lidocaine/tetracaine skin patch (synera) to decrease pain associated with iv placement. because the local anesthetics of the synera patch diffuse deep underneath the skin, in this study the investigators would like to evaluate whether the application of synera patch can decrease the pain associated with propofol injection. children will be randomized to receive either the patch or the ethyl chloride before the iv placement. a total of 33 patients will be enrolled in each group.

Eligibility criteria:
inclusion criteria: * healthy, outpatient children, 6-17 years old * american society of anesthesiologist physical classification rating of 1 or 2 * elective procedure requiring general anesthesia at memorial herman hospital, the medical center, houston, texas exclusion criteria: * skin disease or infection (on dorsum of hands) * allergy to lidocaine or tetracaine

Keywords: propofol pain synera patch gebauer's ethyl chloride topical anesthetic
β-cell function in type 1 diabetes may not be as low as presumed

Conditions: TYPE 1 DIABETES

Summary: enhancing endogenous insulin production in type 1 diabetic patients (t1dp) can improve glycemic control and decrease complications and rates of mortality. however, it can be succesfull even if sufficient β-cell function is present. we aimed to evaluate the extent of β-cell function by determining fasting levels of c-peptide and those after meal stimulus.

background and aims: enhancing endogenous insulin production in type 1 diabetic patients (t1dp) can improve glycemic control and decrease complications and rates of mortality. however, it can be succesfull even if sufficient β-cell function is present. we aimed to evaluate the extent of β-cell function by determining fasting levels of c-peptide and those after meal stimulus. materials and methods: one hundred and thiryfive t1dp were planned to enrolı to the study. ethics comittee of our hospital approved the study protocol, which was in accordance with the helsinki declaration. fasting c-peptide levels of all participants and stimulated (at 90 th minute post mixed meal) c-peptide levels of 54 will be measured by using an electrochemiluminescence assay. two categorizations will be done using fasting (the first categorization ) and at 90th minute post mixed meal test (the second categorization) of c-peptide levels. for the first categorization; the groups will be classified as follows: patients with undetectable ≤0.1 ng/ml (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/ml(group 3) c-peptide levels. for the second categorization, groups will be as follows: patients with undetectable ≤0.1 ng/ml (group 1); with minimal 0.1-0.8 ng/ml (group 2); and with sustained ≥0.8 ng/ml (group 3) c-peptide levels which increased at the 90th minute after the meal ≥150% of fasting c-peptide level.

Eligibility criteria:
inclusion criteria: * type 1 diabetic patients who have accepted to have mixed meal tolarance test exclusion criteria: * patients with type 2 diabetes, * patients with mody

Keywords: β-cells, mixed meal test, c-pepti̇de
a comparison of postoperative tramadol versus acetaminophen with codeine in children undergoing tonsillectomy

Conditions: Tonsillitis; Pain

Summary: tonsillectomy is the most common pediatric surgical procedure performed in the us. the postoperative period can be particularly painful. codeine (usually in mixed formulation with acetaminophen) is the most commonly prescribed opioid in the us. however, evolving data questions its ability to provide optimal pain relief, while avoiding side effects, especially in the postoperative setting. tramadol may be a better option for children in the postoperative setting due to its well-documented analgesic properties, low potential for side effects, and excellent safety profile. seventy-two children scheduled to undergo tonsillectomy (with or without adenoidectomy) at children's will be invited to participate in a randomized, prospective, double-blinded study to evaluate the efficacy and side effects of codeine with acetaminophen versus tramadol. using a 10-day take-home diary, caregivers will be asked to record daily information about their child's postoperative pain and other core outcomes and domains as recommended in the recent consensus statement put forth by the pediatric initiative on methods, measurement, and pain assessment in clinical trials (immpact) (mcgrath et al., 2008). this study will offer new information regarding the efficacy and side effects associated with tramadol as compared with codeine/acetaminophen (the current practice standard) in a pediatric population. hypotheses h1: children who receive scheduled tramadol following tonsillectomy will report better pain control than children who receive scheduled codeine/acetaminophen. h2: children who receive scheduled tramadol following tonsillectomy will report fewer side effects than children who receive scheduled codeine/acetaminophen.


Eligibility criteria:
inclusion criteria: * child must be scheduled to undergo tonsillectomy (with or without adenoidectomy). * child must be between the ages of 4 and 15 at the time of enrollment. * child and caregiver must be english-speaking. * the same caregiver (e.g., mother) must agree to complete all study assessments with child to ensure consistency. exclusion criteria: * child cannot self-assess pain due to conditions such as developmental delays, chromosomal abnormalities, and other syndromes. * child had significant adverse effects to codeine, tramadol, or acetaminophen in the past. * child has a known underlying seizure disorder (not febrile seizure). * child has known underlying renal or liver dysfunction (with creatinine, aspartate aminotransferase \[ast\]/amino alanine transferase \[alt\], above normal value for age, respectively). * child or caregiver is not english-speaking. * the same caregiver (e.g., mother) is unable to complete all follow-up assessments.

Keywords: tonsillectomy pain pediatric opioids tramadol codeine