Kornimate/medical-research-clean huggingface dataset:
effect of lik066 on body weight in patients with elevated body mass index

Conditions: Elevated Body Mass Index

Summary: a 12-week study to assess lik066 effect on body weight in diabetics, prediabetics and normoglycemic patients with elevated body mass index (bmi)


Eligibility criteria:
key inclusion criteria: * subjects with stable health condition as determined by past medical history, physical examination, electrocardiogram, and laboratory tests at screening. * patients with dysglycemia are patients with: fasting plasma glucose \>100mg/dl (5.6 mmol/l), or hba1c \> 5.7% and \< 10% at screening. * fasting plasma glucose ≤250mg/dl (13.9 mmol/l) at screening. * if treated with antidiabetic medications (other than prohibited medications), patients must be on a stable dose for 12 weeks prior to randomization and maintain the dose until the end of the study. * subjects must have a body mass index (bmi) within the range of 35 - 50 kg/m2 at screening, with stable body weight (± 5 kg) within 3 months prior to screening key exclusion criteria: * pre-existing, clinically significant gastrointestinal, liver, cardiovascular, renal or other chronic medical condition which is considered serious or unstable, other than stable cardiovascular disease, treated hypertension, dyslipidemia or other stable chronic disorders * clinically significant gi disorder related to malabsorption or that may affect drug or glucose absorption or history of significant gastrointestinal surgery that could affect intestinal glucose absorption * enrollment in a diet, weight loss or exercise programs with the specific intent of losing weight, within 3 months prior to randomization, or clinical diagnosis of any eating disorder * pregnant or nursing (lactating) women, and women of child-bearing potential

Keywords: dysglycemic, normoglycemic, prediabetes, type 2 diabetes mellitus
evaluation of efficacy and safety of oxc xr as adjunctive therapy for partial seizures

Conditions: Epilepsies, Partial

Summary: evaluation of the safety and efficacy of oxcarbazepine xr as adjunctive treatment for adults with partial onset seizures

multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with refractory partial onset epilepsy.

Eligibility criteria:
inclusion criteria: * capable of complying with the study procedures. * able to provide written informed consent * male or female aged 18 to 65 years, inclusive. * diagnosis of partial onset seizures * minimum of three seizures per 28 days * receiving treatment with 1-3 aeds * refractory to at least one aed * no progressive neurological conditions by recent mri/ct * adequate birth control in women of child-bearing potential exclusion criteria: * refractory to oxc for reasons of efficacy * recent status epilepticus * recent non-epileptic seizures * current diagnosis of major depression * recent suicidal plan or intent or more than one attempt * current use of oxcarbazepine, felbamate for \ 15mcg/ml or frequent need for rescue benzodiazepines * current use of sodium-lowering non-seizure medications. * clinically significant hepatic, renal, or cardiovascular function * history of recent substance abuse * females who are pregnant or lactating. * hypersensitivity to oxc or related drugs * difficulty swallowing study medication

Keywords: partial onset epilepsy partial onset seizures
antibiotic resistant community-acquired e. coli

Conditions: E Coli Infection

Summary: the purpose of this study is to review patients with e. coli infections at upmc from january 1, 2004 to december 31, 2005 to determine if these infections have arisen in the community rather than in hospitals or nursing homes. the occurrence of such resistant isolates could be devastating if they were associated with bloodstream infection, such as sometimes accompanies urinary tract infection, since antibiotic resistant e. coli is not suspected in isolates coming from the community.

the following variables will be followed: age, sex, hospital location at the time of positive culture (er, medical ward, icu etc), prior hospitalization or nursing home admission, receipt of outpatient dialysis or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures.

Eligibility criteria:
inclusion criteria: * ll patients with e. coli infections during the time period of the study will be reviewed. a community-associated e. coli isolate will be defined as one which was recovered from a clinical culture from a patient at upmc-p who had no established risk factors for infection with an antibiotic resistant organism. established risk factors are defined as: * isolation of the organism two or more days after admission for hospitalization or a history of hospitalization, surgery, dialysis, or residence in a long-term care facility within one year before the culture date * or the presence of an indwelling catheter or percutaneous medical device (eg, tracheostomy tube, gastrostomy tube, or foley catheter) at the time of the culture * or previous isolation of an antibiotic resistant organism

Keywords: antibiotic resistant infection
an evaluation of mepolizumab in therapy of eosinophilic oesophagitis in adult patients

Conditions: Oesophagitis, Eosinophilic

Summary: eosinophils play a key role in the pathogenesis of eosinophilic oesophagitis. therapies that suppress eosinophil recruitment and activation may give a benefit. mepolizumab is a humanised monoclonal antibody against interleukin-5 (il-5). this study will evaluate the ability of mepolizumab to decrease the recruitment and infiltration of eosinophils into the oesophagus, thereby reducing the inflammation and symptoms of ee (eosinophilic oesophagitis) in adult patients.


Eligibility criteria:
inclusion criteria: * document evidence/presence of oesophagitis prior to commencing trial drug. * a)histological evidence of oesophagitis: greater than 20x eosinophils per high power field (x400) on histology of esophageal mucosal biopsy * b. at least one episode of dysphagia per week * c.inadequate response to routine ee treatment * d. no other known causes of oesophagitis, or esophageal or generalized eosinophilia * not pregnant or nursing exclusion criteria: * history of seasonal worsening of ee symptoms or requirement of esophageal dilation. * churg-strauss syndrome * wegener's granulomatosis * lymphoma, hematological malignancy, advanced and metastatic solid tumors * active h. pylori infection. * any previous treatment with anti-hil-5, anti-ige monoclonal antibody or other biological agents.

Keywords: anti il-5 oesophagitis eosinophils mepolizumab adults
impact of long-acting bronchodilator- -corticoid inhaled therapy on ventilation, lung function and breathlessness

Conditions: Copd

Summary: multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of bgf 160 on ventilation pattern complexity and variability


Eligibility criteria:
inclusion criteria: * provision of signed informed consent prior to any study specific procedure * female or male subjects aged 40-75 years inclusive at the time of enrolment (visit 1) * documented history of copd with a post-bronchodilator fev1/fvc \<0.70 and a post-bronchodilator 30 % \< fev1 \<70% of predicted normal value (according to ers 1993 reference values for spirometry ) at screening * smoking history \> 10 pack-years * baseline significant dyspnea with a mmrc ≥ 2 exclusion criteria: * history or current diagnosis of asthma or acos (asthma-copd overlap syndrome) * respiratory infection or copd exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening * clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ecg) parameters: * unstable angina/acute coronary syndrome, or coronary artery bypass grafting (cabg), percutaneous coronary intervention (pci) or myocardial infarction within the past 6 months. * congestive heart failure new york heart association (nyha) class iii/iv. * structural heart disease (hypertrophic cardiomyopathy, significant valvular disease). * paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia. * left bundle branch or high-degree av block (second degree av block type 2 and third degree av block) unless the patient has a pacemaker. * sinus node dysfunction with pauses. * ventricular pre-excitation and/or wolff-parkinson-white syndrome. * qtcf interval \>470 msec (qt interval corrected using fridericia's formula; qtcf=qt/\[rr1/3\]). * any other ecg abnormality deemed clinically significant by the investigator. * bradycardia with ventricular rate \< 45 bpm. * uncontrolled hypertension (\> 165/95 mmhg). * clinically relevant respiratory conditions (other than copd) * severe renal impairment egfr \< 30 * hepatic impairment * narrow-angle glaucoma that, in the opinion of the investigator, has not been adequately treated. * symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant * patients not able to perform ios, spirometry, plethysmography, or vt acquisition (10 min) * any contraindication to laba or lama drugs or to inhaled corticosteroids * pregnancy or breastfeeding * woman of childbearing age without effective contraception * any type of cancer within 5 years * patients under guardianship * refuse or incapacity to give an informed consent * absence of social insurance

Keywords: copd bronchodilator ventilatory mode variability forced oscillations spirometry plethysmography dyspnea
a phase iii, randomized, controlled and multi-center study of ak112 and chemotherapy in first-line metastatic colorectal cancer

Conditions: Colorectal Adenocarcinoma

Summary: this trial is a phase iii study. the purpose of this study is to evaluate the efficacy and safety of ak112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. age ≥ 18 years and ≤ 75 years. 3. ecog status of 0 or 1. 4. estimated survival ≥ 3 months. 5. subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 6. subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll. 7. at least one measurable disease based on recist v1.1. 8. adequate organ function per protocol-defined criteria. 9. women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment. exclusion criteria: 1. previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured. 2. participating in other interventional study within 4 weeks prior to the first study drug administration. 3. palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration. 4. current presence of uncontrolled combined disease. 5. active clinical infections. 6. history of severe bleeding tendency or coagulation dysfunction. 7. subjects with known active tuberculosis (tb); suspected active tb should be excluded by clinical examination, known active syphilis infection. 8. received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study. 9. current presence of significant radiographic or clinical manifestations of gi obstruction. 10. toxicities of prior anticancer therapy have not resolved to ≤ grade 1 (nci-ctcae version 5.0). 11. pregnant or lactating women. 12. any condition considered by the investigator to be inappropriate for enrollment. 13. local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.
attainment of person-centred goals after botulinum toxin treatment for upper limb spasticity in real life practice

Conditions: Upper Limb Spasticity

Summary: the primary purpose for this study is to understand the effect of botulinum toxin as a treatment integrated in the management of spasticity (stiffness) in the arm and/or hand, arising from any neurological condition. the study will look at the types of goals that people choose for treatment, and the extent to which these are achieved in different individuals.


Eligibility criteria:
inclusion criteria: * adult patients with uls, in whom a decision has already been made to inject botulinum toxin a (bont a). * patient has provided written informed consent for collection of the data. exclusion criteria: * participation in any interventional clinical study of uls within the 12 weeks prior to the inclusion visit (visit 1). * patient has already been included in the current study, but was subsequently withdrawn.
what should be the next vasopressor for severe septic shock? methylene blue or terlipressin

Conditions: Septic Shock; Refractory Shock

Summary: the icu mortality rate of patients with septic shock was still high upto 54.1%.in first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is map ≥65 mmhg. in refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue * terlipressin (tp) mediate vasoconstriction via v1 receptors coupled to phospholipase c, and increases intracellular ca2+ concentration * methylene blue (mb) directly inhibits nitric oxide synthase (nos) by inhibit the enzyme guanylate cyclase (gc)


Eligibility criteria:
inclusion criteria: * age \>15 years old * diagnosis septic shock as sccm/accp * refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(ne \>0.5 mcg/kg/min) * concent form exclusion criteria: * known case g6pd deficiency * acute respiratory distress syndrome (ards) * hx of drug allergy mb, ne, terlipressin * hx of raynaud's phenomenon, systemic sclerosis, pht * known case coronary heart disease without treatment * current drug use serotonin reuptake inhibitors (ssri), serotonin and norepinephrine reuptake inhibitors (snris) * reject to join project

Keywords: refractory septic shock catecholamine resistance septic shock terlipressin methylene blue
clinical investigation to evaluate the effectiveness and safety of ecg app

Conditions: Arrhythmias, Cardiac

Summary: the purpose of this study is to verify the effectiveness and safety of the huawei device software (ecg app), which can be used to analyze, store and display the ecg data transmitted by the single-lead ecg acquisition device. the software can be used for the analysis of sinus rhythm, atrial fibrillation, and premature beats(ventricular premature beats and atrial premature beats) in adults.


Eligibility criteria:
inclusion criteria: 1. patients over 18 years old, regardless of gender; 2. participants who meet one of the following conditions according to the medical history in the past 3 months or the ecg during the screening period: 1. patients with normal sinus rhythm; 2. patients with persistent or permanent paroxysmal atrial fibrillation or in the onset of paroxysmal atrial fibrillation; 3. patients with frequent premature beats (more than 5 per minute) or in the onset of premature beats; 3. patients who have good compliance, and can cooperate to complete this research by himself/herself; 4）patients who volunteer to participate and have signed an informed consent form. exclusion criteria: 1. patients using cardiac pacemakers or implantable cardioverter defibrillators (icd); 2. patients with atrioventricular block or bundle branch block; 3. patients with significant sinus arrhythmia, sinus arrest or sick sinus syndrome; 4. patients with interpolated premature beats, junctional premature beats, or escape rhythms; 5. patients with atrial tachycardia, atrial flutter, ventricular tachycardia, ventricular flutter, or ventricular fibrillation; 6. patients with a resting heart rate of slower than 50 beats/minute or faster than 110 beats/minute; 7. patients with atrial fibrillation complicated with premature beats; 8. patients who are critically ill, making it difficult to make an accurate assessment of the effectiveness and safety of the device; 9. patients who suffer from tremor diseases or chorea, making it difficult to complete the examination quietly; 10. patients with bullous diseases or large-area skin rashes that are not suitable for body surface electrode recording; 11. patients whose skin is allergic to ethanol; 12. patients with contagious skin diseases; 13. patients with a history of mental illness or with cognitive impairment; 14. patients who have participated in other clinical investigations within the past 30 days that may affect this investigation; 15） other conditions that the investigators consider inappropriate for participation in the investigation.
definition for biliary atresia associated cholangitis after surgery

Conditions: Biliary Atresia; Cholangitis

Summary: cholangitis is the most common postoperative complication of biliary atresia, with a reported incidence of 40-90%, which seriously affects the surgical effect, survival rate and the quality of life and prognosis of patients. without of direct evidence, the diagnosis of cholangitis sometimes is difficult to make, thus most of them are diagnosed based on the symptoms of children. according to literature reports, different centers and regions have different diagnostic criteria for postoperative cholangitis after hepatic portoenterostomy, which has a great influence on the accuracy of the incidence rate and appropriate treatment of cholangitis, and also brings differences in the analysis of the causes and prognostic factors of cholangitis. based on the above reasons, we used the delphi method，in which worldwidely 48 experts participated in, to establish the diagnostic scoring system for postoperative cholangitis after biliary atresia. now we aimed to verify the specificity and sensitivity of the new scoring system through clinical cases, in order to unify and standardize the diagnostic criteria and provide help for the diagnosis and treatment of cholangitis after biliary atresia.


Eligibility criteria:
inclusion criteria: ① admission time: 2019.01.01-2021.12.31; ② the first diagnosis after discharge was cholangitis exclusion criteria: ① cholangitis after non-kasai procedure; * postoperative cholangitis of biliary atresia not operated in the unit; ③ patient has been treated in other hospitals during this episode; ④ the treatment period for cholangitis is not completed or the patient is discharged automatically.
pharmacodynamic effects of sacubitril/valsartan on natriuretic peptides, angiotensin and neprilysin

Conditions: Heart Failure, Systolic

Summary: the study measure multiple neurohormones in patients with heart failure being treated with sacubitril/valsartan in increasing doses over an 8 week period.


Eligibility criteria:
inclusion criteria: 1. patients must give written informed consent before any study assessment is performed. 2. ambulatory ≥ 18 years of age, male or female, treated at ringerike hospital. 3. patients with symptomatic chronic heart failure and reduced ejection fraction (≤ 40%). 4. patients on optimized medical treatment for heart failure. - exclusion criteria: 1. patients not able to comply in the study. 2. patients having contraindication for treatment with entresto; 1. hypersensitivity to the active substances or to any of the excipients listed in section 2. hyperkalemia: \> 5.4 mmol/l 3. known history of angioedema related to previous ace inhibitor or arb therapy. 4. hereditary or idiopathic angioedema. 5. concomitant use with aliskiren-containing medicinal products in patients with diabetes mellitus or in patients with renal impairment (egfr \<60 ml/min/1.73m2) 6. end-stage renal disease (\<15 ml/min per 1.73m2 or treatment by dialysis). 7. severe hepatic impairment, biliary cirrhosis and cholestasis (child-pugh c classification). 8. pregnancy breast-feeding-
acupressure and comfort at childbirth

Conditions: Pain, Labor

Summary: aims: non-pharmacological methods employed for management labor pain also help pregnant women to cope with labor pain and increase their childbirth comfort. the aim of this study is to determine the effect of cold and hot acupressure applications, applied to the acupressure point li4 of primiparous women during labor, on their childbirth comfort. methods: this study was designed a randomized controlled experimental study. the sample consisted of 129 healthy pregnant women including 44 pregnant women in the hot acupressure group, 44 pregnant women in the cold acupressure group, and 41 pregnant women in the control group. the "personal information form", the "labor monitoring form", the "visual analog scale", and the "childbirth comfort questionnaire" were all used to gather the data.


Eligibility criteria:
inclusion criteria: * being a primipara * having intact membranes * no skin diseases (such as urticaria...), * no use of narcotic drugs * having a term pregnancy * having a single fetus at vertex position * planning to have vaginal delivery * having contractions and ongoing regular augmentation * having recent augmentation starting periods * being in the latent phase (0-3 cm dilatation) * having no history of high-risk pregnancy * not using analgesic drugs to reduce pain during delivery * having no systemic and neurologic diseases * having no contraction anomaly (hypotonic or hypertonic contractions) exclusion criteria: • having any of the above criteria

Keywords: pain, labor, comfort
improvement of portal hypertension during viral suppression in patients with hepatitis delta (imphrove-d)

Conditions: Hepatitis D; Hepatitis B; Portal Hypertension; Liver Cirrhosis

Summary: portal hypertension (ph) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. it has been demonstrated that antiviral therapy in patients with chronic hepatitis c infection leads to a decrease of ph and is associated with an improved outcome. recently, bulevirtide was approved for the treatment of patients coinfected with hepatitis b (hbv) and chronic hepatitis delta (hdv) infection, which helps to achieve viral supression in these patients. this study investigates the potential effects of viral supression on ph in patients with chronic hbv/hdv infection and liver cirrhosis.


Eligibility criteria:
inclusion criteria: * chronic hbv/hdv coinfection * suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (hvpg) measurement or liver cirrhosis and hvpg measurement conducted in the past 12 months (conducted prior to antiviral treatment) * indication for antiviral treatment with bulevirtide * age \>18years * must be willing to participate in the study and provide written informed consent exclusion criteria: * patient rejects study participation * no conducted or no indication for hvpg measurement * age \<18years

Keywords: portal hypertension, liver cirrhosis, bulevirtide, hepatitis d, hepatitis b