Kornimate/medical-research-clean huggingface dataset:
the coat trial: cequa's onset of action trial

Conditions: Dry Eye

Summary: cequa's onset of action trial: an investigation of cequa's speed of onset in improving ocular surface health in dry eye patients

the purpose of this study is to examine the speed of onset of cequa ™ in improving the ocular surface among patients with dry eye.

Eligibility criteria:
inclusion criteria: \*patients with the following signs: central or inferior corneal fluorescein staining defined by the oxford scale reduced tear break up time (tbut) ≤ 10 seconds. * able to comprehend and sign a statement of informed consent. * willing and able to complete all required postoperative visits. exclusion criteria: * ocular surgery (e.g., intraocular, oculoplastic, corneal, or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study. * clinically significant ocular trauma. * active ocular herpes simplex or herpes zoster infection * ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator. * ocular infection (e.g., viral, bacterial, mycobacterial, protozoan, or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye). * active, systemic, or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings. * moderate to severe (grade 2-4) allergic, vernal or giant papillary conjunctivitis. * severe (grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis) * eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). * ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity). * participation in this trial in the same patient's fellow eye * patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
a study to evaluate nivolumab in combination with ipilimumab versus pemetrexed with cisplatin or carboplatin for unresectable pleural mesothelioma in chinese participants

Conditions: Mesothelioma, Malignant

Summary: the purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in chinese participants with malignant pleural mesothelioma.


Eligibility criteria:
inclusion criteria: * histologically proven diagnosis of malignant pleural mesothelioma (mpm) with determination of epithelioid vs non-epithelioid histology * must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy) * available tumor samples for centralized testing * eastern cooperative oncology group (ecog) performance status of 0 to 1 * measurable disease exclusion criteria: * primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma * brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy * prior therapy for mpm (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy) other protocol-defined inclusion/exclusion criteria apply

Keywords: malignant pleural mesothelioma (mpm) nivolumab ipilimumab
a retrospective and prospective cohort study of the 21-day fasting-like diet in patients with metabolic and autoimmune diseases

Conditions: Fasting; Chronic Disease; Autoimmune Diseases; Metabolic Disease; High Blood Pressure; Fatty Liver; Kidney Stone; Gall Stone; Hysteromyoma

Summary: effectiveness of fasting or fasting-mimicking diet has been proved an effective approach to treat metabolic and autoimmune diseases in mice. however, clinical trials performing prolonged fasting with more than 7 days have not been reported. investigators conduct an open label, phase i/ii clinical trial to evaluate the safety and effectiveness of the 21-day fasting-like diet in the treatment of metabolic and autoimmune diseases.

although fasting has been proved an effective approach to treat metabolic and autoimmune diseases in mice, prolonged fasting is difficult to implement in human-beings for the safety and feasibility reasons. in this clinical trial, we will recruit metabolic and autoimmune diseases and then follow a traditional chinese 21-day fasting-like diet process with extremely low calorie intake (about 5% of normal diet) and prolonged fasting-like period. blood, urine, stool samples will be collected on day 0 (baseline), day 4, day 7, day 14, day 21 and day 51 after it started up. therefore we can examine the changes of disease-associated physical indexes and metabolic biomarkers pre and post the 21-day fasting-like diet. the purpose of the study is to ascertain the impact of the fasting-like diet during the 21 days. the investigators hypothesize that the 21-day fasting-like diet can reduce the biomarkers associated with aging and age-related diseases and benefit for the treatment of metabolic and autoimmune diseases.

Eligibility criteria:
inclusion criteria: * male or female, aged ≥18 and ≤75 years; * subjects has a confirmed diagnosis of metabolic and autoimmune diseases, including high blood pressure, kidney stone, gall stone, hysteromyoma, fatty liver, psoriasis, and so on. exclusion criteria: * subjects has a confirmed diagnosis of cancer; * females who are pregnant or nursing; * subject requires a prescheduled regularly administration of drugs; * subject has severe renal insufficiency; * subject has cardiac arhythmia.

Keywords: fasting-like diet chronic diseases autoimmune diseases metabolic disorder
effect of cpap treatment in patients with severe uncontrolled asthma: the asthma-sleep trial

Conditions: Obstructive Sleep Apnea; Asthma

Summary: the aim of the study is to evaluate the impact of cpap treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (osa)

background: the prevalence of obstructive sleep apnea (osa) is high in patients with severe uncontrolled asthma and can worsen asthma control. previous observational studies demonstrated that cpap treatment could improve control in patients with mild-moderate asthma. nevertheless, there are no studies in patients with severe uncontrolled asthma. primary objective: to evaluate the impact of cpap treatment on asthma control in patients with severe uncontrolled asthma and aos. methodology: multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (epworth sleepiness scale score ≤10). all included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (ahi) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus cpap. monitoring will be carried out during12 months. patients will be evaluated at inclusion, at 1 month, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * age \>18 years * diagnosis of severe uncontrolled asthma according to the criteria of the spanish asthma management guide (gema) or the global initiative for asthma (gina) and no hospitalizations the month prior to inclusion in the study. * punctuation in the epworth sleepiness scale ≤10 * obtaining informed consent. exclusion criteria: * previous treatment with cpap * patient with central sleep apnea or cheyne-stokes respiration * other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia, * resistant hypertension * active smoking * unstable comorbidities or medications may interfere with asthma control * pregnancy * any process that reduces life expectancy to \<1 year, * any medical or social factor that may limit cpap compliance
acute and chronic effects of dynamic apnea in healthy untrained subjects

Conditions: Apnea

Summary: the inclusion of short periods of apnea (several seconds) during exercise (i.e. dynamic apnea) induces a significant decrease in blood oxygenation and muscle tissue. to date, the immediate effects ("acute apnea") of this decrease in the quantity of oxygen available at the muscle and brain level are poorly understood. moreover, a physical training during which these short periods of apnea ("chronic apnea") would be included could lead to physiological adaptations and to improvement in physical performance similar to those obtained during altitude training. the purpose of this study is to evaluate the effects of acute dynamic apnea on metabolism.


Eligibility criteria:
inclusion criteria: * the cutaneous thickness at the vastus lateralis level lower than 1.5 cm to obtain the reliable muscle oxygenation measurement * subjects will have to sign the inform consent before the beginning of the study exclusion criteria: * contraindications to regular physical exercise practice * to practice an endurance sport more than 1h/week * regular practice of apnea * chronic use of cannabis and/or alcohol * cardiac or metabolic pathology * asthma and/or bronchodilatator treatment * ecg abnormality at rest * regular consumption of tobacco

Keywords: dynamic apnea muscle oxygenation physical performance
comparison of accidents and their circumstances with oral anticoagulants

Conditions: Cardiovascular Complications; Hemorrhagic Disorders; Embolism and Thrombosis

Summary: differences in efficacy and safety between new oral anticoagulants (noac) and vitamin k antagonist (vka) in real practice remain uncertain. the few existing ambulatory studies did not answer all noac specific issues, such as prescription habits and motives, patients characteristics, biological monitoring, as well as the occurrence of major and minor thromboembolic events, especially in france where warfarin is less frequently prescribed. therefore, in order to describe clinical and follow up characteristics of patients receiving oral anticoagulants, the investigators will set up a national prospective cohort to compare the occurrence of thromboembolic events between vka and noac in primary care.

the method includes the use of a national prospective observational cohort, involving 444 general practitioners from april to december 2014, health data of any adult patient consulting a general practitioner and receiving an oral anticoagulant treatment has been entered in a database. each patient received an information for agreement to participate to the study (agreement for stastical analysis of their health data during one year follow up). in march 2015, half of those patients will be chosen (stratification), using a matched stratification process, and will be followed up over one year. every three months, data regarding the occurrence of therapeutics changes, episodes of excessive bleeding, and thromboembolic events will be collected by general practitioners. the data will be analysed by: - describing the characteristics of patients receiving oral anticoagulant treatment; - describing the changes of medications over the year ; - comparing the occurrence of episodes of excessive bleeding ; - comparing the occurrence of thromboembolic events in patients using vka versus patients using noac.

Eligibility criteria:
inclusion criteria : * patient consulting a gp * patient whatever the reason for consultation * aged \>18 years * receiving oral anticoagulant treatment by noac (apixaban, dabigatran or rivaroxaban) or vka (acenocoumarol, fluindione, or warfarin) * whatever the indication (prevention or treatment). * having the following indications for anticoagulant treatment : non-valvular atrial fibrillation, prevention of dvt / pe (excluding orthopedic post-surgery) treatment dvt / pe exclusion criteria : * aged \<18 years * receiving concomitant injectable anticoagulant treatment (including relay phase) * follow up impossible.

Keywords: anticoagulants antithrombins atrial fibrillation intracranial haemorrhage gastrointestinal haemorrhage myocardial infarction stroke venous thrombosis primary care
dismembered pyeloplasty with and without after coming stent

Conditions: Pelviureteric Junction Obstruction; Pyeloplasty; Neonatal Hydronephrosis; Obstructive Uropathy; Urinary Stent

Summary: to compare outcome of pyeloplasty in pediatric population less than 6 months in age using an after coming stent versus stentless pyeloplasty.

a prospective randomized control study including patients divided into two groups,all patient undergoes dismembered pyeloplasty first group will be with an after coming stent ,second group will be stentless to compare outcome of pyeloplasty in pediatric population less than 6 months in age

Eligibility criteria:
inclusion criteria: * pelvi-ureteric junction obstruction (pujo) * asymptomatic obstruction with reduced function (less than 35-40%) * asymptomatic obstruction with antero-posterior diameter exceed 40 mm * asymptomatic obstruction with deterioration on conservative follow up. * symptomatic puj obstruction, e.g. pain, renal mass, fever and stones. exclusion criteria: * secondary pelvi-ureteric junction obstruction * solitary kidney * gross pyuria * ectopic kidney * dilated ureter

Keywords: pelviureteric junction obstruction pyeloplasty neonate affected by hydronephrosis obstructive uropathy urinary stent
short-term use of dapagliflozin to protect kidney function in ckd patients

Conditions: Renal Insufficiency, Chronic; Cardiac Catheterization; Percutaneous Coronary Intervention

Summary: this study aim to investigate the protected effects of short-term use of dapagliflozin (administered within 3 days after procedure) in ckd patients after coronary angiography or percutaneous coronary intervention, as well as observed the incidence of cin.


Eligibility criteria:
inclusion criteria: * age\>18 years * written informed consent * glomerular filtration rate (gfr)≥ 30 ml/min/1.73m2 \[ckd stage g1-g3\] * percutaneous coronary intervention in patients with nstemi, ua, stcd and asymptomatic patients exclusion criteria: * active malignancy * class i or equivalent indication for treatment with a sglt2 inhibitor * pregnancy or willing of pregnancy during the follow up period * active urogenital infection * diabetes mellitus type 1 * history of diabetic ketoacidosis * cardiogenic shock * egfr \< 29 ml/min/1.73m2

Keywords: sodium-glucose transporter 2 inhibitors dapaglifozin chronic kidney disease
the application of dna nanomachines for detecting microrna in blood for the diagnosis of pancreatic cancer. diagnosis of pancreatic cancer

Conditions: Pancreas Adenocarcinoma; MicroRNA

Summary: previous research has shown that micrornas in the blood can serve as biomarkers for early pancreatic cancer, with potential applications including detection, differential diagnosis, and prognosis prediction of pancreatic cancer. the current primary method for detecting micrornas is rt-qpcr, but this process requires repeated temperature cycling, which demands high precision from the equipment. as an alternative, isothermal nucleic acid amplification technology does not require expensive temperature control instruments. our research team has developed various isothermal nucleic acid amplification strategies for microrna sensing platforms, applied to biological sample detection. this study combines the circular strand displacement amplification strategy with dna nanomachines to develop a fluorescence sensing platform that performs dual signal amplification at a constant temperature. it is designed to detect pancreatic cancer-related micrornas, exploring its role and potential applications in the diagnosis of pancreatic cancer patients.


Eligibility criteria:
inclusion criteria: * pancreatic ductal adenocarcinoma * proven by pathology * patients who have not received anti-cancer therapies exclusion criteria: * less than 20 years old * unable to provide inform and consent * patients who have active malignancy other than pancreatic adenocarcinoma * patients who have had pancreatic cancer whose anti-cancer therapies are completed or undergoing * life expectancy less than 3 months

Keywords: microrna pancreas adenocarcinoma
a study evaluating lurasidone for the treatment of schizophrenia or schizoaffective disorder in subjects switched from other antipsychotic agents

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: lurasidone (lurasidone hcl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. switching between antipsychotic medications is common in the treatment of schizophrenia. the current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.


Eligibility criteria:
inclusion criteria: * subject ≥ 18 years of age. * subject meets dsm-iv criteria for a primary diagnosis of schizophrenia or schizoaffective disorder. * subject must be judged by the investigator to be an appropriate candidate for switching current antipsychotic medication due to insufficient efficacy and/or safety or tolerability concerns. exclusion criteria: * presence of an axis i or axis ii disorder other than schizophrenia or schizoaffective disorder that is the primary focus of treatment prior to screening. * subject has experienced persistent lack of improvement in psychotic symptoms despite adequate trials (at least 6 weeks at standard doses), of two or more antipsychotic agents in the 12 months prior to screening. * subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or property. subject has suicidal ideation at baseline or has attempted suicide within 90 days prior to randomization (even without hospitalization).

Keywords: lurasidone schizophrenia latuda
efficacy and safety of itopride vs placebo in heartburn

Conditions: Heartburn

Summary: the purpose of this study is to evaluate the effects of itopride in patients with heartburn.


Eligibility criteria:
inclusion criteria: * otherwise healthy males and females aged 18-70, with at least 3 episodes of heartburn or acid regurgitation per week.
aveir vr coverage with evidence development post-approval study

Conditions: Cardiac Pacemaker; Arrythmia; Bradycardia

Summary: the purpose of this coverage with evidence development (ced) study is to evaluate complications and long-term health outcomes of the single-chamber aveir single-chamber leadless pacemaker device (aveir vr lp).

this is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from abbott and the center for medicare services to compare aveir vr lp safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population. the study will enroll all medicare patients implanted with the aveir vr lp and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Eligibility criteria:
the study cohort will include all medicare patients with continuous claims data implanted with an aveir vr leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any us location inclusion criteria: medicare beneficiaries implanted with an aveir vr leadless pacemaker on or after the study start date (i.e., the date of aveir vr market approval) will be included in the study. or medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date exclusion criteria: none
perceptions of the clinical and psychosocial impact of covid-19 in patients with nmd

Conditions: Neuromuscular Diseases; Neurological Diseases or Conditions

Summary: this study aims to evaluate perceived clinical and psychosocial experiences of patients and their families during the covid-19 pandemic. it is important to understand the implications of the pandemic for this population, particularly given its likely protracted course, and resultant limitations to daily activities and clinical care. this will help clinicians plan support and adaptations to the services they provide in the medium to long term.

as above

Eligibility criteria:
inclusion criteria: adult group * patient over 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder * able and willing to provide informed consent paediatric group * parent of a patient under 16 years of age with a confirmed diagnosis of neuromuscular and/or neurological disorder * able and willing to provide informed consent exclusion criteria: * unwilling for telephone questionnaire to be audio-recorded
the norwegian "icancope with pain" app

Conditions: Pain

Summary: background: research evidence shows that prevalence of pain in adolescents is increasing and is therefore recognized as a growing health problem. psychological interventions delivered remotely through the internet may reduce intensity or severity of pain among children and adolescents with chronic pain. the icancope with pain program is an existing web- and mobile-based self-management program, which is developed as a multi-center study funded by the canadian institutes of health research and is based on identified health care needs and current best practices for pain self-management. objectives: the primary objectives are to describe the translation and cultural adaptation of the norwegian version of the icancope with pain mobile application and evaluate the effect in an upcoming randomized controlled trail with adolescents with chronic pain. study sample: 16-19-year-old adolescents with self-declared persistent and/or chronic pain. recruited from high schools in southern norway. theoretical framework: cognitive behavioral therapy (cbt) is explained by an integration of behavioral and cognitive theories of human behavior and psychopathology and is often the preferred treatment of choice for adolescents with different health disorders. the theoretical framework of cbt is integrated in the icancope with pain app in terms of five components. the intervention group will receive the app with all five components: (i) symptom trackers for pain, sleep, mood, physical, and social function; (ii) goal setting to improve pain and function; (iii) coping toolbox of pain self-management strategies; (iv) social support; (v) age-appropriate pain education. the control group will receive the app with only the first self-registration component (i) symptom trackers for pain, sleep, mood, physical, and social function. methods: both qualitative and quantitative data will be gathered for evaluating the norwegian version of the icancope with pain app. usability testing are assessed in both laboratory settings and in field using observation, interviews and questionnaires, which provide necessary information for an upcoming randomized controlled trail (rct). outcomes will in the rct be measured at baseline (mid-april) and after an 8 weeks intervention (mid-june). the study is part of a phd project.


Eligibility criteria:
inclusion criteria: 1. 16-19-year-old adolescents 2. with persistent and/or chronic pain, weekly suffered and lasting 3 months or more based on subjective reporting 3. be able to read and understand norwegian 4. have their own smartphone. exclusion criteria: 1. adolescents with cognitive disability or diseases, because of the risk of not correctly understanding the icancope with pain program via self-report, goal setting and/or library reading. 2. adolescents that have participated in the usability testing of the norwegian icancope with pain app 3. adolescents with diagnoses from a pathological or medical origin (e.g hematology/oncology patients) will also be excluded because the program was not specifically designed for these pain groups.