Kornimate/medical-research-clean huggingface dataset:
comparison study of brachytherapy and endoscopic stenting for dysphagia in esophago-gastric junction cancer

Conditions: Adenocarcinoma of the Esophago-gastric Junction

Summary: the objective of the study is comparison of the efficacy and safety of palliative therapy with single-dose brachytherapy or selfexpanding metal stents (sems) in malignant dysphagia resulting from adenocarcinoma of the esophago-gastric junction.

over the past two decades it has been observed a clear trend in the increasing incidence of adenocarcinoma of the esophagus and esophago-gastric junction. more than half of these patients already have inoperable disease at presentation. most of them need palliative treatment to relieve progressive dysphagia. presently, endoscopic placement of a covered selfexpanding metal stent is the most commonly used method for treatment of malignant dysphagia. cancer overgrowth and stent migration are the most common complications of endoscopic stenting and they occur more frequently with longer time from stenting. specific location at esophago-gastric junction at the end point of the propulsive force after swallow may predispose stents for easier migration to the stomach. additionally, the advances in chemotherapy have resulted in improved median survival of advanced adenocarcinoma ot the stomach and esophago-gastric junction even up to 10-12 months increasing a potential for higher chance for occurrence of stent complications. brachytherapy has been proved to be a valuable and durable method to treat malignant dysphagia resulting from esophageal and mainly squamous cell cancer. for many years irradiation was not recommended for adenocarcinoma of the esophagus and esophago-gastric junction due to their putative low sensitivity to radiotherapy. recently external beam radiation has been incorporated to a combined modality therapy regimens also for adenocarcinoma of the esophagus. thus, brachytherapy could be an attractive and durable method for improving swallowing in adenocarcinoma of the esophago-gastric junction, as well. single-dose brachytherapy and endoscopic stenting with sems in relieving dysphagia resulting from clearly defined adenocarcinoma of the esophago-gastric junction have not been compared yet.

Eligibility criteria:
inclusion criteria: * adenocarcinoma of the esophago-gastric junction defined as adenocarcinoma involving lower esophagus and upper stomach with epicenter of the primary tumor between 5cm above and 5cm below the anatomic esophago-gastric junction * inoperable cancer - locally advanced irresectible cancer, distant metastasis or patient's condition does not fit to undergo a curative therapy * dysphagia score 2-4 * performance status 60-100 * signed informed consent exclusion criteria: * esophageal squamous cell carcinoma * esophageal adenocarcinoma * gastric cancer * performance status \<60 * instable cardiocirculatory or respiratory disorder * concurrent external beam radiation therapy * previous anticancer therapy related to current adenocarcinoma of the esophago-gastric junction

Keywords: adenocarcinoma esophago-gastric junction dysphagia brachytherapy endoscopic stenting
incidence of dyschromatopsia in glaucoma

Conditions: Glaucoma

Summary: incidence of dyschromatopsia

incidence of dyschromatopsia should be elevated in glaucoma compared to a healthy control population. however, the actual incidence rate is not investigated.

Eligibility criteria:
inclusion criteria: * diagnosis of glaucoma * age between 18 and 99 years old * best corrected visual acuity(bcva) \> 0.2 (decimal snellen) exclusion criteria: * age \< 18 yo * bcva \< 0.2 * known dyschromatopsia * known corneal disease * st.p. corneal surgeries * macula disease * history of medication use that can influence color vision (e.g. hydroxychloroquine)

Keywords: glaucoma, dychromatopsia
the effect of mk 0633 in patients with atherosclerosis (0633-008)(completed)

Conditions: Atherosclerosis

Summary: a study to test the effects of study drug (mk 0633) on patients with atherosclerotic disease


Eligibility criteria:
inclusion criteria: * patients with plaque in coronary or leg arteries, known as atherosclerosis or peripheral vascular disease * inflammatory marker found in your blood, known as hscrp \> 0.5 mg/l exclusion criteria: * age \ 85 * female * heart attack, coronary artery bypass, stroke or unstable angina in last 3 months * liver diseased or abnormalities * hiv infection * lupus, rheumatoid arthritis, cancer \<5 years
korean cohort study for outcome in pediatric patients with chronic kidney disease

Conditions: Chronic Kidney Disease(CKD)

Summary: know-ckd (korean cohort study for outcome in patients with chronic kidney disease) is a nation-wide, ten-year longitudinal cohort study, launched in 2011. the aim of the study is to assess the characteristics and risk factors of progression and complications of ckd of korea. pediatric sub-cohort of know-ckd is planned to enroll 450 children with ckd, stage i to v (pre-dialysis).

seven major pediatric nephrology centers of korea enrolled children younger than 20 years who had ckd. medical history taking, questionaire assessment of socio-economic status, anthropometric measurement, and clinical assessment using laboratory and imaging tests were done. outcome is development of lv hypertrophy or hypertension, growth, neuropsychological status, behavioral status, kidney growth, and quality of life.

Eligibility criteria:
inclusion criteria: * age: \< 20 yr * ckd stage 1 through 5 of kdigo guideline * predialysis exclusion criteria: - dialysis

Keywords: chronic kidney disease(ckd)
safety of cotrimoxazole in hiv- and haart-exposed infants

Conditions: Acquired Immunodeficiency Syndrome; Infant, Newborn; Anemia; Neutropenia; HIV Infections

Summary: the purpose of this study is to determine if prophylactic cotrimoxazole makes severe anemia or neutropenia more common in infants exposed to maternal hiv and combination antiretroviral therapy.

each year, more than 2 million children are born to hiv-infected women. the world health organization (who) recommends that these infants receive cotrimoxazole (ctx) prophylaxis starting at 4-6 weeks of age until the period of infant hiv transmission risk is over, and the infant is known to be hiv-uninfected. there is also increasing interest in studying ctx prophylaxis given to all infants of hiv-infected women at the time of initiation of replacement feeding, regardless of infant hiv infection status, to mitigate the high risk of infant morbidity and mortality associated with formula feeding in the developing world. however, infant in utero exposure to maternal antiretroviral drugs can lead to hematologic toxicities in infants. it is critical to know whether infant ctx prophylaxis exacerbates the hematologic toxicity associated with perinatal arv exposure. this question, with broad public health implications, has never been studied. we will study the hematologic toxicity associated with ctx prophylaxis given to infants exposed to maternal haart in botswana. we will use existing data from a large cohort that did not receive ctx, and enroll a smaller cohort that does receive ctx according to botswana national guidelines.

Eligibility criteria:
both maternal and infant criteria need to be met: maternal inclusion criteria: * documented hiv infection * taking 3-drug highly active antiretroviral therapy at any point during pregnancy (note: can include 2 nrti+nnrti, 2nrti+pi, or 3 nrti) * 21 years of age or older, and able and willing to sign informed consent * proof of botswana citizenship maternal exclusion criteria: * involuntary incarceration infant inclusion criteria: * younger than 42 days of age * able to be brought to regular visits at study clinic until at least 6 months postpartum infant exclusion criteria: * known pre-existing birth anomalies resulting in a high probability that the baby will not survive to 6 months * known hypersensitivity to cotrimoxazole

Keywords: antiretroviral therapy, highly active trimethoprim-sulfamethoxazole combination anemia neutropenia safety hematologic toxicity
development and validation of a comorbidity index in crohn's disease

Conditions: Crohn Disease

Summary: crohn's disease (cd) is a chronic inflammatory bowel disease (ibd). like other chronic diseases, patients with cd may be affected by other diseases called comorbidities. the prevalence of comorbidities in ibd patients ranges from 30 to 70 %. unlike other chronic diseases, there is currently no cd-specific tool to assess the impact of comorbidities on patients' lives in order to take appropriate medical measures. several clinical indexes have been developed for the study of comorbidities, including the charlson index and the groll index, which are widely used. the disadvantage of these indexes is that they are not adapted to patients with cd. the primary objective of this study is to develop and validate a clinical index to evaluate the impact of comorbidities on disability in patients with cd.


Eligibility criteria:
inclusion criteria: 1. patients between 18 and 59 years old 2. established diagnosis of cd with a minimum disease duration of 3 months 3. disease considered by the treating gastroenterologist to have been stable for at least 3 months exclusion criteria: 1. subject unable to comply with study procedures 2. surgery for cd 3 months prior to inclusion visit
the tolerability and pharmacokinetics study of kangdaprevir sodium tablet in healthy adult subjects

Conditions: Chronic Hepatitis c

Summary: the tolerability and pharmacokinetics study of kangdaprevir sodium tablet in healthy adult subjects.

a phase i, single center, randomized, double-blind, placebo-controlled, single \& multiple ascending dose study to access the tolerability and pharmacokinetics of kangdaprevir sodium tablet in healthy adult subjects.

Eligibility criteria:
inclusion criteria: * able to comprehend and sign the icf voluntarily prior to initiate the study; * able to complete the study according to the protocol; * between 18 and 45 years of age（18 and 45 are inclusive）; * body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; body mass index (bmi) is between 18 and 28 kg/m2（18 and 28 are inclusive）; * physical examination and vital signs without clinically significant abnormalities. exclusion criteria: * smokers, who smoke more than 5 cigarettes/day within 3 months before the study; * drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 ml of beer, or 25 ml of strong wine, or 100 ml of grape wine); * donated blood or massive blood loss within 3 months before screening (\>450 ml）; * have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers; * have take any drug that changes liver enzyme activity within 1 month before taking the study drug * have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening; * have participated in any clinical trial or taken any study drug within 3 months before dosing; * viral hepatitis（including chb and chc）and positive test result of anti-hiv ab or syphilis. * have taken any alcoholic products within 24 hours prior to taking the study drug
effect of vibration on muscle properties, physical activity and balance in children with cerebral palsy

Conditions: Cerebral Palsy, Spastic

Summary: the aim of the 6-month randomized controlled trial, with 6-month no treatment follow-up, is to examine the effects of low-magnitude vibration on muscle, physical activity, and balance in children with spastic cerebral palsy.

cerebral palsy (cp) is a movement disorder that affects over 800,000 people in the u.s. due to the limited mobility associated with the disorder, individuals with cp have an increased risk of chronic diseases, such as cardiovascular disease, diabetes mellitus and osteoporosis, compared to the general population. therefore, identifying treatment strategies is of utmost importance. the aim of this study is to examine the acute and chronic effects of low-magnitude vibration on muscle, physical activity, and balance in children with cp. fat concentration and muscle will be assessed using imaging techniques. physical activity will be assessed using activity monitors. balance will be assessed using clinical and biomechanical tests. children with cp will be tested at five time points: baseline, 1 and 6 months after standing on a vibration platform daily 10 minutes per day, 1 and 6 months post treatment (7 months and 12 months from baseline, respectively). the findings from the proposed study will help us determine if vibration shows promise as a treatment for the impaired mobility, lower physical activity and higher risk of chronic disease in individuals with cp.

Eligibility criteria:
inclusion criteria: * spastic cerebral palsy * independent ambulator without an assistive device (gross motor function classification system level i or ii) exclusion criteria: * prior fractures in both femurs or tibias * currently taking bisphosphonates * unable to stand independently * orthopedic surgery on a lower extremity within the last 6 months * children with pure athetoid cp * baclofen pump in the abdomen * botox treatment within the last year
conservative vs surgical treatment for proximal humerus fractures in the elderly

Conditions: Shoulder Fractures

Summary: this is a randomized trial comparing conservative with surgical treatment (with open reduction and locking plate fixation) for proximal humeral fractures in patients aged more than 60 years.

different methods have been used in the treatment of proximal humeral fractures. usually, treatment choice depends on fracture displacement, patient age, osteoporosis, and other characteristics. locking plate fixation has become the most widely used method among surgical techniques, while partial arthroplasty is reserved for older patients and comminuted articular fractures. generally, nonsurgical treatment involves a brief period with sling immobilization and physiotherapy rehabilitation. a recent multicenter study showed no difference between conservative and surgical treatments, including internal fixation with locking plates. two other randomized studies showed mixed results, with no relevant clinical differences between the methods. no previous trial has evaluated the quality of reduction in surgically treated fractures and its relation to outcomes. our study aims to compare both techniques with a detailed radiographic and tomographic evaluation, in elderly patients. we also aim to evaluate the influence of reduction and plate positioning on clinical outcomes. this is a single center trial, in which surgeries will be performed by only two experienced surgeons.

Eligibility criteria:
inclusion criteria: * proximal humeral fractures, involving humeral head, with at least one of the following parameters: * head-shaft angle between 100-200° or \>175° on coronal plane; * shaft translation (on coronal or sagittal plane) \> 1cm; * tuberosity displacement \> 0,5cm; * head shaft angulation \>45° in axial or sagittal plane; * less then 30 days exclusion criteria: * no contact between shaft and humeral head * head-shaft angle \<100° on coronal plane * articular head fracture with displacement \> 2mm * fracture-dislocation * bilateral fracture * open fracture * ipsilateral or contralateral superior limb fracture * pathological fracture (tumors or bone disease, except for osteoporosis) * previous rotator cuff complete tear * previous infection * neurological injury * previous shoulder surgery * inability to answer subjective scores
evaluation of the hemocompatibility of the direct oral anti-coagulant apixaban in left ventricular assist devices

Conditions: Heart Failure

Summary: prospective, randomized, controlled, open label, trial of lvad patients with 1:1 randomization to either apixaban or warfarin.

this pilot study will be a prospective, randomized, controlled, open label, trial of heartmate 3 (hm3) lvad patients with 1:1 randomization to either apixaban or warfarin. all patients will be treated with aspirin 81 mg daily as per the lvad manufacturer instructions for use (ifu).

Eligibility criteria:
inclusion criteria: 1. patients implanted with a heartmate 3 lvad 2. age 18 or greater and able to provide written informed consent 3. females of childbearing age must agree to adequate contraception exclusion criteria: 1. history of post-lvad device thrombosis, stroke, or gastrointestinal bleeding 2. patients who are bridge to transplant and a current unos status 1-3 3. ongoing inotrope therapy after lvad (e.g., milrinone, dobutamine, epinephrine) 4. permanent right ventricular assist device at the time of lvad implant 5. patients with a mechanical heart valve 6. patients with end-stage renal disease on dialysis 7. pregnant patients 8. known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months 9. known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system. 10. recent (\<48 hours) or planned spinal or epidural anesthesia or puncture 11. prior history of known thrombophilia (e.g., factor v leiden, prothrombin gene mutation, protein c or s deficiency, antithrombin 3 deficiency, hyperhomocysteinemia, antiphospholipid antibody syndrome) or indication for higher inr goal (\>2.5) with warfarin. 12. thrombolysis within the previous 7 days 13. patients with an allergy or contraindication to aspirin, warfarin, or apixaban 14. patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline) 15. patients on combined p-glycoprotein and strong cpy3a4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin) 16. known bleeding within the last 30 days requiring emergency room presentation or hospitalization 17. known history of an inherited bleeding disorder (e.g., hemophilia, von willebrand disease) 18. patients with active bleeding or a hemoglobin \< 8.0 g/dl 19. total bilirubin \> 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis 20. inr \> 2.0 not due to anticoagulation therapy 21. platelet count \<100,000 cells/mm3

Keywords: ventricular assist device lvad anticoagulation apixaban warfarin
intravenous thrombosis and patients with prior ischemic stroke within 3 months

Conditions: Stroke; Acute Ischemic Stroke

Summary: the primary hypothesis being tested in this trial is that ischemic stroke patients with prior ischemic stroke within 3 months will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.


Eligibility criteria:
inclusion criteria: 1. patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). patients with ais within 4.5-24 hours of onset must meet the ivt inclusion criteria specified in the guideline 2. patients with prior ischemic stroke within 3 months 3. patients ≥ 18 years old 4. informed consent has been obtained depending on local ethics requirements. exclusion criteria: (1) plan to receive endovascular treatment (2) pre-stroke mrs score \> 2 (3) contraindications for ivt： 1. intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.) 2. previous history of intracranial hemorrhage 3. severe head trauma or stroke history within the last 3 months 4. intracranial tumors, giant intracranial aneurysms 5. intracranial or spinal surgery within the recent 3 months 6. major surgical procedures within the last 2 weeks 7. gastrointestinal or urinary tract bleeding within the last 3 weeks 8. active visceral bleeding 9. aortic arch dissection 10. arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding 11. elevated blood pressure: systolic blood pressure ≥ 180 mmhg or diastolic blood pressure ≥ 100 mmhg 12. acute bleeding tendency, including platelet count \< 100 × 10⁹/l or other conditions 13. received low-molecular-weight heparin treatment within 24 hours 14. oral anticoagulants (warfarin) with inr \> 1.7 or pt \> 15 s; receiving heparin treatment with aptt above the upper limit of the normal range within the last 24 hours of onset, receiving thrombin inhibitors and factor xa inhibitors within the last 48 hours of onset. 15. blood sugar \ 22.22 mmol/l 16. head ct or mri indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) the judgment is left to the discretion of the investigator
4p study: predictive quality with painfree therapies

Conditions: Cardiac Arrhythmias

Summary: the aim of the study is to characterize and quantify the relative effectiveness and contribution of implantable cardioverter defibrillator (icd) therapy to the clinical outcomes under the conditions of daily practice. swiss, multicenter, prospective, observational study.

the main role of icd's is to stop potentially lethal ventricular tachyarrhythmias through overdrive pacing or shock, reducing the risk of sudden cardiac death. the device is programmed to detect episodes of arrhythmias, classify them according to the threat to patient, and deliver therapies to stop the arrhythmias. the actual focus of icd programming has been the application of fast-pacing therapies (atp or antitachy pacing) as first therapy before applying a shock as last resort to terminate an episode. some studies have shown the high success rate of this method in decreasing the number of shock delivered to patients. furthermore significant improvement has been done to improve the sensitivity and specificity of the detection and discrimination algorithm. this study will focus on the latest generation of device and their performance will be reviewed and analyzed by an adjudication board.

Eligibility criteria:
inclusion criteria: * patients having an indication for a protecta icd or crt-d device, or later market released icd (first implant, replacement, or upgrade) * patients monitored with the carelink monitoring system * patients having signed the patient informed consent form * patients older than 18 years exclusion criteria: * patients younger than 18 years of age * patients with a life expectancy of less than 24 months * females, pregnant and of child bearing potential * patients participation to another concomitant trial * patients unable or not willing to provide a signed patient informed consent

Keywords: icd atp therapy rescue shock therapy
individual differences in diabetes risk: role of slow wavesleep

Conditions: Sleep; Diabetes

Summary: this study will examine the relationship between the amount of slow wave sleep (deep sleep) and the ability of the body to bring the blood sugar level to a normal range after receiving glucose.


Eligibility criteria:
inclusion criteria: * healthy volunteers age 18-20 with a bmi \< 27kg/m2 in women and \< 28 kg/m2 in men with normal findings on clinical examination, routine laboratory tests and ekg * only subjects who have regular life styles (no shift work, no travel across time zone during the previous 4 weeks) * habitual bedtimes between 7.0-8.5 hours/night * do not take medications will be recruited exclusion criteria: * women taking hormonal contraceptive therapy and pregnant women will be excluded * individuals with a history of psychiatric, endocrine, cardiac or sleep disorders will be excluded * other exclusion criteria will be: tobacco use, habitual alcohol use of more than 1 drink per day, excessive caffeine intake of more than 300 mg per day

Keywords: sleep insulin diabetes determine association between sleep characteristics and diabetes risk