Kornimate/medical-research-clean huggingface dataset:
the effect of carvedilol vs propranolol in cirrhotic patients with variceal bleeding

Conditions: Liver Cirrhosis; Esophageal and Gastric Varices; Hemorrhage

Summary: to compare the efficacy and safety of carvedilol and propranolol in patients with cirrhosis-related esophagogastric varices after multiple endoscopic treatments for secondary prophylaxis.

the study is a randomized controlled trial. patients randomly enter into two treatment groups: 1)the carvedilol group and 2)the propranolol group. treatment allocation is by block randomization, with an equal number for carvedilol and propranolol. the results are concealed in opaque envelopes. the dose of non-selective β-blocker(nsbb) is titrated according to systolic arterial blood pressure (abpsys) and heart rate (hr). doses are increased every 2-3 days until abpsys is not less than 90 mm hg and hr is not less than 55 bpm. carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. patients receiving propranolol start at a dose of 30 mg/day and the dose will be increased to a maximum dose of 160 mg/day. patients will be followed up with telephone calls every 2 months. after taking these 2 drugs for 6 months, patients come for clinic visits, receiving laboratory tests and endoscopic examinations, and events of primary and secondary outcomes will be analyzed.

Eligibility criteria:
inclusion criteria: * age between 18-70 years old; * cirrhotic patients referred to zhongshan hospital with esophagogastric varices confirmed by endoscopy; * history of variceal bleeding; at least 3 times of endoscopic treatment; * with 1) mild esophageal varices;2) gastric varices with a diameter less than 5mm; or 3) variceal eradication at the time of recruiting. exclusion criteria: patients are excluded when they have * episodes of variceal bleeding after the last endoscopic treatment; * diagnosis of hepatic cellular carcinoma; * severe systemic diseases; * refractory ascites; * contraindication to carvedilol or propranolol, such as: asthma, chronic obstructive pulmonary disease, allergic rhinitis, new york heart association iv chronic heart failure, atrioventricular blockade, severe bradycardia(hr\<50bpm), sick sinus syndrome, cardiogenic shock, severe hypotension(abpsys\<85mmhg); * previous and continued use of β-blockers; * child -pugh class c.

Keywords: secondary prophylaxis propranolol carvedilol comparative effectiveness research
safety and efficacy study in infant with sbs

Conditions: Short Bowel Syndrome

Summary: the objective of this clinical study is to evaluate the efficacy and safety of ntra-9620 compared with placebo in pediatric subjects (aged 28 weeks postmenstrual age to 52 weeks old) with sbs following surgical resection


Eligibility criteria:
inclusion criteria 1. subject must be at least 28 weeks post-menstrual age and up to 52 weeks chronological age at enrollment. 2. subject weight must be at least 500 grams (17.6 ounces) at time of enrollment. 3. after major surgical resection leading to sbs, the subject has maximally 70% of expected bowel length preserved or an ostomy in place such that ≤ 70% of the small bowel is available for nutrient absorption. exclusion criteria 1. subject has undergone any bowel lengthening procedure. 2. subject has a malabsorption disorder due to: * congenital etiology (such as microvilli inclusion disease, tufting enteropathy) * untreated hirchsprung's disease 3. uncontrolled systemic infection, acute gastroenteritis, pneumonia, cardiovascular or other abnormality including ekg findings that in the opinion of the investigator makes the infant unstable and at significant risk of not completing first 12 weeks of the study. 4. subjects with hyperinsulinemia. 5. subjects with unexplained or recurrent hypoglycemia with blood glucose ≤ 50 mg/dl within 48 hours of treatment initiation.
an infant formula trial on dietary management of infantile colic

Conditions: Infantile Colic

Summary: a randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.

a randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic. the hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic. the various time points of the outcome are: v1 (screening : day -5 to day 0); v2 ( randomization: day 0); v3 (day 7); v4 (day 21); phone call (day 28); v5 (end -intervention: day 42); v6 (day 56)

Eligibility criteria:
inclusion criteria: 1. infants aged 21-56 days (both inclusive); 2. gestation age 37-42 weeks; 3. normal birth weight for gestational age and gender 4. 5-minute apgar score \>7; 5. diagnosed with infantile colic ; 6. fully formula fed for at least 7 days before randomisation; 7. written informed consent from the parent and/or legal representative. exclusion criteria: 1. any plausible cause of inconsolable crying as judged by the investigator; 2. presence of non-functional vomiting or failure to thrive; 3. presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition; 4. congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes; 5. known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations; 6. received any special formula (e.g. lactose-free, hydrolysed protein); 7. received any of the following products/medication within 7 days before randomisation: 1. probiotics 2. systemic antibiotics 3. prokinetics 4. proton pump inhibitors 8. twins or triplets or other infant(s) \<6 months of age living in the same household; 9. incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements; 10. current participation in another clinical study involving investigational or marketed products.
dose-related effects of vitamin d3 on immune responses in patients with clinically isolated syndrome

Conditions: Clinically Isolated Syndrome; Multiple Sclerosis

Summary: the primary purpose of this study is to assess the immune response to vitamin d supplementation at two doses (5,000 iu and 10,000 iu daily) in both healthy controls and patients with clinically isolated syndrome compared to placebo. secondary endpoints include (1) disease outcome in the clinically isolated syndrome in terms of clinical relapses and evidence of new lesions on mri (mcdonald's ms), 2) safety of doses used

primary endpoint: to determine the effects of vitamin d supplementation at two doses a) 5,000 iu daily b) 10,000 iu daily compared to c) placebo a 24 weeks period on the change from baseline in frequency of cd4 t cell subsets and cytokine responses by peripheral blood mononuclear cells in 1) patients with the clinically isolated syndrome. 2) healthy control participants. secondary endpoints: 1. to determine whether there is a dose response effect of supplementation using 5,000 iu and 10,000 iu of vitamin d versus placebo over 24 weeks on the change from baseline in the frequency of cd4 t cell subsets and cytokine responses by pbmc in 1) patients with the clinically isolated syndrome (cis) 2) healthy control participants 2. to establish whether there is a clinical response to vitamin d measured by a) change in the number of t2 lesions and gadolinium enhancing lesions on mri scanning at 24 weeks compared to baseline b) reduction in relapses over 24 weeks in treated (both 5,000 iu and 10,000 iu) cis patients versus cis patients receiving placebo.

Eligibility criteria:
inclusion criteria: to be eligible for inclusion, each subject must meet each of the following criteria at screening (visit 1) and must continue to fulfil these criteria at baseline (visit 2). * cis: patients with a clinically isolated syndrome with onset relapse within the previous three months and two or more than two asymptomatic t2 lesions on mri brain scan. * aged 18-55yrs. * not receiving any disease modifying therapy. exclusion criteria: * patients in whom any disease other than demyelination could explain their signs and symptoms. * participants with known disease of the parathyroids, a history of vitamin d intolerance, sarcoidosis, a history of hypercalcaemia of any cause. * participants with a baseline abnormality in serum urea, creatinine, calcium, parathormone. * participants on thiazide diuretics (hypercalcaemia risk). * patients with occurrence of a relapse less than six weeks prior to entry to study. * previous treatment with beta-interferons or glatiramer acetate or steroids in the last three months. * any previous treatment with mitoxantrone or other immunosuppressant. * participants already taking supplemental vitamin d.

Keywords: clinically isolated syndrome multiple sclerosis vitamin d immune response cd4 t cell subsets cytokine
spinal cord stimulation (scs) therapy study

Conditions: Failed Back Surgery Syndrome; Degenerative Disk Disease; Epidural Fibrosis; Arachnoiditis; Radiculopathies

Summary: the purpose of this study is to evaluate the effect of different spinal cord stimulation settings in the treatment of leg pain. subjects will receive a randomized order of four different programmed stimulation settings for 3 weeks each followed by a fifth and final setting.


Eligibility criteria:
inclusion criteria: * at least 22 years of age or older at the time of informed consent * implanted with a medtronic restoresensor or restoreultra scs system for an on-label indication at least 6 months for the treatment of chronic leg pain, with or without back pain * implanted with one or more medtronic leads located in the epidural space within the thoracic area * receiving some level of pain relief with current scs therapy * on a stable dose (no new, discontinued or changes in) of all prescription pain medications and willing to maintain or only decrease the dose of all prescribed pain medications * read and understand english without assistance * willing and able to comply with all study procedures, study visits, and be available for the duration of the study exclusion criteria: * diagnosed with complex regional pain syndrome (crps), peripheral causalgia, or reflex sympathetic dystrophy (rsd), or causalgia * has leg, knee, or foot pain unrelated to on-label indication for scs therapy (for eg, arthritis, knee surgery, etc.) * implanted with both a surgical and percutaneous lead * implanted with a peripheral lead for subcutaneous or peripheral nerve stimulation * has had any of the following procedures: * neuroablative procedure within six months * neurolytic block within two months * injection therapy for pain within four weeks * sympathetic block within two weeks * has an active implanted device (besides restoreultra or restoresensor neurostimulator), whether turned on or off * pregnant or lactating, inadequate birth control, or at risk of pregnancy during this study * has an untreated psychiatric comorbidity * has serious drug-related behavioral issues * has active malignancy or has been diagnosed with cancer and has not been in remission for at least one year * has secondary gains which, in the opinion of the investigator, are likely to interfere with the study * participating or planning to participate in another clinical trial while enrolled in this study
axillary reverse mapping (arm) technique

Conditions: Invasive Breast Cancer; Ductal Carcinoma in Situ of the Breast

Summary: the purpose of this pilot study is to compare a new surgical technique (axillary reverse mapping) to standard axillary surgery in patients diagnosed with invasive or in situ breast cancer.

lymphedema is a major chronic morbidity that occurs in patients undergoing treatment for breast cancer (bc). surgery for bc includes axillary surgery with either sentinel lymph node biopsy (slnb) or axillary lymph node dissection (alnd). lymphedema occurs due to removal or disruption of lymphatic drainage of the arm that overlaps with drainage of the breast. the risk of lymphedema increases significantly with adjuvant radiation. axillary reverse mapping (arm) is a technique where blue dye is injected into the upper arm at surgery, allowing direct visualization of arm lymphatics and nodes during either slnb or alnd. this allows preservation of arm lymphatics unless there is suspicion of metastatic disease in arm lymphatics or if the arm node is/are also the sentinel lymph node. studies to date have largely been observational cohort studies, and mainly with low risk patients undergoing slnb only. there is only one published randomized controlled trial, and this included only patients undergoing modified radical mastectomy.our proposal is a prospective randomized pilot study. the study population includes patients undergoing axillary surgery (slnb with mastectomy or alnd with either bcs or mastectomy or completion alnd after positive slnb). the intervention group will undergo arm; the control will undergo standard surgical treatment. both groups will undergo standardized baseline and postoperative arm measurements and patients will complete symptom and quality of life questionnaires. the purpose is to determine the feasibility of the arm technique, its accuracy in identifying and sparing arm lymphatics, and its ability to reduce the risk of lymphedema.

Eligibility criteria:
inclusion criteria: women diagnosed with invasive breast cancer or ductal carcinoma in situ receiving the following treatment: 1. mastectomy and sentinel lymph node biopsy 2. breast conserving surgery or mastectomy and axillary lymph node dissection 3. completion axillary lymph node dissection after positive sentinel lymph node biopsy 4. cases receiving neo-adjuvant therapy (chemotherapy or hormonal therapy) who are having axillary lymph node dissection as part of their surgical treatment - exclusion criteria: 1. males with breast cancer 2. women less than 18 years of age 3. known allergic reaction to patent blue dye 4. pregnant 5. previous radiation therapy to affected side 6. clinical n2/n3 disease -

Keywords: axillary reverse mapping (arm) sentinel lymph node biopsy (slnb) axillary lymph node dissection (alnd) lymphedema breast cancer surgery
airway responsiveness in patients with aecopd mechanical ventilation by inspiratory and bronchial dilation testchronic obstructive pulmonary disease

Conditions: Lung Disease,Obstructive

Summary: in the patients with copd mechanical ventilation, the bronchial dilatation is very common. however, the evaluation of the efficacy of the medical examination and other subjective indicators, such as doctors, depends on the doctor's experience; at present, there is no objective evaluation index. for patients with mechanical ventilation, the risk of cross infection can not only increase the risk of cross infection, but also increase the workload of clinical doctors and nurses. therefore, this study proposes an objective evaluation method to evaluate the response of copd patients to bronchial dilation. the hypothesis of this study can be used to guide the clinical medication through the test of the bronchus. if the patients with bronchial dilation test positive were used in the test, the patients were not used. in this evaluation method, the changes of airway resistance were measured by the accurate measurement of the patients with inhaled bronchial dilatation.


Eligibility criteria:
inclusion criteria: * acute exacerbation of chronic obstructive pulmonary disease * the mechanical ventilation time of the outdoor endotracheal intubation in the intensive care unit was less than 48 hours exclusion criteria: * asthma * has received tracheotomy * long term mechanical ventilation (which has been accepted for more than 21 days). * severe pneumonia * patients who cannot use a patient with bronchial dilation * there's a taboo on the use of a sedative. * refusal to participate in the study * 48 hours to pull out the tube

Keywords: mechanical ventilation chronic obstructive pulmonary disease airway resistance bronchial dilation test
interventions to enhance medication persistence and compliance in patients with overactive bladder

Conditions: Overactive Bladder

Summary: study objectives: to explore the effectiveness of adjunctive intervention to enhance the medication compliance and persistence in patients with overactive bladder (oab), thereby to improve treatment outcomes study hypothesis: health education intervention (hei) can enhance the medication compliance and persistence, thereby can improve the treatment outcomes in conjunction with pharmacological therapy in oab patients study design: 6-month, randomized, open-label, multi-center trial at 13 university hospitals

treatment - fesoterodine (toviaz) 4 or 8mg interventions (2 arms) - arm 1: no intervention patients in this arm will not be given hei in conjunction with pharmacotherapy (toviaz) which was developed for this trial. - arm 2: health education intervention (hei) hei will be performed by trained study coordinators with the leaflet designed for this trial composed of 4 parts. 1. part 1: understanding oab physiology of bladder definition, symptom and prevalence of oab oab in a treatable condition. there are many options that may help your symptoms. lifestyle change medications bladder training pelvic floor muscle exercise 2. part 2: behavioral/lifestyle modification modification of dietary habits limit bladder irritants- caffeine (coffee, tea, coke...), juice, chemical flavors, spicy food. etc. altering fluid intake weight management learn how weight can affect their condition stop smoking constipation management 3. part 3: bladder training timed voiding- goal is urinating every 3 or 4 hours during the day without fear of wetting accidents. urgency suppression pelvic muscle contraction, count backwards from 100 by 7seconds, etc pelvic floor muscle exercise contraction (fast and slow) and relax the muscle for a count of 3. repeat the fast and slow contractions 10 - 15 times. do those at least 3 times a day. 4. part 4: understanding antimuscarinics how the medicine works how to take it tips that may help manage side effects- dry mouth, constipation therapy expectations 5. hei include 3-day voiding diary for self tracking method.

Eligibility criteria:
inclusion criteria: * female aged ≥ 18 years with oab symptoms for ≥ 3 months * the sum score of the oabss ≥ 3 with the score of the question no.3 (urgency) ≥ 2 * the sum score of the oab v8 ≥ 8 exclusion criteria: * any condition that would contraindication of anticholinergic treatment * symptomatic acute uti during the run-in period * diagnosed or suspected interstitial cystitis * treatment with anticholinergic drugs within 12 months prior to screening and persist over 3 months * treatment within the 14 days preceding screening, or expected to initiate treatment during the study with any other treatment for overactive bladder. * an indwelling catheter or practicing intermittent self-catheterization * pregnant or nursing women

Keywords: medication persistence compliance health education intervention (hei)
comparison of efficacy and ocular surface disease assessment between monoprost and bak-preserved latanoprost

Conditions: Glaucoma; Ocular Hypertension

Summary: comparison of efficacy and ocular surface disease assessment between monoprost and bak-preserved latanoprost in glaucoma or ocular hypertensive patients : phase 4, parallel group design, investigator-blind, active-control, randomized, multi-center study

not provided

Eligibility criteria:
inclusion criteria: * iop \>/= 15mmhg and \< 40 mmhg in each eye using goldmann applanation tonometry at visit 2 * written consent voluntarily to participate in this clinical trial exclusion criteria: * patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc. * best-corrected visual acuity 20/80 or less * patients who have ongoing medical history of ocular inflammation * central corneal thickness is not in between 470um and 591um. * patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it. * pregnant or nursing women
ai-based frailty assessment tool for patients undergoing cardiac surgery

Conditions: Frailty

Summary: the main purpose of this study is to establish a frailty automatic evaluation index "ai frailty index" based on artificial intelligence multi-modal non-contact monitoring information analysis. at the same time, the study will explore the correlation between ' ai weakness index ' and perioperative and long-term prognosis and quality of life.

this is a prospective cohort study. patients who undergoes elective cardiac surgery will be enrolled. we collect frailty scales, clinical information and multi-modal, non-contact monitoring information during hospitalization. one-year follow-up will be done. the non-contact monitoring information are used to predict the frailty scales to establish and validate an ai-based frailty assessment model "ai frailty index". the ai frailty index will be further used to predict perioperative and long-term outcomes.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery exclusion criteria: * emergency surgery * age ≤ 18 years * the clinical situation is unstable, such as frequent occurrence of coronary ischemia events, unstable heart failure, or acute events leading to severe discomfort symptoms or changes in vital signs * unable to cooperate in completing research data collection due to severe neurological and psychiatric abnormalities or other reasons * duration of postoperative ventilation \> 48 hours or inability to obtain scale data on the first day after surgery

Keywords: frailty cardiac surgery artificial intelligence non-contact monitoring
modifying whey protein fortified drinks and foods

Conditions: Individual Difference; Food Sensitivity; Food Preferences

Summary: this study aims to investigate whether consumers differ in mouthdrying sensitivity and if mouthdrying can be modulated.

1. to investigate whether older adults are more sensitive to whey protein derived mouthdrying compared with younger adults 2. to investigate whether increasing fat levels in a solid whey protein model influences mouthdrying perception

Eligibility criteria:
inclusion criteria: * age (18-30 years or over 65 years) * healthy exclusion criteria: * relevant food allergies or intolerance * outside age criteria * diabetic * had oral surgery * had a stroke * smoker * cancer taking prescribed medication that could influence study outcomes anyone who currently has covid-19 symptoms or who has had covid-19 within the last 4 weeks

Keywords: older adults mouthdrying protein fortified foods and beverages