Kornimate/medical-research-clean huggingface dataset:
a retrospective multicenter study of hbv-related pre-acute-on-chronic liver failure in china

Conditions: Liver Failure, Acute on Chronic; Liver Injury

Summary: the definition and diagnostic criteria of acute-on-chronic liver failure (aclf) has been well established by easl canonic study. however, patients with high risk to develop aclf has not been determined, yet. the aim of current study is to establish a preliminary pre-aclf definition, and to demonstrate the corresponding risk factors.


Eligibility criteria:
inclusion criteria: 1. chronic hepatitis b virus infection; 2. any of the followings: alanine aminotransferase (alt)≥3 upper limit of laboratory reference (uln); aspartate aminotransferase (ast)≥3 uln; serum bilirubin≥2 uln; acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections) exclusion criteria: 1. previous decompensation; 2. those who had hepatocellular carcinoma or other types of malignancies; 3. those who combined with severe chronic extra-hepatic disease; 4. pregnant; 5. received liver transplantation or kidney transplantation before or after admission; 6. readmission; 7. death within 24 hours.

Keywords: pre-acute-on-chronic liver failure hepatitis b
extended mesenteric excision in ileocolic resections for crohn's disease.

Conditions: Crohn Disease; Recurrence; Crohn's Ileocolitis

Summary: the study is looking at the role of the mesentery in disease recurrence for ileocolic crohn's disease. it is a prospective study that has been designed to perform extended mesenteric excision on patients undergoing their first ileocolic resection for crohn's disease. endoscopic recurrence will be monitored with the hypothesis that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection.

the current standard of care for ileocolic crohn's disease (cd) is a limited mesenteric resection. there is growing, but still limited, evidence that extended mesenteric excision during ileocolic resection is beneficial in decreasing disease recurrence. we propose a prospective multicenter cohort study to better understand the role of extended mesenteric excision in ileocolic cd and how it affects disease recurrence. the primary outcome of this study will be the rate of endoscopic recurrence at 6 months in patients undergoing first-time resection for ileocolic cd. secondary outcomes will include endoscopic recurrence at 18 months and rates of recurrence requiring surgery by 2 years. these outcomes will be compared to historical controls (limited mesenteric resection). our hypothesis is that patients receiving extended mesenteric ileocolic resection will have reduced endoscopic recurrence at 6 months after resection. as seen in previous studies, advanced mesenteric and mucosal disease predicts increased surgical recurrence.

Eligibility criteria:
inclusion criteria: * adults \>18 years old * diagnosis of cd limited to the distal ileum/ileocolic region * no previous ileocolic resection * all forms of cd presentation will be included - stricturing, fistulizing, perforating etc. exclusion criteria: * previous ileocolic resection * other sites of cd * intraabdominal sepsis
efficacy study of rezular (arverapamil) in the treatment of irritable bowel syndrome with diarrhea (ibs-d)

Conditions: Irritable Bowel Syndrome With Diarrhea

Summary: the purpose of the study is to determine the efficacy and safety of rezular (arverapamil) in the treatment of ibs-d.

we have fulfilled our enrollment requirements for this study. this study has been designed as a multicenter, randomized, double-blind, placebo controlled parallel dose group trial. the study will be open to both women and men. at screening the patient will be assessed to see if they meet the rome iii criteria for ibs-d. after screening, patients will undergo a 14-day run-in period evaluation, during which eligibility to be randomized to drug or placebo will be determined. patients will complete daily telephone diaries during the run-in and double-blind phases of the study. patients will be evaluated at regularly scheduled clinic visits during double-blind phase of the study. patients who complete the study may have the opportunity to rollover to the open-label one-year safety study (ardis-3).

Eligibility criteria:
inclusion criteria: * fulfilling rome iii criteria for ibs-d exclusion criteria: * major cardiovascular disease * psychiatric illness except mild or moderate depression * pregnancy * presence of other gi disease that could explain ibs-like symptoms * history of major gastric, hepatic, pancreatic or intestinal surgery or perforation

Keywords: ibs, ibs-d, r-verapamil, arverpamil, rezular
combination therapy of cord blood and g-csf for patients with brain injury or neurodegenerative disorders

Conditions: Brain Injury; Cerebral Palsy; Amyotrophic Lateral Sclerosis; Parkinson's Disease

Summary: this open label trial is conducted to investigate the efficacy and safety of the combination therapy of allogeneic umbilical cord blood (ucb) and granulocyte-colony stimulating factor (g-csf) for patients with brain injury or neurodegenerative disorders.

current treatments for brain injury or neurodegenerative disorders are palliative rather than curative. preclinical and some clinical studies suggest that ucb and g-csf can be used as restorative approach for such disorders.

Eligibility criteria:
inclusion criteria: should be included one of the 4 disorders * brain injury: onset duration over 12 months, age: 19 years or over * cerebral palsy: spastic, dyskinetic or ataxic, age: 19 years or over * parkinson's disease: modified hoehn and yahr stage 2.5, 3, 4, age: 30 to 75 years * als: definite of possible als, progression during the past 6 months, age: 19 to 65 exclusion criteria: * uncontrolled pulmonary, renal dysfunction at enrollment * uncontrolled seizure * malignant cancer * possibility of hypersensitivity to drugs used in this study * contraindication to the study intervention or assessment * pregnant or breast feeding women * non-compliance with the study visits specified in the protocol

Keywords: umbilical cord blood granulocyte-colony stimulating factor brain injury neurodegenerative disorder efficacy safety
plasma oxalate in patient with short bowel

Conditions: Short Bowel Syndrome; Hyperoxaluria; Hyperoxalemia

Summary: hyperoxaluria due to fat malabsorption is seen in patients suffering from short bowel and can lead to stones and nephrocalcinosis. not all patients are prone to these renal complications. only urinary oxaluria is measured in practice. plasma oxalate shouldn't increase theoretically in these patients. however recent report showed an increase of plasma oxalate in patient with enteric hyperoxaluria. the aim of this study is to assess the plasma oxalate distribution in this specific population to have a new tool to predict renal complication of these patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * type ii short bowel for more than 6 months * affiliated to a social health care exclusion criteria: * primary hyperoxaluria * other type of short bowel than type ii * minor patient or major patient protected by the law
effects of acipimox on insulin action, vascular function, and muscle function in type 1 diabetes

Conditions: Type 1 Diabetes

Summary: insulin resistance (ir) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (t1d). non-esterified fatty acid elevation is a significant contributor to ir in t1d and may be a target of intervention. the hypothesis of the study is that isolated fatty acid lowering with acipimox will improve insulin action and blood vessel function and have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial function in t1d. targeting ir through fatty acid lowering is a novel approach to t1d treatment that may significantly improve current management of tid and of cardiovascular disease (cvd) risk in this high risk population.


Eligibility criteria:
inclusion criteria: 1. men and women, with and without type 1 diabetes between 25-59 years of age, 2. hba1c 6.0-9.5 (t1d only), 3. subjects who are willing to commit to: * 14 days of prescribed diet, * two 44 hour inpatient stays, and * two muscle biopsies. exclusion criteria: 1. any comorbid condition associated with inflammation, insulin resistance, or dyslipidemia, 2. tobacco use, 3. pregnancy, 4. steroid use, 5. scheduled physical activity \>3 days a week, 6. angina or any other cardiovascular or pulmonary disease, 7. history of chronic obstructive pulmonary disease or asthma, 8. systolic blood pressure \>190 at rest or \>250 with exercise, or 9. diastolic pressure \>95 at rest, or \>105 with exercise, 10. proteinuria (urine protein \>200 mg/dl), or 11. creatinine \> 2 mg/dl, suggestive of severe renal disease, 12. severe proliferative retinopathy, 13. niacin treatment, 14. history of peptic ulcers, 15. history of hereditary angioedema, and 16. c1 esterase deficiency.

Keywords: diabetes insulin blood vessel type 1
clinical study of art-123 for the treatment of acute exacerbation of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: the purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of art-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (ipf) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on day 90 as the primary endpoint.


Eligibility criteria:
main inclusion criteria: * patients diagnosed with ipf who meet all criteria from (1) through (4) during the course of ipf * (1)unexplained development or worsening of dyspnea within 1 month during the course of ipf * (2)finding of new, bilateral ground glass opacities and/or consolidation on hrct * (3)no apparent pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure * (4)a decrease\* in pao2 of ≥10 mmhg or spo2 of ≥4% under the same conditions compared with the level at the previous measurements * (\*) in cases where no pao2 or spo2 test values under the same conditions are available, a patient with a p/f ratio ≤300 in the current episode of acute exacerbation is considered to have met criterion (4) * aged 40 years or older and no older than 85 years at the time of informed consent with either sex main exclusion criteria: * have intracranial hemorrhage, pulmonary hemorrhage, gastrointestinal bleeding (continued hematemesis, bloody discharge, gastrointestinal ulcer-induced hemorrhage) * have a history of cerebrovascular disorder (e.g., cerebral hemorrhage or cerebral infarction) within 52 weeks (364 days) before informed consent * patients for whom the completion of hemostatic treatment has not been confirmed after undergoing surgery of the central nervous system or after trauma * have a high risk for fatal or life-threatening hemorrhage * patients with malignant tumors * have acute exacerbation attributable to drug induced pulmonary disorder, after surgery for malignant tumors, chemotherapy, or radiation therapy * have acute exacerbation due to a thoracic surgical procedure (including thoracoscopic lung biopsy) * have a history of acute exacerbation of ipf * receiving mechanical ventilation through intratracheal intubation * patients who are pregnant or nursing, or who may be pregnant * patients with a platelet count less than 100,000/ul at the time of enrollment * patients with severe renal (serum cr: ≥4 mg/dl) or hepatic (ast/alt: ≥500 iu/l or t-bil: ≥10 mg/dl) dysfunction * have been administered a commercially available thrombomodulin alfa (recombinant )(recomodulin® for intravenous injection 12800) within 30 days before the start of investigational product administration * have a history of hypersensitivity for investigational product

Keywords: acute exacerbations idiopathic pulmonary fibrosis recombinant human soluble thrombomodulin art-123
long-term active surveillance study for oral contraceptives (lass)

Conditions: Arterial Thromboembolism; Venous Thromboembolism; Breast Cancer

Summary: the objective of this study is to characterize and compare the risks of long-term use of oral contraceptives containing drospirenone and of other established oral contraceptives.

the lass study is a large, multinational, prospective, controlled, non-interventional, long-term cohort study that follows a series of cohorts. the cohorts consist of new users (first-ever users, switchers and restarters) of three different groups of oral contraceptives (ocs): ocs containing drospirenone (drsp), ocs containing levonorgestrel (lng) and ocs containing other progestogens. a "non-interference" approach is used to provide standardized, comprehensive, reliable information on these groups of ocs under routine medical conditions. the main clinical outcomes of interest for the long-term follow-up are arterial and venous thromboembolism as well as breast cancer. regular, active contacts with the cohort members (=active surveillance) provide all necessary information on health-related events or changes in health status. the study is based on the existing long-term euras cohorts who are still in follow-up. lass succeeds euras and prolongs the follow-up period for another five years. total follow-up time of members of the long-term cohorts will be between 6 and 10 years. by means of annual contacts almost all relevant clinical outcomes will be captured. this will be accomplished by contacting the relevant physicians and by reviewing relevant source documents in the case of relevant clinical outcomes.

Eligibility criteria:
inclusion criteria: * women who are prescribed an oral contraceptive and who are new users (first-ever users, switchers or restarters) of the formulation exclusion criteria: * women who do not consent to participate in the study

Keywords: contraception thromboembolism breast cancer
oral citrulline supplementation in copd patients with malnutrition

Conditions: Chronic Obstructive Pulmonary Disease Severe; Malnutrition

Summary: chronic obstructive pulmonary disease (copd) is complicated by malnutrition in 20-70% of cases. in copd, low fat-free mass is associated with a higher risk of morbidity and mortality. l-citrulline is a non-protein amino acid that has a direct effect on muscle protein synthesis. oral supplementation with l-citrulline (10 g/day) in malnourished patients has shown to increase fat-free mass. the effects of l-citrulline supplementation in malnourished copd patients are unknown. the main objective of this prospective, single-centre, randomised, double-blind, placebo-controlled study will be to determine the impact of 45 days of nutritional supplementation with l-citrulline (10 g/day) on lean body mass (fat-free mass index (in kg.m-2) measured by bioelectrical impedance analysis) in malnourished patients (bmi \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old) with copd at stages 3-4 of the gold classification.


Eligibility criteria:
inclusion criteria: * men and women aged 50 and over * copd stage 3 or 4 according to gold criteria * bmi \< 20 kg/m2 if \< 70 years old or \< 22 kg/m2 if ≥ 70 years old * suspicion of sarcopenia marked by a score of 4 or more on the sarc-f questionnaire * absence of severe copd exacerbation for at least 3 months exclusion criteria: * main respiratory disease other than copd * daily long-term use of systemic corticosteroids (\>6 months per year, whatever the dose) * severe and end-stage renal insufficiency (creatinine clearance \<30ml/min) * patient with severe hypotension, uncontrolled hypertension (at investigator's discretion) * contraindication to l-citrulline intake: vka and/or cancer chemotherapy * osmotic diarrhoea * severe and/or uncontrolled progressive pathology likely to be life-threatening * psychiatric pathology (schizophrenia, dementia, severe bipolar/psychotic disorders, severe depressive syndrome) * pacemaker or other implanted electronic device

Keywords: copd l-citrulline malnutrition
clinical efficacy and safety evaluation of irbesartan high and amlodipine combined therapy in essential hypertension patients

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate efficacy and safety of irbesartan and amlodipine combined therapy in patients with essential hypertension inadequately controlled on irbesartan monotherapy


Eligibility criteria:
inclusion criteria: * patients who are 19 years or older on screening * signed informed consent * patients with essential hypertension * other inclusion applied exclusion criteria: * orthostatic hypotension with symptom * other exclusion applied
electrostimulation, skeletal muscle function, and exercise capacity in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study was designed to test the following hypothesis: the benefit of electrostimulation training will be greater than sham stimulation training in term of muscle strength and mass (muscle hypertrophy), exercise tolerance, reduction of ventilation during exercise and quality of life in copd patients

background: because it has little impact on ventilatory requirements and dyspnea, muscle electrostimulation appears as a promising alternative to general physical reconditioning in advanced copd and its feasibility has been confirmed in this population. however, the physiological mechanisms underlying the proposed benefits of electrostimulation training have not been explored. objective: to evaluate in copd patients the physiological mechanisms of changes in exercise tolerance after electrostimulation training. method: we propose to conduct a controlled, randomized and double blind clinical trial comparing the efficacy of muscle electrostimulation training of the lower limbs to sham training in 24 patients with copd. patients are included in either 6 weeks of electrostimulation training (active treatment group) or 6 weeks of sham electrostimulation. before and after training, patients perform endurance shuttle walking test, muscle function testing, muscle biopsy, blood sampling and health-related quality of life questionnaire. planning analysis: the main outcome will be change in the strength of the quadriceps over the 6-week electrostimulation program. the other end-points will be mid-thigh and calf muscle cross-sectional area, lower limb muscle endurance, ventilation, dyspnea, leg fatigue, operational lung volumes at iso-time and walking time during an endurance shuttle walk, muscle hypertrophying/atrophying pathways and muscle aerobic capacity. for each group, pre- and post-training comparisons will be made using a repeated measures design. the magnitude of the pre- and post-training changes will also compared between both groups with a two-way anova (group, training effect) with repeated measures on the second factor (training effect). a p value \< 0.05 will be considered statistically significant.

Eligibility criteria:
inclusion criteria: * copd * fev1 \< 60% predicted value and fev1/ fvc \< 70% * 6-minute walking distance \< 400 m exclusion criteria: * patients suffering from cardiovascular, neurological, skeletal muscle, or any other condition that could alter their capacity to perform the exercise test * patients taking systemic corticosteroids on a daily basis (patients having received systemic steroids for the treatment of up to two exacerbations in the preceding year and those on inhaled steroids will be allowed) * patients with room air pao2 \< 60 mm hg will be excluded.

Keywords: chronic obstructive pulmonary disease (copd) electrostimulation muscle function exercise ventilation anabolism/catabolism pathway
cryo-touch iii refinement study investigational plan

Conditions: Facial Wrinkles; Skin Aging

Summary: this is a prospective, non-randomized study to evaluate the performance of the myoscience cryo-touch iii device for the treatment of glabellar and/or forehead wrinkles.


Eligibility criteria:
inclusion criteria: * age 30-70 years * subject has a glabellar and/or forehead wrinkle rating by investigator of at least 2 in animation on the 5-point wrinkle scale (5ws)\* * subject has signed institutional review board (irb)-approved informed consent form exclusion criteria: * subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising * subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites * the investigator is unable to substantially lessen facial lines by physical separation * subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months * subject is participating in another facial cosmetic research study patient has any of following conditions: * history of facial nerve palsy * marked facial asymmetry * ptosis * excessive dermatochalasis * deep dermal scarring * thick sebaceous skin * history of neuromuscular disorder * chronic dry eye symptoms * allergy or intolerance to lidocaine * other local skin condition (eg, skin infection) at target treatment site * any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation

Keywords: wrinkle rhytid aging
prodigy registry in nyha class iii heart failure patients

Conditions: Heart Failure NYHA Class III

Summary: this is an observational, prospective, single arm, multi-center registry to evaluate the cordella™ heart failure system (chfs) in up to 250 nyha class iii hf patients .

the subjects in this registry will participate in the screening visit, and follow-up visits. after the screening visit, eligible subjects will be trained on at-home use of the chfs to measure bp, hr, spo2, weight and optional ecg. they will be instructed to perform daily measurements of the parameters which will all be wirelessly transmitted to a secure website for review using the mycordella™ patient management portal (pmp). clinicians will be able to view blood pressure (bp), heart rate (hr), peripheral capillary oxygen saturation (spo2), weight and electrocardiogram (ecg) (optional) data through the mycordella™ pmp. subjects will return for follow up visits at 3, 6, and 12 months after enrollment or until study termination. at month 6, the primary endpoint will be assessed through evaluation of the subjects quality of life using the completed kccq questions. assessment of secondary endpoints will be performed throughout the study duration, including evaluation of adverse events, and heart failure-related hospitalizations and medication changes. additionally, health economics will be assessed per subject and per site via a detailed site questionnaire.

Eligibility criteria:
inclusion criteria: 1. subject has given written informed consent 2. male or female complex ccm eligible patients or equivalent and at least 18 years of age 3. diagnosis of hf ≥ 3 months and nyha class iii hf at the time of screening 4. subject fluent in english (written and oral) and with sufficient eyesight, hearing, and mental capacity to respond to the cordella™ heart failure system audio/visual cues and operate the cordella™ heart failure system 5. subject has sufficient cellular and/ or wi- fi internet coverage at home 6. subject agrees: 1. that the treating investigator is their solely complex ccm physician 2. to return to the treating investigator for all scheduled follow up visits and can return to the hospital for follow up exclusion criteria: 1. subjects enrolled in another investigational trial. 2. subjects who are unwilling or deemed by the investigator to be unwilling to comply with the study protocol, or subjects with a history of non-compliance 3. severe illness, other than heart disease, which would limit survival to \<1 year

Keywords: heart failure nyha class iii