Kornimate/medical-research-clean huggingface dataset:
evaluate the safety and efficacy of xiyanping in pediatric participants with severe influenza-like symptoms

Conditions: Severe Influenza

Summary: this is a multicenter, randomized, open label, add-on study.

this is an add-on study of efficacy and safety of intravenous injection of xiyanping injection in pediatric subjects with severe influenza-like symptoms. the purpose to determine the efficacy and safety of oseltamivir phosphate combined with or without xiyanping injection in the treatment of severe influenza-like symptoms. the study will enroll 72 pediatric severe influenza-like symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive oseltamivir phosphate and xiyanping injection for severe influenza; volunteers from the second group will receive oseltamivir phosphate for severe influenza. xiyanping injection will be administration as intravenous injection of 0.4ml/kg/day once daily for 7-10 days concomitantly with oseltamivir phosphate for severe influenza-like symptoms.

Eligibility criteria:
inclusion criteria: * age between 3 and 6 years old; * clinical diagnosis of severe influenza with hospital treatment needed; * patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment; （1)fever ≥ 39°c (tympanic temperature) for at least 3 days with severe cough,sputum, blood stasis, or chest pain; （2）combined pneumonia; * the rapid viral antigen test of throat swab and nose swab results were positive; * guardians understood and assigned the informed consent; exclusion criteria: * participants allergenic to xiyanping injection, andrographolide or oseltamivir phosphate; * creatinine clearance \<80ml/min or received continuous renal replacement therapy (crrt) test; * need extracorporeal membrane oxygenation (ecmo) at baseline; * glasgow coma rating scale (gcs) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline; * crisis influenza symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring; * use of systemic steroids or other immunosuppressants; * participants with the following underlying diseases, including: heart disease (such as new york heart function classification ii-iv) or clinically significant arrhythmia (such as qtc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( alt and ast ≥ 1.5 × uln; cr and bun \> 1.2 × uln), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc. * participants used influenza virus vaccine within 3 months; * participants with drug dependence or with mental disorders within 1 year; * participants participated in other clinical research in the last 30 days; * any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.

Keywords: severe influenza
personalized research on diet in ulcerative colitis and crohn's disease

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis

Summary: a series of n-of-1 trials will be used to determine the effectiveness of a specific carbohydrate diet (scd) versus a modified scd in patients in reducing symptoms and inflammatory burden at both the individual and population level. this is a four-year study. the study staff will recruit up to 60 patients across up to 21 sites in patients aged 7-18 with mild to moderate disease activity.


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease (cd) or ulcerative colitis (uc) or indeterminate colitis (ic) * age 7-18 years * enrolled in the improvecarenow (icn2) registry * evidence of acute inflammation and/or elevated acute phase reactant as measured by fecal calprotectin 1.5 times the upper limit of normal, lactoferrin 1.5 times the upper limit of normal, crp 1.15 times the upper limit of normal, or esr 1.15 times the upper limit of normal (based on local reference ranges) obtained within 8 weeks of enrollment. * potential participants who are close to meeting one of the acute inflammation and/or elevated acute phase reactant markers and who meet all other study criteria will be considered for study participation on a case by case basis by the investigative study team in consultation with the patient's primary gastroenterologist. exclusion criteria: complex and unstable ibd: * currently or within the past 9 months has had an abscess, fistula, stricturing cd, or ostomy * severe disease activity as measured by a short pediatric crohn's disease activity index (spcdai) score of \>45 or pediatric ulcerative colitis activity index (pucai) score of \>60 assessed within three weeks of enrollment * ever had history of full colectomy * hospitalization or surgery planned within 3 months * ongoing active gastrointestinal infection * severe malnutrition (bmi less than 5th percentile) * recent medication changes including: * thiopurines, natalizumab, or methotrexate started within 8 weeks prior to enrollment * anti tnf (infliximab, adalimumab) started within 8 weeks prior to enrollment * vedolizumab started within 16 weeks prior to enrollment * increase in corticosteroids within 4 weeks of screening or have dose \>20 mg prednisone or equivalent evidence of other complicating medical issues: * other serious medical conditions, such as neurological, liver, kidney, or systemic disease * serious psychological or psychiatric conditions such as eating disorders or self-harm * pregnancy * tobacco, alcohol, or illicit drug abuse inability to complete the protocol * non-english speaking participants * on scd or modified scd anytime within 8 weeks of enrollment * if an otherwise eligible patient is on scd or modified scd within 8 weeks of enrollment but they are noncompliant per the determination of the patient's dietitian/primary gastroenterologist, then this patient is eligible to participant in the study. * participants on a vegan diet * lack of smart phone and data plan for participating caregiver * participating in another concurrent intervention study
cognitive-somatosensory-motor training to improve arm and hand function after stroke (icosmo)

Conditions: Stroke; CVA; Cerebrovascular Accident

Summary: the icosmo study investigates the feasibility and beneficial effects of an intervention combining sensation, motor and cognition to improve arm and hand function after chronic stroke.

the icosmo is a two-arm randomized controlled trial study evaluating the feasibility and efficacy of combined somatosensory-motor intervention using a cognitive approach to improve upper limb recovery in people with chronic stroke. forty participants will be recruited (20 in experimental group and 20 in the control group). icosmo will include active touch and movement exploratory procedures during goal-oriented tasks as well as robotic training using the kinarm exoskeleton device. the experimental group will receive a total of 36 hours of treatment (6 weeks). the control group will receive a matched dose of a home-based motor exercise programme. the outcome measures will include measures of feasibility such as the recruitment and adherence rates and standardised clinical and robotic assessments. the participants will be tested at the start and end of the baseline phase, at post-intervention and at 1-month follow-up.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stroke * must be more than 6 months post-stroke * must be above 18 years old * must have some motor and/or somatosensory deficits in the upper limbs exclusion criteria: * a prior history of central nervous system dysfunction other than stroke * upper limb deficits resulting from non-stroke pathology * inability to cooperate, follow instructions or provide consent
safety and efficacy of immages system in patients recieving iv therapy

Conditions: Sepsis; Bacteriemia; CHF

Summary: the study will evaluate the functionality of immages , an intravenous infusion device system, in patients hospitalized in bait balev hospital. the study will aim to determine how the immages system integrates within iv infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.

using the immages system in patients recieving iv therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.

Eligibility criteria:
inclusion criteria: * inclusion criteria: 1. patients requiring infusion therapy 2. patients receiving infusion therapy by gravity flow or by pump 3. patients are scheduled to receive at least once a day an infusion therapy 4. patients are scheduled to receive an infusion therapy for at least 3 days 5. adult over age of 18 years 6. informed consent form signed by patient. exclusion criteria: 1. informed consent form not signed 2. patients are scheduled to receive less than once a day an infusion therapy 3. patients to receive less than 3 days of infusion therapy 4. patients not hospitalized in a ward that is participating in the study. 5. patients participating in another clinical study or clinical field test 6. patients require isolation treatment
study of safety, tolerability, and pharmacokinetics of multiple ascending doses of regn3500 in adults with moderate asthma

Conditions: Asthma; Moderate Asthma

Summary: purpose of this study is to assess the safety and tolerability of multiple ascending subcutaneous doses of regn3500 to moderate asthmatics.


Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18 to 32 kg/m2 * a diagnosis of moderate asthma (according to gina 2015) for a period of at least 2 years prior to screening. * patient must use a stable medium daily dose level of inhaled corticosteroids (ics) as defined by gina guidelines, ie, total daily dose of ics \>400 μg and ≤800 μg/day of budesonide or equivalent for at least 1 month prior to screening and during the study * a pre-bronchodilator forced expiratory volume in the first sec (fev1) ≥60% and ≤90% of the predicted normal values at screening and pre-dose at screening * a documented positive response to the reversibility test at the screening, defined as improvement in fev1 ≥12% and ≥200 ml over baseline after 400 μg salbutamol pmdi * willing and able to comply with clinic visits and study-related procedures * provide signed informed consent. key exclusion criteria: * clinically significant abnormal cbc, clinical chemistry, and urine analysis at screening. * treatment with an investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to screening. * history of life-threatening asthma * occurrence of asthma exacerbations or respiratory tract infections within 4 weeks prior to screening. * diagnosis of any other airway/pulmonary disease such as chronic obstructive pulmonary disease (copd) as defined by the global initiative for chronic obstructive lung disease (gold) guidelines (gold 2016); or other lung diseases (eg, emphysema, idiopathic pulmonary fibrosis, churg-strauss syndrome, allergic bronchopulmonary aspergillosis cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency or restrictive lung disease). * chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 1 month prior to screening. * use of oral antibiotics/anti-infectives within 2 weeks prior to screening. * known sensitivity to doxycycline or tetracyclines, or to any of the components of the investigational product formulation. * recent (within the previous 2 months) bacterial, protozoal, viral, or parasite infection. * history of tuberculosis or systemic fungal diseases * patients treated with a monoclonal antibody based therapy (such as an anti-ige, anti-il-5), a biologic therapy or immunotherapy (subcutaneous immunotherapy \[scit\], sublingual immunotherapy \[slit\], or oral immunotherapy \[oit\]) in the previous 12 weeks prior to screening and during the study note: other protocol defined inclusion/exclusion criteria may apply
lamelleye for the treatment of dry eye symptoms in pss patients

Conditions: Dry Eye Syndromes; Primary Sjögren Syndrome

Summary: single-blind, randomised, single centre, 2-way crossover pilot study to investigate the effectiveness of lamelleye for the treatment of dry eye symptoms in patients with primary sjögren's syndrome.

the study is a 2-way crossover design comprising 2 treatments: the ce-marked lamelleye dry eye drops, and a ce-marked comparator product. all participants will be allocated to a treatment group in a random order. the study design allows observations to be made between the treatments at both an intra- and inter-patient level regarding relationships between the patient's disease specific quality of life, symptoms and adverse events, and satisfaction with treatments.

Eligibility criteria:
inclusion criteria: to be eligible for inclusion, each participant must meet each of the following: 1. male or female aged ≥ 18 years and ≤ 79 years at date of consent 2. primary sjögren's syndrome diagnosed by a rheumatologist 3. patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate trial of standard topical therapy 4. willing and able to attend glasgow caledonian university vision sciences eye clinic for therapy assessment; and to comply with all procedures and follow-up visits 5. participant must have personally given written informed consent to allow anonymised data to be used in publications and presentations. exclusion criteria: participants are excluded from the study if any of the following criteria are met: 1. females who are pregnant, planning pregnancy or breastfeeding 2. active ocular infection or current corneal ulceration 3. ocular surgery within 6 months of study start date 4. current contact lens wear 5. any prior and/or current topical ophthalmic treatments that in the opinion of the ci or pi may interfere with the study outcomes 6. started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, anticholinergics, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days prior to enrolment 7. participants with known allergies to ingredients in any of the study treatments, or fluorescein 8. participants who are judged inappropriate for inclusion in the study by the ci or pi.
al-15469a for the treatment of bacterial conjunctivitis

Conditions: Bacterial Conjunctivitis

Summary: the purpose of the study is to determine whether al-15469a is safe and effective in the treatment of bacterial conjunctivitis.


Eligibility criteria:
inclusion criteria: * signs and symptoms of bacterial conjunctivitis * other protocol-defined inclusion criteria may apply exclusion criteria: * under 1 mo. age * other protocol-defined exclusion criteria may apply
the use of the diary in neonatal pathology: a mixed-method study for collecting and analyzing the experience of parents and health care personnel.

Conditions: Experience, Life; Stress; Depression, Postpartum; Support, Family

Summary: the study is mixed-methods (qualitative + quantitative observational cross-sectional) and the aims are to explore the use of diaries by parents of newborns admitted to neonatal pathology and to describe some variables related to their experience during their children's hospitalization, such as: stress level, postpartum depression and perceived support. the diary that will be analyzed is already part of current clinical practice. study population: * parents of premature infants with gestational age less than or equal to 35 weeks and infants with birth weight less than or equal to 2kg admitted to neonatal pathology of san raffaele hospital. * health workers of the o.u. of neonatal pathology.


Eligibility criteria:
inclusion criteria: for the parents: * signed informed consent; * parents of premature infant with gestational age less than or equal to 35 gestational weeks and with birth weight less than or equal to 2kg. for healthcare providers: * healthcare personnel from the o.u. of neonatal pathology; * signed informed consent. exclusion criteria: for parents: * non-understanding or inability to express themselves in italian language; * parent of premature infant with gestational age greater than 35 gestational weeks and with birth weight greater than 2kg * unsigned informed consent. for health workers: * healthcare personnel not working in the o.u. of neonatal pathology; * unsigned informed consen
care of critically ill patients enteral nutrition guidelines for the implementation of the effectiveness of the intervention

Conditions: ICU Ill Patients; Enteral Nutrition Feeding

Summary: this study is to find out care of critically ill patients enteral nutrition guidelines for the implementation of the effectiveness of the intervention.


Eligibility criteria:
inclusion criteria: * icu patients elder than 18 years of age * (apache ii) score \> 15 * patients expected to remain in icu for more than 2 days exclusion criteria: * patients that have consented to a do-not-resuscitate document * patients not expected survive more than 2 days * patients that have returned to icu due to their condition worsening after previously leaving icu * patients that have transferred from icu of other hospitals.

Keywords: enteral nutrition feeding
quantification of respiratory-induced prostate motion

Conditions: Prostate Cancer

Summary: patient anatomy and position during the course of radiation therapy can vary from those used for treatment planning; a function of patient movement, uncertainty in positioning system, and organ motion. traditionally, treatment margins are designed to compensate for interfraction prostate setup variability. this approach has the potential to lower the overall effectiveness of treatment because the prostate gland is a continuously moving target whose motion cannot be accurately accounted for solely on the basis of interfraction movement. more recently, the dosimetric relevance of intra-fraction prostate motion has been recognized, and may be compensated for by continuous real-time adaptive radiation therapy afforded by the calypso 4d localization system™. in the current study, the investigators propose to characterize intrafraction prostate motion. the investigators hypothesize that intrafraction prostate motion is correlated with respiratory motion.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage i-iii adenocarcinoma of the prostate gland * age \> 18 years. males of all races and ethnic groups * scheduled to receive radiation for definitive therapy * three (3) electromagnetic transponders implanted into prostate gland exclusion criteria: * does not satisfy inclusion criteria

Keywords: prostate motion respiration
can proprioceptive knee brace improve functional outcome following tka?

Conditions: Knee Osteoarthritis

Summary: osteoarthritis is among the most prevalent form of degenerative joint disease in arthritis. the world health organisation identified osteoarthritis as one of the top ten most disabling cause of disease in developed countries, and the single most common cause of disability for elderly persons. in fact, worldwide statistics for men and women over 60 years of age with signs of symptomatic osteoarthritis are estimated to be at 9.6% and 18.0% respectively. in hong kong, the latest census revealed that 514,000 people suffer from degenerative arthritis, representing 0.7% of the population. although these values are much lower than the international figures reported by the who, it is inevitable that the prevalence of osteoarthritis will continue to rise with an increasing trend of obesity and an aging population in hong kong. similar to any other chronic disease with wide prevalence, the impact of osteoarthritis translates to a substantial socioeconomic burden on a societal level. total knee arthroplasty has become the gold standard to manage the pain and disability associated with end-stage arthritis who have exhausted all conservative measures. although contemporary advances in prosthesis design, surgical techniques, postoperative rehabilitation regimes have hasten patient's recovery, the restoration of proprioception and neuromuscular control is often prolonged despite solid rehabilitation regimes. knee bracing is one of the non-pharmacological modalities designed to evenly distribute load and provide proprioceptive feedbacks for those with knee injuries or knee pain. there are four categories of knee braces for the purpose of prophylactic, functional, rehabilitative and unloader/off-load. this study will mainly be focusing on the effects of the unloader/off-loader brace. previous studies have demonstrated the effects on alteration of kinematic variables, including range of movement (p=0.002), speed of walking (p\<0.001) and knee adduction moment (p=0.001) for knee injuries and osteoarthritis as a part of the conservative management protocol. however, there have few studies that investigated whether proprioceptive knee bracing has any role in functional recovery post total knee arthroplasty.


Eligibility criteria:
inclusion criteria: 1. adult (age over 18 years old) underwent total knee arthroplasty within 2 to 4 weeks; 2. adult who is able to provide written consent and compliance with treatment and assessment regime exclusion criteria: 1. patients with disabilities, wheelchair dependence for mobility; 2. underwent revision total knee arthroplasty; 3. found with complication wounds following surgery; 4. diagnosed with comorbidities e.g. inflammatory arthritis, obesity, dermatological disorders that might affect their compliance to treatment; 5. do not fit to the sizes of knee braces; 6. not to given written consent and be non-compliance with the treatment and assessment regime

Keywords: knee brace knee oa proprioceptive knee brace knee osteoarthritis