Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of anbainuo in chinese patients with ra/as in the real world

Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis

Summary: tnf- α receptor inhibitors have been used widely in practice and are well developed in china. anbainuo is a bio-similar recombinant tnf-α receptor: igg fc fusion protein, approved in 2015. up to now, anbainuo is well applied in patients with rheumatoid arthritis (ra) or ankylosing spondylitis (as). although the phase ii and iii clinical trials both indicated that anbainuo can effectively control the disease activity with good tolerance and safety in ra and as patients, there is no sufficient clinical evidence in the real world. thus, the objective of this study is to evaluate, under the actual conditions of use, dosing patterns of anbainuo. investigators plan to recruit 1000 adult patients with ra or as and to follow them for 48 weeks. it is hypothesized that this study would reflect real clinical conditions (efficacy and safety assessment) of using anbainuo in ra and as patients.


Eligibility criteria:
inclusion criteria: * meet the diagnostic criteria of the american college of rheumatology (acr) (1987); * or meet the diagnostic criteria of ankylosing spondylitis (new york, modified in 1984); * older than 18; * prepare to or already start to use anbainuo. exclusion criteria: * any acute or chronic infection or the history of active tuberculosis * pregnant women or breast feeding women; * malignant tumor; * moderate to severe congestive heart failure (new york heart association, 3-4 grade); * allergic to anbainuo.
glutamine role in preventing vaso-occlusive crisis among scd patients

Conditions: Sickle Cell Disease

Summary: prospective phase iv interventional open label randomized controlled trial to assess safety and efficacy of glutamine in preventing vaso-occlusive crisis (voc) episodes in sickle cell pediatrics and adolescents' patients

vaso-occlusive crisis (voc) episodes are considered to be the cause of 95% of hospitalizations for sickle cell disease (scd) patients. prior studies have described pain management in scd patients with poor outcomes in the short term and decreased quality of life in patients over the long term. although that l-glutamine has been recently approved by the fda for the prevention of acute complications in sickle cell disease. however, there are many gaps in our understanding of its therapeutic implications in scd. this study will assess the safety and efficacy of glutamine in preventing vaso-occlusive crisis (voc) episodes in sickle cell pediatrics and adolescents' patients

Eligibility criteria:
inclusion criteria: children and adolescents diagnosed with sickle cell disease by haemoglobin electrophoresis and had at least two pain crises (no upper limit) documented during the previous year; a pain crisis is defined as pain leading to treatment with a parenteral administered narcotic or ketolac in an emergency department (ed) (or outpatient treatment centre) or during hospitalization. patients receiving hydroxyurea at a fixed dose for at least 3 months before screening. exclusion criteria: patients with sickle cell trait and other hemoglobinopathy. -

Keywords: glutamine, vasooclussive crisis, sickle cell disease, egypt
study of nebulized ampion for the treatment of adult covid-19 patients with respiratory distress

Conditions: Covid19

Summary: this is a phase 1 randomized study to evaluate the safety, tolerability and efficacy of nebulized ampion in improving the clinical course and outcomes of patients hospitalized with covid-19 infection who have respiratory distress.


Eligibility criteria:
inclusion criteria: 1. male or female, ≥ 18 years old. 2. diagnosed with covid-19, as evaluated by pcr test confirming infection with sars-cov-2, or suspected covid-19 diagnosis based on radiological clinical findings. 3. respiratory distress as evidenced by at least two of the following: * radiographic infiltrates by imaging (chest x-ray, ct scan, etc.) * recording of spo2 ≤ 90% or the patient is requiring supplemental oxygen to maintain an spo2 ≥ 90% * requiring supplemental oxygen * diagnosis of mild, moderate, or severe ards by berlin definition 4. a signed informed consent form from the patient or the patient's legal representative must be available. exclusion criteria: 1. in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. 2. patient has a do-not-resuscitate (dnr) or do-not-intubate (dni) order in place 3. patient has severe chronic obstructive pulmonary disease (copd), chronic renal failure, or significant liver abnormality (e.g. cirrhosis, transplant, etc.). 4. patient is on chronic immunosuppressive medication. 5. as a result of the medical review and screening investigation, the principal investigator considers the patient unfit for the study. 6. a history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or excipients in 5% human albumin (n-acetyltryptophan, sodium caprylate). 7. patient has known pregnancy or is currently breastfeeding. 8. participation in another clinical trial (not including treatments for covid-19 as approved by the fda through expanded access or compassionate use). 9. baseline qt prolongation.
nurse intervention project

Conditions: Breast Cancer Patients

Summary: the use of interventions for cancer-related distress is important to reduce this distress. distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. there is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the netherlands. a task force discussed and studied which instrument measures psychosocial problems best. the distress thermometer ("lastmeter") had the best results. a guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the netherlands. however, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. the study focuses on the use of the distress thermometer in breast cancer patients. an efficiency study (rct) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. the clinical and economic impact of the use of the distress thermometer will be assessed in comparison with usual care.the recruitment of patients will take place in the out-patient clinic of a university hospital. patients will be followed from diagnose until two years after finishing their treatment.


Eligibility criteria:
inclusion criteria: * histologically proven malignancy of the breast * curative treatment * dominated the dutch language * age \> 18 year exclusion criteria: * previously treated for a malignancy * psychiatric problems that adherence this study
ipad application-based intervention for post-stroke depression

Conditions: Post-stroke Depression

Summary: we plan to conduct a randomized controlled trial to examine whether usual rehabilitation plus an ipad application-based intervention improves post-stroke depression symptoms compared to usual rehabilitation alone. the purpose of this pilot randomized controlled trial is to investigate the feasibility of the final randomized controlled trial.


Eligibility criteria:
inclusion criteria: * 40 years and older * males and females * center for epidemiologic studies depression scale score ≥16 * mini mental state examination score ≥ 24 * first stroke * native language is japanese * written informed consent prior to participation exclusion criteria: * major depressive disorder before onset of stroke * bilateral hemiplegia * vision or hearing deficits that negatively impact everyday life * severe aphasia * severe unilateral spatial neglect * diagnosis of neurodegenerative disease such as parkinson's disease or multiple system atrophy * current life-threatening severe organ failure, musculoskeletal disorders, or cancer
comparison of two different golimumab dosing regimens for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. the current dosing regimen in european union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with \<80 kg 50 mg q4 weeks. the investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

partial response or loss of response to golimumab is observed in a significant proportion of patients started on golimumab for active ulcerative colitis. the current dosing regimen in european union is based on patients' body weight as maintenance treatment for patients with ≥ 80 kg is 100 mg q4 weeks and for patients with \<80 kg 50 mg q4 weeks. the investigators recent observations in a golimumab pharmacokinetics study of 24 patients however, show large interindividual variations in golimumab trough concentrations. furthermore, it seems that patients with continuous response have higher golimumab trough levels at several time points during treatment compared to patients who lose response. higher induction/maintenance dose of golimumab increases golimumab trough levels, therefore it is likely that higher induction/maintenance dose of golimumab would increase efficacy of golimumab treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed ulcerative colitis exclusion criteria: * active tuberculosis or other opportunistic bacterial, viral and fungal infections * history of moderate to severe heart failure (nyha iii/iv), and potential risk of congestive heart failure * pregnancy * history of allergic reactions to sorbitol (e420), l-histidine, l-histidine monohydrochloride monohydrate, polysorbate80, water for injections.

Keywords: pharmacokinetics pharmacodynamics safety golimumab reactive dose optimisation proactive dose optimisation golimumab concentration mucosal healing therapeutic drug monitoring inflammatory bowel disease personalized medicine comparisons of european with us label
clinical study investigating the effect of sodium nitroprusside infusion on thyroidal function

Conditions: Nitroprusside; Thyroid Hormones

Summary: whether use of snp during cardiac surgery has any effect on thyroid function has not yet been investigated in humans. the aim of this study was to investigate the effects of snp administration during the rewarming period of cardiac operations on circulating levels of thyroid hormones.


Eligibility criteria:
inclusion criteria: patients without history of: * thyroidal disease * hypertension * pulmonary disease * peripheral vascular disease * stroke * recent myocardial infarction within the week prior to operation * unstable angina pectoris * liver or kidney dysfunction * morbid obesity * cachexia * sulfonylurea intake exclusion criteria: * patients who needed positive inotropic pharmacologic support during or after the operation * patients who developed atrial fibrillation in the post operative period requiring amiodarone therapy * in addition, patients receiving any medication known to interfere with any step of thyroid hormone metabolism such as * amiodarone * propranolol * furosemide * non-steroidal anti-inflammatory agents * steroids * estrogens * antacids * diphenylhydantoin * spironolactone

Keywords: sodium nitroprusside thyroid hormones thoracic surgery
investigation of genomic alteration in patients with luminal a or luminal b subtypes

Conditions: Breast Cancer

Summary: this is a translational study in patients with operated early breast cancer of luminal a or luminal b sub types.the hellenic cooperative oncology group (hecog) has designed an observational biomarker-driven study in patients with luminal a or luminal b breast cancer, with the aim to collect valuable biological material from these patients and investigate biomarkers with potential prognostic value.

the he10a/13 study is an observational study of the hellenic cooperative oncology group (hecog). its main purpose is the collection of biological material from patients in search of prognostic / predictive biomarkers. each patient signed an informed consent for the provision of biologic material for future research purposes. the study was conducted in accordance with the declaration of helsinki. the clinical and translational protocol has been approved by the hellenic cooperative oncology group scientific committee and is under review by the institutional review board of metropolitan hospital. patients exclusively with luminal a or luminal b (estrogen receptors (er)-positive with or without progesterone receptors (pgr) positive, her-negative) breast cancer who received adjuvant chemotherapy with positive lymph nodes or node-negative with tumor stage or pathological features according to saint gallen guidelines suggesting high-risk or when genomic testing determined in favor of adjuvant chemotherapy are eligible for registration in the study. before registration to the study, each patient signed an informed consent for the provision of biologic material for research purposes. potential biomarkers will be examined using in situ or molecular methods in formalin fixed paraffin embedded (ffpe) tumor sections. for tumor subtyping immunohistochemistry for er, pgr, her2, ki67 and fluorescence in situ hybridization (fish) will be performed where needed for the assessment of her2 status; for epidermal growth factor receptor (egfr) and ck5 for the classification of basal-like tumors; and, the expression of cd8, cd3 and foxp3 on (tumor- infiltrating lymphocytes (tils) will also be evaluated. moreover, will be evaluated the mutational profile, including actionable genomic alterations, and the immune response -related profile of greek women with breast cancer, via the application of dna/rna next generation sequencing (ngs) technologies, relative also to patient outcome.

Eligibility criteria:
inclusion criteria: * 18 years old or older * luminal a breast cancer sub type * luminal b breast cancer sub type * positive lymph nodes * node- negative with tumor stage or pathological features according to saint gallen guidelines. exclusion criteria: -

Keywords: early breast cancer luminal a breast cancer luminal b breast cancer operated breast cancer
tolerance of cereals for atopic children

Conditions: Allergy

Summary: in this study, non allergenic cereals will be tested in infants with atopic symptoms. the test will be performed in a hospital.

in the majority of food allergy cases, an exclusion diet results in regression of clinical symptoms but this diet may not be nutritionally complete. to feed a baby who has a food allergy, we want a food with low allergenic ingredients. for this reason, a complete cereal has been specially developed and formulated for the weaning period of infants and young children suffering from milk, soy or wheat protein allergy or hypersensitivity due to celiac disease. it allows a smooth transition into and through the weaning period. the ingredients of this product are all from vegetable sources and it is therefore suitable for a vegetarian diet. it has been commercialised for many years and has proved to be completely safe, however so far no study has been specifically designed and powered to assess tolerance of this product in infants with atopic symptoms. in this study we are testing the tolerance (symptoms stability) of non allergenic cereals during an open allergenic test in infants with atopic symptoms and/or positive skin prick test (spt) or positive specific rast-ige or positive patch test. we are also testing the same product containing an additional ingredient with a potential effect in allergy management. such complete cereals is a very good option for allergic children in comparison to an exclusion diet that may not be nutritionally complete.

Eligibility criteria:
inclusion criteria: * infant aged from 4 to 40 months at the time of enrolment * with atopic symptoms and/or positive skin prick test (spt) or positive specific rast-ige or positive patch test * infants who received a specific elimination oligoallergenic diet from the study site for at least 5 days before the day of enrolment * having obtained his/her signed legal representative's informed consent exclusion criteria: * infant on systemic drugs (e.g. antihistamines) according to half-life at time of enrolment * congenital illness or malformation that may affect normal growth (especially immunodeficiency) * infant whose parents / caregivers cannot be expected to comply with treatment. * infant currently participating in another interventional clinical trial

Keywords: weaning cereals allergy atopy open allergenic test
intervention for substance use and sexual risk behavior in homeless youth

Conditions: Substance Use; Unprotected Sex

Summary: this study will evaluate a program called aware, which is a voluntary four session group-based motivational interviewing (mi) intervention to reduce substance use and sexual risk behavior among 18-25 year olds who are experiencing homelessness. the hypothesis is that participants who receive aware will show greater reductions in substance use and sexual risk behavior over a 12 month period compared to participants who do not receive the program.


Eligibility criteria:
inclusion criteria: * age 18 to 25; seeking services at one of the participating drop-in centers; no cognitive impairment observed during the screening process; planning to be in the study area for the next month; has either an email account or cell phone where they can be reached; and english speaking. exclusion criteria: -
effect of pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in parkinson's patients

Conditions: Parkinson Disease; Pilates; Muscle Function

Summary: in this study, it is aimed to investigate the effect of pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in parkinson's patients.

objective: in this study, it is aimed to investigate the effect of pilates application on abdominal muscle function, core stability, musculoskeletal pain, quality of life, anxiety and depression in parkinson's patients. method: the study included 15 idiopathic parkinson's patients over 18 years of age, under stage 3 according to the hoehn-yahr clinical staging. patients were divided into intervention and control groups. pilates training was performed for 6 weeks, twice a week and 60 minutes per session in intervention group. demographic features will be questioned and recorded in the data recording form through mutual interview in patients who meet the inclusion criteria; evaluations will be made regarding muscle thickness and pain. all patients will be evaluated before treatment, after treatment, at the 3rd and 6th months.

Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease * must be older 18 years old * must have 24 and above score on mini mental test * must be the third or lower stage according to the hoehn-yahr staging * must have stable clinical status exclusion criteria: * musculoskeletal or cognitive impairment at a level affecting evaluation and treatment * other neurological disease
a study of subcutaneous mircera for the treatment of anemia in pre-dialysis participants with chronic kidney disease.

Conditions: Anemia

Summary: this single arm study will assess the efficacy and safety of subcutaneous mircera for correction of anemia in participants with chronic kidney disease who are not on dialysis and are not treated with erythropoiesis-stimulating agents (esa). eligible participants will receive mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram \[mcg/kg\]). the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * chronic kidney disease, stage 3 or 4; * anemia (baseline hemoglobin between 9 and 11 grams per deciliter \[g/dl\]). exclusion criteria: * previous therapy with esa within 12 weeks prior to screening; * significant acute or chronic bleeding such as overt gastrointestinal bleeding; * red blood cell transfusions within 8 weeks before screening; * active malignant disease (except non-melanoma skin cancer).
effects of inspiratory muscle training on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: it is extensively reported in the literature that patients with chronic obstructive lung disease may have impairments in balance and postural control which further increase the disease burden. mechanisms related to these impairments include, but are not limited to increased work of breathing, diaphragm weakness, peripheral muscle weakness and systemic inflammation. since the similar symptoms are reported for the children with cystic fibrosis, it is hypothesized that balance and postural control may also be compromised in these patients. inspiratory muscle training (imt) is shown to improve diaphragm strength and pulmonary function. considering the relation between diaphragm which is one of the core muscles, and balance, imt may also have an impact on postural control and balance alongside the standard clinical parameters such as respiratory muscle strength, pulmonary function and functional capacity in these patients. thus, the aim of this study was to investigate the effects of inspiratory muscle training and conventional chest physiotherapy on postural stability, balance, pulmonary function and functional capacity in children with cystic fibrosis.


Eligibility criteria:
inclusion criteria: * cystic fibrosis diagnosis * stable clinical condition (no exacerbation in last 4 weeks) exclusion criteria: * documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility * subjects previously involved in exercise training or physiotherapy programs

Keywords: cystic fibrosis inspiratory muscle training chest physiotherapy balance postural stability pulmonary function test 6-minute walk test