Kornimate/medical-research-clean huggingface dataset:
the effects of educational program using app on pre-discharge knowledge, skills and anxiety of wound care

Conditions: Wound

Summary: the purposes of this study were to understand the effects of mhealth app on wound care knowledge, wound care skills, and anxiety related to dressing change when compared to traditional health education before patients discharged from hospital.

1. research design: this study employed a single-blind experimental design. study participants were randomized into the experimental and control groups. participants in the experimental group used the mhealth app as intervention while those in the control group received normal verbal instructions. the levels of wound care knowledge, skills, and anxiety related to dressing change in the two groups were compared before intervention (t1), after intervention (t2), and before discharge (t3). 2. study setting \& samples: the recruitment site of this study was conducted in a plastic surgery ward at a 1500-bed university hospital located in southern of taiwan. samples were recruited either hospitalized patients or their primary caregivers from march to december 2016. inclusion criteria were of taiwanese nationality, were aged 20 years and above, had a wound classification score of 6-10 points according to strauss (2000), required self-care of wound at home, and had a habit of using smartphones. exclusion criteria included special care conditions, such as (1) other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures) and (2) being a special patient, such as one with mental illness. sample estimation based on the f test of manova statistics was carried out using the g power 3.1 software. each group had at least 31 samples (effect size = 0.25, ∝ = 0.05, power = 0.85). a total of 76 participants satisfied the inclusion criteria for this study. there were 6 patients who were not willing to participate in this study; therefore, 35 participants were randomized enrolled in each of the experimental and control groups.

Eligibility criteria:
inclusion criteria: * aged 20 years and above. * wound classification score of 6-10 points according to strauss (2000). * required wound self-care at home or care by their primary caregivers. * had a habit of using smartphones. exclusion criteria: * other comorbidities (such as severe infection or severe compression injuries with comorbid open fractures). * being a special patient, such as one with mental illness.
effect of extracorporeal shock wave therapy after arthroscopic rotator cuff repair

Conditions: Rotator Cuff Injuries; Pain, Postoperative; Tissue Adhesion

Summary: although radial extracorporeal shock wave therapy (reswt) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. there are no studies using reswt in rehabilitation after arthroscopic rotator cuff repair (arcr). therefore, in this study, there is evidence that reswt promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with reswt during the intensive rehabilitation period of patients after arcr is more effective in controlling pain.


Eligibility criteria:
inclusion criteria: * adults over 18 years old * in case of 6 weeks after receiving arthroscopic rotator cuff repair * when the participants wishes to enroll in the study exclusion criteria: * 65 years old or older * if the tear area is large and augmentation is performed * if there is a previous surgical history at the surgical site * osteoarthritis in the shoulder joint
anti-thymocyte globulins for graft-versus-host disease prophylaxis

Conditions: Leukemia, GVHD, ATG, Transplantation

Summary: age is a risk factor for graft-versus-host disease (gvhd) after human leukocyte antigen (hla)-matched sibling allogeneic stem cell transplantation (allo-sct). the incidence of acute gvhd is significantly higher in patients at 40 years of age or more than those at 18 to 39 years of age after allo-sct. it was found that anti-thymocyte globulins can be used for prophylaxis of both acute and chronic gvhd after allo-sct.prophylaxis of gvhd using atg in patients at 40 years of age or more in matched sibling allo-sct settings might significantly decrease the incidence of acute and chronic gvhd and the incidence of late effect after transplantation.

prophylaxis for gvhd included csa, mtx and mmf±atg. in the trial group, csa was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment. the dosage was adjusted to maintain a trough blood level of 200-300ng/ml. mmf was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation. the dosage of mtx was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation. atg (thymoglobulin 2.5mg/kg per day i.v.) on days -2 through -1. in the control group, csa was started intravenously on day -1, at the dosage of 3 mg/kg, and switched to oral formulation as soon as the patient was able to take medication after engraftment. the dosage was adjusted to maintain a trough blood level of 200-300ng/ml. mmf was administered orally, 0.25g every 12 hours, from day -1 before transplantation to day 30 after transplantation. the dosage of mtx was 15 mg/m2, administered i.v. on day 1, and 10 mg/m2 on days 3, 6, and 11 after transplantation.

Eligibility criteria:
inclusion criteria: * standard-risk of recipients with hematological malignancies (including aml-cr1, all-cr1, cml-cp, mds-ra, rars,rcmd,raeb-1); age from 40 to 60; having hla-matched sibling donor; eastern cooperative oncology group (ecog)≤1, ejection fraction (ef)≥50%; bilirubin≤35µmol/l; ast, and alt lower than or equall to two-fold baseline;creatinie≤130µmol/l. exclusion criteria: * active, uncontrolled infection; severe allergy to atg, including shock or laryngeal edema; secondary stem cell transplant recipient; haplidentical recipients; matched unrelated donor recipients; non-myeloablative condioning regimen recipients; ef\ 35µmol/l; ast, and alt higher than two-fold baseline; creatinie\>130µmol/l.
infliximab and methotrexate in ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: there is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (as). moreover, some patients have a treatment with methotrexate (mtx), others have not. thus, the aim of this study is to assess the effect of mtx on the pharmacokinetic properties of infliximab in 30 patients treated for as, 15 with mtx, 15 without.


Eligibility criteria:
inclusion criteria: * ankylosing spondylitis * needing anti-tnf drugs exclusion criteria: * contra-indications to anti-tnf drugs
sodium fluorescein-guided resection of pediatric neurosurgical tumors

Conditions: Pediatric Neurosurgical Tumors

Summary: sodium fluorescein, which has been shown to be useful for intraoperative guidance regarding the resection of adult neurosurgical tumors, can aid the resection of pediatric neurosurgical tumors.

this study will be a prospective non-randomized cohort study with patients presenting to children's hospital colorado for resection of a central nervous system tumor. this study will employ the use of sodium fluorescein and an fda approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast. fluorescein sodium is a small organic salt that accumulates in areas of diminished blood-brain barrier integrity and allows for determination of the margins between tumor and normal brain function.

Eligibility criteria:
inclusion criteria: * age 31 days through 21 years on date of surgery * undergoing resection of a central nervous system tumor at children's hospital colorado * parent/legal guardian (or adult subject) willing and able to complete the informed consent process exclusion criteria: * tumor in functionally eloquent cortex that precludes maximal surgical resection * severe renal dysfunction * preoperative serum creatinine level \> than normal range and gfr \< 30. * severe liver dysfunction * history of asthma or pulmonary spasm * known allergy to sodium fluorescein or any other contrast dye * previous administration of sodium fluorescein within the last 72 hours * pregnant or nursing mother * other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.

Keywords: sodium fluorescein surgical microscope central nervous system tumors
extension study of ataluren in participants with nonsense mutation cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is an open-label extension study for participants who completed a phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmcf) not receiving chronic inhaled aminoglycosides.

the primary objective of this phase 3 extension study will be to obtain long-term safety data to augment the overall safety database. the secondary objectives will be to augment the efficacy data collected in the double-blind study (ptc124-gd-021-cf; nct02139306).

Eligibility criteria:
inclusion criteria: * completion of study treatment (placebo or active) in the previous phase 3, double-blind study protocol (protocol ptc124-gd-021-cf) * evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or the participant's parent/legal guardian) has been informed of all pertinent aspects of the trial. exclusion criteria: * known hypersensitivity to any of the ingredients or excipients of the study drug. * ongoing participation in any other therapeutic clinical trial.
hookworm immune regulation project

Conditions: Hookworm Infection

Summary: the main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected vietnamese rural population from the periphery of hcm, evolution after infection treatment and during potential naturally reinfection.

population: 20 healthy adults (18-65 years) infected and non infected by hookworm will be recruited and treated according to good clinical practice recommendations. allergy will be excluded by skin prick tests. amount and phenotype of treg will be explored at several time points. subsequent culture with environmental antigen will be performed on cryopreserved cells.

Eligibility criteria:
inclusion criteria: * 18-65 years old adults in good health status * to live in rural regions at risk of soil transmitted helminthes * hookworm infection (infected group) * uninfected by hookworms (control group) exclusion criteria: * pregnant woman * positive allergic history * auto-immune and/or hiv disease * antihelminthics drug in the last 6 months and other current parasitic infection

Keywords: hookworm helminths treg immune regulation vietnam allergic diseases
prevalence of antimicrobial-resistant pathogens in patients admitted for utis

Conditions: Urinary Tract Infections; Urosepsis

Summary: between 2013-2014, our study network of u.s. emergency departments, emergency id net, found that the rate of fluoroquinolone-resistant e. coli was 11.7% among all patients, 6.3% in uncomplicated and 19.9% in complicated. esbl-producing enterobacteriaceae were found in 7.7% of all cases, 2.6% in uncomplicated and 12.2% in complicated. more recently, enterobactericeae and gram-negative non fermenting bacteria have started to show resistance to carbapenems (cres and cr-nf). patients hospitalized with uti and urosepsis represent a higher risk population for infections due to multi-drug resistant bacteria and experience serious adverse outcomes, including death. emergency id net will conduct a study to determine the prevalence of esbl-producing, cres and cr-nfs among this high risk population of patients admitted for uti from u.s. emergency departments.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to 18 years; 2. admitted to the hospital through the ed; 3. primary reason for admission is treatment of uti with or without sepsis (i.e., ed diagnosis of uti and/or sepsis); and 4. provide verbal or written consent to participate in the study or if patient is unable to provide consent (e.g., altered mental status), consent obtained from a legal authorized representative. exclusion criteria: * patients will be later excluded if : 1. they are unable to provide a urine specimen for culture; or 2. their urine culture yields no growth or is contaminated (see definition of positive urine culture below). note: if participant's urine culture is contaminated but their blood culture is positive for a uropathogen, they will not be excluded.
non-interventional study with vinorelbine oral in advanced non-small cell lung carcinoma(nsclc) and metastatic breast cancer (mbc)

Conditions: Non Small Cell Lung Carcinoma; Metastatic Breast Cancer

Summary: the purpose of this non-interventional study is to collect data on efficacy and toxicity of the use of navelbine oral in daily routine in germany (especially after availability of an 80mg capsule). the study focusses on concomitant antiemetic therapy and patient compliance.


Eligibility criteria:
inclusion criteria: * at least 18 years old * male and female patients * advanced nsclc (stage iii or iv) or antracycline-resistant mbc * therapy with navelbine capsules in any palliative treatment line * signed patient informed consent exclusion criteria: * pregnancy and nursing * all other exclusion criteria listed in spc (summary of product characteristics) * lack of signed patient informed consent

Keywords: nsclc non small cell lung carcinoma metastatic breast cancer mbc advanced breast cancer navelbine navelbine-oral vinorelbine vinorelbine-oral daily routine concomitant antiemetic therapy patient compliance germany non-interventional study oral anti cancer therapy quality of life
an observational study on the safety and tolerability of prolonged thrombosis prophylaxis with fragmin®

Conditions: Venous Thromboembolism

Summary: the objective of this study is to observe the safety, tolerability, and compliance in the use of fragmin® for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.

all patients prescribed fragmin® (dalteparin sodium) for prolonged thromboprophylaxis will be eligible for study

Eligibility criteria:
inclusion criteria: * male or female patient, undergoing major orthopedic surgery * at least 18 years old exclusion criteria: * hypersensitivity to fragmin or other low molecular weight heparins or unfractioned heparin; * history of heparin induced thrombocytopaenia type ii * acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage. * serious coagulation disorder; * septic endocarditis; * injuries to and operations in the central nervous system, eye and ear within one month before orthopaedic surgery; * spinal or epidural anesthesia or other procedures requiring spinal puncture and concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and unstable coronary artery disease); * patients with serum creatinine level \> 150 umol/l; * platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy; * high probability that patient will not return to the centre for follow-up; * patient on oral anticoagulation therapy in the last 7 days; * ongoing anticoagulant therapy with other medications or non-pharmacologic therapy during the study period; * weight less than 40 kg; * simultaneous participation in another pharmacological study or receiving any investigational drug 30 days or less before surgery; * pregnancy or breastfeeding; * clinically significant hepatic dysfunction.

Keywords: observational prolonged thromboprophylaxis
metabolic imaging for diagnosis and prognostication of autoimmune encephalitis

Conditions: Paraneoplastic Neurological Syndrome; Autoimmune Encephalitis

Summary: autoimmune encephalitis (ae) is a rare neurological disorder mediated by autoimmune antibody response against neuronal cell surface and intraneuronal proteins associated with specific brain areas, resulting in severe inflammation and damage in the associated brain regions, all most frequently manifesting diverse cognition and memory impairment symptoms at follow-up. however, these symptoms may co-exist or mimic other cns autoimmune and neurodegenerative disorders. the most common guideline for diagnosing autoimmune encephalitis relies on cerebrospinal fluid (csf) antibody testing which might take several weeks to obtain, making it not optimal for the early diagnosis of ae. as for magnetic resonance imaging (mri), which is the most common imaging tool utilized for aiding in the diagnosis of ae, can possess several limitations as some patients, like anti-nmdar ae patients, can present memory and behavioral deficits even in the presence of normal brain mri. positron emission tomography (pet) with 2-deoxy-2-\[fluorine-18\] fluoro-d-glucose (18f-fdg) have been addressed by several studies as an important examination for the early diagnosis of ae . one study demonstrated that the fraction of having an abnormal mri in ae patients is lower than having an abnormal pet, by which certain pet patterns were associated with autoantibody types of ae. moreover, one report demonstrated that even with autoantibody negative test and normal brain mri, fdg-pet examination showed abnormal hypometabolism and hypermetabolism patterns. more specifically, these distinct patterns include medial temporal and striatal hypermetabolism with cortical diffuse hypometabolism. leiris et al. revealed that the methadology used for the analysis of these pet images is highly variable, especially intensity normalization methods, where most possess some limitations (e.g., proportional scaling) as they can impede the accurate differential diagnosis of autoimmune encephalitis (ae) by potentially indicating false hypermetabolism in otherwise preserved brain regions. absolute quantification is not possible since the disease presents both diffuse hypometabolism and hypermetabolism on pet images. so, they suggested that it's best to parametrize the brain's activity by dividing it by that of the striatum. their voxel-based analysis, comparing individuals with ae to both healthy subjects and those with mild cognitive impairment (mci), demonstrated that a decrease in the cortex/striatal metabolic ratio is a robust biomarker for the early diagnosis of ae.


Eligibility criteria:
inclusion criteria: * patient with positivity of auto-antibody in csf * patient \>18 years old * patient with auto-immune encephalitis or paraneoplastic neurological syndrome exclusion criteria: - patient without data

Keywords: paraneoplastic neurological disorders autoimmune encephalitis auto-antibodies pet-scan
histology vabb-histology post surgery pilot project (betty trial)

Conditions: Breast Cancer

Summary: pilot study on patients with invasive ductal breast cancer triple negative or receptor tyrosine-protein kinase erbb-2 (her2) overexpressed, any axillary lymphnodes status (any cn), candidates to neoadjuvant chemotherapy. the principal endpoint of the study will be the accuracy of the result of the histological examination of the vacuum- assisted breast biopsy (vabb) performed pre-surgery in comparison to the result of the histological examination of the definitive surgical intervention in patients with radiological complete response at magnetic resonance imaging (mri) done after the end of neoadjuvant chemotherapy.

the study articulates in five phases: phase one: acquisition of the informed consent followed by positioning a clip into the cancer bed (by radiologist) if not already present; phase two: after radiological confirmation of pathological complete response (pcr) done performing breast ultrasound, mri and 18f-2-fluoro-2-deoxy-d-glucose fluorodeoxyglucose positron emission tomography (18-fdg-pet) after neoadjuvant chemotherapy the patient becomes candidate to vabb pre surgery. phase three: the patient has vabb within 15 day from the term of neoadjuvant chemotherapy phase four: definitive surgical intervention within 30 days from the end of the neoadjuvant chemotherapy phase five: verification of correspondence between histology of vabb and definitive histology. the study hypothesis is that vabb could be used in the patients with pcr to the imaging post-neoadjuvant chemotherapy to confirm sensibility and specificity of 18 fdg tc pet and breast mri to show the absence of breast cancer. the use of vabb with negative histology result could bring to a therapeutic gold standard without over surgical treatment

Eligibility criteria:
inclusion criteria: * age ≥ 18 aa; * histological diagnosis done at european institute of oncology (if not, to does revision of pathological material); * invasive ductal breast cancer triple negative or her2 overexpressed, any cn; * neoadjuvant standard systemic treatment after surgery +/- trastuzumab; * propose of conservative or demolitive surgery; * m0 * cancer bed identified pre neoadjuvant chemotherapy by clip exclusion criteria: * multicentric or bilateral breast cancer * mammography microcalcifications * in situ breast carcinoma * positive anamnesis for previous breast cancer * positive anamnesis for medical or psychological conditions that prevent membership study

Keywords: breast cancer vacuum assisted breast biopsy
the effectiveness and safety of acupuncture for elderly patients of stroke

Conditions: Stroke

Summary: stroke and its sequelae are a major indication for acupuncture. the specific aims of this study are to assess the feasibility of pragmatic clinical trial on acupuncture in primary care setting and evaluate the effectiveness and safety of acupuncture for stroke rehabilitation in hong kong.

the study will help to develop ap treatment patterns for stroke rehabilitation of elderly patients in hong kong. the specific aims of this study are to assess the feasibility of pragmatic clinical trial on acupuncture in primary care setting and evaluate the effectiveness and safety of acupuncture for stroke rehabilitation on motor, sensation, speech, swallowing, cognitive, and other neurological functions. this study includs 2-week run-in, 24-week treatment, 12-week follow up and 9 visits at week 0, 2, 6, 10, 14, 18, 22, 26 and 38. the investigator will recruit totally 500 patients fulfiling the eligibility criteria in four neighbourhood elderly centres of the hong kong sheng kung hui welfare council and chinese medicine clinics of hong kong baptist university. acupuncture treatment will be applied to the patients and seven visits will be arranged within the 24-wk treatment period providing medical consultation and recording improvement and any adverse effect.

Eligibility criteria:
inclusion criteria: - participants who meet the following criteria will be included: (1) 35\~90 years or older; (2) discharged from hospital; (3) diagnosed with cerebral hemorrhage or cerebral infarction through brain computed tomography (ct) or magnetic resonance imaging (mri); (4) stable vital signs; and (5) voluntary participation with informed consents signed in this study. exclusion criteria: - the following participants are excluded: (1) patients with unconsciousness, aphasia, and cognitive dysfunction (mini-mental state examination-korean version (mmse-k) \<24); (2) those with a past history of brain disease (e.g., mental illness, consciousness disorder due to head trauma, previous brain surgery, or spastic disease); (3) those with severe heart, liver, or kidney disease or bleeding disorders; (4) those with other serious diseases (e.g., cancer, dementia (alzheimer's disease or dementia of lewy body), parkinson's disease, and parkinson's syndrome); (5) those who participated in other clinical trials within last three months; (6) those with needle phobia; and (7) pregnant or lactating female patients.

Keywords: stroke chinese medicine acupuncture