Kornimate/medical-research-clean huggingface dataset:
clinical follow-up study of rituximab in the treatment of nephrotic syndrome in children

Conditions: Nephrotic Syndrome; Rituximab; Children; Efficacy

Summary: this was a retrospective study. children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (rtx) and followed up for ≥1 year in the department of pediatrics, the first affiliated hospital of xiamen university from march 2020 to march 2026 were enrolled. personal information, past medical history, clinical examination data and follow-up data before and after the use of rtx were extracted from the medical record system. (1) the median relapse-free survival, the number of relapses and the adverse reactions of rtx were compared before and after rtx treatment, and the clinical efficacy and safety of rtx were evaluated. (2) by comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, b cell reconstitution and adverse drug reactions between prophylactic rtx and post-relapse rtx maintenance regimens; (3) multivariate analysis of risk factors for recurrence of nephropathy after rtx treatment. (4) growth indicators monitoring patient evaluation and rtx medical economic benefit analysis.


Eligibility criteria:
inclusion criteria: * children clinically diagnosed with frns/sdns/srns with complete clinical data; * age \< 18 years old; * for the first time using rtx treatment, and used in nephrotic syndrome ease; * the follow-up for 1 year or more. exclusion criteria: * congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, iga nephropathy, purpura nephritis, hepatitis b nephritis, etc.); * active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases; * estimated glomerular filtration rate (gfr) \<60ml/min/1.73m2.
hyperglycemia in patients with takotsubo syndrome

Conditions: Takotsubo Cardiomyopathy

Summary: patients with takotsubo cardiomiopathy (ttc) have over-inflammation and over-sympathetic tone. however, these conditions could cause higher rate of heart failure (hf) events and deaths at 2 years of follow-up. conversely, hyperglycemia vs. normoglycemia could result in over expression of inflammatory markers and catecholamines thta could result in higher rate of hf and deaths at 2 years of follow-up in ttc patients.


Eligibility criteria:
inclusion criteria: * acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as stemi/evolving coronary syndrome; * cardiac biomarker modifications (creatine kinase-mb and troponin i); * systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the left ventricle (lv) chamber, with hyper-contractile basal lv. exclusion criteria: * patients with previous previous myocardial infarction; * patients with previous ttc event; * patients affected by chronic kidney, liver, and cerebrovascular diseases.
antifugal effect of recombinant human granulocyte-macrophage stimulating factor (rhgm-csf) in patients post allo-hsct

Conditions: Mycoses

Summary: we conducted a prospective, multicenter, open-label randomized trial to compare the antifungal effect of recombinant human granulocyte-macrophage stimulating factor (rhgm-csf), recombinant human granulocyte stimulating factor (rhg-csf) or a combination of rhgm-csf and rhg-csf for neutropenic patients undergoing allogeneic stem cell transplantation.

from sept 2009 to dec 2012, we recruited consecutive patients with hematological diseases undergoing allogeneic stem cell transplantation at 5 institutions in china. recipients between ages of 14 to 60 years old were eligible. eligible patients were randomized to receive once daily subcutaneous 5-7μg/kg/d gm-csf (molgramostim, topleucon®; xiamen amoytop biotech co., ltd., china) (gm-csf group), 5-7μg/kg/d g-csf (g-csf group), or a combination of 2-3μg/kg/d gm-csf and 2-3μg/kg/d g-csf each (g-csf+gm-csf group). administration of csfs was started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count \[anc\] \> 1.5×10(9)/l for 2 consecutive days). if absolute neutrophil count (anc) decreased to \< 1.5×10(9)/l within 5 days after withdrawal of csfs, the same csf would be resumed until the absolute neutrophil count (anc) reached 1.5×10(9)/l again. all patients received antimicrobial prophylaxis with oral levofloxacin 500 mg daily and antifungal prophylaxis with oral fluconazole 200 mg daily.

Eligibility criteria:
inclusion criteria: * age 14\~60 years old * allogenic hematological stem cell transplantation(hsct) patients. * cardiac ejection factor ≥ normal upper limit, aspartate aminotransferase and/or alanine aminotransferase \< 2 upper limit of normal, and/or total bilirubin \< 2.5 upper limit of normal, creatinine \< upper limit of normal. * informed consent. exclusion criteria: * evidence of proven, probable or possible fungal infection at the time of enrollment. * patients were receiving anti-fungal treatment with proven sfi before transplantation. * a history of hypersensitivity to g-csf or gm-csf.

Keywords: allo-hsct rhgm-csf systemic fungal infection (sfi)
acupuncture for post operative pain following total knee or hip arthroplasty

Conditions: Arthroplasty Complications

Summary: post operative pain (pop) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .pain after orthopedic surgery is considered especially difficult to manage. approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. various modalities of treating orthopedic pop exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.we suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.


Eligibility criteria:
inclusion criteria: * signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty exclusion criteria: * known mental disease, active cancer disease, coagulopathy, hepatitis b,c.
rescue and reverse long-term follow-up

Conditions: Leber Hereditary Optic Neuropathy

Summary: the goal of this clinical trial is to assess the long-term safety and efficacy of gs010, a gene therapy, and assess the quality of life in subjects with lhon due to the g11778a nd4 mitochondrial mutation and who were treated in the rescue or reverse studies.

seven investigational centers from the rescue and reverse studies also participated in the restore study, located in the european union and in the usa. primary objectives: to assess the long term safety of intravitreal injection up to 5 years of post treatment in subjects who were treated in the rescue or reverse studies. secondary objectives: (1) to assess the long-term efficacy of intravitreal gs010 administration up to 5 years post-treatment in subjects who were treated in the rescue or reverse studies; and (2) to assess the quality of life (qol) in subjects who were treated with gs010 in the rescue or reverse studies for up to 5 years post-treatment. methodology: this was a phase iii prospective long-term follow-up (ltfu) clinical study of subjects previously treated with gs010 and sham during 2 phase iii studies-rescue and reverse. the ltfu study followed subjects for an additional 3 years, for a total of 5 years post-injection. the ltfu study included 5 visits at 2, 2.5, 3, 4, and 5 years after the investigational medicinal product (imp) injection. safety, efficacy, and qol variables were assessed during each of the 5 ltfu visits, and descriptive summaries and statistical testing were used for the analysis of the data. this report presents the final analysis of results at year 5 after treatment administration in rescue and reverse. number of analysed subjects: all subjects completing recue and reverse studies who provided consent for the restore study: 62 subjects.

Eligibility criteria:
inclusion criteria * subject was treated with gs010 ivt injection in either of the rescue or reverse phase iii clinical studies * subject of legal consent age has provided informed consent; subjects that are not of legal consent age have undergone their country-approved clinical trial enrollment consent process non-inclusion criteria * subject is unwilling or unable to comply with the protocol requirements * subject has any medical or psychological condition that, in the opinion of the investigator, may compromise his or her safe participation in the study * subject is taking or intending to take idebenone during the long-term follow-up study period

Keywords: heredity optic atrophy leber hereditary optic atrophy leber hereditary optic neuropathy lhon eye diseases hereditary eye diseases inborn genetic disease gene therapy intravitreal injections mitochondrial disease aav2 vectors nervous system diseases neurodegenerative disease heredodegenerative disorders of the nervous system
maternal kir and fetal hla-c genes in recurrent miscarriages

Conditions: Recurrent Miscarriages

Summary: for implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. we have found a combination of maternal immune genes (the kir family) and fetal genes (hla-c) strongly associated with pre-eclampsia where placenta does not implant adequately. the aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.

little is known about reasons for early pregnancy failures. it is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. this project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (kir) with their ligand (hla-c) in the fetus was strongly associated with the disease. we will tissue type the fetus, mother and father in cases of unexplained miscarriages. we hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.

Eligibility criteria:
inclusion criteria: couples with 3 or more unexplained miscarriages exclusion criteria: previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities
stellate ganglion block in patients with cerebral small vessel disease

Conditions: Dysphagia; Cerebral Small Vessel Diseases; Cognitive Impairment

Summary: a prospective study was conducted on 84 csvd patients with dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given sgb. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

in order to observe the effect of stellate ganglion block (sgb) on swallowing function, cognitive function and activities of daily living in patients with cerebral small vessel disease (csvd), a prospective study was conducted on 84 csvd patients with dysphagia and cognitive impairment. they were divided into the comparison group and observation group evenly. all the patients were provided with routine therapy, while the patients in the observation group were given sgb. the swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by penetration-aspiration scale, mini-mental state examination and modified barthel index.

Eligibility criteria:
inclusion criteria: * age\>18 years. * meeting the diagnostic criteria for cerebral small vessel disease imaging proposed in 2013 by the international cerebral small vessel disease expert group, and the "consensus on diagnosis and treatment of cerebral small vessel disease in china" in 2017. * dysphagia confirmed by videofluoroscopic swallowing study * mini-mental state examination (mmse)\<27, indicating the existence of cognitive impairment. * no history of prior stroke. * stable vital signs. exclusion criteria: * dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc. * cognitive impairment that might be caused by other diseases, such as alzheimer's disease, parkinson's disease, brain injury, etc. * neurological blockade contraindications such as bleeding tendency, blocked site infection. * mmse\<10, or unable to successfully finish the assessment of this study (patients with severe mental illness or intellectual disability might have difficulty to cooperate with the assessment). * complicated with severe liver and kidney failure, tumors, or hematological disorders. * simultaneously in need to undergo other therapy that might affect the outcomes of this study. * pregnant or nursing females.
more-2-eat; implementation of inpac

Conditions: Acute Care Medical

Summary: m2e is a developmental evaluation of the implementation of the integrated nutrition pathway for acute care, in five medical units in five hospitals in canada.


Eligibility criteria:
inclusion criteria: * admitted to study unit * no delirium or dementia * return to community anticipated exclusion criteria: * unable to communicate in english or french

Keywords: malnutrition food intake frailty
naloxone nasal spray pharmacokinetic study

Conditions: Opioid Overdose

Summary: this study aims to compare the pharmacokinetics of naloxone when administered as the mitovie nasal spray (test product) and as a solution for injection (comparator product) administered intranasally using a mucosal atomization device (mad).

naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. it has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the solution for injection using a mucosal atomization device (mad). however, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. the study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.

Eligibility criteria:
inclusion criteria: * male or female * 18-60 50 years of age * provide written informed consent prior to completing any study specific procedure. * body mass index (bmi) range 18.5-30 kg/m2 * clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ecg * using reliable contraception exclusion criteria: * intranasal problems * taking prescribed or over the counter medications * intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.

Keywords: intranasal nasal spray opioid overdose
atorvastatin before prostatectomy and prostate cancer

Conditions: Prostatic Neoplasms

Summary: this single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.

in this trial 160 men who have been diagnosed with prostate cancer, and whose first-line treatment will be radical prostatectomy (surgical removal of the prostate), are randomized to receive either 80 mg atorvastatin or placebo daily for 2-5 weeks until the operation. blood cholesterol and serum psa are measured before starting the study drug use and before the operation. after the operation change in psa and histological inflammation, apoptotic rate and ki-67 staining intensity are compared between atorvastatin-treated and placebo-treated men. the correlation between changes in serum cholesterol or prostate specific antigen (psa) and the tissue characteristics is evaluated. after recruiting 60 men we will perform an interim analysis on primary end-points without breaking the blinding to treatment allocation. if we observe a statistically significant difference in all primary end-points, the trial will be stopped early and the results published. additionally, atorvastatin concentration in the blood and the prostate tissue is measured with mass spectrometry to determine penetrance of atorvastatin into the prostate. dna- and rna-samples are obtained from the prostate tissue and the blood. these will be used to study how gene expression of statin- and cholesterol-modifying enzymes affects the responses observed in prostate tissue. as a secondary end-point we will measure recovery of erectile function after the operation and compare between the two study arms. erectile function is measured using iief-5 questionnaire once before the operation and again 3, 6, 9 and 12 months from the prostatectomy.

Eligibility criteria:
inclusion criteria: * prostate cancer proven histologically in prostate biopsy * radical prostatectomy selected as the first-line treatment * willingness to participate and sign informed consent exclusion criteria: * previous oncological treatments for any malignancy * previous usage of statins, finasteride or dutasteride within a year prior to prostate cancer diagnosis * clinically significant liver- or kidney insufficiency (plasma alanine aminotransferase level is twice over the recommended upper limit or serum creatinine level is over 170 µmol/l) * previous adverse effects from cholesterol-lowering treatment * ongoing use of drugs having interactions with statins (st john's wort, hiv protease inhibitors, ciclosporin, macrolide antibiotics, fusidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication)

Keywords: apoptosis atorvastatin inflammation pre-surgical trial proliferation prostate cancer
image enhanced endoscopy ibd

Conditions: Inflammatory Bowel Diseases; Dysplasia

Summary: dye- spray chromoendoscopy remains the recommended gold standard approach for ibd dysplasia surveillance colonoscopy however recently published european and american guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. the newer imaged enhanced endoscopy technologies txi and lci have not formally been evaluated in ibd surveillance in a randomised controlled trial setting. these modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.


Eligibility criteria:
inclusion criteria: * patients with inflammatory bowel disease aged 18 to 75 years, that meet australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study. exclusion criteria: * any active disease * inadequate bowel preparation * previous surgical resection involving the colon * history of bowel cancer
building strength for menopause

Conditions: Strength Training Effects; Menopausal Women; Cognitive Function

Summary: a pilot study investigating whether heavy resistance training is enjoyable, acceptable, and feasible for middle-aged women undergoing the menopausal transition. additional outcomes to be assessed include changes to strength and muscle composition as well as changes to cognitive function and self-reported measures of fatigue, cognition, self-efficacy, and mood.


Eligibility criteria:
inclusion criteria: * 40-60 years of age at study enrollment * currently experiencing symptoms related to menopause * low physical activity levels at study enrollment (not meeting cdc guidelines of 150 minutes moderate/75 minutes vigorous activity per week) * no regular (\>1x per week) participation in heavy resistance training or yoga exercise within the past 6 months * physician's consent to participate in strength testing and the exercise program (if deemed necessary) * ambulatory * absence of health conditions that may be exacerbated by exercise * good or corrected vision and hearing * intention to remain in the boston area for the duration of the study * willingness to complete study assessments * ability to read, write and understand english * not currently enrolled in another pa study exclusion criteria: * under 40 or over 60 years * pregnant or planning to become pregnant * moderate to high physical activity levels at enrollment (meeting cdc guidelines) * currently participating regularly (\>1x per week) in a heavy resistance training or yoga program * non-consent of physician (if deemed necessary) * non-ambulatory (e.g. use of walkers, wheelchairs) * presence of health conditions that may be exacerbated by exercise (arthritis, musculoskeletal disorders, etc.) * problems with vision or hearing * intent to move or take an extended (\>2 weeks) vacation during the testing time points (baseline, 4 months) * unwilling to complete study assessments * currently enrolled in another pa study

Keywords: menopausal women, strength training, cognitive function