Kornimate/medical-research-clean huggingface dataset:
spsipb vs. sapb in breast surgery

Conditions: Postoperative Pain; Quality of Recovery

Summary: the effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.


Eligibility criteria:
inclusion criteria: * patients who have received informed consent form patients who will undergo breast cancer surgery aged between 18-65 exclusion criteria: * \ 65 years * asa ≥ iv * history of allergy to local anesthetics * clinical diagnosis of coagulation disorders * infection near the entry site * chronic analgesic use patients who will undergo bilateral breast cancer surgery * body mass index \>35 * clinical diagnosis of dementia or confusion * lack of cooperation

Keywords: postoperative pain pain scores pain management fasial plane blocks
prospective study on modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer

Conditions: Stomach Neoplasms

Summary: the purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.

a prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and billroth-i anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. the evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 years (including 18 and 75 years old) * primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy * ct1-4a, n0-3, m0 at preoperative evaluation according to the american joint committee on cancer (ajcc) cancer staging manual seventh edition * expected curative resection through distal subtotal gastrectomy with d2 lymphadenectomy * performance status of 0 or 1 on eastern cooperative oncology group scale (ecog) * american society of anesthesiology score (asa) class i, ii, or iii * written informed consent exclusion criteria: * women during pregnancy or breast-feeding * severe mental disorder * history of previous upper abdominal surgery (except laparoscopic cholecystectomy) * history of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging * history of other malignant disease within past five years * history of previous neoadjuvant chemotherapy or radiotherapy * history of unstable angina or myocardial infarction within past six months * history of cerebrovascular accident within past six months * history of continuous systematic administration of corticosteroids within one month * requirement of simultaneous surgery for other disease * emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * fev1\<50% of predicted values

Keywords: stomach neoplasms laparoscopy billroth i operation
a study with gb004 in adult subjects with active ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: a 2-part study, comprising of a 36-week placebo-controlled period (pcp) and a 24-week open-label extension (ole) period, to assess the efficacy and safety of 2 dose regimens of gb004 when added to background uc therapy of 5-aminosalicylate (5-asa) with or without systemic steroids.


Eligibility criteria:
inclusion criteria: * adult male and female subjects aged ≥ 18 years at the time of signing the informed consent form (icf) prior to initiation of any study specific activities/procedures. * uc diagnosed at least 3 months prior to first dose of investigational product (ip) on day 1. * currently receiving treatment for uc, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-asa (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments: 1. prednisone ≤ 20 mg/day or equivalent or 2. beclomethasone ≤ 5 mg/day or 3. budesonide or budesonide multi-matrix (mmx) of ≤ 9 mg/day exclusion criteria: * prior approved biologic therapy used for the treatment of uc. * diagnosis of crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection. * tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of day 1. * azathioprine, or 6-mercaptopurine within 1 day of day 1. note: other inclusion/exclusion criteria may apply per protocol.

Keywords: inflammatory bowel disease
in vitro maturation (ivm) of human oocytes

Conditions: Infertility

Summary: the objectives of this study are to evaluate the clinical efficacy of natural in vitro fertilization and in vitro maturation.

collection of one mature egg from a follicle in the ovary without gonadotropin medications (natural cycle ivf) results in low pregnancy rates. one way to improve natural cycle ivf is to combine this procedure with the removal of immature eggs from the ovary and mature these eggs in the laboratory ( in vitro maturation-ivm). the in vitro mature eggs are fertilized and the resultant embryos are cultured using conventional ivf techniques.

Eligibility criteria:
inclusion criteria: 1. each subject must be female. 2. each subject must have an indication for coh and ivf with or without icsi. 3. each subject must be willing and able to provide written informed consent for the trial 4. each subject must be 25 to ≤42 years of age at the time of signing informed consent. 5. each subject must have a normal cervical smear result (no atypical or abnormal cells, or in case of atypical squamous or glandular cells, no signs of malignancy; corresponding to papanicolaou \[pap\] i or ii) obtained within 12 months prior to signing informed consent must be available exclusion criteria: 1. subject with premature ovarian failure 2. subject with endocrine abnormalities such as hyperprolactinaemia or thyroid dysfunction 3. subject with malformation or absence of uterus 4. subject has tested positive for human immunodeficiency virus (hiv) or hepatitis b (by local laboratory; results obtained within 1 year prior to signing icf are considered valid). 5. subject with contraindication or allergy/hypersensitivity to hcg, estrogen and progesterone

Keywords: infertility in vitro maturation (ivm) in vitro fertilization (ivf) natural cycle
interventional study on the evaluation of functionality, safety of a robotic prosthesis for transtibial amputations

Conditions: Amputation; Amputation; Traumatic, Leg, Lower

Summary: the goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees. the main question it aims to answer are: * is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device. * provide an indication of the functional effectiveness of the device and its satisfaction by patients. participants will perform: * walking tests inside parallel bars on flat and/or inclined terrain; * walking tests on treadmill; * stair climbing/descent tests.


Eligibility criteria:
inclusion criteria: * trans-tibial lower limb amputation; * medicare functional classification: level k3-k4; * subjects who have worn prostheses for at least 1 year (experienced wearers); * use of prosthesis with energy-returning prosthetic foot. exclusion criteria: * relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits); * wearers of implantable cardiac medical devices (pmk or aicd); * cognitive impairment (mmse corrected for age and education \<24); * inability or unavailability to provide informed consent; * severe depressive and/or anxious symptoms.

Keywords: lower limb transtibial
concurrent transcranial direct current stimulation and gait training in parkinson's disease

Conditions: Parkinson's Disease

Summary: to investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with parkinson's disease.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic pd * hoehn and yahr stages i-iii * mini mental status examination (mmse) score ≧ 24 * could walk 10m independently with or without gait aid exclusion criteria: * concurrent medication likely to affect mental performance * tdcs contraindication * significant neurological, vestibular, visual disorders or psychiatric illness * musculoskeletal or cardiopulmonary disease * sensory system pathology

Keywords: dual task performance executive function transcrainal direct current stimulation (tdcs)
a study to evaluate the efficacy and safety of br1015 combination therapy

Conditions: Essential Hypertension

Summary: the objective of this clinical trial is to evaluate the efficacy and safety of br1015 combination therapy group in comparison with fimasartan monotherapy group at week 8 for essential hypertension patients who do not adequately responded by fimasartan 30 mg


Eligibility criteria:
* inclusion criteria: * patients with uncontrolled essential hypertension at screening(v1) under the following criteria: * naïve : 140 mmhg ≤ sisbp \< 180 mmhg * use antihypertensive drugs : 130 mmhg ≤ sisbp \< 180 mmhg * patients with uncontrolled essential hypertension at randomization(v2) after fimasartan 30mg monotherapy for 4 weeks under the following criteria: * selected reference arm : 140 mmhg ≤ sisbp \< 180 mmhg (for patients with cardiovascular disease, diabetes or chronic kidney disease (ckd) with albuminuria, 130 mmhg ≤ sisbp \< 180 mmhg) * treatment compliance of fimasartan 30 mg ≥70% at baseline visit (v2) * voluntarily provided a written consent to participate in this clinical study * able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion * exclusion criteria: * patients taking three or more antihypertensive drugs of different families * patients with blood pressure results showing sisbp ≥ 180 mmhg or sidbp ≥ 110 mmhg in the selected reference arm at screening(v1) and randomization(v2) * patients with a difference of sisbp ≥ 20 mmhg and sidbp ≥ 10 mmhg in blood pressure measured three times on both arms at screening(v1) * patients with secondary hypertension: secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) * patients with orthostatic hypotension accompanied by symptoms * patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
exploring biomarkers in age stratified pumch dementia cohort

Conditions: Dementia; Dementia, Vascular; Dementia Frontal; Dementia, Mixed; Dementia Alzheimers; Dementia With Lewy Bodies

Summary: biomarkers are important for early and precise diagnosis of dementia. however, the causes of dementia in different age are different. we designed an age stratified dementia cohort and tried to explore biomarkers of different groups of dementia, incorporating neuropsychology, multi-model neuroimaging, metabolics and proteomics based fluid biomarkers as well as genetic biomarkers. autopsy after clinical follow up help to verify the biomarkers.

baseline data collection and cohort establishing: detailed clinical information including demographic data, clinical history, past history and physical examination are collected. formatted neuropsychological battery is used in all patients, including screening tests (mmse, moca-pumch, adl, had) and domain specific evaluation (memory, executive function, visual spatial, calculation, language). samples including serum, csf, urine, skin, saliva are stored. every patient is followed up every 6 months. autopsy brain tissue will be collected if patients died. multi-model neuroimaging evaluation: structure and functional brain 3t-mri; 7t-mri； pet-ct including fdg, aβ（18f-av45）,tau（18f-thk5317, 18f-t807）; eeg multi-omics biomarkers research: csf ad biomarkers (aβ40,42, ptau181, ttau, nfl, neurogranin), comparison of different methods, including elisa, electrochemical, mass spectroscopy. the standardization of csf biomarkers analysis in china. exploring new fluid biomarkers: csf and urine proteomics; csf and serum glycomics and metabolomics. to explore new biomarkers in differentiation of different causes of dementia, age onset and prognosis of dementia. genetic biomarkers evaluation: including pathogenic gene mutation panel examination and wes. data analysis and biomarkers evaluation: dementia patients are stratified based on age onset, cause of dementia, cognition severity, effect of therapy, prognosis. identify multi-omics biomarkers in different groups. comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. autopsy based accurate diagnosis help further defining biomarkers. acquiring stratified biomarkers with high sensitivity and specificity.

Eligibility criteria:
inclusion criteria: * neurodegenerative dementia diagnosis based on 2011 nia-aa criteria of dementia * fixed care giver and can follow up regularly exclusion criteria: * not demented, including mci * systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation * without fixed care giver * reject informed consent * expected life shorter than 2 years

Keywords: biomarkers diagnosis
evaluation of patient satisfaction of metered dose inhaler (mdi) with counter in asthmatics and chronic obstructive pulmonary disease patients (copd).

Conditions: Asthma

Summary: the purpose of this study is to evaluate the level of satisfaction experienced by asthma or chronic obstructive pulmonary disease (copd) patients when using the fluticasone/salmeterol hfa metered dose inhaler (mdi) with counter, as compared to using fluticasone/salmeterol hfa mdi without counter.


Eligibility criteria:
inclusion criteria: * outpatient * documented physician diagnosis of asthma or copd * requires use of a controller and long acting beta 2 agonist * ability to provided written informed consent exclusion criteria: * patients with life threatening asthma or copd * historical or current evidence of significant diseases * immediate or delayed hypersensitivity to inhaled short acting beta2agonist or sympathomimetic drug or any component of the mdi formulation * history of drug or alcohol abuse abnormal chest x ray not consistent with asthma or copd * use of supplemental oxygen; systemic corticosteroids; short acting beta2agonists other than ventolin hfa; antibiotics for respiratory infections; anti-arrhythmics; anticonvulsants; central nervous system stimulants; tricyclic antidepressants and monoamine oxidase inhibitors.

Keywords: fluticasone propionate healthcare professional satisfaction patient satisfaction metered dose inhaler with counter salmeterol chronic obstructive pulmonary disease (copd)
study on the expression level and clinical significance of vista in patients with vascular cognitive impairment

Conditions: Cerebrovascular Disease Small Vessel

Summary: 1. explore the expression level of immune checkpoint vista in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors; 2. discuss the correlation between different risk factors (mainly hypertension, diabetes, smoking, hyperlipidemia, hyperhomocysteinemia, etc.) and the expression level of immune checkpoint vista in peripheral blood and cerebrospinal fluid of patients with cerebrovascular diseases and immune-inflammatory related diseases of the nervous system; 3. explore the correlation between different immune inflammatory factors (il1, il6, il10, infγ, tnfα) and the expression level of immune checkpoint vista in peripheral blood and cerebrospinal fluid of patients; 4. track and explore the dynamic changes of immune checkpoint vista in peripheral blood and cerebrospinal fluid of patients with cardiovascular risk factors in 3 months, 1 year, 3 years, and 5 years.

the prospective observational study design was adopted to screen patients with cardiovascular risk factors who visited the department of neurology in the first hospital of harbin medical university since november 2022. the patients mainly categorize into two groups: without cognitive impairment (control) and with cognitive impairment (vci).. general information, imaging, functional assessment, immune checkpoint vista in peripheral blood and cerebrospinal fluid, and blood-related indicators were collected. some patients who could cooperate were followed up for 3-5 years. by analyzing the correlation between the content of immune checkpoint vista in peripheral blood and cerebrospinal fluid, disease risk factors, imaging, functional scores and blood indicators, the relationship between immune checkpoints and nervous system diseases was better understood.

Eligibility criteria:
inclusion criteria: 1. the study included 100 subjects, including 50 patients with vci and 50 normal controls. the diagnosis of vci was based on the diagnostic criteria for psychiatric disorders in the fifth revised edition of the "diagnostic and statistical manual of mental disorders" of the american psychiatric association; 2. all relevant examination and cognitive testing work in this study obtained informed consent from the subjects and their families. exclusion criteria: 1. in line with the exclusion criteria for vci diagnosis in the "chinese guidelines for the treatment of vascular cognitive impairment 2019"; complicated with autoimmune diseases, blood diseases, malignant tumors, heart, liver, and kidney dysfunction, infectious diseases, family genetic diseases, recent acute or chronic inflammatory diseases, myocardial infarction, etc.; taking antibiotics, steroids, immunosuppressants before the trial; having a history of cranial trauma or surgery.
observational safety study in women with neuromyelitis optica spectrum disorder (nmosd) exposed to uplizna® during pregnancy

Conditions: Neuromyelitis Optica Spectrum Disorder; Pregnancy Related

Summary: this is an observational study to monitor female participants exposed to uplizna during pregnancy. this study requires voluntary reporting of pregnancies in female participants with nmosd exposed to uplizna during pregnancy or within 6 months preceding conception. pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. the schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. duration of the study is 10 years, at minimum.

acquired from horizon in 2024.

Eligibility criteria:
inclusion criteria: * provide informed consent * are a female of reproductive potential with a confirmed or suspected diagnosis of nmosd * have been exposed to uplizna during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception note: other protocol defined inclusion/exclusion criteria apply

Keywords: neuromyelitis optica spectrum disorder pregnancy uplizna inebilizumab birth complications
isolation of pulmonary veins with pvac gold in elderly patients

Conditions: Atrial Fibrillation Paroxysmal; Cardiac Arrythmias

Summary: it is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (pvac gold) in relation to clinical treatment during an one year of segment. the patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. this trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. the proposed imaging tests was the transesophageal echocardiogram before each procedure. the cerebral mri was performed in the 24 hours post invasive procedure and angio-tomography of the pulmonary veins in the 6-month segment.

objective: pulmonary vein isolation (pvi) for atrial fibrillation (af) has become progressively safer and more effective with advances in single-shot devices. the aim of this study was to compare catheter ablation (ca) of second-generation pulmonary vein ablation catheter (pvac) gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal af (paf) without structural heart diseases. methods: prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) pvac ablation group and (2) antiarrhythmic drugs therapy group. primary outcomes were af recurrences, progression to persistent af forms. as secondary outcomes, changes in mini-mental state examination and af quality of life score were accessed.this study doesn't include payment of participants. all patients signed the informed consent.

Eligibility criteria:
inclusion criteria: * indication for isolation of pulmonary veins * age \>= 65 years old * association with the following characteristics: 1. symptomatic atrial fibrillation; 2. sinusal rhythm maintenance failure for at least 1 antiarrythmic drugs; 3. diagnosis of atrial fibrilation on resting eletrocardiogram and/or 24h holter. exclusion criteria: * prior atrial fibrillation ablation; * atrial fibrillation permanent and/or persistent; * left atrial size \> 55 mm; * mechanical prothetic mitral valve replacement; * presence of atrial thrombus; * cardiac invasive procedure \< 90 days; * cerebral embolism \< 6 months; * hypertrophic cardiomyopathy; * contraindications to antiocoagulation and cerebral mri.

Keywords: radiofrequency ablation atrial fibrilation pvac gold catheter elderly patients
a study of nktr-214 combined with nivolumab vs nivolumab alone in participants with previously untreated inoperable or metastatic melanoma

Conditions: Melanoma

Summary: the purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called nktr-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of ≤1 (adults 18 years or older)/lansky performance score ≥ 80% (minors ages 12-17 only) * histologically confirmed stage iii (unresectable) or stage iv melanoma * treatment-naive participants (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma) with the exception of prior adjuvant and/or neoadjuvant treatment for melanoma with approved agents exclusion criteria: * active brain metastases or leptomeningeal metastases * uveal melanoma * participants with an active, known or suspected autoimmune disease other protocol defined inclusion/exclusion criteria apply

Keywords: nktr-214 nivolumab immunotherapy bempegaldesleukin (bempeg: nktr-214)