Kornimate/medical-research-clean huggingface dataset:
disposable powered articulating linear cutter stapler in gastrointestinal tissue cutting and anastomosis

Conditions: Gastrointestinal Neoplasm

Summary: to evaluate whether the anastomosis success rate of the main effectiveness evaluation indexes is not inferior to the similar products produced by johnson \& johnson when the fengh disposable powered articulating endoscopic linear cutter stapler used for gastrointestinal tissue cutting and anastomosis

in this clinical trial, prospective, multi-center, stratified group randomization, incomplete blind setting, parallel positive control and non-inferiority test were used to evaluate the disposable powered articulating endoscopic linear cutter stapler manufactured by jiangsu fengh medical co., ltd. when used for gastrointestinal tissue cutting and anastomosis. to determine whether there is any difference in the incidence of adverse events, serious adverse events, device defects and other safety evaluation indicators compared with similar products produced by johnson \& johnson.

Eligibility criteria:
inclusion criteria: 1. the subjects are 18 \~ 75 years old, regardless of gender: 2. subjects need to use a linear stapler for gastrointestinal tissue cutting and anastomosis: 3. the subject or his legal representative can understand the purpose of the study and show sufficient compliance with the study protocol and sign informed consent. exclusion criteria: 1. the subject plans to perform emergency gastrointestinal surgery: 2. subjects with moderate malnutrition (bml \< 17kg / m2) and severe anemia (hb \< 60g / l): 3. subject bmi 228kg / m2; 4. subject platelet (plt) \ 1.5; 5. subject forced expiratory volume per second (fev1) / expected value ≤ 50%, or forced expiratory volume per second (fev1) / forced vital capacity (fcv) \< 60%; 6. subject's cardiac ejection fraction ≤ 50%; 7. have important organ failure or other serious diseases (e.g. preoperative subject aspartate amino acid) transferase (ast), or alanine aminotransferase (alt), or serum creatinine (ser) exceeds normal values upper limit 3 times and above: subjects with fasting blood glucose value \> 10.0mmol/l before operation: 8. the subjects were pregnant or lactating women; page 16 of 53 version no.: 1.1/version date 20190125 clinical trial on the efficacy and safety of linear cutting stapler and components for disposable electric endoscopy for cutting and anastomosis of gastrointestinal tissue 9. subjects participated in clinical trials of other drugs or devices within 3 months before the trial; 10. other conditions that the researchers judged not suitable for inclusion.
neoadjuvant immunotherapy and chemotherapy followed by surgery in unresectable stage ⅲ nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety and efficacy of camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with unresectable stage iii non-small cell lung cancer.

concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage iii non-small cell lung cancer(nsclc), although surgery offers the chance of cure. with combined radiation and chemotherapy, the prognosis of unresectable stage iii nsclc remains poor. immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (nsclc) without targetable genetic aberrations. camrelizumab, a humanised monoclonal antibody against pd-1, has shown its efficacy in the treatment of advanced nsclc. this study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage iii nsclc.

Eligibility criteria:
inclusion criteria: * written informed consent provided. * age 18-70 when signing the consent form, both male and female; * the ecog score is 0 or 1; * unresectable stage iii non-small cell lung cancer confirmed by histopathology or cytology（iii a-bulky n2, iii b，iiic）; * adequate hematological function, liver function and renal function; * female participants should not be pregnant or breast-feeding. exclusion criteria: * egfr mutation or alk mutation was positive; * previously received systemic anti-tumor therapy for non-small cell lung cancer; * subjects who have received chest radiotherapy in the past; * known human immunodeficiency virus (hiv) infection; * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease); * pregnancy or breast-feeding women; * ingredients mixed with small cell lung cancer patients.

Keywords: unresectable stage ⅲ nsclc neoadjuvant chemoimmunotherapy camerlizumab pd-1 sugery
effects of peginterferon consolidation therapy on hepatic cccdna dynamics in chb patients achieving clinical cure.

Conditions: Chronic Hepatitis b

Summary: this is a single-center, prospective, exploratory clinical study. the study plans to enroll 30 chronic hepatitis b (chb) patients which achieved hbsag clearance based peginterferon α-2b treatment. eligible subjects will receive either 12-24 weeks interferon consolidation therapy (180μg administered subcutaneously in the abdomen or thigh once weekly) or not according to physician's recommendation and patient's preference, with regular follow-up for hbv recurrence. patients will be followed up every 12 weeks. the study will evaluate changes in intrahepatic covalently closed circular dna (cccdna) and peripheral blood hbv pregenomic rna (pgrna) levels after achieving hbsag clearance.


Eligibility criteria:
inclusion criteria: * voluntarily enroll in the study, able to understand and voluntarily sign the informed consent form; * aged 18-65 years (inclusive), no gender restriction; * a history of hbsag positivity for at least 6 months or other evidence suggesting chronic hepatitis b; * first observed clinical cure after treatment with peginterferon α-2b (pegintron®), either as monotherapy or in combination with nas, defined as serum hbsag negative (\<0.05iu/ml), hbv dna undetectable (hbv dna\<20iu/ml), and hbeag negative, within a 4-week window from the first observed day of clinical cure at the time of screening; * agreement to undergo two liver biopsies during the study; * negative pregnancy test within 24 hours before the first liver biopsy (for childbearing-age females); and subjects (both male and female) should use effective contraception during the study period. exclusion criteria: * lactating women; * evidence of acute severe liver injury: such as alt \> 10 uln, or significantly elevated alt with significantly elevated bilirubin; * evidence of decompensated liver disease: such as ascites, esophageal varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or history of decompensated cirrhosis; * evidence of hepatocellular carcinoma; * prothrombin time (pt) or inr \> uln; * participation in other interventional trial studies within 3 months before screening or other conditions deemed unsuitable for inclusion by the investigator.

Keywords: peginterferon α-2b injection cccdna pgrna
disability and self-rated health following primary knee replacement

Conditions: Osteoarthritis; Knee Replacement

Summary: knee replacement is an effective treatment in late-stage osteoarthritis. it reduces pain and improves quality of life. there is, however, limited data concerning its results in older people and on its effect on how patients survive in regular activities of daily living (adl), such as bathing and shopping. in this study, the results of knee replacement are evaluated from the point of view of disability in everyday activities and self-rated health. moreover, association with adl performance and clinical knee scores and severity of osteoarthritis are assessed.

this is a cross-sectional study with a 12 month follow-up for recruited patients. most data are gathered by a postal questionnaire.

Eligibility criteria:
inclusion criteria: * age 75 years or more at the time of operation * diagnosis of knee osteoarthritis * scheduled for or operated on with primary knee replacement exclusion criteria: * died during the follow-up * inflammatory arthritides

Keywords: knee replacement disability older people
embryo transfer: direct versus afterloading trial

Conditions: Infertility

Summary: the purpose of this study is to evaluate two types of embryo transfer procedure. the investigators will compare direct embryo transfer against afterloading embryo transfer.


Eligibility criteria:
inclusion criteria: * patients in ivf/cicsi program * transfer day:2 or 3 after ovum pick-up exclusion criteria: * none

Keywords: embryo transfer ivf ultrasound embryo transfer
accuracy and safety of real time continuous glucose monitoring before, during and after surgery

Conditions: Glucose Metabolism Disorders; Perioperative Care

Summary: the purpose of this study is to determine the safety and accuracy of the real-time continuous glucose monitoring system (rt-cgms)in measuring glucose in patients scheduled for surgery; before, during and after surgery.

rationale:strict glycaemic control improves outcome of critically ill patients. real time continuous glucose monitoring system (rt-cgms) is a novel system which can provide health care professionals with real time information about the blood glucose level without the need for multiple invasive measurements. furthermore, with continuous monitoring it is possible to identify trends in glycaemic profiles. its accuracy and safety have never been tested in a population of patients admitted to an intensive care unit. objective:to investigate the accuracy and safety of the rt-cgms in patients scheduled for elective cardiac surgery. our secondary objective is to define the possible factors interfering with reliable and adequate glucose measurements and to investigate the effect of rt-cgms on glucose control. study design: open label, randomised controlled trial. study population:patients scheduled for elective cardiac surgery. intervention:after informed consent and randomisation, all patients will have the rt-cgms inserted pre-operatively. in one group (control group; 15 subjects), the rt-cgms will be blinded, so that no information on blood glucose values measured and stored by the rt-cgms will be available to care-givers, investigators or patients during the study period. in the other group (active group, 15 subjects), the rt-cgms will not be blinded. the system will alert whenever a glucose level falls below or rises above preset values. sensor values are not intended to be used directly for making therapy adjustments. whenever a value is below or above the preset value, the blood glucose level will be measured using separate blood analysis and therapy adjustments based on this value will be done according to the (icu) protocol. study endpoints: correlation between data obtained with the rt-cgms and the conventional method. degree of glucose control defined as the time spent in normoglycaemia, hypoglycaemia and hyperglycaemia, as recorded both with sensor measurements and ward measurements. occurrence of significant clinical events and its effect on rt-cgms.

Eligibility criteria:
inclusion criteria: * patients scheduled for elective cardiac surgery * age \>18 years * both patients with diabetes mellitus as non-diabetic patients are eligible exclusion criteria: * failure to obtain informed consent * pre-admission insulin treatment for diabetes mellitus

Keywords: blood glucose hyperglycemia hypoglycemia perioperative care inpatient
the resistance exercise training for worry trial: replication and expansion

Conditions: Analogue Generalized Anxiety Disorder

Summary: this protocol details the full methods of a ten-week moderate-to-high intensity, guidelines-based resistance exercise training intervention compared to a low intensity sham attention control among young adult women with analogue generalized anxiety disorder.

a recent clinical trial supported the anxiolytic effects of regularly-performed resistance exercise training compared to a waitlist control among young adults with and without at least subclinical, or analogue, generalized anxiety disorder. although the evidence to date is promising, waitlist control conditions cannot control for potential social and psychological benefits of engaging with most interventions, including social contact, expectations for improvement, and mastery experiences, which could potentially be achieved from easier activities. therefore, this trial aims to replicate the previously investigated world health organization and american college of sports medicine guidelines-based resistance exercise training program, and expand on this research by more rigorously examining the effects on anxiety and worry symptoms, independent of potential social and psychological benefits of engagement with the intervention. consequently, this trial quantifies the acute and chronic effects of moderate-to-high intensity, guidelines-based resistance exercise training compared to a low intensity sham attention control on signs and symptoms of generalized anxiety disorder among at-risk young adult women with analogue generalized anxiety disorder. this trial consists of a two-week familiarization protocol, eight weeks of formal resistance exercise training, and a one-month post-intervention follow-up.

Eligibility criteria:
inclusion criteria: * female * aged 18-40y * met criteria for analogue generalized anxiety disorder exclusion criteria: * medical contraindications to doing resistance exercise training * currently involved in formal resistance exercise training * currently pregnant or post-partum

Keywords: analogue generalized anxiety disorder young adults female worry strength training resistance training
phase 1 to evaluate the safety and pharmacokinetic characteristics of fixed-dose combination of yyc506

Conditions: Dyslipidemias

Summary: to evaluate the safety and pharmacokinetics characteristics between yyc506 and concomitant administration of yyc506-t and yyc506-a

phase 1 to evaluate the safety and pharmacokinetics characteristics between yyc506 and concomitant administration of yyc506-t and yyc506-a. which is designed as ramdomized, oral, single dose, two-way crossover.

Eligibility criteria:
inclusion criteria: * over 19 ages healthy men * over 50.0kg, 18.0kg/m2 ≤ bmi ≤ 30.0kg/m2 * men who don't have congenital disease and other cronic disease need to be cared. etc. exclusion criteria: * men who have congenital liver disease (ast, alt, ck ≥ 2x uln) * men who have drunken or eatten something including caffeine within 24 hours before. etc.
chromosome abnormalities in chronic myeloid leukemia (cml) on imatinib. gist patients on imatinib

Conditions: Chronic Myeloid Leukemia; Gastrointestinal Stromal Cell Tumors; Chromosome Abnormality

Summary: in order to distinguish between clonal instability driven by imatinib in cml and actual changes with secondary clones induced by imatinib we would like to investigate the karyotype of non-cml patients treated with imatinib such as gist patients.

chronic myeloid leukemia (cml) is a myeloproliferative disorder characterized by the presence of the philadelphia (ph) chromosome - a t(9:22) translocation that results in the production of a bcr/abl fusion protein with abl kinase activity. imatinib mesylate (gleevec) specifically targets a limited set of protein tyrosine kinases - abl, arg (abl-related gene), c-kit, platelet-derived growth factor receptor (pdgf-r) - and their oncogenic forms, most notably bcr/abl imatinib is also a potent inhibitor of a receptor-type c-kit tyrosine kinase. therefore imatinib was examined for therapeutic efficacy against malignant gastro-intestinal stromal tumors (gist) recent articles have drawn attention to the development of new ph-negative, cytogenetically unrelated clones after therapy of ph-positive cml with imatinib. trisomy 8 and monosomy 7 are the most frequent defects, but other aberrations have also been reported. some of these cytogenetic abnormalities are associated with acute myeloid leukemia and mds.

Eligibility criteria:
inclusion criteria: * gist patient on imatinib for more than 12 months exclusion criteria: * nil

Keywords: chronic myeloid leukemia gastrointestinal stromal cell tumors chromosome abnormality imatinib bone marrow aspiration
study to assess the effect of leucine along with resistance exercise on muscle strength and quality of life in elders

Conditions: Ageing

Summary: the purpose of this study is to determine whether a nutritional supplement with an amino acid called leucine along with resistance exercise are effective in the improvement of muscle strength and quality of life in elderly people.

physiological aging is accompanied by functional loss and changes in different organs, including the skeletal muscle, with a progressive reduction in muscle mass. this is called physiological sarcopenia of the elderly. in any population of autonomous individuals over 65 years, a proportion between 3% and 32% depending on age, meets the criteria of the so-called frailty syndrome. frailty is characterized by a decrease in reserves and resistance to aggression, conferring increased vulnerability, disability and poor vital prognosis. a feature of the frailty syndrome is the potential reversibility of many of the elements at the initial stages of frailty. currently, available treatment for frailty is limited. one of the tools should be the prevention of sarcopenia, where nutritional treatment and exercise have a vital role. protein synthesis in aged muscle can be improved by increasing leucine concentration above physiological levels by a higher intake. regarding exercise, progressive resistance training is one of the interventions that have shown better results in the increase of mass and muscle strength in elderly people. the hypothesis raises the possibility that an intervention consisting of a leucine supplement along with progressive resistance training, is superior to the same training program and a placebo in improving muscle strength and quality of life in elderly people.

Eligibility criteria:
inclusion criteria: * over 70 years of age. * subjects capable of doing resistance exercise. exclusion criteria: * hospitalized patients. * disabled patients (i.e., not being able to exercise). * patients that usually train in resistance exercise. * patients with chronic renal failure. * patients with a fractured extremity during the last 6 months. * patients that follow diets with a protein restriction. * patients with oral nutritional support, enteral or parenteral nutrition. * patients in a low calorie diet to lose weight. * patients using pharmacological treatment with anorexigenic effects, anabolic steroids or corticosteroids. * patients with cognitive impairment or major psychiatric disorder. * non-signed informed consent. * any patient not capable to properly follow the treatment or not considered adequate by the researchers.

Keywords: aging functionality sarcopenia leucine progressive resistance exercise
mulligan mobilization in rheumatoid hand

Conditions: Rheumatoid Arthritis

Summary: the goal of this randomized-controlled study is to learn about the effectiveness of the mulligan mobilization in rheumatoid hands. the main question it aims to answer are: -does mulligan mobilization reduce effusion in wrist joints with rheumatoid arthritis? participants will take mulligan mobilization application and active rom exercises for their hands. researcher will compare treatments group ith sham mobilization.

rheumatoid arthritis (ra) is a systemic disease that can lead to chronic pain, bone and soft tissue damage, and disability retirement. alleviating pain and maintaining joint range of motion in ra are important for reducing disability. joint mobilizations are manual therapy techniques used to increase range of motion and reduce pain. the aim of this study is to investigate the effects of rheumatoid hand exercise and protective approach and joint mobilization applications on pain, functional status and quality of life.

Eligibility criteria:
inclusion criteria: * having been diagnosed with ras according to acr and eular criteria, * being under the control of a physiatrist for at least 1 year, * have not had any upper extremity surgery in the last 6 months * have the cognitive capacity to understand commands, * not to be involved in any other rehabilitation program or study, exclusion criteria: * presence of soft tissue injury and chronic bone damage in the hand, * presence of acute inflammation in any joint in the previous week, * presence of a degenerative or non-degenerative neurological condition that causes a change in pain perception,

Keywords: mulligan mobilization hand rheumatoid arthritis
predictive factors of lymph node metastasis in patients with papillary microcarcinoma of the thyroid

Conditions: Thyroid Cancer; Lymph Node Metastases

Summary: papillary thyroid microcarcinoma (ptmc), defined as a tumor with larger diameter ≤ 1 cm, is considered a tumor with an indolent course and an excellent prognosis. nevertheless, the incidence of lymph node metastasis in ptmc is not negligible, reaching up to 65% in some series. the aim of this study was to assess the incidence of lymph node metastasis in patients with ptmc and to evaluate predictive factors for lymph node metastasis.


Eligibility criteria:
inclusion criteria: patients with papillary microcarcinoma of the thyroid exclusion criteria: patients with thyroid nodules \> 1 cm; incomplete data
to evaluate the efficacy and safety of luminomark injection in patients with nonpalpable breast lesions(phase 3)

Conditions: Breast Diseases

Summary: this study is a multicenter, randomized, open-label, parallel, phase 3 clinical trial in 8 weeks for screening, once investigational product injection, follow up visit.

the purpose of this study is to evaluate the efficacy and safety of luminomark inj. (conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility criteria:
inclusion criteria: 1. 19 years ≤ age ≥ 80 years 2. those who have lesion vial mammography and breast ultrasound 3. those who be expected to do operation about non palpable breast lesion excision 4. written consent voluntarily to participate in this clinical trial exclusion criteria: 1. patients who be expected to do mastectomy 2. patients with multiple tumor or diffuse microcalcification 3. patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection 4. patients who were treated with moderate to severe radiotherapy 5. patients who were treated with neoadjuvant chemotherapy 6. patients with active invading skin connective tissue disease 7. patients with local progressing breast cancer or inflammatory local progressing breast cancer 8. patients who have an allergy to investigational product or any of the component with the investigational product 9. patients who disagree about contraception for this clinical trial 10. a pregnant women or lactating women 11. patients who participated in other clinical trials within the past 12 weeks from the date of informed consent 12. patients who investigators determines unsuitable for this clinical trial

Keywords: nonpalpable breast lesions