Kornimate/medical-research-clean huggingface dataset:
a study of chinese herbal compound dendrobium huoshanense granules in ncrt for patients with locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: the study evaluates the addition of chinese herbal compound dendrobium huoshanense granules to capecitabine and irinotecan in neoadjuvant chemoradiation(crt) in locally advanced rectal cancer. half of participants will receive crt with dendrobium huoshanense granules, while the others will receive crt with placebo. we will evaluate whether dendrobium huoshanense granules can enhance the immune function and alleviate symptoms caused by the tumor and crt .


Eligibility criteria:
inclusion criteria: * pathological confirmed rectum adenocarcinoma * clinical stage t3-4 and/or n+ * the distance from anal verge less than 10 cm * without distance metastases * performance status score: 0\~1 * ugt1a1\*28 6/6 or 6/7 * without previous anti-cancer therapy * able to follow the protocol during the study period * sign the inform consent exclusion criteria: * pregnant or breastfeeding women * those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ * if there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. * clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, new york heart association (nyha) class ii or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months * organ transplantation requires immunosuppressive therapy * severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases * subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / l; absolute neutrophil count (anc) ≥ 1.5 × 109 / l; alanine transaminase (alt), aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (alp) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / l * anyone who is allergic to any research medication * dpd deficiency * ugt1a1\*28 7/7

Keywords: neoadjuvant chemoradiotherapy dendrobium huoshanense irinotecan capecitabine
influence of body composition on chemotherapy outcomes in localized breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if pharmacokinetics of docetaxel is modified by the body composition (assessed by the bmi but also by ct-scan) in patients treated by docetaxel as adjuvant treatment of a localized breast cancer

half of the patients treated for a localized breast cancer are obese or overweighted. recently published post-hoc analyses of a large randomised trial (big-2-98) revealed that bmi could impact the benefit of a docetaxel based chemotherapy, but not of an anthracyclin based chemotherapy. one of the hypothesis is that the distribution volume of hydrophobic drugs, such as docetaxel, may be influenced by the bmi, and more precisely by the amount of total fat. in that context, we aim to assess the docetaxel pharmacokinetics during its first exposure for localized breast cancer, and compare these results according to 3 groups of patients (lean, overweight and obese).

Eligibility criteria:
inclusion criteria: * woman older than * early breast cancer * ct-scan of less than 3 months, including l3 level * indication of docetaxel at 100 mg/m² as adjuvant ct exclusion criteria: * her2 amplified or triple negative tumors * pregnant or breastfeeding women * patients under guardianship or curatorship * concomitant administration of another cytotoxic drug or targeted therapy * psychosocial disorder * administration of another cytotoxic drug or targeted therapy within 20 days prior to blood collection

Keywords: breast cancer body composition docetaxel pharmacokinetics
effectiveness of antidiabetic treatment applied in childhood obesity

Conditions: Childhood Obesity; Insulin Resistance

Summary: in our study, there are 33 healthy children with normal weight (control group) and 52 obese children who will be treated with metformin. to observe the efficacy of the 3-month treatment before and after metformin treatment, zn, zinc α-2 glycoprotein (zag), peroxisome proliferation activating receptor γ (pparγ), leptin (lep) and adiponectin (adipo) levels were compared, as well as anthropometric measurements and routine biochemistry tests.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) \> 95th percentile * having insulin resistance * having a family history of type 2 diabetes mellitus (t2dm) exclusion criteria; * alcohol consumption and smoking * having t1dm and t2dm * history of drug use

Keywords: obesity metformin biomarker
epidermoid cancer development in esophageal achalasia

Conditions: Achalasia; Epidermoid Carcinoma

Summary: esophageal achalasia is a precancerous condition for epidermoid carcinoma; incidence and risk factors for cancer development are not defined. incidence and risk factors for epidermoid carcinoma development in achalasia patients were investigated.

in order to define incidence and risk factors for epidermoid carcinoma 681 patients affected by esophageal achalasia observed since 1973 were followed up with no time limits according to a prospective follow-up protocol. the local institutional review board approved using the database from the division of thoracic surgery for research purposes. clinical, radiological and endoscopic data of achalasia patients were collected and analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of primary esophageal achalasia achieved by means of radiology, endoscopy and manometry exclusion criteria: * pseudoachalasia

Keywords: epidermoid carcinoma esophageal achalasia risk factors
the effect of volitional pursed-lips breathing

Conditions: COPD

Summary: simulation of pursed-lips breathing by defined stenoses in pulmonary function diagnostics to quantify the effect of the pursed-lips breathing

since many years it is recommended for copd patients to reduce the crossdiameter of the lips in order to improve the exhalation by means of so-called pursed-lips breathing (plb). but the effects have never been studied quantitatively. in this study, the plb effect is simulated during lung function diagnostics, using different sized resistors inserted into the routine mouthpiece of the flow sensor to resemble the effective airway resistances of a plb maneuver. this prospective, randomized study includes 20 healthy subjects and 50 copd patients, who will perform lung function testing with 4 different sized resistors.

Eligibility criteria:
inclusion criteria: patients: * copd (gold i- iv) * stable respiratory situation that allows routine lung funtion * capable of communication healthy: * lung healthy * capable of communication exclusion criteria: * invasive ventilation * other serious acute physical illnesses that require immediate intensive medical treatment * acute hypercapnic decompensation with a ph \< 7.35 in the capillary bga * pregnancy or nursing * not able to give consent * not willing or able to follow the study protocol

Keywords: pursed-lips breathing resistor
the efficacy and safety of apatinib monotherapy in maintenance treatment of extensive-stage small-cell lung cancer

Conditions: Apatinib in Maintenance Treatment

Summary: 52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.

52 patients with extensive-stage small-cell lung cancer, who had a best response of complete response (cr), partial response (pr), or stable disease (sd) after completing chemotherapy will receive apatinib monotherapy as maintenance therapy after chemotherapy to evaluate the efficacy and safety of maintenance apatinib after chemotherapy for small-cell lung cancer. at the same time, we will explore the correlation between efficacy and tumor stem cell markers expression by taking peripheral blood to detect tumor stem cell markers. the primary end point is progression-free survival (pfs). the secondary end point is overall survival (os), toxicity, and the correlation between efficacy and tumor stem cell markers expression.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy) * having a best response of complete response (cr), partial response (pr), or stable disease (sd) after completing chemotherapy, or combining sequential radiotherapy * prior treatment without c-kit targeted drugs * life expectancy of more than 3 months * age ≥ 18 years * oncology group performance status of 0 to 2 * informed consent. exclusion criteria: * mixed lung cancer or other types of lung cancer * have previously received c-kit targeted drugs * hemoglobin\<8.0 g/dl, white blood cell \<3 x 10\^9/l, platelet count \<75 x 10\^9/l, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times * known or suspected allergy to the investigational agent or any agent given in association with this trial * patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation * uncontrol hypertension, \>160/100 mmhg after treatment * pregnant or lactating patients * known history of human immunodeficiency virus (hiv), hepatitis c virus (hcv) infection * patients who are suffering from serious autoimmune disease * patients who had active infection * patients who are suffering from serious organ dysfunction * patients who are suffering from other cancer * other situations that the researchers considered unsuitable for this study. * other concurrent uncontrolled illness
prophylactic non-invasive ventilation during surgical procedure in rhythmology

Conditions: Cardiac Electrophysiology; Anesthesia; Acute Respiratory Failure

Summary: acute respiratory failure is frequent during rhythmology procedure under light sedation in high risks selected patients. non invasive ventilation (niv) is recommended for acute cardiogenic pulmonary oedema and sleep apnea. the investigators will perform a monocentric, prospective, randomized controlled trial to compare the efficacy of niv which associated pressure support ventilation (psv: 5 to 15 cmh2o) and positive end expiratory pressure (peep: 5 to 10 cmh2o) with standard oxygen therapy in prevention of peroperative respiratory event. our hypothesis is that peroperative use of niv should reduce the incidence of apnea and hypoxia during procedure in rhythmology under light sedation.

this study is an investigator-initiated, monocentric, two-arm parallel-group trial with electronic system based randomization. the study protocol was approved by a central ethics committee (france) according to french law. our teaching hospital have a long experience with peroperative use of niv during light sedation and acute respiratory failure. this study is designed as a probe study (prospective randomized open with blinded evaluation) : the investigators will provide a blinded analysis of peroperative computer collected data.

Eligibility criteria:
inclusion criteria: * age of 18 years old or above * procedure in electrophysiology laboratory * high risk patient defined by an american society of anesthesiology (asa) score of 3 or 4 exclusion criteria: * planned orotracheal intubation * asa 1 or 2 * sleep apnea treated with home non invasive ventilation * major contraindication to niv use * pregnancy * consent refusal * patients protected under the french law l1121-5 to l1121-8
korea national diabetes program

Conditions: Type 2 Diabetes Mellitus; Diagnosis; Treatment; Prevention; Complications

Summary: this is an observational study done by creating a cohort of korean patients with diabetes and those at high risk of developing diabetes. by the creation of this cohort we aim to establish efficient preventive, diagnostic, and therapeutic measures based on the characteristics of korean patients with diabetes, and by doing so, we hope to ultimately decrease our country's diabetes-related-mortality and increase the quality of life of patients with type 2 diabetes.

it is estimated that in 20 years the number of patients with diabetes will be over 6 million. therefore the importance of diagnosis, treatment, and prevention of diabetes needs no further emphasis. at the moment, current studies demonstrate that mortality has increased twofold in the last 10 years due to lack of adequate control, and that medical expenses related to diabetes is increasing. therefore, the necessity to find means for effective prevention and management of diabetes seems pressing. however, unfortunately, in korea, results of systematic clinical trials carried out in the korean population are not available. all the currently available management guidelines have been formulated based on the results of clinical trials carried out in other populations, on patients with perhaps different characteristics compared to ours. there are quite a number of problems in applying these guidelines to our patients. this study's purpose is to create a basis on which we could establish effective prevention, diagnosis, and therapeutic plan based on specific characteristics of korean patients with type 2 diabetes.

Eligibility criteria:
inclusion criteria: (group 1:diagnostic criteria for type 2 diabetes based on ada 2004 guidelines) * random plasma glucose \>200mg/dl + symptoms such as polyuria, polydipsia, unexplained weight loss * fasting plasma glucose \>126 mg/dl or 75g oral glucose tolerance test (ogtt) 2h plasma glucose \>200 mg/dl (group 2: high risk for diabetes based on ada 2004 guidelines) * ifg: fasting plasma glucose 100-125 mg/dl and 75g ogtt 2h plasma glucose \<140 mg/dl * igt: fasting plasma glucose \<100 mg/dl and 75g ogtt 2h plasma glucose 140-199 mg/dl (group 3: gestational diabetes based on ada 2004 guidelines) * 50g ogtt 1h plasma glucose \>140 mg/dl * 100g ogtt fasting plasma glucose \>95 mg/dl, 1h plasma glucose \>180 mg/dl, 2h plasma glucose \>155 mg/dl, 3h plasma glucose \>140 mg/dl exclusion criteria: -
observation study of clinical manifestation and outcome in chinese patients with pulmonary vasculitis

Conditions: ANCA-associated Vasculitis; Granulomatosis With Polyangiitis; Microscopic Polyangiitis; EosinphilicGranulomatosis With Polyangiitis

Summary: the purpose of this study is to observe the clinical manifestation, lab findings including chest ct scans, pathological findings and outcomes in chinese patients with pulminary vasculitis.

presentation of patient with suspected vasculitis 1. established diagnosis clinical findings laboratory workup tissue biopsy angiogram where appropriate 2. evaluating respiratory system chest hrct pulmonary function test bronchoscopy exam(balf, tbb) lung biopsy(needle biopsy, vast) 3. screening underlying damage to other system paranasal sinus, vision \& audition nervous system kidney gastrointestinal tract heart \& vessel skin hematology muscle, bone \& joint 4. treatment 5. prognosis evaluation 1. study visits occurred at baseline; at weeks 4; and at 2, 4, 6,12,18,24,30 months. 2. disease activity was measured on the basis of the bvas/wg and the physician's global assessment. 3. damage related to disease or treatment was scored according to the vasculitis damage index (scores for this index range from 0 to 64, with higher scores in- dicating more severe damage). 4. health related quality of life was scored with the use of the med- ical outcomes study 36-item short-form health survey (sf-36).scores on this scale range from 0 to 100, with higher scores indicating better health. 5. serial serum samples were tested for proteinase 3-anca and myeloperoxidase-anca by means of a direct enzyme-linked immunosorbent assay (elisa).

Eligibility criteria:
inclusion criteria: * males and females * aged from 18-75 years with informed consent * patients with anca-vasculitis 1. wegener's granulomatosis, microscopic polyangiitis or css 2. positive serum assays for proteinase 3-anca or myeloperoxidase-anca 3. manifestations of activity disease, and birmingham vasculitis activity score for wegener's granulomatosis (bvas/wg) of 3 or more (scores range from 0 to 63, with higher scores indicating more active disease) exclusion criteria: * females planning to bear a child recently or with childbearing potential * secondary vasculitis, cancer,infective disease or drug induced vasculitis

Keywords: anca-associated vasculitis granulomatosis with polyangiitis microscopic polyangiitis wegner's granulomatosis eosinphilic granulomatosis with polyangiitis
melanoma vaccine in treating patients with stage iii melanoma after surgery to remove lymph nodes

Conditions: Melanoma (Skin)

Summary: rationale: vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells. purpose: this phase i/ii trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage iii melanoma after surgery to remove the lymph nodes.

objectives: * determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic cells pulsed with tumor antigen peptides in patients with stage iii melanoma following lymphadenectomy. * determine the immune response (skin test of delayed-type hypersensitivity and flow cytometric enumeration of peripheral blood cd8+ lymphocytes producing ifn-γ) to this regimen in these patients. * determine clinical outcome (disease-free survival, overall survival, and adverse events) in patients treated with this regimen. outline: patients undergo leukapheresis for collection of peripheral blood mononuclear cells (pbmcs) and bone marrow mononuclear cells. autologous dendritic cells (dcs) prepared from pbmcs and bone marrow mononuclear cells are exposed to various antigens and peptides, and autologous tumor cell lysate, if available. patients receive autologous dcs pulsed with melanoma-associated antigen peptides, and autologous dcs pulsed with tumor lysates (if available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. patients with no evidence of disease may receive another booster injection 5 years after the start of vaccination. blood samples are examined via flow cytometry and skin testing is performed to evaluate immune response.

Eligibility criteria:
disease characteristics: * diagnosis of stage iii melanoma * has undergone therapeutic lymphadenectomy * more than 1 lymph node involvement or extracapsular extension of metastatic melanoma cells (stage n1b-n3 disease according to ajcc 2002) * hla type a1 and/or a2 or a3 (if autologous tumor lysate is available) * no presence of distant metastases patient characteristics: * no other malignancy * no evidence of lung, heart, liver, or renal failure or severe neurologic disorder * no autoimmune disease or atopic allergy * no hiv infection or presence of anti-hiv antibodies * no presence of hepatitis b surface antigen or antibodies against hepatitis c virus prior concurrent therapy: * see disease characteristics

Keywords: stage iii melanoma
assessment of relation between recurrence of enterocutaneous fistula and preoperative c-reactive protein level after complete surgical repair

Conditions: Enterocutaneous Fistula

Summary: a prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ecf. the investigators used preoperative serum c-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.

there is a controversy in timing of operation. the timing depends on clinical assessment, laboratory tests and radiological investigations. the cornerstone of this decision is to control sepsis and inflammatory condition before surgery. this issue made surgeons favor longer interval between incidence of ecf and definite surgical treatment. in some cases there may be a hidden place for infection or continuation of the inflammatory situation without clear signs, which necessitated the presence of a possible indicator helps in making the surgical decision. serum c-reactive protein is the common inflammatory marker used to exclude inflammatory condition. although its level is within normal range but some cases showed high recurrence rate when the level exceeded certain as the investigators believed in their study. now the investigators can say that the perioperative serum c-reactive protein level can be used as an objective parameter for helping to make surgical decision and reduce recurrence of ecf.

Eligibility criteria:
inclusion criteria: * patients with ecf were included in the study exclusion criteria: * cases submitted for surgical treatment with protecting stoma or terminal were excluded from our study. other fistulas like perianal, pancreatic, biliary and internal fistulas were not involved due to their different nature, treatment and prognosis

Keywords: enterocutaneous fistula - c-reactive protein- surgical repair
a dual energy catheter (pfa and rfa) and a pfa catheter for the treatment of peaf

Conditions: Persistent Atrial Fibrillation

Summary: the goal of this clinical trial is to treatment of patients with persistent atrial fibrillation with pfa/rfa. 10 patients will be treated by pfa/rfa catheter or pfa catheter only. participants will followed 1、3 month after catheter ablation


Eligibility criteria:
inclusion criteria: 1. aged 18-75 years old; 2. documented symptomatic persistent atrial fibrillation, defined as persistent atrial fibrillation lasting more than 7 days and less than 1 year； 3. ineffective or intolerable after treatment with at least one class i or class iii antiarrhythmic drug; 4. fully understand the treatment protocol and voluntarily sign the informed consent form and be willing to undergo the tests, procedures and follow-ups required by the protocol. exclusion criteria: 1. patients who have undergone left atrial surgery 2. left atrial thrombosis 3. patients with combined atrial tachycardia and atypical atrial flutter 4. patients of childbearing age who are unable to use effective contraception during the 3-month period following enrollment 5. anterior and posterior left atrial diameter ≥ 55mm 6. left ventricular ejection fraction (lvef) ≤ 40% 7. previous atrial septal repair or atrial mucinous tumor 8. active implants (e.g. pacemakers, icds, etc.) in the body 9. nyha class iii-iv cardiac function 10. clear cerebrovascular disease within the last 6 months (including cerebral hemorrhage, stroke, transient ischemic attack) 11. cardiovascular events within the last 3 months (including acute myocardial infarction, coronary intervention or heart bypass surgery, prosthetic valve replacement or repair, atrial or ventriculotomy) 12. those with acute or severe systemic infections 13. patients with severe liver or kidney disease, malignant tumors or end-stage disease that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial 14. patients with significant bleeding tendency, hypercoagulable state and severe hematologic disorders 15. patients who have participated or are participating in other clinical trials within 3 months prior to enrollment 16. patients who have other conditions that the investigator considers inappropriate for participation in this trial.

Keywords: pfa peaf pfa/rf