Kornimate/medical-research-clean huggingface dataset:
clinical observation of s1 capsule for stage ⅱ-ⅲa non-small cell lung cancer after complete resection

Conditions: Non-small Cell Lung Cancer Stage Ⅱ; Non-small Cell Lung Cancer Stage ⅢA

Summary: the purpose of this study is to evaluate s1 capsule plus cisplatin as adjuvant treatment in stageⅱ and ⅲa non-small cell lung cancer. it is the first study in the world to investigate the safety and efficacy of s1 capsule using in stageⅱ and ⅲa non-small cell lung cancer patients after the complete resection.

lung cancer is the leading cause of cancer death worldwide. only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. non-small cell lung cancer (nsclc) accounts for more than 85% of all lung cancer cases. for individuals with stage ⅱ-ⅲa nsclc after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. various treatment regimens have been developed to improve survival. s-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. s-1 capsule was considered to be an active single agent against nsclc.

Eligibility criteria:
inclusion criteria: * patient with completely resected stage ⅲa non-small cell lung cancer(nsclc) * must be able to receive the therapy of the study within four weeks after the completely resection exclusion criteria: * systemic anticancer treatment * local radiotherapy

Keywords: stage ⅱ-ⅲa nsclc s1 capsule completely resection
a study of ags-1c4d4 in pancreatic cancer subjects previously treated in protocol 2008002

Conditions: Pancreatic Cancer; Carcinoma, Pancreatic Ductal; Pancreatic Disease

Summary: the purpose of this study is to continue the safety and immunogenicity of ags-1c4d4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.

subjects will receive a maintenance dose of ags-1c4d4 every 3 weeks (q3w) in addition to the gemcitabine administration. if subjects have grade 4 adverse events considered to be related to ags-1c4d4 at anytime during the study, ags-1c4d4 treatment will be discontinued for that subject. subjects will continue to have their tumor status assessed by computerized tomography (ct) and magnetic resonance (mri) scans according to response evaluation criteria in solid tumors (recist version 1.1) guidelines every eight weeks (q8w). subjects without evidence of disease progression will continue to receive ags-1c4d4 and gemcitabine until intolerability, disease progression or consent withdrawal. subjects who discontinue ags-1c4d4 for any reason will undergo an end of study visit 4 weeks after their last ags-1c4d4 infusion.

Eligibility criteria:
inclusion criteria: * subject has stable disease or better per response evaluation criteria in solid tumors (recist) criteria v.1.1. in protocol 2008002 exclusion criteria: * more than 6 weeks (2 doses) has lapsed from the time of the last infusion in ags-1c4d4 protocol 2008002 * use of the following prohibited medications / therapies: * monoclonal antibody therapy, other than ags-1c4d4 * chemotherapy, other than gemcitabine * investigational therapy other than ags-1c4d4 * erlotinib (tarceva) * any clinical condition which would not allow safe conduct of this study

Keywords: gemcitabine asp6182 ags-1c4d4 pancreatic cancer
relative bioavailability of of olodaterol and ketoconazole

Conditions: Healthy; Pulmonary Disease, Chronic Obstructive

Summary: this clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol


Eligibility criteria:
inclusion criteria healthy male and female volunteers exclusion criteria
didgeridoo treatment to improve pharyngeal compliance in obstructive sleep apnea-hypopnea syndrome in children

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the therapeutic management of obstructive sleep apnoea syndrome in children remains a debated subject, only otorhinolaryngology surgery (adenoidectomy) has been studied on a large scale. pathophysiologically, increased pharyngeal collapsibility is a major endotype of the disease and the investigators have shown that this surgery can improve pharyngeal compliance. the development of approaches to treat pharyngeal hypotonia by maxillofacial rehabilitation supports the treatment of this endotype. a study in adults showed a benefit from playing the didgeridoo, a wind instrument, for 3 months, without pathophysiological explanation. the investigators hypothesise that playing this instrument improves pharyngeal compliance (re-education effect) in a similar way to the effect observed after otorhinolaryngology surgery. this proof-of-concept study aims to demonstrate the effect of didgeridoo in children without syndromic pathology with a formal otorhinolaryngology surgical indication resulting from tonsillar hypertrophy (brodsky grades iii and iv) and symptomatology suggestive of obstructive sleep apnoea syndrome (pediatric sleep questionnaire score ≥ 0.33). the investigators will take advantage of the long delay in performing the adenoidectomy (\~6 months) in their university hospital to evaluate, before the scheduled surgery, the effect of the didgeridoo used for three months.

randomised controlled trial, with minimisation criteria, single blind, bicentric. the subjects will be divided into 2 groups, according to the strategy of care before the date of the scheduled surgery: 1. abstention (routine care) 2. didgeridoo rehabilitation. the primary objective is to improve pharyngeal compliance measured non-invasively by acoustic pharyngometry in the didgeridoo arm compared to a no treatment arm. the secondary objectives are to demonstrate the effect of the didgeridoo on clinical signs associated with obstructive sleep apnoea syndrome and on an indirect index of apnea-hypopnea during sleep.

Eligibility criteria:
inclusion criteria: * clear tonsillar hypertrophy (brodsky grade iii to iv), justifying surgery * pediatric sleep questionnaire ≥ 0.33 * discontinuation of any prescribed medication for obstructive sleep apnea syndrome (anti-histamine and montelukast) * access to the didgeridoo course * consent of the holders of parental authority and agreement of the child exclusion criteria: * syndromic pathology * lack of affiliation to a social security scheme * holders of parental authority under guardianship or curatorship

Keywords: didgeridoo
construction of clinical diagnostic model for pulmonary hypertension

Conditions: Pulmonary Hypertension

Summary: primary objective: to establish a non-invasive diagnostic model for pulmonary hypertension based on laboratory indicators and echocardiographic parameters. secondary objectives: to investigate the correlations between laboratory test indicators and echocardiographic data, and to develop new parameters based on preliminary analysis to assist in the diagnosis of pulmonary hypertension

data collection: collect vital signs (age, sex, etc.), clinical laboratory tests (complete blood count, biochemistry, bnp, d-dimer, and related derived parameters), and echocardiographic data from both the control group and pulmonary hypertension (ph) patients. obtain hemodynamic data measured via right heart catheterization (rhc) in ph patients. model development: construct a clinical diagnostic model using laboratory and echocardiographic data. fit hemodynamic parameters of ph patients based on their laboratory indicators, then assess the hemodynamic status using the fitted parameters and compare with actual measurements. secondary analyses: investigate correlations between echocardiographic parameters and laboratory test indicators in ph patients. identify core variables to develop novel diagnostic parameters and evaluate their diagnostic performance.

Eligibility criteria:
inclusion criteria: * patients diagnosed with any subtype of pulmonary hypertension (ph) confirmed by right heart catheterization (rhc) between 2020 and 2025. no gender restrictions; age \>18 years. availability of complete rhc records, transthoracic echocardiography (tte), and laboratory test results (echocardiography and lab tests must be performed within one month before or after rhc). exclusion criteria: * pulmonary veno-occlusive disease (pvod) active or history of malignancy (or malignant tumors if referring to current cases) hematologic disorders

Keywords: pulmonary hypertension diagnosis machine learning heamodynamic status
optical coherence tomography: an adjunct to flexible bronchoscopy in the diagnosis of lung cancer

Conditions: Lung Cancer

Summary: optical coherence tomography will be a feasible adjunct to flexible bronchoscopy, and provide images with good sensitivity and specificity to determine the presence of endobronchial malignancies.

oct could become a powerful tool in diagnostic pulmonary medicine, not only in the early recognition of lung cancer, but also in the evaluation and monitoring of microstructures in the lower respiratory tract that are affected by other inflammatory or invasive disease processes. initially, oct could be used to guide the location of biopsies which would likely provide increased specificity to traditional bronchoscopy. however, if the sensitivity and specificity of oct images are comparable to histologic specimens, this technology may in the future provide a non-invasive "optical biopsy", which could potentially obviate the need for conventional biopsies in patients with high risks for complications, such as bleeding.

Eligibility criteria:
inclusion criteria: * subjects 18-99 years of age * presence of an endobronchial mass * need for flexible bronchoscopy, with endobronchial biopsies exclusion criteria: * pco2 \> 47 mm hg, and/or long term oxygen therapy * unwillingness to undergo fiberoptic bronchoscopy * coagulopathy, defined as a platelets count \ 1.4, or known clinical bleeding disorder * therapy with anticoagulant, including coumadin and clopidogrel * renal dysfunction, defined as a creatinine \> 2 mg/dl * life-threatening arrhythmias, or history of myocardial infarction within 6 months * cerebrovascular accident within the preceding 6 months * facial abnormality preventing safe introduction of the bronchoscope * uncontrolled hypertension * active liver disease * pregnancy or breastfeeding * prisoners * inability to give informed consent

Keywords: lung cancer bronchoscopy optical coherence tomography
nutrition and frailty in older persons

Conditions: Frailty

Summary: the purpose of this study is to investigate the association between nutrition and frailty in older community-living persons.

nutrition is regarded as an important etiologic factor in the development of frailty in older adults. to date the relation between nutrition and frailty is only poorly described. thus, it is the purpose of this study to investigate the association between different nutrition characteristics and frailty in older community-living persons. 206 volunteers aged 75 years or older were included in this cross-sectional study. nutritional assessment included the mini-nutritional assessment (mna), a food-frequency questionnaire and a standardised three-day dietary record. intake of energy and nutrients was calculated using the german nutrient database bls ii.2. dietary patterns were described by different dietary scores. frailty was defined according to fried et al. based on the following criteria: weight loss, exhaustion, grip strength, walking speed and physical activity. in addition several standardised tests were performed to characterise physical performance (timed up \& go, repeated chair stands, balance tests). the association between nutritional aspects and physical performance is evaluated in an explorative manner.

Eligibility criteria:
inclusion criteria: * age of 75 years and older * living independently at home exclusion criteria: * acute illness * cognitive impairment (mini mental state examination ≥ 24 out of 30 points)
stn-stimulation versus best medical treatment in advanced pd

Conditions: Parkinson's Disease

Summary: assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus compared with drug treatment alone in patients with advanced parkinson's disease.

patients are randomized either to medical treatment or subthalamic stimulation. the observation period was 6 months. the primary outcome criterium: pdq-39 and updrs iii.

Eligibility criteria:
inclusion criteria: advanced parkinson's disease with updrs iii score \>29/104 or dyskinesia score \> 2 or tremor \>2 exclusion criteria: age\>75 years depression psychosis surgical contraindications
open-label study to assess the safety and efficacy of cdp6038 (olokizumab) in patients who completed ra0056

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the long term safety and tolerability of cdp6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis who completed study ra0056 (nct01242488).

male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg cdp6038 (olokizumab), every two weeks, for the treatment of active rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: * subject completed the ra0056 study (week 12 visit) * subject must have maintained their stable dose (and route) of methotrexate (mtx) between 12.5 to 25mg/week in ra0056, and plan to maintain this same dose and route of administration for at least 12 weeks * female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). abstinence is not considered an acceptable method of contraception for this study * female subjects of childbearing potential must agree to use 2 methods of adequate contraception during the study and for 6 months (24 weeks) after their last cdp6038 (olokizumab) dose * male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of cdp6038 (olokizumab) exclusion criteria: * subject has an ongoing serious adverse event from the ra0056 study * female subject of childbearing potential has a positive pregnancy test at week 12 in study ra0056 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of study medication * subject has evidence of active or latent tuberculosis * subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug other than mtx * subject has an alcohol consumption of more than 1 unit per weekday. one unit equals 1 glass of beer or lager (\~330ml), a glass of wine (125ml), or a measure of spirits/hard liquor (25ml) * subject with any other condition in ra0056 (eg, clinically significant laboratory values, frequent adverse events) which in the investigator's or sponsor's judgment would make the subject unsuitable for inclusion in the study

Keywords: rheumatoid arthritis cdp6038 interleukin-6
effect of anti-inflammatory diet in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases

Summary: for the first time, this study developed an anti-inflammatory diet （aid） recipe suitable for inflammatory bowel disease（ibd） patients and developed an aid application program to verify the intervention effect of aid on ibd patients, which not only promoted the application of aid in ibd patients and promoted the promotion of aid model, but also provided new ideas for the prevention and treatment strategies for ibd patients.

this study aims to verify the intervention effect of aid on ibd patients, promote the promotion of aid model, and provide new ideas for the prevention and treatment strategies of ibd patients. in this study, 66 ibd patients who met the inclusion criteria were divided into experimental group and control group by randomized controlled trial method. the experimental group was based on routine nursing measures, and the intervention group taught patients to take anti-inflammatory diet and use the anti-inflammatory diet mini-program developed by the researcher, daily anti-inflammatory diet, intervention time was 8 weeks, and observed the inflammatory indicators (white blood cells, neutrophils, erythrocyte precipitation, crp), quality of life, anxiety and depression, self-efficacy and other conditions in the blood results of the patients before and after intervention.

Eligibility criteria:
inclusion criteria: 1. diagnosis of inflammatory bowel disease, the diagnostic criteria refer to the 2018 revised consensus opinion on the diagnosis and treatment of inflammatory bowel disease; 2. the patient has clear consciousness and certain understanding, language expression and writing ability; 3. patients participated in this study knowingly and voluntarily; 4. at least 18 years old. exclusion criteria: 1. cognitive impairment, mental illness, accompanied by mental disorders; 2. alcohol and drug abusers. 3. the patient could not participate in the researcher due to the deterioration of the condition; 4. patients who voluntarily quit due to other reasons; 5. those who did not complete the assessment scale during the experiment.

Keywords: anti-inflammatory diet inflammatory index quality of life
extension study to assess long term safety, tolerability, and efficacy of valsartan and enalapril combined and alone in children with hypertension

Conditions: Hypertension

Summary: the purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.


Eligibility criteria:
inclusion criteria: * successful completion of 12 weeks of double-blind treatment in core protocol cval489k2302. * patients participating in study cval489k2302 who may have discontinued prematurely due to uncontrolled hypertension defined as mssbp \> 20%, but \< 25% above the 95th percentile for age, gender, and height after visit 5, qualifies a patient for entry into this extension study. exclusion criteria: * renal artery stenosis. * current diagnosis of heart failure (nyha class ii-iv). * second or third degree heart block without a pacemaker. * concurrent potentially life threatening arrhythmia or symptomatic arrhythmia. * clinically significant valvular heart disease. * patient that demonstrates clinically significant ecg abnormalities other than those associated with left ventricular hypertrophy and av block controlled with a pacemaker. * previous solid organ transplantation except renal, liver or heart transplantation. renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator. * patients who experienced any adverse events considered serious and drug related in protocol cval489k2302. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: children pediatrics high blood pressure hypertension valsartan enalapril
engineering gut microbiome to target breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to find out if using probiotics will help the body's immune system react to breast cancer. new studies showed that diverse species of bacteria inside the bowel might help improve immune system, particularly the ability of immune system to recognize cancer. this study will investigate how probiotics will affect the subjects' immune system on breast cancer.


Eligibility criteria:
inclusion criteria: * post-menopausal females ≥ 18 years of age * histologically confirmed adenocarcinoma of the breast ≥1.0 cm operable stage i-iii * must have adequate organ function, * not receive systemic neoadjuvant therapy * be willing to provide tissue, blood, and stool samples for research study. * must not have taken any probiotics in the past 60 days prior to enrollment. exclusion criteria: * patients with autoimmune disease, immune deficiency such as hiv, irritable bowel, known diverticulosis, and other serious gi conditions at treating physician's discretion will be excluded.
gluten free diet in diminishing side effects patients with acute myeloid leukemia undergoing induction chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: this randomized phase ii trial studies how well a gluten free diet works in diminishing side effects in patients with acute myeloid leukemia undergoing induction chemotherapy. a gluten free diet may result in less intestinal side effects and blood infections during the induction chemotherapy compared to a standard diet.

primary objectives: i. to determine if a gluten free diet (gfd) modulates the rate and severity of bacteremia and gastrointestinal toxicity (measured by total parenteral nutrition \[tpn\] or nothing by mouth \[npo\] order) in patients undergoing standard acute myeloid leukemia (aml) induction chemotherapy. secondary objectives: i. to determine the tolerance of, and compliance with, a gfd in patients undergoing standard aml induction chemotherapy. outline: patients are randomized to 1 of 2 groups. group i: patients receive gfd prepared by the hospital per dietary/nutrition pharmacy standards from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). patients also complete a daily food intake diary. a stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis. group ii: patients receive a standard diet for from the initiation of induction chemotherapy until hospital discharge (approximately 30 days). patients also complete a daily food intake diary. a stool sample is collected from patients at baseline, day 14, and on the day of hospital discharge for gut microbiome analysis.

Eligibility criteria:
inclusion criteria: * patients undergoing aml induction chemotherapy with an anthracycline + cytarabine-based chemotherapy regimen * no history of celiac disease or non-celiac gluten sensitivity * no grade 3 or 4 gastrointestinal (gi) toxicity at time of initial screening * no documented bacteremia at time of initial screening * eastern cooperative oncology group (ecog) performance status 0, 1 or 2 at time of initial screening exclusion criteria: * pregnant women