Kornimate/medical-research-clean huggingface dataset:
the effectiveness of high-dose intravenous vitamin c with very low carbohydrate diet for terminal colon cancer patients

Conditions: Colon Cancer Stage Iv

Summary: the purpose is to evaluate the effectiveness of high dose intravenous vitamin c (ivc) therapy plus very low carbohydrate diet (vlcd) for stage iv colon cancer (with kras and braf mutation ) with or without chemotherapy.

high dose ivc induces pro-oxidant effects, inhibits energy metabolism, acts as cytotoxic effect, and induces cancer cell apoptosis and necrosis. the recent advance in warburg effect makes a new direction in high dose ivc therapy. the warburg effect is the enhanced conversion of glucose to lactate observed in tumor cells, even in the presence of normal levels of oxygen. converting glucose to lactate, rather than metabolizing it through oxidative phosphorylation in the mitochondria, is far less efficient as less atp is generated per unit of glucose metabolized. therefore, a high rate of glucose uptake is required to meet increased energy needs to support rapid tumor progression.. vitamin c shares very similar structure with glucose. the high-dose ivc gets accessibility to glucose transporter, with competition to glucose. having a reduced level of blood sugar seems to be a necessary parameter to increase ivc's anticancer effectiveness. vlcd with high dose ivc showed effectiveness in case series. the investigator's project is a single-centered, clinical trial (pilot study) for stage iv colon cancer patients with or without chemotherapy. the experimental group will receive high dose vitamin c 75 or 100g (with blood vitamin c level \> 350 mg/dl) in 1000 ml distilled water in 2-hour infusion, twice per week for 12 weeks. then maintenance dose is 75-100 g once per 2 weeks for 12 weeks. very low carbohydrate diet will be executed for the first 12 weeks. the control group will be matched for age, sex and chemotherapy and target therapy medication. the control group will receive usual care. the primary outcome will be the response rate by computerized tomography (ct) of the chest, abdomen and pelvis at 12 weeks and 24 weeks. the secondary outcome will be the improvement of tumor markers (cea and ca199). this is the first clinical trial of ivc therapy with vlcd for stage iv colon cancer in taiwan and in the world. this innovation will give us a primitive answer on the effectiveness of ivc therapy with vlcd for cancers. vitamin c is a cheap and harmless therapy. the study result will open a door for alternative cancer treatment.

Eligibility criteria:
inclusion criteria: * stage iv colon cancer * with kras and braf mutation exclusion criteria: * g-6-pd deficiency, * metastatic kidney disease, * obstructive uropathy, * nephrotic syndrome, * under other alternative medicine treatment or intravenous vitamin treatment, * pregnant or lactating women, * impaired renal function with a serum creatinine ≥ 132.6µmol/l(1.5 mg/dl) * significant fluid retention(pleural effusion, ascites, lower leg edema), * terminal heart failure, * incapability to make decision,

Keywords: high dose vitamin c very low carbohydrate diet
chronic obstructive pulmonary disease endpoints study

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will last for approximately 14 weeks and will involve 5 visits. the study is being carried out to look at different ways of measuring the effect of drug treatment on copd. copd is a respiratory disease which can affect your breathing and daily life. symptoms of copd can include breathlessness, cough, and wheeze. copd varies enormously from patient to patient. the effects of drug treatment are usually measured by conducting lung function tests (breathing tests) using a machine called a spirometer but this does not always provide a complete picture of how well your copd is responding. in this study we therefore want to look at new and more sensitive ways of measuring copd. the results of this research will help in the assessment of new drugs for copd in the future.

evaluation of novel endpoints in subjects with chronic obstructive pulmonary disease (copd) in a randomized, double-blind, placebo-controlled study of treatment with fluticasone propionate/salmeterol 500/50mcg combination (fsc 500/50) and its individual components, fluticasone propionate 500mcg (fp500) and salmeterol 50mcg (sal 50)

Eligibility criteria:
inclusion criteria: * diagnosis of copd * current or ex-smoker at least 10 pack- years exclusion criteria: * diagnosis of asthma * active respiratory disorder other than copd * evidence of clinically significant uncontrolled non-pulmonary disease * carcinoma not in complete remission for last 5 years * lung volume reduction surgery in previous 12 months * nocturnal positive pressure for sleep apnea * other inclusion and exclusion criteria will be evaluated at the first study visit.

Keywords: copd impulse oscillometry system computerized tomography
duragen versus duraguard in chiari surgery

Conditions: Chiari Malformation

Summary: the study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of chiari malformation. one material (duragen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (duraguard) is made out of bovine pericardium and has to be sutured during application. the study compares these two materials used for duraplasty of patients undergoing chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.

the study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. this study follows patients with chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.

Eligibility criteria:
inclusion criteria: * symptomatic chiari malformation exclusion criteria: * presence of ventriculoperitoneal shunt * pregnancy

Keywords: chiari malformation; duraplasty; posterior fossa decompression; duragen; duraguard
self-system therapy for older adults with lung cancer

Conditions: Lung Cancer Stage III; Lung Cancer Stage IV

Summary: the purpose of this study to use self-system therapy (sst), to treat depression and lung-cancer-related distress in older adults (65 years and older).

the investigator will examine whether delivering the sst intervention will be both feasible and acceptable to study participants. the investigator will also examine whether participation in sst can help alleviate symptoms of depression and distress while helping improve overall functioning in older adults with advanced lung cancer.

Eligibility criteria:
inclusion criteria: * age ≥ 65 years * english-speaking * the patient has a diagnosis of late-stage (iii-iv) lung cancer and is living at her/his home. exclusion criteria: * unable to provide informed consent * visual or hearing impairments that preclude participation * serious mental illness
acute effects of smoking on airway dendritic cells

Conditions: Tobacco Use Disorder

Summary: airway dendritic cells control pulmonary immune responses to inhaled particles. it is the aim of the present study to investigate the acute effects of smoking on the number and surface molecule expression of human airway dendritic cells.


Eligibility criteria:
inclusion criteria: * active smoking (at least 10 cigarettes per day) * age \> 18 years exclusion criteria: * any chronic diseases * any regular medication * any signs or symptoms of an acute infection

Keywords: cigarette smoking airway dendritic cells
a study of arq 197 in combination with erlotinib

Conditions: Advanced/Recurrent Non-small-cell Lung Cancer

Summary: this is a phase i study to determine the safety, tolerability and recommended phase ii dose of arq 197 given in combination with erlotinib as primary endpoints in cyp2c19 poor metabolizer patients with advanced/recurrent non-small-cell lung cancer. the pharmacokinetic profile and antitumor activity of arq 197 administered alone or in combination with erlotinib will also be determined as secondary endpoints.


Eligibility criteria:
inclusion criteria: * voluntary written informed consent for study participation must be obtained * a histologically or cytologically confirmed advanced/recurrent non-small-cell lung cancer * history of ≥1 prior chemotherapy regimen (treatment with egfr tyrosine kinase inhibitors will be counted as one regimen) * ecog ps of 0 or 1 * life expectancy of ≥3 months * poor metabolizers as defined by cyp2c19 genotype exclusion criteria: * anti-cancer chemotherapy, anti-cancer therapy with egfr-tki, hormone therapy, radiotherapy, immunotherapy, other investigational agents or anti-cancer antibody therapy within 28 days prior to arq 197 dose * surgery for cancer within 28 days prior to arq 197 dose * active double cancer * known symptomatic brain metastases * an intercurrent illness that is uncontrolled (e.g., infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic arrhythmia, interstitial pneumonia) * pregnant or lactating * subjects who wish to have a child and who would not agree to use contraceptive measures
diagnosis of tuberculosis infection in health care workers using ex-vivo interferon-gamma assay

Conditions: Latent Tuberculosis Infection

Summary: the present study was to evaluate the usefulness of a whole-blood interferon-r release assays (igras) as diagnostic tool of the latent tuberculosis infection for healthcare workers.


Eligibility criteria:
inclusion criteria: * doctors and nurses newly hired at samsung medical center between february, 2008 and november, 2008. exclusion criteria: * non-applicable

Keywords: interferon-gamma release assay
lung health of early copd: a multi-center cohort study

Conditions: COPD

Summary: this is a multi-center, prospective, cohort study in early copd patients. this study aims to elucidate the lung function decline and its association with smoking and other risk factors. other biomarkers and image markers from chest ct scan are also analyzed to investigate the lung function in early copd patients.


Eligibility criteria:
inclusion criteria: 1. gender: male or female 2. age: 35-75 years old 3. post-bronchodilator spirometry: fev1/fvc \< 0.8 and fev1%pred ≥80% exclusion criteria: 1. other diseases may affect lung function, like lung cancer, bronchiectasis, interstitial lung disease or chest surgery. 2. bmi \> 35 kg/m2 3. dementia or other severe neurological disease 4. pregnancy 5. conditions that contraindicated lung function test

Keywords: early copd spirometry lung health
improvement of cardiac function in patients with ischemic cardiomyopathy by extracorporeal shock wave therapy: a multicenter clinical study

Conditions: Coronary Artery Disease

Summary: cardiac shock wave therapy (cswt) is a noninvasive new therapeutic option in the treatment of chronic refractory angina pectoris. many domestic and international researches have revealed that cswt contributes to revascularization by stimulating angiogenesis. we were aimed to evaluate the safety and efficiency of cswt in the treatment of refractory angina.


Eligibility criteria:
inclusion criteria: * patients were 18 to 80 years old; * coronary angiography (ca) or multi-slice ct coronary angiography (ctca) suggestive of moderate to severe coronary artery stenosis; * chest tightness, onset of shortness of breath, and poor exercise tolerance after receiving formal drug treatment (with or without stent or bypass graft); * hospitalized more than 2 times within 1 year due to the aforementioned problems; * ccs angina grading higher than grade ii, and new york heart association (nyha) class i-iii; * more than 1 month after acute myocardial infarction (ami) and 1 month after percutaneous coronary intervention (pci) surgery. exclusion criteria: * ami、pci or coronary artery bypass graft (cabg) within the 4 weeks prior to the study; * history of heart transplantation; * history of metal valve replacement surgery; * intra-cardiac thrombus; * left ventricular ejection fraction (lvef) \< 30 % and unstable hemodynamics; * arrhythmia with a rate \ 120 bpm; * skin ulceration or infection in the treatment area; * severe obstructive lung disease.
evaluation of the impact of non-slip socks on motor recovery in the elderly

Conditions: Aging; Acute Care Unit; Fall Injury

Summary: some authors suggest a possible clinical interest of anti-slip socks. the scientific literature presents studies with methodological limitations. it is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population. the investigatorswould therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.

some authors suggest a possible clinical interest of anti-slip socks. the scientific literature presents studies with methodological limitations, but above all a different population than the one the investigators are interested in. it is therefore not currently possible to judge the specific interest of anti-slip socks in an elderly hospitalized population. evaluating the value of these socks could allow to recommend them with solid data. preventing this iatrogenic loss of autonomy would have a positive impact on the motor capacities of patients, a quicker and easier return home, and a reduction in health costs. the investigators would therefore like to know the interest of wearing non-slip socks in the management of these patients, and more particularly on the main objective of rehabilitation in geriatric physiotherapy: motor function.

Eligibility criteria:
inclusion criteria: * patient in geriatric acute care or post-emergency medicine, * patient 75 years and older, * patient requiring physiotherapy, * patient with a minimum of 7 days of physical therapy * patient arrived with unsuitable footwear (assessment at the discretion of the clinician: no back support, unsuitable size, etc.) or without footwear, * patient able to walk at least 10 m with or without technical assistance, * patient who has given oral consent * patient with social security coverage. exclusion criteria: * inability to understand or perform study-specific clinical tests * known cognitive impairment, disease or condition that compromises comprehension of information or informed consent by the patient * blind patient * patient under guardianship or curatorship * patient participating in an interventional clinical research protocol that may alter the assessments of this protocol. * patient previously included in the charm study * patient with an identified risk of being unable to wear socks or to walk barefoot within the next 7 days (need for compression stockings or socks, wound, excessive edema, orthostatic hypotension, other)

Keywords: non slip socks aging rehabilitation
deep brain stimulation (dbs) for the treatment of parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the safety and effectiveness of boston scientific's vercise deep brain stimulation (dbs) system in the treatment of patients with with advanced, levodopa-responsive bilateral parkinson's disease (pd) which is not adequately controlled with medication.

the study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. guide xt may be used for planning of programming as needed.

Eligibility criteria:
key inclusion criteria: * diagnosis of bilateral idiopathic pd (h\&y ≥ 2) with a duration of pd ≥ 5 years. * persistent disabling parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy. * able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. key exclusion criteria: * any intracranial abnormality or medical condition that would contraindicate dbs surgery. * have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol * any other active implanted devices including neurostimulators and /or drug delivery pumps * any previous thalamotomy, pallidotomy or subjects who have undergone a dbs procedure. * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Keywords: intrepid, vercise, pd, dbs, boston scientific
a single-center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing

Conditions: Sleep Apnea

Summary: this is a single center pilot study evaluating the immediate effects of low-dose acetazolamide on respiratory control in subjects with treatment emergent sleep disordered breathing. the purpose of this study is to assess the immediate effect one-time low-dose acetazolamide on sleep breathing in (treatment emergent sleep disordered breathing) te-csa subjects compared to subjects' baseline evaluation without acetazolamide. investigators will also try to determine the immediate effect of one-time low-dose acetazolamide on subjects' resting ventilation and ventilatory response slope compared to subjects' baseline evaluation without acetazolamide.


Eligibility criteria:
inclusion criteria: * age ≥18 to 80 years * te-csa * subjects are capable of giving informed consent exclusion criteria: * hypersensitivity to acetazolamide or other sulfonamides * intake of carbonic anhydrase inhibitors within the last 72 hours * intake of medication that influences breathing, sleep, arousal or muscle physiology * cheyne-stokes respiration * heart failure * renal failure * liver failure * chronic hypercapnea * hyponatremia * hypokalemia * pregnancy * breastfeeding mothers * active drug/alcohol dependence or abuse history

Keywords: acetazolamide treatment emergent sleep disordered breathing sleep apnea
sleep apnea: age effects on prevalence and natural history

Conditions: Lung Diseases; Sleep Apnea Syndromes

Summary: to identify the prevalence of sleep apnea in men and its relationship to age, assess the natural history of the disorder, and predict those men at risk.

background: sleep apnea is potentially a life-threatening disorder commonly associated with the aging process. often sleep apnea is accompanied by considerable morbidity for both physical and mental health; the associated excessive daytime sleepiness, cardiovascular abnormalities, and cognitive impairment impact greatly on daytime functioning. in 1990, the prevalence of sleep apnea in the general population was undetermined, and there was much speculation regarding its natural history. design narrative: for the prevalence study, 4,364 randomly-sampled men selected from the general population and stratified by age were evaluated for risk factors for sleep apnea. a total of 741 men found to be at risk were evaluated in the sleep laboratory to determine the degree, if any, of sleep apnea or sleep disordered breathing. prior to recording subjects in the sleep laboratory, a thorough history was obtained from each subject and a physical examination completed. all men entering into the first four years of the prevalence portion of the study who were found to have sleep apnea or sleep disordered breathing were reevaluated yearly over a five year period in the natural history part of the study. the natural history portion also included 150 men previously studied in the sleep laboratory for apnea but who were not part of the random sample of 4,000 and who were not part of the prevalence study.

Eligibility criteria:
stratified random sample based on risk severity for sleep disordered breathing based on phone interview
a study to evaluate the safety of xolair in moderate to severe persistent asthma patients (alto)

Conditions: Asthma

Summary: this was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma. a total of 1899 subjects were randomized (2:1) to either the active treatment group or the control group. upon successful completion of the screening period (\~2 weeks), each subject entered the 24 week study.


Eligibility criteria:
inclusion criteria: * documented physician diagnosis of moderate to severe, persistent asthma, defined in the national heart, lung, and blood institute (nhlbi) guidelines as fev1 \< 80% predicted for height, age, and sex or a history of fev1 \< 80% * between 6 and 75 years old at the time of screening (visit 1 \[week -2\]) * current treatment with the following medications: moderate doses of any inhaled steroid preparation on a daily basis for at least 30 days prior to screening; and/or oral steroids at a stable dose on a daily basis for at least 30 days prior to screening; and currently treated with at least one of the following drugs on a daily basis at a stable dose for at least 30 days prior to screening: long-acting β-adrenergic (salmeterol), leukotriene receptor antagonist (ltra), xanthine derivatives, or sodium cromoglycate * signed informed consent (in the case of a minor, consent must have been given by the child's parent or legal guardian) * serum ige level of ≥ 30 iu/ml and ≤ 1300 iu/ml and a body weight ≥ 20 kg and ≤ 150 kg and fell within the protocol-defined dosing table ranges * for females of childbearing potential, in the opinion of the investigator, use of an effective method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study * willingness to participate fully for the duration of the study exclusion criteria: * current active aee defined as requiring initiation or increase in oral steroid dose or treatment with at least a doubling of inhaled steroid dose * thrombocytopenia as evidenced by platelets \< 100,000/ul * pregnancy or lactation * previous randomization in this study * use of any experimental drug within 30 days prior to study screening * known hypersensitivity to any ingredients of xolair, including excipients (sucrose, histidine, polysorbate 20) * diagnosis of aspirin or nonsteroidal anti-inflammatory drug-induced asthma * active lung disease other than asthma (e.g., chronic bronchitis, emphysema, cystic fibrosis, chronic obstructive pulmonary disease) * history of smoking within 2 years of the study screening visit or history of smoking ≥ 10 pack years * significant systemic disease (e.g., infection, hematologic, renal, hepatic, coronary heart disease or other cardiovascular diseases, endocrinologic or gastrointestinal disease) within the previous 3 months * history of neoplasia * history of noncompliance to medical regimens * any systemic condition requiring regular administration of immunoglobulin

Keywords: alto