Kornimate/medical-research-clean huggingface dataset:
a study of ramucirumab combination therapy in japanese participants who have advanced stomach cancer

Conditions: Stomach Neoplasms

Summary: the main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and antitumor response of ramucirumab in combination with platinum/fluoropyrimidine regimens in japanese participants with advanced gastric/gastrooesophageal junction cancer who have not received chemotherapy.


Eligibility criteria:
inclusion criteria: * a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (gej) adenocarcinoma which is metastatic or locally advanced and unresectable. a participant with esophageal cancer is not eligible. * not have received prior first-line systemic chemotherapy for locally advanced and unresectable and/or metastatic disease. participants whose disease has progressed after \>6 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible. * measurable or nonmeasurable, but evaluable, disease, determined using guidelines in response evaluation criteria in solid tumors (recist) v1.1. * eastern cooperative oncology group performance status (ecog ps) of 0 or 1 at the time of enrollment. * the participant has adequate organ function. * resolution to grade ≤1 by the national cancer institute common terminology criteria for adverse events (nci ctcae; version \[v\]4.03) of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer. * female participants of childbearing potential must have a negative serum or urinary pregnancy. have an estimated life expectancy of ≥12 weeks in the judgment of the investigator. exclusion criteria: * a significant bleeding disorder, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to enrollment. * uncontrolled arterial hypertension, despite standard medical management. * a serious or nonhealing wound or peptic ulcer or bone fracture at enrollment. * undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device (reservoir) placement within 7 days prior to enrollment. * radiation therapy within 14 days prior to enrollment. * received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (vegf) or the vegf receptor signaling pathways. * cirrhosis at a level of child-pugh b (or worse); or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. * a serious illness or medical condition(s). * pregnant or breastfeeding. * dysphagia for oral medication. * known allergy or hypersensitivity to any study treatment. * human epidermal growth factor receptor (her) 2 status of positive. * received treatment within 28 days of the initial dose of study drug with an investigational product or non-approved use of a drug or device.
observational study of the enlightn renal denervation system in europe

Conditions: Uncontrolled Hypertension

Summary: the purpose of this observational study is to further evaluate the safety and performance of the enlightn™ renal denervation system in the treatment of participants with uncontrolled hypertension in clinical routine practice.

the enlightn european observational study is designed to collect more data, critical to the benefit of the therapy, within a clinical routine setting.

Eligibility criteria:
inclusion criteria: * subject is planned to undergo a renal denervation procedure for the treatment of hypertension * subject is ≥18 years of age at time of consent * subject must be able and willing to provide written informed consent * subject must be able and willing to comply with the required follow-up schedule * subject has office sbp ≥ 140 mmhg * subject has established hypertension (diagnosed ≥12 months prior to baseline) and is on a guideline based drug regimen at a stable (≥ 14 days) and a fully tolerated dose consisting of ≥3 anti-hypertensive medications (including 1 diuretic) exclusion criteria: * subject has known significant renovascular abnormalities such as renal artery stenosis \> 30% * subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts * subject has a history of hemodynamically significant valvular heart disease * subject has blood clotting abnormalities * subject life expectancy is \< 12 months, as determined by the study investigator * subject is participating in another clinical study which has the potential to impact his/her hypertension management (pharmaceutical/ device/ homeopathic) * subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods * subject has active systemic infection * subject has known renal arteries with diameter(s) \< 4 mm * subject has an estimated gfr \<45 ml/min per 1.73 m2 using the modification of diet in renal disease (mdrd) formula * subject had a renal transplant or is awaiting a renal transplant
musical intervention in non-invasive ventilation

Conditions: Respiratory Failure

Summary: non-invasive ventilation (niv) might be associated with anxiety, thus leading to niv failure, and intubation. music therapy has been used in various clinical context, including in icu patients under mechanical ventilation. we aim to evaluate the effect of a musical intervention on respiratory comfort during niv for acute respiratory failure.

we plan a randomized controlled trial with 3 different arms, in icu patients requiring niv for acute respiratory failure : "usual care", "sensory isolation" and "sensory isolation and musical intervention".at the onset of respiratory failure, each patient will be randomized in one of the 3 arms. "usual care" assigned patients will receive niv according to each unit protocol; "sensory isolation" assigned patients will receive niv associated with a mask obscuring the eyes and a noise-reducing headset."musical intervention patients" will receive a 30 minutes musical intervention during each niv session. respiratory discomfort will be blindly assessed before, immediately after niv is correctly set (5 minutes), at 30 minutes, and at hours 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 according to niv session length, and at the end of niv session during each niv session.

Eligibility criteria:
inclusion criteria: * respiratory distress requiring niv * glasgow coma score above 12 exclusion criteria: * niv contraindication : hemodynamic failure, neurologic failure, head trauma, vomiting * severe hypoacusis people without hearing device * decision to limit active treatment with an estimated life expectancy of less than 48 hours

Keywords: respiratory failure niv musical intervention
the efficacy, safety and genetic polymorphism of hypoca and adalat oros in hypertensive patients

Conditions: Hypertension

Summary: nifedipine and barnidipine act as calcium channel blockers, and are widely prescribed for pressure control of prehypertension and stage 1 hypertension. cyp3a4 is responsible for the metabolism of nifedipine and nifedipine, while the contribution of cyp3a5 remains ambiguous. this study is aimed to analyze the association between antihypertensive effects of nifedipine as well as barnidipine and single nucleotide polymorphisms of cyp3a4, cyp3a5 and calcium channels.

for each drug, 20 patients will be enrolled. patients' blood pressure and heart rates will be measured at first visit, followed by visits at week4 , week 8 and week 12. blood samples will be drawn at week 4 and week 12 for following analyses of drug plasma concentrations. snps in cyp3a4, cyp3a5 and calcium channel v 1.2 will be genotyped using snpstream. the differences in the decrease of blood pressures and the durg plasma concentrations between genotypes will be analyzed.

Eligibility criteria:
inclusion criteria: * 20\~90 years old patient * mild to moderate hypertensive patients * can finish this study * can sign agreement exclusion criteria: * severe hypertension * heart failure, arrhythmia * liver or kidney failure * pregnant women * allergy to dihydropyridines * attend other clinical trials in past 3 month

Keywords: hypertension snp nifedipine barnidipine
single dose pharmacokinetics of repaglinide, metformin and combination tablet in fed healthy volunteers

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers (female not pregnant, lactating or breastfeeding) * bmi (body mass index) between 19-29 kg/m\^2, both inclusive * fasting plasma glucose from 70-115 mg/dl * subject is judged to be in good health on the basis of their medical history, physical examination, ecg (electrocardiogram), and routine laboratory data exclusion criteria: * any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease * clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening * positive results on screening for hepatitis b surface antigen, hepatitis c antibody and hiv (human immunodeficiency virus) antibody * positive results on the drug abuse/alcohol screen * any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to visit 2 (trial product dose administration) and for the duration of the study * subject is currently a smoker (more than one cigarette per day or equivalent) * use of grapefruit or grapefruit juice within 7 days of trial product dose administration * blood donation, surgery or trauma with significant blood loss (500 ml) within the last 2 months prior to dosing
erlotinib as 1st line treatment in nsclc stage iiib/iv

Conditions: Non Small Cell Lung Cancer

Summary: to evaluate the efficacy and toxicity of erlotinib as first line treatment in patients with locally advanced/metastatic (stages iiib/iv) nsclc, with clinical predictors of response to tyrosine kinase inhibitors (erlotinib, gefitinib), such as female gender, never-smoking status and adenocarcinoma histology. furthermore, erlotinib-sensitivity will be correlated with the presence of egfr mutations in exons 18, 19 and 21, in this population

a randomized, placebo-controlled phase iii trial of erlotinib versus placebo, with more than 700 patients demonstrated that therapy with this tyrosine kinase inhibitor (tki) prolongs survival after first or second line therapy in patients with advanced nsclc. statistically significant and clinically relevant differences were observed for overall and progression free survival in favour of erlotinib. moreover, several clinical factors had been correlated with response to gefitinib or erlotinib, including never smoking status, female gender, asian ethnicity and adenocarcinoma histology (especially bronchioalveolar carcinoma).

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed, unresectable locally advanced (stage iiib with pleural effusion) and/or metastatic (stage iv) nsclc * no previous therapy for advanced/metastatic nsclc is allowed * age \>18 years * bidimensionally measurable disease * non-smokers (or ex-smokers with less than 5 pack-years smoking history) * adenocarcinoma histology * performance status (who) 0-3 * adequate liver (serum bilirubin \<1.5 times the upper normal limit (unl); ast and alt \<2.5 times the unl in the absence of demonstrable liver metastases, or \<5 times the unl in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the unl); and bone marrow (neutrophils ≥ 1.5x 109 /l, and platelets ≥ 100x 109 /l) function * previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields * patient able to take oral medication * tissue sample for tumour mutational analysis is required exclusion criteria: * serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation * active infection * history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * malnutrition (loss of ≥ 20% of the original body weight) * performance status: 4 * psychiatric illness or social situation that would preclude study compliance * pregnant or lactating women

Keywords: erlotinib biological therapy tyrosin kinase inhibitor therapy
motivational interviewing (mi) for african americans with peripheral arterial disease (pad) pilot

Conditions: Peripheral Arterial Disease

Summary: the investigators are conducting a pilot study for a clinical research trial to establish the feasibility and acceptability of the intervention and the most effective recruitment strategies prior to the full study.

the eight week pilot will be conducted to establish the feasibility of implementing motivational interviewing as a means to counsel african americans with peripheral arterial disease (pad) to increase their walking. additionally, we will determine the acceptance of culturally sensitive print material on managing pad. finally, we will utilize the pilot to develop best practice methods for successfully carrying out the full study.

Eligibility criteria:
inclusion criteria: * african american (determined by self-report) * lived most of their life in the united states * resting abi \<0.95 * english speaking * has a telephone exclusion criteria: * currently walking for exercise at least 5 days per week (i.e., a pace score ranging from 5-8) * prior major amputation (foot or lower leg) or critical leg ischemia (tissue loss, gangrene, or ulcers) * rest pain with abi \<0.4 and non-palpable femoral pulses without prior evaluation by a vascular surgeon, given the need for evaluation for the role of more invasive therapy prior to recommending walking therapy * leg revascularization within 3 months of enrollment or plans for revascularization during the study period * use of supplemental oxygen * myocardial infarction within the preceding 3 months * resting blood pressure \> 200/110 mmhg * exercise-induced coronary ischemic symptoms, or exercise-induced st depression \> 2.0 mm * inability to walk for 2 minutes; the rationale being that people who cannot walk for 2 minutes would not be able to complete the necessary submaximal treadmill test, which is used to screen for coronary ischemic symptoms. we will also exclude anyone who can walk for 20 minutes or more during the submaximal treadmill test. anyone who can complete the submaximal test would not have significant walking impairment and would not get that much out of the study. * short physical performance battery score of 10 or higher as such persons do not have a clinically significant impairment in mobility; therefore, we will exclude anyone who scores a 10 or higher (out of a maximum of 12 points).

Keywords: peripheral arterial disease walking motivational interviewing
colposeptine for the treatment of bacterial vaginosis

Conditions: Vaginosis, Bacterial

Summary: this is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. a total of 480 subjects were planned to be enrolled in various centers in china.


Eligibility criteria:
inclusion criteria: * female subjects in reproductive age and older than 18 year * subjects with normal sexual activity * subjects with symptoms such as vulva-vaginal irritation or abnormal vaginal discharge * subjects with nugent score greater than or equal to 7 * subjects who are willing to use contraception * subjects who are willing to refrain from the use of other vaginal products throughout the study * subjects who sign informed consent form and agree to follow-up on time exclusion criteria: * subjects without sexual activity * pregnant or lactating female subjects * subjects with a history of recurrent bacterial vaginosis * subjects diagnosed with trichomonas vaginitis，vulvovaginal candidiasis，chlamydia or gonococcus infection. * subjects who are unwilling to refrain from the ingestion of any alcoholic beverages during the 7 day course of oral metronidazole therapy * subjects who are under treatment by lithium, phenobarbitone, coumadine anticoagulant, cyclosporine or disulfiram by the time of inclusion (interactions with other products and metronidazole) * subjects who are undergoing systemic or topical treatment with antibiotics, steroids, immunosuppressive, cytostatic or antimetabolic agents by the time of inclusion * female subjects with a history of peripheral neuropathy * female subjects who have participated in another clinical trial or have taken an experimental drug within the past 30 days * subjects who are unable to give written informed consent

Keywords: vaginosis, bacterial colposeptine metronidazole
a pilot study of metformin treatment in patients with well-differentiated neuroendocrine tumors

Conditions: Well-differentiated Neuroendocrine Tumors

Summary: neuroendocrine tumors are rare but recent data showed a relevant increase in its incidence. the mammalian target of rapamycin (mtor), one of most important area of research, has demonstrated be a therapeutic target in these tumors. the metformin has demonstrate in preclinical studies having an antineoplastic action by inhibiting the mtor pathway, and may be an alternative treatment for this disease. eligible patients for this study should have metastatic gastroenteropancreatic neuroendocrine tumors well differentiated (grade 1 or grade 2) and will be treated with metformin 850 mg every 12 hours, and each cycle will consist of 30 days. after 180 days of treatment the efficacy of metformin under the control of disease progression will be evaluated. as a secondary outcome the investigator will check the patient adherence to the treatment, the control of patient symptoms with functioning neuroendocrine tumor, and disease free survival. also will be performed an analysis of immunohistochemical expression of mtor pathway proteins of these patients.


Eligibility criteria:
inclusion criteria: * metastatic well-differentiated neuroendocrine tumor grade 1 or 2 with histological confirmation; * performance status according to eastern cooperative oncology group (ecog) 0 to 2; * able to take pills; * age ≥ 16 years; * ability to provide written informed consent; * adequate organ function; exclusion criteria: * patient with out of control severe hormonal syndrome; * diabetic patients under metformin treatment, or those who have received treatment with metformin within 3 months; * patient with hypersensitivity to biguanides, kidney or liver failure, or other conditions that predispose to lactic acidosis; * history of severe clinical or psychiatric illness, that would prevent participation in the study by clinical judgment; * patients who participate in other protocol with experimental drugs; * patients under any kind of active infection; * patients who have received chemotherapy within 3 weeks; * patients pregnant or lactating; * diabetic patients who require higher dose of metformin 850mg x 2 daily;

Keywords: neuroendocrine tumors the mammalian target of rapamycin (mtor) metformin
efficacy and safety of modified release cefpodoxime formulation in the treatment of acute sinusitis.

Conditions: Sinusitis; Sinusitis, Acute; Rhinosinusitis; Rhinosinusitis Acute; Sinus Infection

Summary: the aim of this study is to compare the efficacy and safety of cefpodoxime 200 mg immediate (b.i.d) and cefpodoxime 400 mg modified release (q.d) tablet formulations in the treatment of acute bacterial rhinosinusitis.


Eligibility criteria:
inclusion criteria: 1. 18 years and older patients who have acute bacterial rhinosinusitis sign and symptoms (i, ii, iii) according to idsa clinical practice guideline for acute bacterial rhinosinusitis in children and adults: i. onset with persistent symptoms or signs\* compatible with acute rhinosinusitis, lasting for ≥ 10 days without any evidence of clinical improvement, ii. onset with severe symptoms or signs of high fever \> 39 and purulent nasal discharge or facial pain lasting for at least 3-4 consecutive days at the beginning of illness, iii. onset with worsening symptoms or signs characterized by the new onset of fever, headache, or increase in nasal discharge that lasted 5-6 days and were initially improving. (\*major symptoms: purulent anterior nasal discharge, purulent or discolored posterior nasal discharge, nasal congestion or obstruction, facial congestion or fullness, facial pain or pressure, d hyposmia or anosmia. \*minor symptoms: headache, ear pain, pressure, or fullness, halitosis, dental pain, cough, fatigue) 2. patients who are able to give culture sample from middle meatus (microorganisms to be teste: streptococcus pneumoniae, haemophilus influenzae \[including beta-lactamase producing strains\], streptococcus pyogenes and moraxella catarrhalis \[including beta-lactamase producing strains\]). 3. patients who are able to use oral drugs, 4. if patient is a women of childbearing age; female patients who applies appropriate birth control, 5. patients who have ability to communicate with investigators, 6. patients who commits to adhere to the study protocol, 7. patients who sign informed consent form. exclusion criteria: 1. patients who have hypersensitivity to beta-lactam antibiotics, penicillin and cefpodoxime, 2. patients who hypersensitivity to peanut and soy, 3. patients who have kidney or liver deficiency, 4. patients who have history of more than 2 bacterial sinusitis episode within last 12 months, 5. patients who have chronic sinusitis, 6. patients who have history of head and neck surgery and/or severe sinusitis complication (brain abscess or venous thrombosis), 7. patients who are hospitalized within 4 weeks prior to the start of study, 8. patients who have immunodeficiency (i.e; hiv, corticosteroid use, immunosuppressive use), 9. patients who used antibiotics within 30 days prior to the start of study, 10. patients who need to use of antibiotics other than investigational drugs for concomitant disease, 11. patients who used aluminium and magnesium containing anti-acids, probenecid and iron containing drugs within 2 weeks prior to the start of study, 12. pregnant and lactating female patients.
evaluation of qtc interval by continuous holter ecg recording in antipsychotic drug-treated patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective; Bipolar Disorder

Summary: the aim of this study is to evaluate the utility of continuous holter ecg recording with automated, computerized data analysis for measuring antipsychotic-related qtc prolongation during a 24-h period under clinical conditions


Eligibility criteria:
inclusion criteria: 1. subjects will be males or females between 18 - 65 years of age. 2. patient subjects will have a definite diagnosis by dsm-iv criteria, schizophrenia, schizoaffective disorder, or bipolar disorder. 3. patient subjects are currently under treatment with any antipsychotic, any mood stabilizer, any antidepressant or any combination of the above at the therapeutic dose for at least 3 months. 4. patients have a history of taking the medications listed in item 3 as prescribed. 5. the subjects must be able to provide written informed consent exclusion criteria: 1. subjects with a dsm-iv diagnosis of substance dependence as defined by dsmn within three months prior to selection. 2. subjects who are currently taking other medications that have been shown to prolong the qtc, including tricyclic antidepressants (e.g. amitriptyline, imipramine, maprotiline), fluoroquinolones, or antiarrhythmics (e.g. quinidine, procainamide, amiodarone, sotalol). -