Kornimate/medical-research-clean huggingface dataset:
anemia in patients with a non-myeloid malignancy

Conditions: Neoplasms; Anemia

Summary: chemotherapy can often cause anemia in patients with cancer. anemia is a low number of red blood cells. the symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. recombinant human erythropoietin is fda approved to treat anemia in cancer patients receiving chemotherapy. this clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. this medication has not been approved to treat cancer patients with anemia, however it has been approved by the fda to treat chronic renal failure patients with anemia.


Eligibility criteria:
inclusion criteria: * men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug * screening hemoglobin concentration less than or equal to 11.0 g/dl * ecog performance status of 0 to 2 (inclusive) exclusion criteria: * history of seizure disorder * primary hematologic disorder that could cause anemia * unstable or uncontrolled disease/condition related to or affecting cardiac function * clinical evidence of chronic infection/inflammatory disease * positive test for hiv infection * previously confirmed neutralizing antibodies to rhuepo * received rhuepo or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 rbc transfusion occurences

Keywords: anemia of cancer/chemotherapy non-myeloid malignancies drug therapy
feasibility study of sleep endoscopy under hypnosis in a sleep center

Conditions: Drug Induce Sleep Endoscopy; Hypnosis; Obstructive Sleep Apnea Syndrome

Summary: it is proposed to induce in a obstructive sleep apnea syndrome patient, a hypnotic trance leading to intense muscle relaxation, capable of reproducing in the upper airways (vas) the muscle relaxation observed in sleep, at the origin of obstructive apnea and snoring. the collapsibility type obtained, classified according to kezirian, will allow specific management by oam in the event of predominant anteroposterior stenosis. there are no risks fort the patient. the drug induce sleep endoscopy (dise) is a fibroscopy of upper aerodigestive tract.


Eligibility criteria:
inclusion criteria: * patient, women or men over 18 years old * moderate obstructive sleep apnea syndrome (hypopnea apnea index between 15 and 30) without any serious sign * simple ronchopathy * indication of video-fibroscopy of upper airways * affiliated subject or beneficiary of a social security scheme * patient having signed the free and informed consent exclusion criteria: * psychiatric disorders that can be decompensated by hypnosis (bipolarity, schizophrenia, ...) * smoking less than 10 cigarettes per day * alcoholism, chronic or serious disabling pathology * medical history of cancer of upper airways, radiotherapy * pregnancy * recent supper airway infection, rhinosinusitis * active allergy * non-obstructive sleep apnea syndrome * severe non-obstructive sleep apnea syndrome (hypopnea apnea index\> 30) * dental contraindication to mandibular advancement device * intolerance or allergy to local anesthesia with xylocaine spray 5% known * refusal to participate in the study * protected patients: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, breastfeeding or parturient woman * hospitalized without consent
safety and efficacy of s-8184 in second line treatment of relapsed stage iiib or iv non small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: phase iia, multicenter, dose escalation study evaluating the safety and efficacy of weekly s-8184 paclitaxel injectable emulsion in second line treatment of patients with relapsed stage iiib or iv non small cell lung cancer.

the goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of s-8184 in this patient population.

Eligibility criteria:
inclusion criteria: histologic diagnosis of non small cell lung cancer relapsed or unresectable stage iiib or iv disease one and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent dosed at 60 mg/m2 or higher per cycle for cisplatin and auc 6 per cycle for carboplatin documented response of at least stable disease while on first line therapy adult (18 years of age or older) patients adequate hematologic function (anc greater than 1500 cells/mm3 and platelets greater than 100,000/mm3) serum creatinine less than 2.0 mg/dl total bilirubin less than 1.5 mg/dl; sgot and sgpt less than 3 times the upper limit of institutional normal values ecog performance status of 0 - 2 bidimensional measurable or clinically evaluable disease patients who have signed an irb / ethics committee approved informed consent life expectancy at least 12 weeks patient has fully recovered from any previous surgery (at least 4 weeks since major surgery) patient has a negative pregnancy test prior to study entry if premenopausal. (patients of child bearing potential must use a medically effective form of contraception during the treatment.) exclusion criteria: patients who have received any taxane-containing preparation including taxol (paclitaxel) or taxotere (docetaxel) patients with intracranial metastases having neurologic function stabilized for less than 4 weeks prior to study entry females who are pregnant or lactating patients with peripheral neuropathy nci-ctc grade 2 or greater patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry patients who have had an investigational agent within 4 weeks of study entry patients receiving concurrent anticonvulsants known to induce p450 isoenzymes
study on the safety of bay 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study drug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight

Conditions: Clinical Pharmacology

Summary: bay 63-2521 is intended to be used for a disease that affects the blood flow through the lungs. renal impairment is a common condition in patients with this disease. the goal of the study is to learn more about the safety of bay 63-2521, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 1 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight


Eligibility criteria:
inclusion criteria for all subjects: * male and female white subjects with 18 to ≤79 years of age, bmi between 18 and 34 kg/m\^2 * women without childbearing potential or with childbearing potential but only if the pregnancy test is negative and are under highly effective contraception inclusion criteria for subjects with renal failure: - stable renal disease, ie. a serum creatinine value determined at least 3 - 6 months before the pre-study visit was not allowed to vary by more than 20% from the serum creatinine value determined at the pre-study visit inclusion criteria for healthy subjects: - mean age and body weight not allowed to vary by more than +/- 10 years and +/- 10 kg from the subjects with renal impairment, respectively exclusion criteria for all subjects: * febrile illness within 1 week before the start of the study * hypersensitivity to riociguat and / or to inactive constituents * smoking exclusion criteria for subjects with renal failure: * resting heart rate in the awake subject below 45 bpm or above 90 bpm * acute renal failure or nephritis * any organ transplant * diastolic blood pressure (dbp) \>100 mmhg and / or systolic blood pressure (sbp) \>180 mmhg * hemoglobin \ 8 g/24 hours, serum albumin \<30 g/l, platelet count \<100 x 109/l * history of bleeding within the past 3 months * diabetes mellitus with a fasting blood glucose \>220 mg/dl or hba1c \>10% * concomitant use of any medication except medications necessary for the treatment of the kidney disease or related complications * concomitant use of phosphodiesterase-5 inhibitors, endothelin receptor antagonists (eras, eg bosentan), intravenous or inhalative prostacyclins, or nitrates * concomitant use of potent cyp3a4 inhibitors exclusion criteria for healthy subjects: * conspicuous findings in medical history or pre-study examination * history of relevant diseases of vital organs, central nervous system, or other organs * sbp below 100 mmhg or above 145 mmhg and / or dbp above 95 mmhg * regular daily consumption of more than 1 liter of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
ceftobiprole in hospital acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole), referred to as ceftobiprole is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. this is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. the patients will be randomized to receive ceftobiprole plus placebo or the comparator. the primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. the patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). patient safety will be monitored throughout the study. in december 2006, this study (bap00307) and another similar study (bap00248, see nct00229008) were amended (changed) to create 1 study (bap00248/307).therefore, the results reported for this study will be combined with the results reported for study bap00248. patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility criteria:
inclusion criteria: * patients suffering from nosocomial pneumonia or ventilator-associated pneumonia * female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening exclusion criteria: * known or suspected hypersensitivity to any related antibiotic medications * any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information * treatment with any investigational drug within 30 days before enrollment * prior enrollment to this study

Keywords: ceftobiprole medocaril nosocominal pneumonia ventilator-associated pneumonia cephalosporins methicillin-resistant staphylococcus aureus
the linfu® u.s. registry in patients with ipmn (intraductal papillary mucinous neoplasm of the pancreas)

Conditions: IPMN, Pancreatic; Pancreas Cancer; Pancreatic Cyst

Summary: in this study, linfu® will be evaluated in patients who have been identified with ipmn to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). the study will also help determine if linfu® results in earlier intervention, treatment and improvement in patient outcomes.

adenocyte has developed a proprietary pancreatic cancer detection method, linfu®, (low intensity non-focused ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. linfu® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. the sensitivity of cytological examination of the pancreatic fluid obtained by linfu® can also be potentially enhanced by neural network-based computer-assisted analysis. in this study, linfu® will be evaluated in patients who have been identified with ipmn to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. in addition, patients identified with pdac or precursor lesions only with linfu® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether linfu® results in earlier intervention, treatment and improvement in patient outcomes

Eligibility criteria:
inclusion criteria: 1. both males and females will be enrolled and must be at least 18 years of age and under age of 90 2. patients with a documented history of ipmn by any imaging method. 3. all patients must undergo contemporaneous imaging (within 90 days before or after the linfu® procedure) with one or more of the following: eus, ch-eus, ceus, mri/mrcp, pet/ct, ct 4. patients undergoing eus-fna may be enrolled but the fna must be performed after the linfu® procedure 5. institutional review board (irb)-approved consent must be signed by patients to participate in this study. exclusion criteria: 1. patient under the age of 18 and over the age 90 2. contraindications to linfu® as determined by study investigators: 1. patient with uncorrectable coagulopathy 2. patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist 3. unstable medically (cardiopulmonary, neurologic, or cardiovascular status) 3. patients with ipmn that has been subjected to fna or biopsy prior to the linfu procedure 4. patients with pancreatic cystic neoplasms other than ipmn i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions 5. pregnant females will be excluded 6. patient that is unable to provide informed consent 7. patient with known allergy to the microbubble contrast agent or secretin study design overview:
long-term remote ischemic preconditioning improve long-term prognosis of acute myocardial infarction patients without emergency reperfusion therapy

Conditions: Myocardial Infarction

Summary: patients with acute myocardial infarction (ami) are in critical condition especially without emergency reperfusion therapy. for example, heart failure, heart rupture, malignant arrhythmia are in high level. it was reported remote ischemic preconditioning (ripc) may play an effective endogenous cardiac protection. this study will investigate whether long-term ripc can improve the short-term and long-term (1 year) prognosis of ami patients without emergency reperfusion therapy. 220 ami patients without emergency reperfusion therapy were randomly divided into 2 groups: long-term ripc group (once ripc/day for a year) or control group (routine treatment). cardiac troponin (tni), high-sensitivity c-reactive protein (hscrp), adenosine, vascular endothelial growth factor (vegf), hypoxia inducible factor-1 (hif-1), echocardiography and magnetic resonance（mr）were detected in hospital, 1 month and 1 year after discharge. patients will be followed up by telephone at the end of one year. the major adverse cardiovascular events (mace) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.


Eligibility criteria:
inclusion criteria: * age between 18-80 years; * acute myocardial infarction (stemi); * without emergency reperfusion therapy. exclusion criteria: * age more than 80 or less than 18 years; * renal failure with creatinine \>2 mg/dl; * reject taking part in the study.
study of personalized dietary intervention for the control of essential hypertension

Conditions: Essential Hypertension

Summary: an ongoing case study of psoriasis, shows reproducibly that ingestion of hydrogenated fats, and some flavourant or sweetener compounds, leads to relapse of psoriasis, and secondary food intolerances, followed by remission over a couple of months (cpcpsoriasis.blogspot.com). hence a personalized categorical food avoidance diet averts relapse and maintains remission of psoriasis, with side benefit on blood pressure and other metabolic parameters (j hypertension 2012; 30: e-suppl 1, poster 158). study hypothesis: this dietary approach would improve the control of essential hypertension. a randomized controlled clinical trial is proposed to compare this dietary approach with conventional dash-type dietary counselling. 40 study participants will be randomly assigned to either conventional or interventional dietary counselling. they will be comprehensively monitored (including gene expression studies) for two years. outcome criteria will include blood pressure, complications of hypertension, side-benefit on comorbidity, and requirement for antihypertensive drugs.


Eligibility criteria:
inclusion criteria: 1. average blood pressure exceeds 160/100mm hg (140/90 if additional vascular risk), regardless of whether on treatment 2. on one or two antihypertensive drugs and average bp exceeds 140/90 (130/80 if additional risk) 3. on three or more antihypertensives, regardless of whether bp controlled 4. sufficiently literate to follow detailed dietary instructions 5. informed consent exclusion criteria: 1. disabling complications of hypertension 2. secondary cause of hypertension 3. pregnancy 4. age less than 18 years

Keywords: hypertension dietary intervention personalized nutrition randomized controlled trial
does cervical pessary prevent spontaneous preterm birth in twin pregnancies with short cervical length?

Conditions: Preterm Birth

Summary: spontaneous preterm birth (sptb) remains the number one cause of perinatal mortality in many countries, including the united states. multiple gestations are at increased risk of sptb. a short cervical length (cl) on transvaginal ultrasound (tvu) has been shown to be a good predictor of sptb, in both singletons and twins. the cervical pessary is a silicone device that has been used to prevent sptb. the efficacy of the cervical pessary has been assessed in several populations including singletons with short cl, unselected twins, twins with short cl, and triplet pregnancies. several randomized clinical trials (rcts) have been published, and several are ongoing. however, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * twin pregnancy (limits the participants to female gender) * short cervical length (less than or equal to 30 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation exclusion criteria: * singleton or higher order than twins multiple gestation * monoamniotic twins * twin twin transfusion syndrome * ruptured membranes * lethal fetal structural anomaly * fetal chromosomal abnormality * cerclage in place (or planned placement) * vaginal bleeding * suspicion of chorioamnionitis * ballooning of membranes outside the cervix into the vagina * painful regular uterine contractions * labor * placenta previa
salto - symbicort single inhaler therapy use in adolescent adults and adults with persistent asthma

Conditions: Asthma

Summary: the primary objective is to compare the efficacy of symbicort single inhaler therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.


Eligibility criteria:
inclusion criteria: * minimum of 3 months documented history of asthma, diagnosed according to the american thoracic society (ats) definition. * prescribed inhaled gcs at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to visit 1. exclusion criteria: * use of any b-blocking agent, including eye-drops. * use of oral gcs as maintenance treatment. * known or suspected hypersensitivity to study therapy or excipients. * a history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
patterns of injury and mortality in free-fall trauma patients

Conditions: Trauma

Summary: in this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a taiwan level one trauma center.

falls from height is the leading cause of accidental deaths. the mechanism of free-fall injury is abrupt vertical deceleration and the severity is dependent on the height, body weight, posture and contact area...etc. most victims presented to emergency department with major trauma, so initial evaluation and timely management are crucial for the survival. the knowledge of unique pattern of injuries helps clinicians to facilitate the diagnosis. in this study, the investigator aimed to analyze the demographic characteristics, patterns of injury and mortality after free fall in a taiwan level one trauma center.

Eligibility criteria:
inclusion criteria: * adult patients with free-fall trauma exclusion criteria: * adult patients with free-fall trauma, not relating with traffic accidents