Kornimate/medical-research-clean huggingface dataset:
an all-oral combination of capecitabine and cyclophosphamide in patients with metastatic breast cancer (mbc)

Conditions: Breast Cancer

Summary: the primary objective of this study is to evaluate the time to progression. secondary objectives are safety, os and pharmacogenetic analysis. sixty patients will be enrolled into this study.

xeloda (capecitabine) is converted to 5-fluorouracil by thymidine phosphorylase, and cyclophosphamide is capable of upregulating the expression of thymidine phosphorylase suggesting a synergistic effect.

Eligibility criteria:
inclusion criteria: * histologically confirmed breast cancer * anthracycline and taxane pretreated metastatic breast cancer * have not been previously treated with capecitabine * ecog performance status of ≤ 1 * are female and ≥ 18 and ≤ 70 years of age * have at least one target lesion according to the recist criteria exclusion criteria: * pregnant or lactating women * ecog ≥ 2 * have been treated with capecitabine * evidence of cns metastasis * history of another malignancy within the last five years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix or a contralateral breast cancer * abnormal laboratory values: hemoglobin \ upper limit of normal (uln), serum bilirubin \> uln, alt and ast \> 5×uln, akp \> 5×uln * serious uncontrolled intercurrent infection * life expectancy of less than 3 months

Keywords: metastatic breast cancer capecitabine synergistic effect chemotherapy
uridine triacetate as antidote for patients at excess risk of 5-fu toxicity due to overdosage or impaired elimination

Conditions: Toxicity Due to Chemotherapy

Summary: the purpose of this study is to provide emergency treatment of adult and pediatric patients: * following a fluorouracil or capecitabine overdose regardless of the presence of symptoms or * who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous systems, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration.

demographics, baseline disease information, prior disease-directed therapy including fluorouracil or capecitabine, and details of the fluorouracil or capecitabine overexposure (dose, cause, and timing) will be collected. adverse events information will be collected and recorded. patients will be followed for 30 days unless the patient expires or resumes chemotherapy within the 30 day period.

Eligibility criteria:
inclusion criteria: * the patient received a fluorouracil or capecitabine overdose (regardless of the presence of symptoms) or * the patient is exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions (e.g., gastrointestinal toxicity and/or neutropenia) within 96 hours following the end of fluorouracil or capecitabine administration * judged by the investigator to have the initiative and means to be compliant with the protocol * able to take oral medications * able to start treatment with uridine triacetate within 96 hours after the end of fluorouracil or capecitabine administration * provides written informed consent (patient or legally authorized representative) exclusion criteria: * has a known allergy to uridine triacetate or any of its excipients * unable to have the initiative and means to be compliant with the protocol * unable to be compliant with taking oral medications * more than 96 hours have elapsed since the completion of 5-fu dosing * unable to provide written informed consent (patient or legally authorized representative)

Keywords: fluorouracil overdose fluorouracil toxicity capecitabine overdose capecitabine toxicity
efficacy of t1675 versus placebo in patients with bilateral treated moderate dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: to evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with t1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome

the aim of the present study is to evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with t1675 versus placebo in patients with bilateral moderate dry eye syndrome already treated with tear substitutes, and to point out, through several parameters, the best efficacy parameter that could be used for a future clinical phase iii study.

Eligibility criteria:
inclusion criteria: * signed and dated informed consent. * male or female aged from 18 to 90 years old. * known treated bilateral dry eye. * dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, but and schirmer, performed within the last 12 months before inclusion visit, for both eyes. * bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and questioning on patient's feeling (score \>=3). * fulfilling the following criteria of dry eye syndrome in both eyes defined by: keratoconjunctivitis defined by a lissamine green score ≥ 4 (van bijsterveld score) and schirmer test \<= 10 mm in 5 min or but \< 10 s exclusion criteria: * severe dry eye symptom * eyelid dysfunction * severe progressive rosacea * any relevant ocular anomaly interfering with ocular surface * best corrected far visual acuity \<= 1/10 * history of ocular allergy * traumatism, infection, inflammation within last 3 months * ocular surgery and laser within the last 3 months * lasik, laser, pkr within the last 12 months * contact lenses * any concomitant nutritive supplementation, vitamins * any topical concomitant treatment
the relationship between helicobacter pylori infection and irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: evaluating any possible relationship between irritable bowel syndrome occurrence and helicobacter pylori infection


Eligibility criteria:
inclusion criteria: * all patients will be selected according to rome iv criteria for the diagnosis of ibs, which include: recurrent abdominal pain at least 1 day/week in the last 3 months, with two or more of the following criteria: * related to defecation * associated with a change in frequency of stool * associated with a change in form of stool. criteria achieved for the last 3 months with symptom onset at least 6 months before diagnosis exclusion criteria: * • rectal bleeding * anemia * weight loss * onset after 50 years of age * recent antibiotic use * abnormal abdominal examination (organomegaly, lump) * family history of colorectal cancer. * family history of inflammatory bowel disease, or celiac disease.

Keywords: helicobacter pylori irritable bowel syndrome
inhaled nitric oxide for preventing chronic lung disease in premature infants

Conditions: Lung Diseases; Bronchopulmonary Dysplasia

Summary: to determine whether or not inhaled nitric oxide (ino) safely decreases the incidence of chronic lung disease (cld) in premature infants.

background: despite advances in medical, nursing, and respiratory care, cld affects up to 50 percent of premature infants. as a result, nearly 50,000 infants in the united states develop cld. it is desirable to investigate therapies that decrease the incidence of cld because it is associated with failure to thrive, developmental delay, increased risk of pulmonary infection, reactive airway disease, pulmonary hypertension, and death. design narrative: this is a randomized, double-blind, placebo-controlled, multi-center study. three specific hypotheses will be tested: 1) ino reduces the incidence of cld; 2) ino reduces serum and lung (tracheal aspirate) markers of inflammation; and 3) ino does not increase the incidence of intraventricular hemorrhage in premature neonates. the primary endpoint is survival without cld (defined as continued oxygen requirement) at 36 weeks post conceptional age. a total of 793 premature newborns will be enrolled from 14 centers within 48 hours of birth. they will be randomly assigned to receive either placebo or ino at 5 ppm until the breathing tube can be safely removed or after 21 days. the ino will be delivered by an inovent delivery system in such a way that physicians and nurses will not know which treatment each participant is receiving. management strategies for aspects of patient care including mechanical ventilation, surfactant administration, fluid administration, and steroid use will be determined by physicians at each center. serial cranial ultrasounds and methemoglobin levels will be monitored to determine adverse events. the first 200 patients will have serial blood samples and tracheal aspirates obtained for measurements of inflammatory mediators, including interleukin-6 (il-6), interleukin-8 (il-8), interleukin-10 (il-10), endothelin-1, myeloperoxidase, neutrophil counts (tracheal aspirates), and endothelin-1 (blood). participants will be seen at 12 and 24 months of age to monitor the long-term effects on the cardiopulmonary or neurologic systems. at these visits, a health questionnaire will be administered and bayley ii scales of infant development will be completed.

Eligibility criteria:
inclusion criteria: * weighing between 500 to 1250 grams at birth * gestational age of less than 34 weeks * less than 48 hours old * respiratory failure on mechanical ventilation * absence of structural heart disease (pda, asd less than 1 cm, or vsd less than 2 mm are permitted if known prior to study entry) * absence of lethal congenital anomaly exclusion criteria: * concurrent participation in another experimental study (observational studies will be allowed with prior approval by the steering committee and data and safety monitoring board) * active pulmonary hemorrhage * unevaluated pneumothorax * high frequency jet ventilation * expected short duration of ventilation (less than 48 hours from birth)
accessing peripheral occluded lesions ii (apolo-ii)

Conditions: Femoropopliteal Occlusive Disease

Summary: the current study is a prospective, single-arm, non-randomized, multi-center study to evaluate the outcome of the enabler-p catheter system for crossing chronic total occlusions during endovascular intervention for femoral-popliteal occlusive disease.


Eligibility criteria:
inclusion criteria: * documentation from a previous attempt or a concurrent reasonable attempt (at least 5 minutes) during this procedure, demonstrating resistance to conventional guidewire crossing; * patient must have objective evidence of lower extremity ischemia; * totally occlusive lesion in a native femoropopliteal artery classified angiographically as absolute (100% occlusion with no flow), where no antegrade filling beyond the occlusion is visible; * target occlusion length is \>1cm and ≤ 30 cm; * patient's reference vessel diameter is ≥ 4.0 mm and ≤6.0 mm (by visual angiographic estimation) * patient must be an acceptable candidate for pta, peripheral artery bypass surgery or peripheral artery stent implantation; * female patients of child bearing potential must have a negative pregnancy test within 48 hours prior to the study procedure; * patient must have been informed of the nature of the study, agree to its provisions, and provide written informed consent; * patient is ≥ 21 years of age. exclusion criteria: * patient has hypersensitivity or contraindication to aspirin, heparin, plavix or radiographic contrast agents which cannot be adequately pre-medicated; * the patient requires immediate treatment in more than one occluded vessel, in any combination of grafts or native vessels; * patient has planned femoropopliteal intervention scheduled within 30 days after index procedure; * the patient is currently participating in another investigational drug or device trial that may conflict with study data collection and has not completed the entire follow-up period; * patient has no collateral flow distal to the occlusion; * patient's target occlusion has a dissection that occurred within the past 30 days caused by a guidewire attempt; * patient has a history of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency; * patient suffered recent (within the past 6 months) significant gastrointestinal (gi) bleeding; * patient's target lesion or the vessel proximal to the target lesion reveals significant ectasia, dissection, aneurysm or thrombus; * patient has other medical illnesses (i.e., cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, confound the data interpretation or is associated with life-expectancy less than 1 year.

Keywords: chronic total occlusion cto
identification of biomarkers in cervical mucus

Conditions: Cervical Mucus Dysfunction; Infertility, Female

Summary: cervical mucus is a biological fluid secreted by the endocervical glandular epithelium whose quantitative and qualitative characteristics vary in response to the hormonal stimulus produced by the ovary during the woman's menstrual cycle. as a fertility factor, it performs numerous biological functions: transport, nourishment, defense and capacitation of spermatozoa, defense against pathogens of the female genital tract. the aim of this research will be to deepen the knowledge of the biochemical characteristics of cervical mucus, in particular to perform characterization by infrared spectroscopy, for the identification of diagnostic, prognostic and predictive biomarkers for disorders affecting the female reproductive system. a healthy control population and a cohort of patients affected by unexplained infertility will be enrolled for the longitudinal study of the menstrual cycle with ultrasound and hormonal monitoring and serial sampling of cervical mucus.


Eligibility criteria:
inclusion criteria: * healthy control * women of 18-45 years old, * use of the billings ovulation method® for at least three months in the last three years * proven fertility * study cohort * women of 18-45 years old, * women affected by unexplained infertility exclusion criteria: * virgo women * women incapable of understanding and wanting * women who have had sexual intercourse in the two days prior to cervical mucus sampling * pregnancy, exclusive breastfeeding * amenorrhea * gynecological hormone ongoing therapies or suspended for less than three months * cervico -vaginal infections * psychiatric pathologies * untreated/decompensated endocrine-metabolic disorders * coagulopathies and renal pathologies under dialysis treatment * refusal of informed consent * previous, current or suspected oncological pathology
changes of oropharyngeal flora

Conditions: Pharyngeal Bacterial Colonization; Pneumonia

Summary: hospitalised patients have in contrast to healthy people enteric pathogenic bacteria in their oropharynx increased risk of pneumonia due to the pathogens in the oropharynx probiotics can reduce such bacteria in intubated critically ill patients this study will use two strain of probiotic bacteria for half of the patients and a placebo for the rest active arm gurgles with a suspension twice a day cultures at inclusion and at set time intervals the results of cultures from the two groups will be compared as will the use of antibiotics

when patients are admitted to hospital some of them are already colonized in the oropharynx with pathogens that are normally found as commensal or possible pathogens in the gastrointestinal tract. this is probably a consequence of the illness that is the cause of their hospital admission. most patients admitted to hospital are elderly. those patients often have their natural functions down regulated including their ability to secure their airway from aspiration. acute illness whether you are old or young leads to changes in the intestinal microbiological flora. bacteria normally found in the colon or distal ileum frequently appear in the stomach and more alarming in the oropharynx. weakened by the illness, acute or chronic, there is an increased risk of aspiration and when there are pathogenic bacteria in the oropharynx, aspiration is likely to induce pneumonia - health related pneumonia. for intubated icu patients we have demonstrated a reduction of colonization with enteric bacteria by applying probiotics in the mouth. after a screening period to find out what groups of patients that are most vulnerable, we will in a randomised way give probiotics to half of the included patients and to the other patients only the filling material (maltodextrin). with this procedure our aim is to show a reduction of pathogens in the oropharynx and as a secondary outcome we hope to see a reduction of pneumonia. samples for microbiological analysis will be taken during the first day of admission to hospital and then at specified intervals.

Eligibility criteria:
inclusion criteria: * admitted to hospital * anticipated length of hospital stay 3 days or more exclusion criteria: * immune insufficiency * prior participation in the study * not being able to understand study information
intra-abdominal hypertension and abdominal compartment syndrome in patients after pancreatic procedures.

Conditions: Intra Abdominal Pressure; Abdominal Compartment Syndrome; Pancreatic Surgery; Pancreatic Fistula After Pancreaticoduodenectomy; Delayed Gastric Emptying; Anastomotic Leaks; Overload Fluid

Summary: this study investigates the development of intra-abdominal hypertension and compartment syndrome in patients undergoing elective pancreatic procedures. main objective is to determine the proportion of patients after pancreatic operation who develop elevated intra-abdominal pressure and assess its association with postoperative complication rates. another goal of the study is to compare open versus robotic pancreatic procedures regarding the occurrence of intra-abdominal hypertension and abdominal compartment syndrome.

hypa study is designed as a prospective observational study. the primary objective of this study is to assess the risk and prevalence of intra-abdominal hypertension and abdominal compartment syndrome following pancreatic procedures. the secondary objective aims to explore potential correlations between intra-abdominal hypertension and the development of postoperative complications, such as anastomotic dehiscence, postoperative pancreatic fistulas, prolonged postoperative ileus, or delayed gastric emptying. the third objective is to compare the incidence of intra-abdominal hypertension in patients undergoing robotic versus open pancreatic procedures

Eligibility criteria:
inclusion criteria: * patients ≥ 18-year-old * indication for elective pancreatic procedure * written informed consent exclusion criteria: * patients \<18 years old. * contraindication for urinary catheter placement. * refusal to participate in the study.

Keywords: intra-abdominal hypertension compartment syndrome pancreatic surgery robotic surgery
social media and cancer screening information

Conditions: Colorectal Cancer

Summary: norc/amerispeak will recruit participants who meet the study criteria and invite them to complete a 15-minute survey. participants will be randomly assigned to one of five conditions, with approximately 400 people in each condition, and will respond to various questions after viewing the study messaging. once 2,000 participants complete the survey, the data will be de-identified and provided to the study team for analysis.

norc/amerispeak will put all of the study content into their system. they will send out the opportunity to participate in the study, which should take about 15 minutes, to people in their panel who meet our participation criteria. participants will be directed to the study information sheet that includes all elements of consent. participants who agree to participate will start the survey experiment. the survey experiment will randomize participants into one of five conditions: (1) control (no exposure), (2) overall median ranked messages (from the prior study), (3) messages preferred by all participants, (4) messages preferred by black american participants, and (5) messages preferred by white american participants. approximately 400 people will complete each condition. after viewing the study stimuli (or no stimuli in the control condition), participants will respond to various outcomes and other variables of interest (see questionnaire draft included). after all 2,000 people have completed the study, the study team will receive a de-identified data file from norc/amerispeak with all study data and engage in analysis. this study is planned to close the study around that time as the study team completes data analysis and write-up the findings.

Eligibility criteria:
inclusion criteria: * identify as white/caucasian or black/african american. exclusion criteria: * do not identify as white/caucasian or black/african american. * previously diagnosed with colorectal cancer * non-english speakers
the pharmacokinetic characteristics and safety between hip2001 and hgp2001 in healthy volunteers

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to evaluate the pharmacokinetic characteristics and safety between hip2001 and hgp2001 in healthy volunteers.


Eligibility criteria:
inclusion criteria: * 19 kg/m\^2 ≤ bmi \ 60kg * 90 mmhg ≤ sbp \<140 mmhg, 50 mmhg ≤ dbp \<900 mmhg * agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug. exclusion criteria: * a history of hypersensitivity reactions or clinically significant hypersensitivity reactions * a history of gastrointestinal diseases or surgery that may affect the absorption of clinical trial drugs * a history of substance abuse or who test positive for drugs of concern for abuse in the urine drug screening test * positive results of serological tests * have taken other investigational drugs or bioequivalence drugs within 6 months before the first administration of the investigational drug * donated whole blood within 60 days prior to the screening date or donated components within 30 days or received a blood transfusion within 30 days * have drank more than 210 g/week of alcohol within 30 days before the screening date * have smoked more than 10 bills/day within 30 days before the screening date * ast, alt value is more than 2 times the unl or bilirubin level is more than 1.5 times the unl, egfr \ 1.31 inr or aptt \> 39.7 sec * 12-ecg qtc \>450 ms
color doppler ultrasonography in prediction of arteriovenous fistula maturation in hemodialysis patients

Conditions: Arteriovenous Fistula

Summary: the transplant is the definitive treatment of renal insufficiency, in our days. while waiting for it, the arteriovenous fistula surgery is standard procedure.

ultrasound is the main method of diagnostic imaging, because of its low cost, noninvasive without ionizing radiation associated or iodized contrast. vascular procedures and their complications represent a major cause of morbidity hospitalization and cost for patients in hemodialysis . many fistulas do not mature appropriately for being used in dialysis. so,the early recognition through the ultrasound examination of problems in the arteriovenous fistula maturation or possible complications that may compromise their viability, offers the opportunity of correction or appropriate treatment . criteria for maturation after arteriovenous fistula creation: * vein diameter larger than 4 mm remote from the site of fistula. * vein located at a depth of \<5 mm from skin surface.

Eligibility criteria:
inclusion criteria: * 1) patients of chronic renal failure with newly placed avf. 2)clinically stable patients for assessment of maturation of avf. 3) complaints of hand pain or numbness following creation of the access. exclusion criteria: * 1)previously failed av fistulas. 2)deformed or scarred upper limb.