Kornimate/medical-research-clean huggingface dataset:
a study of different durations of treatment with grazoprevir (mk-5172) in combination with ribavirin in participants with chronic hepatitis c (mk-5172-039)

Conditions: Hepatitis C

Summary: this study will compare two different durations of treatment with grazoprevir (mk-5172) in combination with ribavirin (rbv) in treatment-naïve non-cirrhotic interferon-eligible interleukin 28b cc (il28b cc) genotype participants with genotype 1 (gt1)-positive chronic hepatitis c (chc). participants will be randomized to receive 12 or 24 weeks of combination therapy.


Eligibility criteria:
inclusion criteria: * chronic, compensated hcv gt 1 hepatitis c * il28b cc genotype * absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease, or cirrhosis * no evidence of cirrhosis and hepatocellular carcinoma by biopsy or noninvasive tests (fibroscan and/or fibrotest) * agree to use two acceptable methods of birth control from at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female subject who is of childbearing potential or male subject with female sexual partner who is of childbearing potential) exclusion criteria: * non-gt 1 hcv infection, including a mixed gt infection (with a non-gt 1) or a non-typeable genotype * previous treatment with any interferon, rbv, approved or experimental direct acting antiviral(s), or other investigational therapies for hcv * human immunodeficiency virus (hiv) positive or known to be co-infected with hepatitis b virus * evidence of hepatocellular carcinoma (hcc) or under evaluation for hcc * currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study * diabetes and/or hypertension with clinically significant ocular examination findings * current moderate or severe depression or history of depression associated with hospitalization, electroconvulsive therapy, or severe disruption of daily functions, or suicidal or homicidal ideation and/or attempt, or history of severe psychiatric disorders * clinical diagnosis of substance abuse * current or history of seizure disorder, stroke, or transient ischemic attack * immunologically-mediated disease * chronic pulmonary disease * clinically significant cardiac abnormalities/dysfunction * active clinical gout within the last year * hemoglobinopathy or myelodysplastic syndromes * history of organ transplants * poor venous access * indwelling venous catheter * history of gastric surgery or malabsorption disorder * severe concurrent disease * evidence of active or suspected malignancy, or under evaluation for malignancy, or history of malignancy, within the last 5 years * pregnant, lactating, or expecting to conceive or donate eggs * male participant whose female partner is pregnant * member or a family member of the investigational study staff or sponsor staff directly involved with this study * history of chronic hepatitis not caused by hcv
plasma extracellular rnas and biomarkers of heart failure during decongestion: pearl-hf study

Conditions: Congestive Heart Failure

Summary: the primary objective is to measure the association between extracellular rna (ex-rna) levels in plasma in patients receiving aggressive outpatient therapy for chf with (1) cardiac remodeling and (2) cardiovascular events. the investigators will follow patients during standard medical therapy for chf to assess changes in ex-rna levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.

nearly 5 million people in the united states have congestive heart failure (chf). although medical therapy such as beta-blockers, angiotensin converting enzyme (ace) inhibitors, angiotensin-receptor blockers (arbs) and aldosterone antagonists has improved prognosis, the overall rate of hospital admissions has continued to rise in the last decade and the mortality for patients with symptomatic heart failure remains worse than the majority of cancers in this country. accordingly, significant opportunities exist for the improvement in outcomes of patients with chf, both from a morbidity and mortality standpoint. such opportunities may lie in the outpatient medical management of patients with chf. in this study, the primary objective is to measure the association between extracellular rna (ex-rna) levels in plasma in patients receiving aggressive outpatient therapy for chf with (1) cardiac remodeling and (2) cardiovascular events. the investigators will follow patients during standard medical therapy for chf to assess changes in ex-rna levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.

Eligibility criteria:
inclusion criteria: 1. age \> 21 years of age 2. left ventricular ejection fraction ≤ 50% (at any time in the past) 3. symptomatic (nyha class ii-iv) heart failure (as diagnosed by clinician, radiographic images, or abnormal natriuretic peptide level) 4. hospital admission, emergency department visit, or outpatient diuretic escalation of therapy for destabilized hf at least once in the 6 months prior to enrollment exclusion criteria: 1. severe renal insufficiency defined as serum creatinine \> 2.5 mg/dl 2. united organ network sharing status 1b for heart transplantation (outpatient inotrope use, lv assist device) 3. inoperable aortic valvular heart disease 4. life expectancy \<1 year due to causes other than hf such as advanced cancer 5. cardiac transplantation or revascularization indicated or expected within 6 months 6. severe obstructive or restrictive pulmonary disease, defined as a forced expiratory volume in 1 sec \<1 l (when diagnosed as standard of care) 7. subject unable or unwilling to provide written informed consent 8. coronary revascularization (percutaneous coronary intervention or bypass surgery) within the previous 3 months
non-interventional observational study of stereotactic body radiotherapy (sbrt) for oligometastatic cancer

Conditions: Neoplasm Metastasis

Summary: the investigators recently published 2 phase ii trials on the use of helical tomotherapy for oligometastatic colorectal cancer \[1,2\]. despite a dose increase from 40 to 50 gy, delivered in 2 weeks time, the one-year local control was 54% only \[1,2\]. the high local failure rate is probably the result of geographical misses due to tumor motion and a biologically effective dose (bed) of \< 100 gy. the current study will investigate whether the one-year local control rate can be improved to 70%, using respiration correlated ct to individualize the margin needed to account for tumor motion, to avoid geographical miss, together with a monte carlo or collapsed cone dose calculation algorithm delivering 50 gy to the 80% isodose, allowing higher doses in the tumor core. as the concept of an internal target volume (itv) may result in large margins for patients displaying metastases in high mobile organs, such as liver and lung, which may lead to exposure of a relatively high dose to a large volume of normal tissue, dynamic tumor tracking by the vero sbrt system will be applied in those patients.


Eligibility criteria:
inclusion criteria: 1. patients with metastatic cancer from any primary origin and no more than 5 metastases on ct--scan 2. primary tumor treated with curative intention (surgery, radiotherapy, chemoradiotherapy) 3. functional liver volume \> 1000cc in case of liver metastases and a lung diffusion capacity for carbon monoxide (dlco) of \> 30% if lung mets 4. no child b or c liver cirrhosis 5. no systemic treatment within 1 month before initiation of radiotherapy 6. no contra-indications for radiation of all metastatic disease (= no violation of constraints of organs at risk (oar)) 7. no metastases from another carcinoma 8. eastern cooperative oncology group (ecog) performance status ≤ 2 9. age \> 18 years

Keywords: neoplasm metastasis oligometastatic cancer stereotactic body radiation therapy sbrt real-time tumor tracking (rttt) itv internal target volume respiratory motion management image-guided radiotherapy igrt
enhanced recovery after surgery exercise improve perioperative frailty

Conditions: ERAS; Frailty

Summary: a randomized, controlled, clinical trial on the efficacy of eras exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery objective to evaluate the efficacy of eras exercise improve perioperative frailty in patients undergoing elective laparoscopic colorectal surgery participants: patients undergoing elective laparoscopic colorectal surgery over 18 years old. the research intervention was eras exercise the study design was a randomized, parallel controlled trial eras exercise in perioperative period as the experimental group. no eras exercise group was the control group. the sample size was estimated according to the main efficacy index ( the attenuation of frailty after 7 days surgery) of this study. it was assumed that the attenuation of frailty in the eras exercise group was better than that of the control group. the parameters were set as test level (alpha) of 0.050 using a two-sided two-sample unequal-variance t-test, β = 0.9, according to the results of previous clinical trials and combined with literature, the population mean difference was 0.6 with standard deviations of 0.8 for the experimental group and 0.8 for the control group. the experimental group: the control group was 1:1, 39 cases in each group, considering the 20% shedding rate, 49 cases in the experimental group and 49 cases in the control group were selected. 1. the experimental group the patients take eras exercise from hospitalization to 30 days after operation. 2. the control group the patients do not take eras exercise in perioperative period. efficacy evaluation 1. the primary endpoint of the study was the attenuation of frailty via frailty phenotype (fp) between before surgery and 7days, 30 days after surgery. 2. secondary endpoints included the 6-minute walk test (6mwt),nutritional risk screening (nrs2002), anxious and depressive states, activities of daily living (adl),postoperative complications and mortality,short-term recovery quality,postoperative pain.


Eligibility criteria:
inclusion criteria: * patients receiving elective laparoscopic colorectal surgery. * 18≤age≤100 years old, no gender limit; * the asa score is between i and ⅲ; * clearly understand and voluntarily participate in the study, and sign an informed consent form. exclusion criteria: * emergency surgery; * those with a history of cognitive dysfunction; * those with a history of neuromuscular diseases,; * american society of anesthesiologists class ⩾iv; * those with a history of spontaneous pneumothorax, coagulation dysfunction, * acute and systemic infectious diseases, moderate or higher fever; * pregnant women; * history of drug abuse; * those who judged by the physician in charge to be unsuitable for eras-exercise; * other severe cardio-pulmonary diseases that would affect the 6mwd * those failure to obtain informed consent.

Keywords: eras frailty exercise activity
reinforcing effects of brief exposures to nitrous oxide - 8

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. comparisons between nitrous oxide, opiates, and benzodiazepine antagonists will be made. to examine reinforcing effects of brief exposures to nitrous oxide in healthy volunteers.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide reinforcer subjective effects healthy volunteer
cleari (clinical efficacy assessment on recurrent upper-respiratory tract infections) study

Conditions: Recurrent Upper-Respiratory Tract Infections

Summary: the purpose of this study is to assess the efficacy and safety of j022x st for prevention of recurrent upper-respiratory tract infections (rurti) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.


Eligibility criteria:
key inclusion criteria: patients with all the following criteria will be eligible for inclusion in year 1: * children, male or female * aged 3 to 4 years * children known for recurrent urtis in the past year (based on medical recording or reported history) * children at risk for urti in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive). patients with all the following criteria will be eligible for randomisation in year 2: * children, male or female * aged 4 to 5 years * suffering from rurti, i.e. at least 6 urti episodes medically confirmed, with a maximum of 18, during the year 1 of the study. key exclusion criteria: presence of diseases (chronic suppurative otitis media, acute broncho-pulmonary infection, immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis...) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study

Keywords: recurrent common cold laryngitis pharyngitis/tonsillitis acute rhinitis acute rhinosinusitis acute otitis media
pharmacology of mupirocin in nasal application in healthy volunteers: monocentric study

Conditions: Healthy; Staphylococcus Aureus Infection

Summary: mupirocin is an old antibiotic used topically since the 1970s. initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for staphylococcus aureus (sa) carriage, in association with chlorhexidine. this decolonization strategy has been recommended in france for preoperative cardiac surgery in nasal sa carriers since 2013 by the french hospital hygiene society, and recommended for cardiac and orthopedic surgery in sa carriers by the world health organization (who) since 2016. this strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively. as a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for staphylococcus aureus carriage), thus further increasing the use of this molecule. mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril. mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. this lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application. it therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy.


Eligibility criteria:
inclusion criteria: * subject affiliated or entitled to a social security plan * subject having signed the consent to participate in the study exclusion criteria: * pregnancy in progress * acute or chronic rhinorrhea * allergy to mupirocin calcium or excipients * any medication taken during the week preceding the beginning of the study * notable medical history (cardiovascular, pulmonary, neurological pathology, etc.)

Keywords: staphylococcus aureus mupirocin pharmacokinetic
bariatric surgery and pharmacokinetics of lercanidipine

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on lercanidipine are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics lercanidipine
evaluate the safety and efficacy of bremelanotide in women with female sexual arousal disorder (fsad)

Conditions: Sexual Arousal Disorder

Summary: this 8 week at home study is designed to explore efficacy endpoints and evaluate the safety of intranasal bremelanotide in women with female sexual arousal disorder. efficacy will be assessed vs. a parallel placebo group.


Eligibility criteria:
inclusion criteria: * post menopausal and in general good health * in a stable relationship with a male partner for at least 6 months * willing to attempt sexual activity once a week with your partner
alpha lipoic acid and insulin resistance

Conditions: Insulin Resistance

Summary: subjects will be screened with a 2 hour oral glucose tolerance test. after this screening visit, their insulin resistance will be measured. subjects will then be given either alpha lipoic acid (antioxidant) or placebo for 6 weeks. the insulin resistance test will be repeated after the 6 weeks. we believe these studies will confirm the beneficial effect of alpha lipoic acid on insulin sensitivity.

we propose to perform a placebo-controlled study of alpha lipoic acid (la) administration in a cohort of non-obese, non-diabetic, insulin resistant subjects. the insulin sensitivity of 180 subjects will be initially estimated by measuring fasting glucose and insulin levels (homeostasis model assessment) and oral glucose tolerance test (ogtt). the 60 most insulin resistant subjects will then be randomized to 6 weeks of therapy with either 600 mg three times a day of la or placebo. to quantitate the ala-induced improvements, euglycemic hyperinsulinemic clamps to evaluate insulin sensitivity, ogtt using deuterated glucose to evaluate glycolytic glucose disposal, and muscle biopsies to evaluate insulin signaling pathways, will be performed before and after treatment. we believe these studies will (1) confirm the beneficial effect of cr-ala on insulin sensitivity; (2) further our understanding of the molecular mechanisms of la action; and (3) because these insulin resistant subjects are at risk for the development of type 2 diabetes, the metabolic syndrome, and coronary artery disease (cad), a demonstration of the beneficial effects of la on insulin action could ultimately have important public health consequences.

Eligibility criteria:
inclusion criteria: * healthy, not exercising regularly exclusion criteria: * diabetes, impaired glucose tolerance, heart disease, liver disease, hiv, abnormal tsh results, other abnormal lab values

Keywords: diabetes insulin resistance healthy controls anti oxidants
study of the nervous control of the anal sphincter

Conditions: Spinal Cord Injuries

Summary: anal incontinence and constipation are frequently observed in patients with neurological disease. the purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. this technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.


Eligibility criteria:
inclusion criteria: * healthy volunteers * patients with spinal lesion * patients with cauda equina syndrome exclusion criteria: * pregnant women * pacemaker or other metallic material implanted * epileptic patients * organic colorectal disease * obese patients * previous neurological surgery

Keywords: spinal cord injuries - anal sphincter - evoked potentials
therapeutic effect of sodium selenite on oxidative stress in patients with severe sepsis

Conditions: Severe Sepsis

Summary: this study looked at parenteral administration of selenium to septic patients and subsequently monitored dynamic changes of selected activities of antioxidant enzymes and the development of clinical status.

patients will be divided into two groups. se-group who received selenium supplementation during hospitalization in the form of sodium selenite pentahydrate at 750 mg/day for 6 days immediately after admission to our department (1000 mg of sodium selenite pentahydrate = 333 micrograms of selenium) (selenase, vivax; selenium hereinafter). the placebo group will receive continuous saline nacl 50 ml/day for 6 days as a continuous infusion (excluding additional infusion therapy). patients will be further divided into subgroups according to oi on the day of admission to icu. the oxygenation index (oi) pao2/fio2 (partial pressure of oxygen in arterial blood/ fraction of inspired oxygen) ratio in patients will be calculated daily. the determination of biochemical and hematological parameters of blood samples will be as a part of the routine diagnostic methods. data collection for the se-aox study will be performed at two-day intervals: t1 (1st-2nd day), t2 (3rd-4th day) and t3 (5th-6th day). kinetic methods for estimating the activities of glutathione peroxidase (gpx, e.c. 1.11.1.9), glutathione reductase (gr, e.c.1.6.4.2) will be performed using a kit (sigma-aldrich, germany) and that of superoxide dismutase (sod, e.c. 1.15.1.1) by means of the sod-assay kit-wst (fluka, japan) following the user manual provided.

Eligibility criteria:
inclusion criteria: * sepsis, severe sepsis or septic shock, apache ii score between 19 and 24 points after admission exclusion criteria: * mechanical ventilation for less than 24h, neuromuscular disease and terminal illness were also excluding criteria

Keywords: oxidative stress, sepsis, selenium
a follow-up study with children who participated in the tempo study in their first year of life

Conditions: Allergy; Infections

Summary: this is a follow-up study of a randomised clinical trial, called tempo (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. the investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.


Eligibility criteria:
inclusion criteria: * subjects are eligible to participate in the tempo follow-up study in case: * they completed the final (12 months) visit in the tempo study. * parents agree that their contact details will be shared with a third party for study purposes. * parents agree that data collected in the tempo study will be used in the tempo follow-up study. * parents provide written informed consent for participation in the tempo follow-up in accordance with local law. exclusion criteria: * parents who do not have a smartphone, tablet or personal computer with internet access.