Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of dexlansoprazole modified release formulation to treat gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to assess the efficacy and safety of dexlansoprazole modified release (mr) (30 mg once daily \[qd\] or 60 mg qd) compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in subjects with symptomatic, nonerosive gastroesophageal reflux disease (gerd).

this is a phase 3, randomized, double-blind, multicenter, placebo-controlled, 3-arm study with a 4 week treatment period. this study will compare the efficacy of dexlansoprazole mr (30 mg qd and 60 mg qd) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. the study is designed to evaluate symptom relief in subjects with symptomatic nonerosive gerd. approximately 900 subjects will be enrolled at approximately 200 united states (us) and potentially ex-us sites. the study consists of two periods: a screening period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Eligibility criteria:
inclusion criteria: * subjects identifying their main symptom as a burning feeling in the mid epigastric area and/or chest area (ie, heartburn). * subject has a history of episodes of heartburn for 6 months or longer prior to screening. * subject must have a history of episodes of heartburn for 4 or more days during the 7 days prior to day -1. exclusion criteria: * endoscopic barrett's esophagus and/or definite dysplastic changes. history of dilatation of esophageal strictures. * subjects with erosive esophagitis (ee) as shown by endoscopy. * evidence of uncontrolled systemic disease. co-existing diseases affecting the esophagus. current or history of zollinger-ellison syndrome. * subject has abnormal laboratory values. * subjects with active gastric or duodenal ulcers within 4 weeks of the first dose. * subject known to have acquired immunodeficiency syndrome (aids). * known hypersensitivity to any proton pump inhibitor (ppi), any component of dexlansoprazole mr, or antacid. * use of prescription or non-prescription ppis, histamine (h2) receptor antagonists, or sucralfate. * chronic (\>12 doses per month) use of nonsteroidal anti-inflammatory drugs (nsaids) or cyclo-oxygenase-2 (cox-2) inhibitors. * use of antacids (except for study-supplied gelusil® ). * use of drugs with significant anticholinergic effects. * subjects who cannot discontinue the use of misoprostol or prokinetics * need for continuous anticoagulant therapy. * females who are pregnant or lactating. * history of gastrointestinal surgery except for simple oversew of ulcer. * history of cancer within 3 years prior to screening. * subject has participated in a previous dexlansoprazole study. * subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.

Keywords: gastroesophageal reflux disease(gerd) heartburn
patient-ventilator asynchrony during noninvasive ventilation assessed using diaphragm ultrasonography

Conditions: Diaphragm; Ultrasonography

Summary: fifteen healthy subjects under non-invasive ventilation will be have a recording of surface electromyogram, measurements of airway flows and pressures as well as a continuous ultrasound. the provocation of leaks on the ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator. these records will help to assess the agreement between the detection of asynchronies using electromyography of the respiratory muscles (technique of reference) and the diaphragmatic echography. we will also compare the respective performance of two techniques of diaphragmatic exploration (excursion and thickening of the diaphragm). a sensitivity of ultrasound technique of at least 90% will be interpreted as a satisfactory index of concordance.


Eligibility criteria:
inclusion criteria: * healthy volunteer (male or female) * free and informed consent exclusion criteria: * known pregnancy, parturient or nursing mother * minor under 18 years of age * major incapable * non-affiliation to the social security scheme * any history of respiratory pathology
microbiome in cancer patients with high dose chemotherapy with stem cell transplantation

Conditions: Hematologic Neoplasms

Summary: numerous in vitro and animal studies as well as growing number of clinical studies support the important role of microbiome in carcinogenesis and cancer treatment. detection of changes in patients´ microbiome following hematopoietic cell transplantation/car-t cell therapy and correlations with adverse transplant outcomes, mainly infectious complications, acute and chronic gvhd, disease recurrence etc. could serve as predictive markers of immune recovery and treatment response.

currently, available findings coming mainly from allo-hsct (hhematopoietic cell transplantation) studies, link particular changes in microbiota with overall survival and post-transplant disorders, especially gvhd. according to limited data, further evaluation of associations between the alterations in microbiome composition and toxicities. detail investigation of both the microbiome and host immune system may help to find microbiome markers useful for very early identification of patients at risk for major transplant-related complications. this might bring the possibility to modulate the gut microbiota in patient´s specific manner to achieve optimal therapeutic outcome and follow-up, while avoiding severe post-transplant complications. this is prospective, single center, non-randomized, hypothesis generating study. patients will be asked to provide a sample of blood, urine and stool. this blood will be used for plasma and serum banking for further analysis, including micro rna (mir) and chemokine detection. stool will be used for microbiome studies - isolation of total dna/rna and 16s (rna component of the small subunit of a prokaryotic ribosome) rrna (ribosomal ribonucleic acid) gene sequencing for bacterial taxonomic classification. furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used including characterization of potentially clinically relevant features of the microbiome such as antibiotic resistance and microbial virulence factors.

Eligibility criteria:
inclusion criteria: * signed written informed consent * aged 18 years or older * patients planned to be treated by high-dose chemotherapy and hematopoietic cell transplantation or by car-t cell therapy in national cancer institute, slovakia exclusion criteria: - patients not-matching inclusion criteria

Keywords: cancer microbiome high dose chemotherapy stem cell transplantation car-t cell
superb microvascular intraocular tumor imaging study (smitis)

Conditions: Ocular Tumor

Summary: the diagnosis and monitoring of intraocular tumors are based on multimodal imaging in addition to the clinical examination (ultra-widefield retinal imaging, echography, angiography). nevertheless, it may be difficult in cases of retinal hemorrhage, small tumor size or atypical presentation. the study of microvascular flow (superb microvascular imaging, smi) of intraocular tumors could improve the confidence of differential diagnosis when evaluating these suspicious lesions, or even determine whether a lesion is benign or malignant by describing the vascularization of the lesion. the investigators propose to study the microvascular flow patterns of intraocular tumors prior to proton therapy.

the ultrasound equipment available in ophthalmology does not have doppler technology and does not allow the study of the vascularization and microvascularization of intraocular lesions. the interest in the system used in this study is to import smi into ophthalmology to study tumor microvascularization. the study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * intraocular tumor not previously treated with proton therapy exclusion criteria: * severe active ocular, periocular or intraocular inflammation * intraocular pressure \> 30 mmhg
reporting patterns and results of initial antibiotic treatment in patients with cuti, ciai,np including vap

Conditions: Urinary Tract Infection (cUTI); Intra-abdominal Infection (cIAI) and; Nosocomial Pneumonia (NP)

Summary: reporting patterns and results of initial antibiotic treatment in patients with complicated urinary tract infection (cuti), complicated intra-abdominal infection (ciai) and nosocomial pneumonia (np) including ventilator-associated pneumonia (vap) - recommend study

this will be an observational, historical cohort study from medical chart review of adult hospitalized patients for each of the three conditions of interest (complicated urinary tract infection (cuti), complicated intra-abdominal infection (ciai) and nosocomial pneumonia (np) including ventilator-associated pneumonia (vap)). for this study, the proposed patient selection period extends for 12 months, from july 1, 2013 to june 30, 2014. patients selected during this period will be followed from diagnosis (i.e., diagnosis of cuti, ciai or np) until symptom resolution, discharge or 30-days post discharge \[based on data availability to assess readmission and outpatient visits\], death while hospitalized, loss to follow-up or the end of study period if not yet discharged from index hospitalization \[december 31, 2014\]).

Eligibility criteria:
inclusion criteria: icf to be obtained (refer slides 26-30) adult (≥18 years) patients patients with a diagnosis of at least one of the three conditions hospitalised during the period july 1, 2013 to june 30, 2014 hospital acquired or healthcare associated cuti hospital acquired or healthcare associated ciai np including vap exclusion criteria: the patient participated in a clinical trial during the patient selection period (01-jul-2013 to 30-jun-2014) or during the follow-up period\* for patients diagnosed with cuti: the patient has a diagnosis of hospital acquired or healthcare associated cuti with concomitant presence of fungal uti with colony count \> 10\^3/ml
vte incidence after curative colon cancer surgery in an eras program

Conditions: Deep Vein Thrombosis, Pulmonary Embolus; Colon Cancer

Summary: based on data on a cohort of 2,141 patients undergoing elective colonic cancer resection in an eras program, the incidence of postoperative thromboembolic events is estimated in patients no receiving prolonged thromboembolic prophylaxis.

the copenhagen complete mesocolic excision study (comes) database contains comprehensive data on preoperative, intraoperative, postoperative and tumor related variable on patients undergoing elective colonic cancer resection at four public university clinics providing all colorectal cancer treatment for the 1.8 million residents of the capital region of denmark during the period 2014-2017. none of these hospitals had implemented prolonged thromboembolic prophylaxis after discharge. the medical records were reviewed with focusing on vte prophylaxis, ongoing preoperative and postoperative anticoagulant treatment, the length of hospital stay (los), and readmission to ensure high data validity.

Eligibility criteria:
inclusion criteria: * elective macroradical resection for uicc stage i-iii colonic adenocarcinoma exclusion criteria: * concomitant rectum resection * soly appendix carcinoma * diagnosed with pulmonary embolism or deep venous thrombosis before primary discharge * dying before discharge from the hospital or discharged at postoperative day 28 or later * treatment with vitamin k antagonists, heparin or new oral anticoagulants before or after surgery * vte less than 3 months before the colon resection

Keywords: prolonged thromboembolic prophylaxis
translational study of mss, tp53 mutation and chromosome instability relationship in endometrial carcinoma

Conditions: Endometrial Neoplasms; TP53 Gene Mutation; Chromosomal Instability; Microsatellite Stable Endometrial Carcinoma

Summary: the objective is to understand the relationship between tp53 mutation, mss and chromosome instability in endometrial cancer and the effect on clinical prognosis.we will collect a small amount of tumor tissue samples. ngs panel detection and wgd/as analysis were performed on the tissue. paracancer tissue was used as a negative control and relevant information in medical records during the operation. then we will collect clinical diagnosis and disease information through telephone follow-up after the completion of the operation.

the test is sequenced using illumina high-throughput sequencers and accompanying kits. conduct preliminary quality control on the samples, and the tumor cell content of the tissue samples shall not be less than 30%. tissue dna was extracted from tumor tissue samples according to the instructions of the qiagen dna extraction kit. samples qualified for quality control shall be arranged for further library construction. the extracted dna samples were sequentially purified by fragment purification, terminal repair, splicing, fragment size selection, pcr amplification, product purification, library enrichment, and library product quality control. after qualified quality control, the constructed library was sequenced by illumina matching kit. bioinformatics analysis would be conducted.

Eligibility criteria:
inclusion criteria: * willing to participate in the study and sign the informed consent * age ≥18 years old * researchers evaluated that it was suitable to participate in this translational study * endometrial cancer was confirmed histologically * histopathological molecular classification was consistent with pmmr type and pole wild type * the tumor tissue obtained by operation was the primary lesion exclusion criteria: * received chemotherapy within 14 days prior to sample collection, or received anti-tumor drug therapy such as radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, within 21 days prior to sample collection * previously treated with kif18a inhibitors * researchers believed that the subjects were not suitable for the translational study for other reasons

Keywords: endometrial cancer chromosomal instability microsatellite stability tp53 gene mutation whole genome duplication
study of aflibercept and modified folfox6 as first-line treatment in patients with metastatic colorectal cancer

Conditions: Colorectal Neoplasms; Neoplasm Metastasis

Summary: the primary objective of the study is to estimate the progression-free survival rate at 12 months for the two arms of the study. secondary objectives include the evaluation of overall objective response rate to treatment, progression-free survival, overall survival, safety and documentation of potential immunogenicity of aflibercept. this study was a non-comparative randomized trial and was not powered for a comparison of any of the efficacy endpoints. rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and safety of aflibercept combined with a modified folfox6 regimen. in such type of non-comparative randomized trial, the control folfolx6 arm was intended to only act as a check on the similarity of the current patients to the historical controls with respect to clinical outcome when given folfox6 treatment.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the colon or the rectum * metastatic disease not amenable to potentially curative treatment exclusion criteria: * prior therapy for metastatic cancer of the colon or the rectum * prior treatment with angiogenesis inhibitors the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: angiogenesis colon cancer rectal cancer oxaliplatin
longitudinal study of music therapy's effectiveness for premature infants and their caregivers

Conditions: Preterm Birth

Summary: background: preterm birth has major medical, psychological and socio-economic consequences worldwide. a recent systematic review suggests positive effects of music therapy (mt) on physiological measures of preterm infants and maternal anxiety, but methodologically rigorous studies including long-term follow-up of infant and parental outcomes are missing. drawing upon caregivers' inherent resources, this study emphasizes caregiver involvement in mt to promote attuned, developmentally-appropriate musical interactions that may be of mutual benefit to infant and parent. this study will determine whether mt, as delivered by a qualified music therapist during neonatal intensive care unit (nicu) hospitalization and/or in home/municipal settings following discharge, is superior to standard care in improving bonding between primary caregivers and preterm infants, parent well-being and infant development. methods: design: international multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. a feasibility study has been completed; ethical approval for the main trial is pending. participants: 250 preterm infants and their parents. intervention: mt focusing on singing specifically tailored to infant responses, will be delivered during nicu and/or during a post-discharge 6-month period. primary outcome: changes in mother-infant bonding until 6 months corrected age (ca), as measured by the postpartum bonding questionnaire. secondary outcomes: mother-infant bonding at discharge and over 12 months ca; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months. discussion: this study fills a gap by measuring the long-term impact of mt for preterm infants/caregivers, and of mt beyond the hospital context. outcomes related to highly involving parents in mt will directly inform the development of clinical practice in scandinavia and other contexts with similar social welfare practices. by incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.


Eligibility criteria:
inclusion criteria (infants): * born below 35 weeks gestational age * determined by medical staff to have achieved sufficient medical stability to start mt * likely to be hospitalized longer than 2 weeks from time of recruitment inclusion criteria (parents): * willing to engage in at least 2 of 3 mt sessions per week during nicu and/or in 5 of 7 mt post-discharge sessions, if randomized to receive mt * live with reasonable commuting distance from the treating nicu * sufficient understanding of the respective national language(s) to answer questionnaires and participate in mt exclusion criteria (parents): * documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments

Keywords: parent-infant bonding music therapy
study on the incidence of early deep vein thrombosis after peripherally inserted central catheter insertion

Conditions: Venous Thrombosis

Summary: deep vein thrombosis (dvt) is one of the most important complications after peripherally inserted central catheter (picc) insertion. this study goals are to understand when and why dvt develops.

deep vein thrombosis (dvt) is one of the most important complications after peripherally inserted central catheter (picc) insertion. this study goals are to understand when and why dvt develops. patients will be studied with ultrasound for 4 weeks after picc insertion, one visit a week. the final outcome of piccs will be collected.

Eligibility criteria:
inclusion criteria: * peripherally inserted central catheter insertion exclusion criteria: * pre-existing deep vein thrombosis

Keywords: peripherally inserted central venous catheter
analysis of the hospital node in the management of acute events of patients referred to pediatric palliative care

Conditions: Pediatric Palliative Care

Summary: this study aims to analyze the role of the hospital node in the acute event management of pediatric patients referred to pediatric palliative care. patients eligible for pediatric palliative care experience frequent hospitalizations. in oncology patients, hospitalizations are mainly for the treatment of the disease and the performance of diagnostic and/or therapeutic procedures, whereas in the case of non-oncology children, admissions occur particularly for the occurrence of complications, which may affect different organs and systems. hospitalization times are on average longer, so much so that in some cases they can even exceed 100 consecutive days, and have a high risk of re-hospitalization.

in italy, the prevalence of children needing cpp is estimated at 34-54 per 100,000 population, for a total number between 20,000 and 35,000 children. prevalence data and projections performed on the british population show that children with life-limiting conditions are progressively increasing. the reason for this increase can be attributed to medical and technological advances that have enabled reductions in neonatal and pediatric mortality and increased the survival of pediatric patients with severe and life-threatening disease. caring for these patients is complex as they require specific medical and management knowledge and coordination within the health care system. the care of children with medical complexity is interdisciplinary, with different professionals playing a central role for these children. teamwork is necessary not only for responding to clinical problems but also for defining goals of care and for communication to the patient and family.

Eligibility criteria:
inclusion criteria: * living patients aged \<18 years at the time of the event * patients with conditions eligible for ppcs according to association for children's palliative care/royal college of pediatrics and child health exclusion criteria: * na

Keywords: pediatric palliative care
platelet transfusion in acute intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: * to prove whether use of antiplatelet agents results into a rapid enlargement of hematoma after onset of acute intracerebral hemorrhage. * to prove the efficacy and safety of platelet transfusion for prevention of hematoma growth in patients who were stricken by acute intracerebral hemorrhage while being on antiplatelet medication.

* hematoma growth is a well-known powerful determinant of mortality and poor outcome after intracerebral hemorrhage. * some observations suggest that previous use of antiplatelet agents associates with rapid hematoma enlargement and poor outcome after cerebral hemorrhage. * immediate platelet transfusion for such patients may prevent hematoma growth but also cause thromboembolic complications.

Eligibility criteria:
inclusion criteria: * being on either aspirin or clopidogrel or a combination of aspirin and dipyridamole * acute primary ich * \> 17 years * admitted within 6 h after onset of ich * ich score \< 4 exclusion criteria: * other type of ich than acute primary intracerebral hemorrhage * patients who need neurosurgery * life expectancy less than 3 months due to comorbid disorders * confirmed malignant disease (cancer) * confirmed acute myocardial infarction * hepatitis and/liver cirrhosis * renal failure * infectious disease (hiv, endocarditis etc.) * current or previous hematologic disease * women of childbearing age if pregnant * participation in another study within the preceding 30 days

Keywords: intracerebral hemorrhage hematoma enlargement antiplatelet agent platelet transfusion outcome