Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of milrinone versus sildenafil in the treatment of neonates with persistent pulmonary hypertension

Conditions: Persistent Pulmonary Hypertension

Summary: compare the effect of milrinone versus sildenafil in treatment of neonates with persistent pulmonary hypertension.

40 neonates with pphn, met inclusion criteria, randomly assigned to 2 groups, each includes 20, first group received intravenous milrinone and second group received nasogastric sildenafil. both groups receive other supportive care.

Eligibility criteria:
inclusion criteria: * gestational age \>34 weeks * postnatal age \<10 days exclusion criteria: * neonates with congenital heart disease * neonates with congenital diaphragmatic hernia
magnetic resonance elastography in patients with acute closed traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is a major public health issue, and intracranial hypertension in the acute phase remains a critical scientific issue. many patients with acute closed tbi received conservative, non-surgical treatments at first, while 5%\~19% of which develops intractable intracranial hypertension that requires emergent surgery. therefore, it is of great clinical significance to identify patients who are at high risk of deterioration in the early stage. previous studies have found that brain compliance is a contributive factor to intracranial pressure, and might serve in the development of intracranial hypertension after tbi. we made assumption that intracranial pressure has a negative relationship with brain compliance providing that the volume of hematoma remains constant. however, few studies have applied magnetic resonance elastography (mre) in evaluating brain compliance in patients with tbi. therefore, this study is designed to enroll patients with acute closed traumatic brain injury who are initially treated non-surgically. magnetic resonance elastography (mre) sequences are performed to non-invasively assess patients' brain compliances, in the hope of exploring the potential value of mre biomarkers to predict the short-term outcome in patients with acute closed tbi who are initially receive non-surgical treatments.


Eligibility criteria:
inclusion criteria: * age 18-60 years old * acute closed traumatic brain injury within 7 days * not receiving surgical intervention according to the judgement of neurosurgeons * expected tolerance of magnetic resonance imaging (mri) scan 7 days from injury exclusion criteria: * vital organ failure: congestive heart failure, respiratory failure, renal failure (ckd≥stage 3), severe hepatic dysfunction (child-pugh stage b or c) * any central nervous system (cns) pathology prior to injury: stroke, epilepsy, cns tumour/infections, dementia or other neurodegenerative diseases * ct reveals infratentorial hematoma * contraindications of mri * currently enrolled in other researches

Keywords: traumatic brain injury magnetic resonance elastography brain compliance
alteration of stool microbiota in preterm infants with anemia

Conditions: Anemia, Neonatal; Necrotizing Enterocolitis; Dysbiosis

Summary: this study evaluates the relationship between anemia and stool microbiota in premature infants. it also evaluates the relationship between blood transfusion and stool microbiota.

necrotizing enterocolitis (nec) is a leading cause of death in preterm infants, yet the disease mechanism is not well understood. among the factors that have been studied are the change in stool microbiota (dysbiosis), severe anemia, and transfusion. studies suggest that dysbiosis occurs in neonates with nec. large studies and meta-analyses have shown a predominance of gammaproteobacteria, a decrease in firmicutes, and decreased bacterial diversity in stool from infants with nec. studies do not support a relationship between transfusions and nec since there are conflicting findings on this topic. there is a suggestion, however, that severe anemia may be associated with nec though this requires further study. no studies have been done evaluating the relationship between anemia and change in stool microbiota, or blood transfusion and change in stool microbiota. this study aims to primarily evaluate the relationship between anemia and stool microbiota, and secondarily evaluate the relationship between transfusion and stool microbiota.

Eligibility criteria:
inclusion criteria: * preterm infants less than 32 weeks gestation at birth * age at enrollment between 7 days and less than/equal to 30 days * minimum 100 ml/kg/day enteral feeds exclusion criteria: * development of necrotizing enterocolitis (nec) prior to enrollment * prior surgery * major congenital anomalies * oxygen requirement with fio2 (fraction of inspired oxygen) \>50% (at time of enrollment)

Keywords: nec transfusion microbiome premature
safety study of three formulations of the dermal implant elapr

Conditions: Skin Conditions

Summary: this is a phase i study to assess the safety of three formulations of the dermal implant elapr.

a phase i study to assess the safety of three formulations of the dermal implant elapr in healthy subjects.

Eligibility criteria:
inclusion criteria: * good general health status exclusion criteria: * clinically significant abnormalities of haematology or biochemistry testing * bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged aptt or pt * chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents * history of keloid formation * systemic corticosteroids within last 12 weeks * diabetes or metabolic disorders * any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication * pregnancy/lactation * a history of anaphylaxis or allergic reactions including any known hypersensitivity to hyaluronic acid or lidocaine

Keywords: skin
a phase 3, open-label study to investigate the efficacy and safety of sofosbuvir plus ribavirin in chronic genotype 1, 2, 3 and 4 hepatitis c virus (hcv) and human immunodeficiency virus (hiv) co-infected adults

Conditions: Chronic Hepatitis C; Human Immunodeficiency Virus

Summary: this is an open-label phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 hcv infection who are co-infected with hiv-1.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years with hiv-1 and chronic hcv genotype 1, 2, 3, or 4 co-infection * hcv rna \> 10,000 iu/ml at screening * hcv treatment history: * treatment-naive for hcv genotypes 1, 2, 3, or 4, or * treatment-experienced for hcv genotypes 2 or 3 * hiv antiretroviral (arv) criteria: * on a stable, protocol-approved, hiv arv regimen with undetectable hiv rna for \> 8 weeks prior to screening, or * arv untreated for ≥ 8 weeks prior to screening, with a cd4 t-cell count \> 500 cells/mm\^3 * presence or absence of cirrhosis; a liver biopsy may be required * healthy according to medical history and physical examination with the exception of hcv and hiv diagnosis * agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication exclusion criteria: * hcv genotype 1 or 4 with previous hcv treatment * poor control with hiv arv regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing * a new aids-defining condition diagnosed within 30 days prior to screening * prior use of any other inhibitor of the hcv ns5b polymerase * history of any other clinically significant chronic liver disease * evidence of or history of decompensated liver disease * chronic hepatitis b virus (hbv) infection * hepatocellular carcinoma (hcc) or other malignancy (with exception of certain resolved skin cancers) * chronic use of immunosuppressive agents or immunomodulatory agents * clinically relevant drug or alcohol abuse within 12 months of screening * history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
dexmedetomidine premedication in children

Conditions: Premedication

Summary: the aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

one hundred children between the ages 2-6 years of asa i status underwent full mouth dental rehabilitation were enrolled in the study. group dex (n=50) received 1µg/kg dexmedetomidine in apple juice and group control (n=50) received apple juice only. patients' ramsey sedation scale (rss), the parental seperation anxiety scale (psas), mask acceptance scale (mas) and post anesthesia emergence delirium scale (paeds) and hemodynamic parameters were noted from their patient file. premedication period was 45 minutes and measurements of rss and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. the data were analysed using the kruskal-wallis test, two sample t- tests, chi-square tests and anova.

Eligibility criteria:
inclusion criteria: * the inclusion criteria is age between 2 to 6 years and american society og anesthesiology (asa) grade 1. exclusion criteria: * the exclusion criteria included congenital disease, dex, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

Keywords: dexmedetomidine child premedication emergence delirium dental treatment
virtual reality colonoscopy : a study from nancy

Conditions: Colorectal Neoplasms; Colorectal Polyp

Summary: colonoscopy is an exam which can be responsible for pain and discomfort for the patient. therefore colonoscopy is performed most of the time under general anaesthesia. moreover, drug-induced sedation comes with adverse effects especially among fragile patients. besides, monitoring patients during and after sedation is both logistically demanding and costly. virtual reality offers immersive and three dimensional experiences that distract the attention and might improve patients comfort. the aim of the study is to investigate the use of virtual reality during colonoscopy versus general anaesthesia.

the study is based on a home made questionnaires completed by the operator and the patient before and after the colonoscopy.

Eligibility criteria:
inclusion criteria: * patient needed planned colonoscopy * able to fill in questionnaires in french exclusion criteria: * visual or auditor impairments * dementia patient * limited french language skills * diagnosis of balance disorders or epilepsy
reminder messages for lung cancer screening

Conditions: Skin Flaps; Lung Cancer

Summary: to test lung cancer screening reminder messages to help adults who 1) 50 to 80 years of age, 2) smoke or have smoked, and 3) do not have history of lung cancer by self-report.

primary objectives: -in this project we will develop, refine, and test reminders for lcs to ensure they are acceptable to patients who have a history of cigarette use.

Eligibility criteria:
inclusion criteria: * adults ages 40-80 years * currently use combustible tobacco products or used combustible tobacco products in the past * english or spanish speaker (based on self-report) or an adult caregiver/care partner or family member of someone with a history of combustible tobacco product use (may participate in focus groups, cognitive interviews, surveys) exclusion criteria: • history of lung cancer (based on self-report)
low dose hemi-body radiation for recurrent prostate cancer

Conditions: Prostate Cancer

Summary: older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. to study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. participants will be followed on study for 12 months, capturing psa, cbc, qol and blood samples for immunological analysis.


Eligibility criteria:
inclusion criteria: * a confirmed diagnosis of prostate cancer. * having undergone prior prostate surgery or radiotherapy or both. * evidence of recurrence of the disease as demonstrated by rising psa levels. patients are eligible if on androgen blockade or hormone naïve. exclusion criteria: * prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-223. * receiving treatment with immunosuppressive medications. * platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l). * other medical conditions or co-morbidities which, in the opinion of the investigator, may interfere with the participant's ability to participate in the study. * language difficulties which may hinder the patient's ability to complete the trial. * inability of the potential participant to provide consent. * lack of independence in daily living activities and any other conditions which, in the opinion of the investigator, will hinder the participant's ability to participate and complete the study obligations.
the effect of an electronic medical record (emr) alert on hepatitis b screening

Conditions: Hepatitis B

Summary: asian and pacific islander americans at risk, but never tested for chronic hepatitis b have been randomized to receive an electronic alert in their electronic medical chart to remind primary care physicians to screen them for chronic hepatitis b.


Eligibility criteria:
inclusion criteria: asian and pacific islanders (api) who have not yet received hbsag testing. api will be identified using a novel algorithm which identifies them using their surname, language preference, country of origin. - exclusion criteria: previous hbsag completion. -

Keywords: mass screening
use of lipid emulsion or nanoemulsion of propofol on children undergoing ambulatory invasive procedures.

Conditions: Leukemia

Summary: the purpose of this study is to compare the safety and efficacy of the of propofol nanoemulsion and lipid emulsion for sedation in non-invasive ambulatory procedures.

nanoemulsion of propofol has been developed without lipid solvent in the formulation to minimize the adverse events such as pain of injection, redness, heat, phlebitis.

Eligibility criteria:
inclusion criteria: * lumbar puncture or myelogram * peripheral intravenous access available in the veins on the dorsal region of the hand * the informed consent signed by the legal responsible of the child allowing the participation in the study exclusion criteria: * relative or absolute contraindications use of propofol and excipients * contraindications to the patient undergo general anesthesia or sedation with drug * allergy derived from egg or soy * use of pre-medication * patient receiving psychotropic drugs * use of opioid within 24 hours * the responsible for the children unable to decide for his participation * the severity of the condition wich compromises vital functions such as ventilation and hemodynamic balance * liver cancer which compromises its function * changes in the blood tests * others comorbidities in the investigator opinion

Keywords: sedation children leukemia bone marrow biopsy
adherence to blood pressure diaries with personalized visuals

Conditions: Neurovascular Disorder

Summary: this trial randomizes patients with a neurovascular diagnosis to a type of blood pressure diary for secondary stroke prevention (conventional blood pressure diary or blood pressure diary including patient-provided images). outcomes include adherence and patient-reported outcomes.

in this prospective trial, the investigators randomized persons with diagnoses of stroke or transitoric ischemic attack into two groups: (i) 10 patients received a personalized blood pressure diary with pictures of their choosing. (ii) 10 patients received a blood pressure diary without photographs. the investigators instructed participants in either group to document their blood pressure at home twice daily over twenty-eight days.

Eligibility criteria:
inclusion criteria: * diagnosis of tia or stroke (ischemic or hemorrhagic) upon admission. exclusion criteria: * modified rankin scale score of ≥4 at inclusion * inability to provide informed consent * pre-existing legal guardianship.

Keywords: adherence blood pressure diary stroke tia
tamoxifen in treating women with breast cancer

Conditions: Breast Cancer

Summary: rationale: estrogen can stimulate the growth of breast cancer cells. hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. purpose: randomized phase iii trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

objectives: * compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years. outline: this is a randomized study. patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. patients are randomized to 1 of 2 treatment arms. * arm i: patients discontinue tamoxifen after at least 2 years of prior treatment. * arm ii: patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression. patients are followed annually. peer reviewed and funded or endorsed by cancer research uk projected accrual: a total of 8,000-20,000 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed breast carcinoma that has been completely excised * clinically relapse free * must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer and have no clear indication for or against receiving further tamoxifen * no significant endometrial hyperplasia * no patients with negligibly low risk of breast cancer death * hormone receptor status: * any status allowed patient characteristics: age: * not specified sex: * female menopausal status: * any status allowed performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other life threatening disease * no retinopathy * no psychiatric disorder or other condition that would preclude study compliance * no serious toxicity (e.g., depression) thought to be due to tamoxifen * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * see disease characteristics radiotherapy: * not specified surgery: * see disease characteristics other: * any primary treatment allowed

Keywords: stage i breast cancer stage ii breast cancer
a measles, mumps, and rubella investigational vaccine trial (v205c-010)(completed)

Conditions: Measles

Summary: the purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rha (recombinant human albumin).

the duration of treatment is 6 weeks.

Eligibility criteria:
inclusion criteria: * healthy children 12 to 18 months of age. exclusion criteria: * previous receipt of measles, mumps, rubella and/or varicella vaccine. * prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster. * any medical condition that might interfere with the immune response to the given vaccines (including hiv infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy. * history of seizures (convulsions) * allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin. * a recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° f \[37.5° c\]).

Keywords: prevention of measles
immune responses induced by different licensed influenza vaccines

Conditions: Immune Response

Summary: the goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.

there are currently five licensed inactivated influenza vaccines approved for use in the united states by the food and drug administration.current influenza virus vaccines consist of 3 components: the ha protein from an h1n1 virus, an h3n2 and an influenza b virus.influenza vaccines are evaluated and approved by the fda on the basis of ha and na content. however, different manufacturing processes are involved in the preparation of these commercial vaccines and evidence suggests that each of these vaccines contain similar patterns of ha protein but different patterns of influenza influenza internal proteins such as np and m1. the presence of these additional internal proteins of influenza virus which are targets of t cell responses suggest not only the potential for additional protection derived from influenza vaccines other than antibody mediated protection but also differential levels of t cell mediated protection between different manufacturers of commercial influenza vaccines.each subject will have four blood samples taken- prevaccination and at days 7, 14,30 and 3-5 months post vaccination. these samples will be tested for t and b cell responses and the results compared between different manufacturers.

Eligibility criteria:
inclusion criteria: * adults (18-50 years of age) * willing to donate a blood sample multiple times * willing to sign informed consent and hipaa exclusion criteria: * known systemic hypersensitivity reactions to egg proteins (eggs or egg products), to chicken proteins * known hypersensitivity to neomycin, thimerosol (mercury derivative), neomycin, or polymyxin * previous life threatening reaction to influenza vaccine * individuals with altered immunocompetence state from medical condition ( hiv, cancer) or through immunosuppressive therapy(irradiation,corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) * occurrence of neurological syndrome within six weeks of previous influenza immunization * active neurological disorder characterized by changing neurological disorder * pregnancy * acute febrile illness * history of anemia or bleeding disorders

Keywords: influenzavirus a influenzavirus b human influenza t lymphocytes influenza vaccines
an observational study of roactemra/actemra in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label, retrospective, observational study will evaluate the compliance to roactemra/actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. six months data will be collected from patients records.


Eligibility criteria:
inclusion criteria: * adult patients, over 18 years of age * moderate to severe rheumatoid arthritis * roactemra/actemra treatment must have been initiated 6 months prior to signing the informed consent form exclusion criteria: * patients with rheumatic autoimmune disease other than rheumatoid arthritis * patients who are not willing to sign the informed consent form * patients who participate in interventional trials during the period of this observational study