Kornimate/medical-research-clean huggingface dataset:
effects of oral sildenafil on mortality in adults with pah

Conditions: Pulmonary Arterial Hypertension

Summary: this is a blinded study in adult patients with pah evaluating the relative effects of sildenafil on mortality when administered at the three doses (80 mg, 20 mg or 5 mg, all three times per day \[tid\]). in addition, the relative effects on clinical worsening and 6-minute walking distance (6mwd) will be assessed.


Eligibility criteria:
inclusion criteria: subjects ≥ 18 \<75 years of age with any of the following conditions: * idiopathic primary pulmonary arterial hypertension (ipah) * pah secondary to connective tissue disease * pah with surgical repair (at least 5 years previously) of atrial septal defect (asd),ventricular septal defect (vsd), patent ductus arteriosus (pda) and aorto-pulmonary window * pah diagnosis confirmed by right heart catheterization performed within 12 months prior to randomization * functional class ii-iv; baseline 6mwd ≥ 50 m. exclusion criteria: * significant (ie, \>2+) valvular disease other than tricuspid regurgitation or pulmonary regurgitation * history of cardiac arrest, respiratory arrest, hemodynamic collapse, cpr, ventricular tachycardia, ventricular fibrillation, or uncontrolled atrial fibrillation * history of pulmonary embolism; history of chronic lung disease / restrictive lung disease (eg, chronic obstructive pulmonary disease (copd) or scleroderma) with impairment of lung function * no prior long term treatment with pde-5 inhibitors * treatment with bosentan or riociguat within 3 months of randomization * current treatment with nitrates or nitric oxide

Keywords: pulmonary arterial hypertension pulmonary hypertension pah sildenafil revatio
nutraceutical citrulline in pregnancy

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine if oral of l-citrulline (3 grams/day) for 3 weeks provided in mid-pregnancy to pregnant women with type 2 diabetes will increase the plasma l-arginine/adma ratio, lower maternal blood pressure and increase maternal levels of placental growth factor (plgf).

the pregnancy-specific syndrome preeclampsia is a leading cause of maternal and fetal morbidity and mortality. the underlying cause of preeclampsia is unknown, however several pre-existing maternal conditions are associated with an increased risk of preeclampsia including: diabetes, hypertension, renal dysfunction, obesity and history of preeclampsia. specifically, the risk of preeclampsia is five times greater in women with diabetes. several lines of evidence indicate that endothelial dysfunction is a central feature of the pathophysiology of preeclampsia. asymmetric dimethylarginine (adma) is a methylated metabolite of the amino acid l-arginine and an endogenous inhibitor of nitric oxide synthase (nos). high concentrations of adma contribute to endothelial dysfunction and adma inhibits angiogenesis and arteriogenesis, activities important in pregnancy and deficient in preeclampsia. adma concentrations are higher early in pregnancy among women who later develop preeclampsia. this protocol describes a randomized placebo-controlled trial of l-citrulline in 40 pregnant women with type 2 diabetes from approximately sixteen to nineteen weeks gestation, to determine whether l-citrulline supplementation increases the plasma l-arginine/adma ratio, lowers maternal blood pressure and increases a circulating marker of placental function (placental growth factor plgf).

Eligibility criteria:
inclusion criteria: * singleton pregnancy * type 2 diabetes with hemoglobin a1c \<8 * gestational age at randomization between 14 and 16 weeks based on clinical information * maternal age between 14 and 40 years exclusion criteria: * chronic hypertension * major fetal anomaly * fetal demise * planned termination of the pregnancy * collagen vascular disease (autoimmune disease) on medication * renal disease * epilepsy or other seizure disorder * active or chronic liver disease * heart disease, known illicit drug or alcohol abuse during current pregnancy * already taking l-citrulline as a supplement (1gram/day or more)

Keywords: pregnancy type 2 diabetes asymmetric dimethylarginine l-arginine l-citrulline placental growth factor (plgf) blood pressure
falls prevention in acute care hospital

Conditions: Falls

Summary: the aim of this study is to evaluate the effect of a multifactorial falls prevention program in an acute internal medicine ward.


Eligibility criteria:
inclusion criteria: * all patients admitted to internal medicine ward exclusion criteria: * none
closed incisional negative pressure wound therapy in post-surgical wound care of patients with periprosthetic joint infection

Conditions: Wound Heal; Periprosthetic Joint Infection

Summary: in the proposed study, we will apply prevena on the surgical wound right after closure of the wound in the operating theater. prevena will be used for 7 days, unless there is ongoing infection or much wound drainage that requires debridement. most periprosthetic joint infections are from hematogenous origin. hence, it is considered clean wound unless there is a discharging sinus.


Eligibility criteria:
inclusion criteria: 1. patients with periprosthetic joint infection 2. indicated for debridement surgery 3. high risk for wound complication, including one of the followings: diabetes mellitus, use anticoagulants other than aspirin, current smoker, on immunomodulators or steroids, malnutrition, liver disease, renal failure, bmi \> 35 kg/m2 exclusion criteria: 1. previous flap surgery on the indexed joint 2. younger than 18 years of age 3. silver allergy
operations research to improve newborn health

Conditions: Pregnancy Complications

Summary: this study is designed to look at how operations are carried out in relation to improving the health and survival of newborn babies in india.

the proposed study aims to evaluate the impact of a basic package of obstetric and neonatal care practices implemented by care-india as part of their ten-year, two-phase integrated nutrition and health program (inhp). building on the lessons learned from the integrated nutrition and health project i (inhp i) in seven indian states during 1996-2001, care-india has designed inhp ii, which focuses on six technical interventions. care-india aims to implement this program in 100,000 villages across eight states of india by the year 2006. one of the technical interventions is a focused package of newborn care to be implemented at the community level to improve the health and survival of the newborns, including improvements in care-seeking for maternal and newborn conditions. the services and behaviors promoted include: 1. antenatal care, 2. iron-folate supplementation, 3. tetanus toxoid vaccination, 4. maternal nutrition and rest, 5. birth planning, 6. essential newborn care, 7. immediate and exclusive breastfeeding, 8. prevention of hypothermia, 9. aseptic cord care, and 10. identification and referral of cases with danger signs for both pregnancy/delivery complications and newborn conditions. the services are provided by first-line community-based health workers. care-india invited johns hopkins bloomberg school of public health (jhbsph) to help evaluate their newborn program in an operations research mode. jhbsph's role is limited to assisting care with the design and evaluation of newborn intervention.

Eligibility criteria:
inclusion criteria: * newborn exclusion criteria: * infant/child

Keywords: newborn operations research newborn survival neonatal illness/mortality delivery complications
circadian rhythm and delirium in icu

Conditions: Circadian Rhythm; Sleep Quality; Intensive Care Unit Delirium

Summary: the study aims to investigate the status of circadian rhythm and sleep quality in icu patients and their influence factors. and explore the pathway of circadian rhythm on icu delirium. the hypothesis of study is that icu patients experience circadian and sleep rhythm disorder, especially in patient who have delirium.

delirium is an acute and fluctuating alteration of mental state characterized by a disturbance in attention, level of consciousness and cognition. at present, there is no unified conclusion on the pathogenesis of delirium. there are many different hypotheses, such as the neuroinflammation hypothesis, the neuronal aging hypothesis, the oxidative stress hypothesis, the neurotransmitter hypothesis, the neuroendocrine hypothesis and the circadian rhythm disturbance hypothesis. among them, the circadian rhythm disturbance hypothesis believes that the circadian rhythm disorder caused by various reasons, which leads to sleep disturbance and melatonin secretion disorder promotes the occurrence of acute cognitive impairment, which in turn leads to the occurrence of delirium. circadian rhythm refers to the rhythm of any biological process in the human body that repeats and maintains within 24 hours without external stimulation. by far, the most common way to measure circadian rhythm is through vital signs rhythms, hormone secretion (cortisol and melatonin levels), and sleep-wake cycle. due to the special environment and treatment needs in icu make patients' circadian rhythm easily broken, and produced a large latent harm to patients. most studies are in the process of delirium and sleep research, selecting a small subgroup to evaluate the circadian rhythm indicators of patients, and the overall relationship between delirium and circadian rhythm is not clear. thus, the study aims to investigate the status of circadian rhythm and sleep quality in icu patients and their influence factors, and explore the pathway of circadian rhythm action on icu delirium.

Eligibility criteria:
inclusion criteria: * aged above 18 * rass\>-4 exclusion criteria: * history of mental or psychological illness * the patient remained in coma or deep sedation * delirium was occurring at the time of admission * unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand chinese * neurosurgery and maternal patients
colchicine for prevention of the post-pericardiotomy syndrome and post-operative atrial fibrillation (copps-2 trial)

Conditions: Cardiac Surgery; Post-pericardiotomy Syndrome; Atrial Fibrillation; Pericardial Effusion; Pleural Effusion

Summary: this is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.

this is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.

Eligibility criteria:
inclusion criteria: * age \> 18years * candidate to cardiac surgery but cardiac transplantation * informed consent exclusion criteria: * atrial fibrillation * candidate to cardiac transplantation * severe liver disease or elevation of serum transaminases (\> 1.5 times the upper reference limit) * serum creatinine \> 2.5 mg/dl * preoperative elevation of ck or known myopathy * known chronic intestinal diseases or blood dyscrasias * pregnancy, lactation or women of childbearing potential not protected by a contraception method * hypersensitivity to colchicine * treatment with colchicine for any cause

Keywords: cardiac surgery post-pericardiotomy syndrome atrial fibrillation pericardial effusion pleural effusion prevention colchicine
the effect of prophylactic probiotic lactobacilli in enteral feeding on nosocomial pneumonia rates in critically ill patients

Conditions: Critical Illness

Summary: to assess the effect of addition of probiotic lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients. the study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections. the null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic lactobacilli.

the patients are randomised to one of three treatment groups. each comprising of 100 patients. 1. standard therapy group. patients will receive enteral feeding (with fibre) aiming at the target feeding rate that is determined by the treating physician and the icu dietician, as is standard current practice. two capsule containing placebo will be given 12 hourly via the feeding tube. 2. the first active treatment group, will receive enteral feeding (with fibre) plus probiotic lactobacillus fermentum included in the feeding regime. two capsules containing lactobacillus fermentum (10 11 organisms per capsule) will be delivered via the feeding tube 12 hourly. 3. the second active treatment group will receive enteral feeding (with fibre) plus the probiotic lactobacillus acidophilus included in the feeding regime. two capsules containing lactobacillus acidophilus (2x10 9 organisms per capsule) will be delivered via the feeding tube 12 hourly.

Eligibility criteria:
inclusion criteria: 1. adult patients (18 years or over)admitted to icu with an expected stay of more than 48 hours. 2. patients who are commenced on enteral feeding via gastric or post pyloric routes. 3. patients who consent or if the patients is incompetent, their next of kin who consent, to inclusion in the study exclusion criteria: 1. patients less than 18 years old. 2. patients who are already receiving probiotic treatment. 3. the lactobacillus acidophilus preparation to be used in the study, contains a very small amount of msg (total dose of 20mg/day, equivalent to 10% of the initial dose used to test msg sensitivity) and as a precaution, patients with asthma or recurrent urticaria will be excluded. 4. patients with hiv infection, pre-existing immunosuppression, or who are pregnant. as the lactobacillus is a live micro-organism, immunosuppressed and pregnant pateints will be excluded. 5. patients with a contra-indication to enteral feeding. 6. patients with contra-indication to placement of enteral feeding tube. 7. patients or next-of-kin who do not consent to inclusion in the study. 8. patients who are already enrolled in another study that may influence the outcome of the probiotic study.

Keywords: nosocomial rates in critically ill patients
clinical trial evaluating the optimal technique for chest tube removal

Conditions: Chest Tube Removal

Summary: there are two commonly used methods to remove chest tubes following thoracotomy. one is to remove the chest tube at maximum inspiration, (patient is asked to take a deep breath in and hold it), and the other is to pull the chest tube at maximum expiration,(patient is asked to blow out as much air as they can can and hold it). there has been considerable discussion among thoracic surgeons that one of these two methods may decrease the risk of pneumothorax, the most common complication associated with chest tube removal. the investigators will compare the two methods, and also identify risk factors of developing pneumothorax during chest tube removal.


Eligibility criteria:
inclusion criteria: * patients who are post thoracotomy, pulmonary resection (wedge, lobectomy, segmentectomy, pneumonectomy), and * have at least one chest tube. exclusion criteria: * less than 19 years old, * with interstitial lung disease, or * any patient intubated.

Keywords: thoracotomy inspiration expiration chest tube pneumothorax method of chest tube removal
laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation

Conditions: Cirrhosis; Hypertension; Splenectomy; Laparoscopy

Summary: this study aimed to evaluate whether synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (svel) is effective and safe, and to determine whether svel can effectively decrease the incidence of postoperative esophageal variceal re-bleeding.

after successful screening the cases of cirrhosis of liver irrespective of the etiology who have prior esophageal/gastroesophageal variceal bleeding will be enrolled. the baseline parameter will be recorded and the patient will be randomized into either interventional (synchronous vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation (svel)) or control (single vagus nerve-preserving laparoscopic splenectomy and azygoportal disconnection without intraoperative endoscopic variceal ligation (svel)) group. from postoperative day 3, all patients will receive 100 mg oral aspirin enteric-coated tablets (bayer, leverkusen, germany) once daily for 1 year, low-molecular-weight heparin (cs bio, hebei, china) subcutaneously (4.100 iu/day) for 5 days, and 25 mg of oral dipyridamole (henan furen, henan, china) thrice daily for 3 months. at months 3, 6, and 12 after operation, endoscopic intervention will be done for all patients. endoscopic variceal ligation was made if the diameter of the esophageal varices was \>5 mm. postoperative complications of esophageal variceal re-bleeding and death due to re-bleeding will be recorded during the postoperative first year monitoring in the both groups as per the primary or secondary outcome.

Eligibility criteria:
inclusion criteria: * a clinical, radiological or histologic diagnosis of cirrhosis of any etiology * splenomegaly with secondary hypersplenism * esophageal/gastroesophageal variceal bleeding * no evidence of portal vein system thrombosis by ultrasound evaluation and angio-ct * informed consent to participate in the study exclusion criteria: * hepatocellular carcinoma or any other malignancy, * hypercoagulable state other than the liver disease related * drugs- oral contraceptives, anticoagulation or anti-platelet drugs. * child - pugh c * recent peptic ulcer disease * history of hemorrhagic stroke * pregnancy * uncontrolled hypertension * age\>75 yrs * human immunodeficiency virus (hiv) infection

Keywords: vagus nerve esophageal variceal re-bleeding cirrhosis hypertension laparoscopy
effects of maternal obesity on offspring brain development

Conditions: Healthy

Summary: the goal of this study is to see if there are negative effects of maternal obesity during pregnancy on offspring's brain development.

this study will recruit pregnant women who are either obese or normal weight and otherwise healthy. we will measure their body composition, food intake and other characteristics during pregnancy. when their babies are born, we will evaluate the brain development of their babies using magnetic resonance imaging and electroencephalography at age two weeks. we will then compare the findings and see if their are differences.

Eligibility criteria:
inclusion criteria: * bmi 18.5-25 or \>30 with early ob visit medical records accessible * singleton pregnancy * about 36wks of pregnancy * at least 18 years of age exclusion criteria: * hypertension, diabetes, or other preexisting medical conditions * medications known to influence fetal growth * recreational drugs, nicotine or tobacco use of alcohol use while pregnant * pregnancy conception with assisted fertility treatment * medical complications developed during pregnancy
safety & prevention outcomes study

Conditions: Drug Overdose; Opioid-Related Disorders

Summary: unintentional poisoning is a developing public health problem in the u.s. unintentional poisoning (or "overdose") deaths increased 157% among adults between 1999 and 2008. there were \~700,000 emergency department (ed) visits due to overdoses in 2007. medication-related overdoses, particularly prescription opioid overdoses, have accounted for much of this increase. there have been parallel increases in sales of opioids (with a 6 fold increase between 1997 and 2007), as well as both medical and non-medical use of prescription opioids. prescription opioids are now among the most common of drugs used non-medically in the u.s. the specific aims of this project are to: 1) develop an ed-based tailored brief prescription opioid overdose prevention intervention. we will examine therapeutic alliance, perceived satisfaction, and perceived utility of the intervention; 2) examine intervention effects on precursors of overdose risk behavioral change immediately post-intervention. we will compare intervention and control participants on knowledge, self-efficacy, readiness to change, and behavioral intentions regarding overdose risk behavior; and 3) examine intervention effects on overdose risk behaviors six months post-intervention. we will compare intervention and control participants on: 1) use of high dose/quantity of opioids; 2) using opioids in combinations with certain psychoactive substances (i.e., alcohol, heroin, cocaine, and sedatives); and, 3) route of administration.


Eligibility criteria:
inclusion criteria: * patients 18-60 presenting to the ed for medical care * ability to provide informed consent * additional criteria for intervention: past extramedical opioid use exclusion criteria: * patients who do not understand english * prisoners * patients classified by medical staff as a "level 1" trauma (e.g., in need of immediate lifesaving procedures) * patients deemed unable to provide informed consent * patients treated in the ed for suicide attempt or sexual assault
dexmedetomidine versus propofol sedation for drug-induced sleep endoscopy in pediatric obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. a second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.


Eligibility criteria:
inclusion criteria: 1. diagnosed with obstructive sleep apnea (osa) by the following criteria: obstructive apnea index (oai) ≥ 1 or apnea hypopnea index (ahi) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using american academy of sleep medicine pediatric criteria in an accredited sleep lab. 2. considered to be a surgical candidate for adenotonsillectomy to treat osa by an board-certified or board-eligible otolaryngologist. 3. clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include: 1. obese (\>95th percentile of body mass index for age) 2. severe preoperative osa (ahi ≥10 events/hour) 3. discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity; 4. african american race 5. age ≥7 years old 4. male or female ages 3.00 - 11.99 years 5. parent/guardian ability to understand and willingness to sign a written informed consent.. 6. parent/guardian must understand/read/speak english or spanish and be able and willing to complete questionnaires. exclusion criteria: 1. previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment. 2. major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results 3. history of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane 4. allergy to eggs, egg products, soybeans or soybean products. 5. contraindication to receiving general anesthesia

Keywords: drug-induced sleep endoscopy propofol dexmedetomidine