Kornimate/medical-research-clean huggingface dataset:
grazoprevir (mk-5172) and elbasvir (mk-8742) combination for chronic hepatitis c virus (hcv) genotypes 1, 4, and 6 (mk-5172-065)

Conditions: Hepatitis C

Summary: this is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (fdc) of grazoprevir (mk-5172) 100 mg + elbasvir (mk-8742) 50 mg in participants with chronic hepatitis c virus (hcv) genotype (gt) 1, gt4 or gt6 with inherited blood disorders. the primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving sustained virologic response (svr) 12 weeks after the end of all study therapy (svr12) will be greater than the reference rate of 40%.


Eligibility criteria:
inclusion criteria: * has hcv gt1, gt4, or gt6 with sickle cell anemia, thalassemia, or hemophilia/von willebrand disease * has cirrhosis or is non-cirrhotic * is human immunodeficiency virus (hiv) coinfected or not infected with hiv * is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception exclusion criteria: * has evidence of decompensated liver disease * is coinfected with hepatitis b * has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * has hepatocellular carcinoma (hcc) or is under evaluation for hcc * has clinically-relevant drug or alcohol abuse within 12 months of screening
nurse initiated acupressure for pain management

Conditions: Pain, Postoperative; Pain, Acute

Summary: the purpose of pilot study is to test the feasibility of nurse initiated post-operative bilateral auricular acupressure as an adjunct to medication for post-operative pain management.

postoperative pain management has become an area of concern over the last decade due to the opioid epidemic and concerns related to their use as the primary pain management strategy. joint commission requires that hospitals have additional pain non-pharmacologic pain management tools at their disposal to an effort decrease the reliance on opioids. acupuncture and acupressure have been used for centuries in the management of a variety of disorders including pain. unlike acupuncture, acupressure can be easily applied with limited training and is within the scope of practice for nurses, according to the north carolina board of nursing. thus evidence based non-pharmacologic strategies that can be deployed by nursing are of benefit to hospital organizations.

Eligibility criteria:
inclusion criteria: * adults 18-80 admitted for knee or hip arthroplasty * pre-surgery morphine equivalent \< 50 * american society of anaesthesiologists (asa) score \< 3 exclusion criteria: * participants with a history of skin disease (psoriasis), adhesive allergy, history of delirium, or cognitive impairment

Keywords: auricular acupressure anesthesia
comparison of post-operative analgesia after percutaneous nephrolithotomy.

Conditions: Pain; Postoperative Pain

Summary: the rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following pcnl in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

the rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following pcnl in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Eligibility criteria:
inclusion criteria: * all patients undergoing pcnl * age from 12-65 years * normal renal functions * no history of chronic pain * asa i, ii \& iii * both genders exclusion criteria: * history of local anaesthesia allergy * redo pcnl * multiple punctures during pcnl * excessive intra-operative bleeding * diabetes mellitus * coagulopathy * mental disorder * asa iv \& v * active urinary tract infection.

Keywords: local anesthesia, percutaneous nephrolithotomy.
study of ngm282 in patients with nonalcoholic steatohepatitis (nash)

Conditions: Nonalcoholic Steatohepatitis (NASH)

Summary: the purpose of this study is to determine the safety, tolerability, and efficacy of ngm282 in patients with nonalcoholic steatohepatitis.


Eligibility criteria:
inclusion criteria: * males or females, between 18 and 75 years of age, inclusive * histologically confirmed nash diagnosis exclusion criteria: * clinically significant acute or chronic liver disease * prior liver transplantation
accuracy of scoring systems for risk assessment in neonatal intensive care unit

Conditions: Neonatal Death

Summary: early detection of neonates with higher risk of death is quite important for paying more attention to these cases, timely referral to tertiary neonatal intensive care unit (nicu), and provision of meticulous critical care, which ultimately may improve outcomes. several scoring systems have recently been developed for assessment of the intensity of illness and prognosticate the risk of not only neonatal mortality but also short- and long-term morbidities. the accuracy of these scoring systems has been investigated in several nicus from different countries, such as usa, uk, canada, brazil, india, and iran. previous egyptian studies have investigated the accuracy of clinical risk index for babies ii (crib ii), score for neonatal acute physiology ii (snap-ii) and its perinatal extension ii (snappe-ii). however, the accuracy of sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar (stops), modified sick neonatal score (msns), and neonatal sequential organ failure assessment (nsofa) has not been investigated in egyptian nicus. therefore, more studies are required to investigate the utility and accuracy of neonatal risk assessment scores in egyptian nicus.


Eligibility criteria:
inclusion criteria: * admission within 24 hours after birth. * length of hospital stay at the first admission to nicu ≥12 hours exclusion criteria: * major congenital anomalies. * discharge against medical advice * transportation to other places. * missing data on items of scoring systems
single-use digital flexible ureteroscope vs nondisposable fiber optic vs digital ureteroscope

Conditions: Urolithiasis

Summary: the aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

with the advancement of technology, flexible ureteroscopy (f-urs) has become an attractive option for surgical management of kidney stones. however, the durability of flexible ureteroscope still remains a major concern. due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining furs programs worldwide, especially in the developing countries. nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.

Eligibility criteria:
inclusion criteria: 1. aged 18-70 years 2. american society of anesthesiology (asa) score 1 and 2 3. renal or upper ureteral stone of diameter ≤ 2.0 cm exclusion criteria: 1. ureteral stricture, renal or ureteral deformity 2. pregnancy 3. patients with chronic kidney disease, ckd (serum creatine\> 177 umol/l)
risk of pneumothorax with and without chest tube clamping in patients with pleural pathology

Conditions: Pneumothorax; Chest Tube; Pleural Diseases

Summary: through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: the first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping. the data will be prospectively collected from patient records from the national institute of respiratory diseases ismael cosío villegas.

patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal). incidence of 24hour pneumothorax after chest tube removal will be recorded.

Eligibility criteria:
inclusion criteria: * patients aged 16 years and more. * patients hospitalized in the national institute of respiratory diseases. * patients who had a chest tube placement during their stay at the hospital, by any cause. exclusion criteria: * patients who refuse to sign the informed consent and who refuse to participate in the study. * patients who die before randomization. * patients who gets chest tube removal before being randomized.

Keywords: chest tube pneumothorax pleural diseases
safety and efficacy of deucravacitinib in participants with moderate to severe ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (uc).


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have active ulcerative colitis (uc) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit * must have documented diagnosis of uc of at least 3 months' duration prior to screening * must have active moderate to severe uc, as defined by a modified mayo score of 5 to 9 points, inclusive, which includes a stool frequency (sf) subscore of ≥ 2, and a rectal bleeding (rb) subscore ≥ 1, and a screening endoscopic (es) subscore of ≥ 2 exclusion criteria: * previous/current documented diagnosis of cd, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with clostridium difficile \[c. difficile\]) * stool positive for c. difficile toxin at screening visit * current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation other protocol-defined inclusion/exclusion criteria apply
iron overload in patients undergoing donor stem cell transplant

Conditions: Cancer; Hematopoietic Stem Cell Transplantation; Allogeneic Hematopoietic Cell Transplantation

Summary: rationale: learning about the effect of excess iron in the liver of patients undergoing donor stem cell transplant may help doctors plan treatment. purpose: this study is investigating the effects of iron overload in patients undergoing donor stem cell transplant.

objectives: primary * determine the impact of pre-transplant iron overload (defined as liver iron concentration \[lic\] above normal \[\> 1.8 mg/g\] on an mri of the liver measuring tissue proton transverse relaxation rates \[r2 mri\]) on the probability of 1-year overall survival of patients undergoing allogeneic hematopoietic stem cell transplantation (hsct). secondary * determine the impact of pre-transplant iron overload on the composite endpoint of non-relapse mortality and complications (e.g., serious infections, hepatic veno-occlusive disease, or organ failure) within 1 year after allogeneic hsct. * determine the impact of pre-transplant iron overload on the 1-year cumulative incidence of acute or chronic graft-vs-host disease in patients with acute leukemia or myelodysplastic syndromes undergoing allogeneic hsct. * determine the impact of pre-transplant iron overload on the 1-year probability of overall survival and non-relapse mortality in patients undergoing allogeneic hsct. * determine the prevalence of pre-transplant iron overload in adult patients undergoing allogeneic hsct. * determine the correlation between pre-transplant ferritin levels and lic on r2 mri. * compare the longitudinal measures of serum ferritin levels after allogeneic hsct in patients with iron overload vs those without iron overload. * estimate the cumulative incidence of iron overload at 1 year after allogeneic hsct. outline: patients undergo blood sample collection to measure serum ferritin levels at baseline (pre-transplant) and then at 3, 6, 9, and 12 months after transplant. patients with serum ferritin \> 500 ng/ml also undergo an r2 mri at baseline (pre-transplant) and at 12 months after transplant to determine liver iron concentration. patients with serum ferritin \> 500 ng/ml at 12 months after transplant also undergo an r2 mri.

Eligibility criteria:
inclusion criteria: * planning to undergo allogeneic hematopoietic stem cell transplantation using either myeloablative or reduced-intensity conditioning * any diagnosis allowed * not pregnant * weight ≤ 350 lbs * must be able to give written informed consent indicating the investigational nature of the study and its potential risks. exclusion criteria: * claustrophobia * other contraindication for mri (e.g., cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, insulin or infusion pump, or implanted drug infusion device)

Keywords: iron overload
a study to determine the safety and efficacy of albiglutide in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: a study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * bmi 20-45kg/m2 inclusive exclusion criteria: * females who are pregnant, lactating or within \<6 weeks post-partum * current symptomatic heart failure (nyha class iii-iv)

Keywords: diabetes
rapid blood culture identification panel in pediatric patients in guatemala

Conditions: Bacteremia; Sepsis

Summary: the purpose of this study is to assess the clinical impact of a rapid multiplex pcr blood culture identification panel on time to optimal antimicrobial therapy when compared to conventional microbiological culture methods in children hospitalized in a low resource setting in guatemala city.

a retrospective review of positive blood cultures was performed on pediatric patients at a tertiary hospital in guatemala city. these will serve as retrospective controls. the prospective portion of this study will implement the biofire filmarray blood culture identification panel (bcid2). laboratory technicians will perform bcid2 simultaneously with standard culture after it flags positive on the automated blood culture system. bcid2 will be performed on those blood culture specimens that become positive during normal laboratory daytime working hours. those specimens that become positive overnight will not have the bcid2 performed and will serve as concurrent controls. physicians will be notified of panel results for the bcid2 intervention group and standard culture results per current laboratory protocol. this study will compare time to optimal antimicrobial therapy (primary outcome), as well as secondary outcome measures, between the intervention group and the 2 control groups.

Eligibility criteria:
inclusion criteria: * age \<18 years of age * first positive blood culture during the hospitalization exclusion criteria: * non-blood specimens * repeat positive blood cultures from the same admission * patients who expire prior to positive culture * outpatient blood cultures

Keywords: bacteremia sepsis antimicrobial resistance bcid2 multiplex pcr pediatric
the combination of pecs ii block and parasternal block for radical mastectomy

Conditions: Breast Cancer

Summary: the combination of pecs ii and parasternal block provides analgesia after radical mastectomy

the cambionation of pecs ii block and parasternal block

Eligibility criteria:
inclusion criteria: * asa status patients:1,2 and 3 * patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction exclusion criteria: * patients with allergy to local anesthetics * asa status patients: 4 * breast anatomy abnormalities * neurological diseases * septic conditions * coagulopathies * drug abuse history

Keywords: pecs ii block, parasternal block, analgesia
pharmacokinetics of levetiracetam (keppra) in neonates

Conditions: Seizures; Epilepsy

Summary: the primary objective of this study is to determine the pharmacokinetic profile of a loading dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm infants with seizures. secondary objectives are to evaluate the safety and efficacy of levetiracetam in term and preterm infants with seizures.


Eligibility criteria:
inclusion criteria: * gestational age ≥ 32 weeks * postnatal age ≤ 30 days * birth weight ≥ 2000 grams * admitted to the nicu at cincinnati children's hospital or good samaritan hospital * clinical or electrographic seizures of any etiology * seizures or seizure prophylaxis requiring treatment with levetiracetam * parental consent obtained exclusion criteria: * infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time * infants who have previously received levetiracetam * parents refuse consent * attending physician does not wish the infant to be enrolled in the study * infants who are currently receiving an investigational drug

Keywords: seizures epilepsy neonatal levetiracetam
a clinical study of xin'an medicine in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: complementary and alternative medicine has been employed over thousands of years to relieve knee osteoarthritis (oa) pain. xinfeng capsule, a patent chinese herbal medicine, has been used in the treatment of knee osteoarthritis (koa) some studies involving animal subjects may explored its mechanism. however, presently, there is a lack of large-sample, multicenter, randomized, controlled trials to evaluate the effects of xinfeng capsule treated for koa. therefore, the investigators designed a randomized, placebo-controlled, double-blind, multicenter trial to evaluate the effectiveness and safety of xinfeng capsule in the treatment of koa.


Eligibility criteria:
inclusion criteria: * participants must meet the american college of rheumatology (acr) 1995 revised criteria for koa. * participants must be aged between 40 and 75 years. * participants shall not take non-steroidal anti-inflammatory drugs (nsaids) or corticosteroids during the 7 days prior to screening. * participants shall not take chinese medicine for the treatment of koa during the 7 days prior to screening. * joint function in the i-iii, x-ray stage in the i-iii. * all participants shall agree to participate in the study and sign an informed consent form. exclusion criteria: * patients whose joint clearance is significantly narrow or joint bone bridge connection is formed between a bony rigidity. * patients who have knee cancer, rheumatoid arthritis, tuberculosis, acute purulent or intra-articular fractures. * persons have obvious inside and outside of the knee varus deformity and a history of limb vascular nerve injury . * patients with severe cardiovascular, brain, lung, liver, kidney, or hematopoietic diseases. * pregnant women or breastfeeding mothers or individuals with known psychiatric disorders. * patients who are hypersensitive to the trial medication.

Keywords: xinfeng capsule knee osteoarthritis randomized controlled trials double-blind
urine sample collection from fop patients

Conditions: Fibrodysplasia Ossificans Progressiva

Summary: the purpose of this study is to collect urine samples from patients with fibrodysplasia ossificans progressiva (fop) for the assessment of biomarkers related to disease, disease progression and for prediction of flare-ups of the disease. disease related biomarkers in these patients are currently unknown. this study aims to support the development of novel therapy/ies for this disease.


Eligibility criteria:
inclusion criteria: * male and female patients ≥ 5 and ≤ 35 years of age with a diagnosis of fop. * physically able to provide first-morning urine sample of at least 30 ml * able to communicate well with the investigator, to understand and comply with the requirements of the study * about half of the patients enrolled should have a flare-up, which is defined as an acute exacerbation of disease activity characterized by two or more of the following symptoms: pain, swelling, decreased range of motion, impaired function exclusion criteria: * diagnosis of diabetes * diagnosis of other systemic inflammatory disorder (juvenile idiopathic arthritis, systemic lupus erythematosus, etc.) * diagnosis of cancer other than nonmelanomatous skin cancer.
the effectiveness of perioperative cpap to reduce obstructive sleep apnea related adverse events

Conditions: Obstructive Sleep Apnea (OSA)

Summary: objective of the study: to determine whether perioperative auto-cpap treatment prevent postoperative worsening of osa and improve nocturnal oxygen saturation in surgical patients with moderate and severe osa.

the patients will be approached by the study coordinators at the preoperative clinic. if the patient is interested in participating the study, stop-bang and epworth questionnaires will be implemented to determine the risk for osa.if the patients are classified as high risk of having osa, they are scheduled for an overnight sleep study at home. the patients with apnea-hypopnea index (ahi)\>15 from the sleep study will be randomized into two study groups: perioperative cpap group or control group (routine care). in the perioperative cpap group, patients will be treated with auto-cpap for 2-3 nights preoperatively and 5 nights postoperatively. all patients will undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for 2-3 nights preoperatively and 5 nights postoperatively.

Eligibility criteria:
inclusion criteria: the patients who meet the following criteria will be recruited * patients who are scheduled for inpatient surgery that required a minimum of three nights of hospital stay * age: \>18 and \<80 years old. * identified as high risk of having osa or diagnosed with osa without using cpap. exclusion criteria: * undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery. * unwilling or unable to give informed consent. * currently undergoing treatment for sleep apnea including cpap. * requiring prolonged postoperative ventilation. * new york heart association functional class iii and iv. * having valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina. * having myocardial infarction or cardiac surgery within 3 months. * having chronic obstructive pulmonary disease, or asthma. * having a presence of tracheostomy, facial, neck, or chest wall abnormalities. * having abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months. * visiting preoperative clinic less than 3 days before scheduled surgery date. * on nasogastric tube postoperatively.

Keywords: obstructive sleep apnea (osa), continuous positive airway pressure(cpap), surgery, anesthesia
macular detachment associated with intrachoroidal cavitation

Conditions: Macular Detachment; Macular Retinoschisis; Intrachoroidal Cavitation

Summary: evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.


Eligibility criteria:
inclusion criteria: * eyes with macular detachment or macular retinoschisis exclusion criteria: * optic pit maculopathy, vitreomacular traction syndrome

Keywords: macular detachment macular retinoschisis vitrectomy
evaluate efficacy and safety of tolterodine extended release capsule compared with tolterodine immediate release tablet

Conditions: Urinary Incontinence

Summary: to evaluate efficacy of tolterodine extended release formulation compared with immediate release formulation in subjects with symptoms of overactive bladder


Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of overactive bladder. exclusion criteria: * subjects with significant stress incontinence as determined by the investigator. * subjects with recurrent urinary tract infections defined as treated for uti; 5 times in the last year.