Kornimate/medical-research-clean huggingface dataset:
clinical impact of an antibiotic stewardship program in a neonatal intensive care unit

Conditions: Neonatal Sepsis

Summary: antimicrobial resistance is one of the biggest and most urgent threat to global health. initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. implementing these programs in neonatal intensive care units (nicu)is very important and crucial despite of its difficulty, where antibiotics are used extensively. the aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at nicu.

background: implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. the present study aimed to assess the clinical impact of the antibiotics stewardship program (asp) in the neonatal intensive care unit (nicu) of assiut university children's hospital. methods: the study was conducted in two phases from january 2019 to june 2020. the pre-asp phase (603 patients) included making nicu-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the asp. the asp intervention phase (597 patients) included implementation of the asp, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes. results: the asp intervention phase showed a significant increase in the number of c-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. the prescribing rates of antibiotics and their consumption levels were changed according to the nicu-specific antibiogram. there was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the asp intervention phase. conclusion: asp implementation was successful in improving antibiotic prescribing and patients outcomes.

Eligibility criteria:
inclusion criteria: * received antibiotics for more than 72 hours. exclusion criteria: * hospital stay was less than 72 hours. * did not receive any antibiotics during hospital stay.

Keywords: antibiotics antimicrobial resistance antibiotic stewardship program neonatal intensive care unit neonatal sepsis
study of prevalence of colorectal adenoma in 30- to 49-year-old subjects with a family history of colorectal cancer

Conditions: Colorectal Neoplasms

Summary: current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer are controversial. the aim of this study was to prospectively define the prevalence of colorectal adenoma 30- to 49-years-old asymptomatic subjects with a first relative history of colorectal cancer and to compare the data with controls. design: single-center prospective study

colorectal cancer screening is recommended for average-risk persons beginning at age 50. a family history of colorectal cancer is recognized as a risk factor for colorectal adenoma. however, the strength of this association is uncertain. current guidelines for initiating screening colonoscopies in patients younger than 50 years of age who have a first relative history of colorectal cancer have proved controversial. the conflicting recommendations are partly attributable to the lack of data about the prevalence of crc and adenomas among 30- to 49-year-old individuals with a first relative history of colorectal cancer. this prospective study will quantify the prevalence of adenomas (any size) and advanced adenomas among 30- to 49-year-old individuals undergoing their first screening colonoscopy because of a first relative history of colorectal cancer and compare the data with controls(asymptomatic subjects without a first relative history of colorectal cancer).

Eligibility criteria:
inclusion criteria: * 30- to 49-year-old asymptomatic subjects * first relative history of colorectal cancer exclusion criteria: * previous colonoscopy for any reason * personal history of colorectal adenomas or crc * history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease * documented history of occult gi bleeding, lower gastrointestinal tract bleeding not attributable to hemorrhoid, or * iron deficiency anemia * unexplained weight loss of \>10% of the body weight in the 6 months before colonoscopy * incomplete examination of entire colon

Keywords: colonoscopy colorectal neoplasms screening family history
a study of alpharadin with docetaxel in patients with bone metastasis from castration-resistant prostate cancer (crpc)

Conditions: Bone Metastases; Castration-Resistant Prostate Cancer

Summary: the main purpose of this study is to establish a recommended dose of alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.

the trial was initially conducted and submitted by algeta asa. after acquiring algeta, bayer is now the sponsor.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the prostate. * two or more bone metastases (hot spots) confirmed by bone scintigraphy within 8 weeks prior to study entry * known castration-resistant disease * karnofsky performance status (kps): ≥70% within 14 days before start of study treatment (ecog 1) * life expectancy at least 6 months. * acceptable hematology and serum biochemistry screening values * eligible for use of docetaxel according to the product information (package insert or similar). exclusion criteria: * has received an investigational therapeutic drug within the last 4 weeks prior to start of study treatment, or is scheduled to receive one during the treatment period. * has received external radiotherapy within the last 4 weeks prior to start of study treatment. * has an immediate need for radiotherapy. * has received prior hemibody external radiotherapy . * has received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. * has received cytotoxic chemotherapy within the last 4 weeks prior to start of study treatment, or has not recovered to grade 1 or 0 from adverse events due to cytotoxic chemotherapy administered more than 4 weeks earlier. * has received more than ten previous infusions of docetaxel. * previous known experience of grade ≥ 3 docetaxel related toxicities or docetaxel toxicity related dose interruption or discontinuation. * previous use of g-csf for persistent neutropenia after docetaxel treatment. * has received blood transfusion or erythropoietin (epo) within the last 4 weeks prior to start of study treatment. * has received prior treatment with alpharadin. * malignant lymphadenopathy exceeding 3 cm in short-axis diameter. * symptomatic nodal disease, i.e. scrotal, penile or leg edema. * visceral metastases from crpc (\>2 lung and/or liver metastases \[size ≥2cm\]), as assessed by ct scan or mri of the chest/abdomen/pelvis within the last 8 weeks prior to start of study treatment. * uncontrolled loco-regional disease. * other primary tumor (other than crpc) including haematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). * has imminent or established spinal cord compression based on clinical findings and/or mri. * unmanageable fecal incontinence

Keywords: the target population is patients with bone metastasis from castration-resistant prostate cancer intended for treatment with docetaxel
the use of pentoxifylline and vitamin e in the treatment of late radiation related injuries

Conditions: Wounds and Injuries

Summary: patients with radiation induced injuries experience significant pain and negative effects on quality of life. currently, no standard therapy for these patients exists, with some patients treated symptomatically, and others treated with hyperbaric oxygen or pentoxifylline/vitamin e. this study will examine prospectively the safety and efficacy of using a regimen of pentoxifylline and vitamin e in patients with late radiation induced injuries.


Eligibility criteria:
inclusion criteria: * clinically documented symptomatic radiation induced injury (e.g. fibrosis, necrosis, ulceration) * prior treatment with radiation therapy to the affected area - completed at least 3 months prior to study entry * pain in irradiated volume after 3 months (not attributable to acute inflammation) * ecog performance status must be 0, 1 or 2 * life expectancy is greater than 6 months * age 18 to 75 years; informed consent exclusion criteria: * patient is still responding to other therapies for soft tissue injury * active malignant disease * any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment, including but not limited to, acute myocardial infarction, severe coronary artery disease, active internal bleeding or a history of hemorrhagic diathesis, peptic ulcer, impaired kidney or liver function * pregnant or lactating women * no contraindication to treatment with pentoxifylline. (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine, recent cerebral and/or retinal hemorrhage) * concurrent treatment with warfarin or other anticoagulant, or with erythromycin * concurrent treatment with other experimental agents or other treatment for fibrosis * patients treated with radiotherapy for breast cancer 3 months to 3 years prior to study entry * blood pressure \< 90/60 mm hg or orthostatic hypotension
sequence of vessel interruption and circulating tumor cells in surgical lung cancer

Conditions: Circulating Tumor Cell; Lung Cancer; Surgery

Summary: this study aims to define the impact of the sequence of vessel interruption on change in ctc and ctc clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.


Eligibility criteria:
inclusion criteria: * nsclc with preoperative pathological evidence, * pure solid nodule or part-solid (\>50%) ground glass nodule on ct scan * clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion) * video-assisted thoracoscopic lobectomy or bi-lobectomy exclusion criteria: * pneumonectomy, segmentectomy, non anatomic resection * history of thoracic surgery on the same side * necessity to perform a non-anatomic resection in addition to the lobectomy * no preoperative histological diagnosis * pure ground glass nodule on ct scan * clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion * clinical stage node ≥1 * neoadjuvant therapy * second cancer or cancer in the past 5 years * first approach through thoracotomy with ribs spreading * pregnancy, \<18 years of age * pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)
medi-573 in combination with soc in unresectable or metastatic hcc.

Conditions: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)

Summary: a phase 1b/2, open-label, randomized study to evaluate medi-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years or minimum age of consent per local regulations at the time of screening * unresectable or metastatic hepatocellular carcinoma * ecog performance status ≤ 2 * life expectancy of ≥ 3 months; exclusion criteria: * child-pugh score for cirrhosis mortality \> 7 points * prior or current system anti-cancer therapy for hcc, including cytotoxic, biologic, targeted or experimental therapy * prior local treatment for hcc less than 4 weeks prior to initiating study treatment * active second malignancy * major surgery, open biopsy or significant traumatic injury within 4 weeks prior to initiating study treatment * thrombotic or embolic events within 6 months prior to initiating study treatment * ongoing pancreatitis * uncontrolled or refractory ascites * evidence of ongoing spinal cord compression, known carcinomatous meningitis, or known leptomeningeal carcinomatosis * hepatic encephalopathy \> grade 1 * active brain metastases with exceptions * poorly controlled diabetes mellitus * active coronary artery disease * uncontrolled hypertension

Keywords: hcc, liver cancer, hepatocellular carcinoma, medi-573, anti-igf
improved care after esophagectomy using an algorithm for postoperative complications - rescue trial

Conditions: Diagnosis and Treatment of Complications After Esophagectomy

Summary: the objective of the rescue-trial is to investigate whether implementation of a consensus-based clinical care algorithm to standardize diagnosis and management of postoperative complications reduces 90-day mortality, icu (re)admission and surgical interventions after esophagectomy for esophageal cancer.


Eligibility criteria:
inclusion criteria: in order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. age ≥ 18 years 2. histologically proven esophageal or gastro-esophageal junction carcinoma (ct1-4an0-3m0) 3. scheduled to undergo curatively-intended esophagectomy with gastric tube reconstruction. all techniques (i.e. minimally invasive, robotic, hybrid, open) and approaches (i.e. transthoracic, transcervical, transhiatal) of esophagectomy are suitable for inclusion. 4. ability to provide written informed consent exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: 1. emergency resection 2. patients who underwent (additional) total gastrectomy 3. patients who underwent reconstruction using colonic or jejunal interposition 4. patients in whom no anastomosis is created during resection 5. secondary malignancy which determines prognosis

Keywords: diagnosis treatment complications esophagectomy
study evaluating etanercept for the treatment of moderate to severe psoriasis

Conditions: Plaque Psoriasis; Psoriasis

Summary: the purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.


Eligibility criteria:
inclusion criteria: * 18 years of age or older at time of consent. * active, moderate to severe chronic plaque psoriasis defined by the following criteria: clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (bsa) or pasi greater than or equal to 10. * in the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: methotrexate (mtx), cyclosporine and psoralen plus ultraviolet a radiation (puva) therapy. exclusion criteria: * evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis. * rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes. * active or recent (within 2 years) tuberculosis (tb) infection.

Keywords: enbrel psoriasis topical psoriasis wyeth psoriasis active psoriasis
effects of early exercise in patients with moderate to severe stroke.

Conditions: Stroke

Summary: purpose: to investigate the efficacy of early exercise in patients with moderate to severe stroke regarding functional outcome and walking ability. methods: patients with medium to severe stroke (nhiss \>7) were recruited 24 - 48 hours after stroke onset from two stroke units in sweden. both groups received usual care. the intervention group received even 20 minutes bed-cycling 5 days per week with a maximum of 15 sessions. functional outcome was measured with modified rankin scale (mrs) and barthel index and walking with the 6-minute walking test (6mwt). measurements were performed pre- and post-intervention (3 weeks), and at 3-months follow-up.


Eligibility criteria:
inclusion criteria: * age over 18 years. * diagnose stroke with the national institutes of health stroke scale (nihss) 7-42 points. * ability to understand the swedish language. * approval of medical responsible physician to participate in the study. exclusion criteria: • medical or neurological diseases that can affect the performance of the exercise and severe cognitive impairment.

Keywords: stroke rehabilitation exercise bedcycling
efficacy study of polyethylene glycol 3350-electrolyte solution (golytely®) versus lactulose in patients with hepatic encephalopathy.

Conditions: Hepatic Encephalopathy; Cirrhosis; Portosystemic Encephalopathy; PSE

Summary: this study is being done to find out if the laxative polyethylene glycol (also known as golytely® or miralax®) can treat your hepatic encephalopathy (confusion due to your liver disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). in this study, the investigators will evaluate if polyethylene glycol (golytely®) is more effective than lactulose on neurocognition (memory and thinking skills) and determine if it decreases the hospital stay.


Eligibility criteria:
inclusion criteria: 1. ages 18-80 2. male and female subjects of all races and ethnicities including spanish speaking subjects 3. cirrhosis of any cause 4. any grade of hepatic encephalopathy (1-4) 5. a legally authorized representative has to be able and willing to comply with all protocol procedures and to understand, sign and date an informed consent document, and authorize access to protected health information on the subjects behalf exclusion criteria: 1. acute liver failure 2. structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) 3. other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy) 4. previous use of rifaximin or neomycin in past 7 days 5. prisoners 6. pregnancy 7. \<18 years old 8. serum sodium \<125 meq/l 9. receiving \> 1 dose of lactulose prior to enrollment 10. uncontrolled infection with hemodynamic instability requiring vasopressors

Keywords: hepatic encephalopathy he cirrhosis pse portosystemic encephalopathy hepatic coma ams altered mental status complications of cirrhosis chronic liver disease
efficacy of two temozolomide regimens in adjuvant treatment of patients with brain high grade glioma

Conditions: Glioblastoma Multiforme of Brain; Anaplastic Astrocytoma of Brain

Summary: this is a phase iii, non-blinded, blocked randomized clinical trial. the study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during march 2018 and march 2019. the patients will be randomized to 6-cycle and 12-cycle adjuvant temozolomide groups using block randomization method (1:1).

this study aimed to compare the overall survival and progression free survival between 6 cycles and 12 cycles adjuvant temozolomide regimens in patients with brain glioblastoma and anaplastic astrocytoma. the main inclusion criterion includes patients newly diagnosed with glioblastoma and anaplastic astrocytoma whose diagnosis is confirmed by histologic evaluation. the main exclusion criteria involve chronic renal, hepatic or cardiac failure. the patients will initially undergo surgery. within 4 to 6 weeks after surgery, all patients will receive chemoradiation. after completion of chemoradiation, the cases will receive 12 cycles of adjuvant temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). in the control group, the patients will receive 6 cycles of adjuvant temozolomide (in the same dosage). this is a phase iii, non-blinded, blocked randomized clinical trial. the study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during march 2018 and march 2019. the patients will be randomized to 6-cycle and 12-cycle adjuvant temozolomide groups using block randomization method (1:1). this study will be conducted in the oncology clinic of omid hospital and imam reza hospital, mashhad. blinding is not observed in this study. the primary endpoints of study are overall survival and progression free survival.

Eligibility criteria:
inclusion criteria: * newly diagnosed glioblastoma and anaplastic astrocytoma * age between 18 and 70 years * karnofsky performance scale index equal or more than 60 percent * signed informed consent exclusion criteria: * chronic hepatic * renal failure * cardiac failure * history of hematologic malignancies

Keywords: glioblastoma multiforme anaplastic astrocytoma adjuvant treatment extended chemotherapy
efficacy study for surgery after previous failed catheter ablation

Conditions: Atrial Fibrillation Ablation

Summary: specific aims: the primary objective of this registry is to determine the percentage of patients who are free from atrial fibrillation (af) at 6 and 12 months following a surgical ablation procedure when the patient has a history of failing one or more previous catheter based ablations for af. the first 3 months following surgical ablation will be a blanking period; any arrhythmia occurring during this time will not be used to determine success. primary objectives: 1. determine the percent success of surgical ablation for af at 6, and 12 months both on and off of antiarrhythmic drugs (aad) following a failed catheter based ablation for af 2. record and evaluate all complications associated with the surgical procedure. secondary objectives: 1. evaluate usage of anticoagulants at 6, and 12 months. 2. determine the percentage of pulmonary veins (pv) that were electrically isolated by intra-operative, pre-surgical mapping


Eligibility criteria:
inclusion criteria: * diagnosis of atrial fibrillation * has undergone one or more catheter based ablation procedures for af and the procedure failed * has undergone a minimal access surgical ablation procedure for the treatment of af following failure of catheter based ablation for af

Keywords: atrial fibrillation maze ablation