Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety and efficacy of using insulin-like growth factor-1 in patients with a heart attack

Conditions: Heart Failure; Myocardial Infarction

Summary: when a patient has a heart attack, a blockage occurs in a coronary artery that delivers oxygen to the heart muscle. the heart muscle may weaken, causing heart failure. the body naturally makes a protein called insulin-like growth factor-1 (igf-1) that may protect the heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs. igf-1 is also available as a drug called mecasermin. in this study, heart attack patients will be given either a dose of mecasermin or a placebo (inactive treatment) after their coronary artery has been opened by a stent. the purpose of the study will be to evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart failure by evaluating a cardiac magnetic resonance imaging (mri) taken one day and eight weeks after the heart attack.


Eligibility criteria:
inclusion criteria: * age 18 - 75 * presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain * ecg evidence of myocardial infarction * undergoing percutaneous coronary intervention (pci) for st-elevation myocardial infarction * left ventricular ejection fraction during pci of 40% or less * timi flow grade 3 in the infarct-related artery following reperfusion and stenting exclusion criteria: * history of prior myocardial infarction * prior history of heart failure, left ventricular dysfunction or cardiomyopathy * active or suspected neoplasia * known impaired liver function * cardiogenic shock * estimated glomerular filtration rate \< 45 ml/min/1.73m2 * history of hypoglycaemia requiring hospitalisation * history of primary insulin-like growth factor-1 deficiency or growth hormone disorders * contraindication to cardiac magnetic resonance imaging * pregnancy or nursing mothers * known allergy to study drug or any of its inactive ingredients * treatment with another investigational agent within 30 days of enrolment * subjects unable or unwilling to comply with follow-up requirements of study * subjects unable to provide written informed consent

Keywords: heart failure myocardial infarction
impact of kuvan® on gastric relaxation in women with diabetic gastroparesis.

Conditions: Gastroparesis

Summary: kuvan® (sapropterin dihydrochloride) for improving gastric accommodation in women with diabetic gastroparesis (kiga-dg)

patients are invited to participate in a research study of kuvan® (sapropterin dihydrochloride). we hope to learn whether treatment with kuvan® is safe and effective in improving the ability of the stomach to relax after eating and improving the symptoms of diabetic gastroparesis. women are selected as a possible participant in this study because they have diabetes and moderate to severe gastroparesis (meaning stomach empties slowly).

Eligibility criteria:
inclusion criteria:inclusion criteria patients with moderate to severe symptoms of diabetic gastroparesis will be studied (gcsi \>21). patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. in order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria: 1. diagnosis of diabetes mellitus \> 5 years requiring medical therapy 2. female gender 3. ages 18-65 years 4. documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment) 5. symptoms of gastroparesis for at least 6 months with gastroparesis cardinal symptom index (gcsi) score \> 21 indicating moderate to severe symptoms 6. recent negative upper endoscopy or upper gi series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease) exclusion criteria:exclusion criteria patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in the study: 1. diabetes diagnosed \< 5 years prior to the study 2. male gender 3. normal gastric emptying 4. gastroparesis from post-surgical etiologies 5. another active disorder, which could explain symptoms in the opinion of the investigator 6. pregnancy 7. history of significant cardiac arrhythmias and/or prolonged qtc 8. daily use of narcotic analgesics for abdominal pain 9. contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae. 10. underlying seizure disorder 11. known history of cardiac ischemia 12. recent clinically significant gastrointestinal bleeding 13. patients taking levodopa 14. any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study 15. failure to give informed consent 16. surgery for placement of a gastric stimulator within the past 6 months (patients \> 6 months post-op with persistent symptoms and delayed gastric emptying are eligible). 17. a normal upper endoscopy not performed within 2 year of study entry. 18. patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil 19. patients with renal impairment (i.e. creatinine \> 2.5 mg/dl) 20. patients with hepatic dysfunction (i.e. alt and ast values \> 2.5x uln and t. bilirubin \> 1.5x uln) 21. patients with uncontrolled diabetes, such as hba1c \> 10 mg/dl at screening/baseline will be excluded.
assessing a new proforma for maternal cardiac arrest

Conditions: Maternal Death; Cardiac Arrest; Heart Arrest

Summary: during the multidisciplinary obstetric and midwifery simulation (moms) course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link. the delegates observing the cardiac arrest scenario will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. in addition, the proforma will be provided to the team taking part in the simulation. delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma.

the use of standardised proformas can improve the quality and completeness of data collection in healthcare settings. in a previous study we have found that medical records examined by the confidential enquiries into maternal deaths (cemd) 2009-2012 were variable in their quality, often poor and in need of improvement. in view of this, we have developed a proforma to assist the quality of record-keeping during maternal cardiac arrest, using a modified delphi process amongst a multidisciplinary group of cemd assessors. the present application is for a study evaluating clinicians' views of this proforma and its usefulness in a simulator setting (as maternal cardiac arrest is so rare, evaluation in actual cases would be a very lengthy and expensive venture; such a study would have to be multicentre and would require a preliminary evaluation such as the one being proposed here, anyway). one hundred participants will take part in the study during the routine multidisciplinary obstetric and midwifery simulation (moms) training course at the chelsea and westminster hospital. during the course, groups of delegates manage simulated clinical emergencies, whilst the remaining delegates observe the scenario via a video link. a brief information sheet and explanation will be provided before consent is sought to take part in the study. during the cardiac arrest scenario, the delegates observing will be asked to refer to the proforma and record those details of events that they are able to see/hear from the video link. in addition, the proforma will be provided to the team taking part in the simulation. one or more team members would routinely be given the role of 'scribe', recording events as they occur. delegates (observers plus scribes) will then be asked to complete a questionnaire seeking their opinions on the usefulness of the proforma. all of the data will be collected pseudo-anonymously.

Eligibility criteria:
inclusion criteria: * delegates taking part in the routine multidisciplinary obstetric and midwifery simulation training course at the chelsea and westminster hospital. exclusion criteria: * unwillingness to participate and provide written consent.

Keywords: maternal cardiac arrest clinical scenarios simulation
is short antibiotherapy duration after drainage suitable for patients admitted in intensive care medicine with a severe acute cholangitis?

Conditions: Acute Cholangitis

Summary: acute cholangitis (ac) occurs when biliary stenosis, due to various benign causes (often gallstones) or the presence of a tumour, leads to cholestasis and biliary infection. ac is a life-threatening infection if not diagnosed and treated in time, its mortality ranges from 1.4% to 5.2%. ac can be classified into different stages of severity depending on organ failure. a severity classification has been proposed by the asian recommendations of tokyo 2013: grade i (benin), grade ii (moderate) and grade iii (severe). ac treatment includes endoscopic or percutaneous bile drainage in combination with systemic antibiotic treatment. it is currently recommended that patients with severe ca (grade iii) have biliary drainage within 24 hours, although it has not been shown to improve their survival. the emergence of antibiotic-resistant germs, which is a public health issue, calls for reasonable and considered use of antibiotics. reducing the duration of antibiotic therapy is a fundamental measure of antimicrobial management and antibiotics sparing. 7 to 10 days of antibiotic treatment is common in the treatment of ca. a 14-day treatment is recommended in case of associated bacteremia. a recent study of 263 patients showed that reducing the duration of antibiotic therapy to less than 7 days in patients with ca associated with bacteremia with effective drainage does not increase the risk of recurrence or mortality at 30 days. however, this study was monocentric retrospective and compared groups that were unbalanced in terms of ca severity. the optimal duration of antibiotic therapy in the treatment of ca in critically ill patients hospitalized in intensive care remains poorly known. the main purpose of this study is to compare short antibiotic therapy with long antibiotic therapy in terms of mortality in patients with ac admitted in intensive care unit (icu).

using electronic patient data monitoring systems, the investigators reviewed all patients with a diagnosis of ac admitted to digestive liver disease unity or icus at the nantes university hospital, rennes university hospital from january 1, 2006, to december 31, 2018. for enrolled patients, general clinical characteristics were collected. patients were categorized into two groups according to antibiotics duration, and the differences of these characteristics between two groups were evaluated.

Eligibility criteria:
inclusion criteria: adult patients (age \>18 years) with acute cholangitis admitted in intensive care units with a successful biliary drainage and treated with antibiotics exclusion criteria: patients under 18 years unable to receive a drainage or inefficient drainage patients with a decision to limit care at the admission pregnancy
efficacy of one a day weightsmart advanced versus caffeine and placebo on energy expenditure, thermogenesis and perceived energy levels in women.

Conditions: Energy Expenditure

Summary: the study is considered research because efficacy (how well a drug works) information is needed in healthy, 25-45 year-old, female subjects with moderate caffeine intake. the investigational product is available in the united states without a prescription (over-the-counter) as a nutritional supplement. the purpose of this study is to assess whether one-a-day weightsmart advanced is safe and can increase metabolism and perceived energy in female subjects compared with caffeine or placebo (inactive drug). participation in this study will last approximately 4 weeks and require about 4 outpatient visits to st. luk's-roosevelt hospital center. about 21 subjects are expected to participate in this study.

- primary efficacy endpoints are area under the curve (auc) over the first 2 hours and the last 2 hours of resting metabolic raterespiratory quotient- the secondary efficacy endpoints are:perceived energy scales visual analog scale (vas) change from baseline for systolic blood pressure (sbp), diastolic blood pressure (dbp) respiration, average heart rate over 1st 20 minutes, average heart rate over last 20 minutes, and temperature

Eligibility criteria:
inclusion criteria: * be a healthy, ambulatory female between the ages of 25 and 45 years old with a body mass index (bmi) between 20 and 35 kg/m2 (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, brief physical examination, including vital signs, and clinical laboratory tests) * consume a habitual caffeine intake (\<300 mg/day or \</= 2 caffeinated drinks/day) exclusion criteria: * pregnant, planning to become pregnant or lactating females * using ephedra- or caffeine-containing products or chronic medications other than contraceptives or hrt * lost or gained more than five pounds of weight in the preceding three months * engage in intense physical activities * use of tobacco or nicotine products * a medical history with known thyroid disease, blood pressure \>140/90 mmhg, diabetes, depression, psychiatric disorders, glaucoma, or seizure disorders and other relevant illnesses that can interfere with the trial in the opinion of the investigator

Keywords: energy expenditure nutritional weight control
patient performance and acceptance of virtual reality visual field devices

Conditions: Visual Field Defect, Peripheral; Visual Field Defect, Nasal Step; Visual Field Defect, Paracentral Scotoma of Both Eyes

Summary: the purpose of this research is to study the effectiveness and patient experience when measuring visual fields using virtual reality goggles.


Eligibility criteria:
inclusion criteria: * any patient \>13 years old at bascom palmer eye institute * patients who either have glaucoma, are glaucoma suspects, or have a strong family history of glaucoma exclusion criteria: * adults unable to consent, pregnant women, prisoners * patients under the age of 13

Keywords: retinal sensitivity
clinical outcomes of preservation versus resection of portal/superior mesenteric vein during pancreaticoduodenectomy in pancreatic cancer patients who respond to neoadjuvant treatment

Conditions: Pancreatic Head Cancer Patients Who Underwent Surgery After Neoadjuvant Treatment

Summary: 1. there is a lack of evidence on the need to perform portal/superior mesenteric vein (pv/smv) resection routinely in pancreatic ductal adenocarcinoma (pdac) patients with venous involvement who responded to neoadjuvant treatment (nat). 2. there is no significant differences in r0 rate, 5-year overall survival and recurrence-free survival between the pv/smv preservation (pvp) group and pv/smv resection (pvr) group. 3. pvp group showed significantly better 5-year pv/smv stenosis free survival than the pvr group. 4. we propose that if dissection is possible and there is a high likelihood of achieving r0 resection after nat, routine pvr may be unnecessary in pdac patients with venous involvement.


Eligibility criteria:
inclusion criteria: * pancreatic head cancer patients who underwent surgery after neoadjuvant treatment between january 2012 and december 2022 at seoul national university hospital exclusion criteria: * metastatic unresectable and locally advanced pancreatic cancer * resectable pancreatic cancer without portal/superior mesenteric vein invasion * cancer aggravation after neoadjuvant treatment * portal/superior mesenteric vein encasing and narrowing after neoadjuvant treatment * patients who underwent palliative surgery * non-pancreatic ductal adenocarcinoma patients * patients who death within 30 days of surgery * loss of follow-up patients * patients who underwent resection for suspected main artery and adjacent organ invasion
meropenem penetration across bbb in patients with cns infection and optimization of meropenem treatment

Conditions: Central Nervous System Infections

Summary: a prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (cns) infection, especially its bbb penetration into cerebrospinal fluid (csf).

meropenem is important for management of post-neurosurgical meningitis, but the data about its penetration across blood-brain barrier (bbb) are inadequate. this prospective, open-label study investigated the pharmacokinetic profile of meropenem in patients with post-neurosurgical central nervous system (cns) infection, especially its bbb penetration into cerebrospinal fluid (csf). a total of 82 patients with post-neurosurgical cns infection were included to receive meropenem intravenously according to regimen of 2g q8h, 1g q8h or 1g q6h. after infusion of 4 doses, blood and csf samples were collected simultaneously at predefined timepoints. high-performance liquid chromatography ultraviolet method was used to determine the concentration of meropenem.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * requiring continuous drainage of csf or gram-negative bacteria were identified from csf culture * have temperature fever (t \> 37.5℃) * have signs of meningeal irritation * white blood cells in csf \> 300 × 10\^6/l exclusion criteria: * hypersensitive to meropenem * did not receive at least 3 days of meropenem treatment * are receiving hemodialysis * unstable vital signs * have lumbar puncture contraindications and so inappropriate for sample collection * severe hepatic or renal dysfunction * status epilepticus * potential neurodegenerative diseases * pregnancy * breast-feeding
pregabalin in treatment of postdural puncture headache

Conditions: Postdural Puncture Headache

Summary: lumbar puncture (lp), often known as a "spinal tap," is a standard medical technique pioneered in the late 1900s by heinrich quincke. it involves the retrieval and analysis of cerebrospinal fluid (csf) from the spinal cord, serving as the benchmark for diagnosing conditions like subarachnoid hemorrhage, meningitis, and specific neurological conditions. pregabalin, an anticonvulsant medicine that blocks calcium entry, is used to treat a variety of diseases. it has been used to relieve pain in a variety of patient groups, including those with chronic pain, epilepsy, and anxiety disorders


Eligibility criteria:
inclusion criteria: * age from 21 to 65 years old, * both genders, * confirmed diagnosis of postdural puncture headache (pdph) exclusion criteria: * patient refusal * known allergy to the drug used in the study * patients with a history of convulsions * chronic headaches * contraindications to regional anesthesia (such as local infection and coagulation abnormalities). * clinical indications of elevated intracranial pressure or associated risk factors * deteriorated patients
appendicoliths in acute complicated appendicitis patients with abscess

Conditions: Acute Complicated Appendicitis With Abscess

Summary: complicated appendicitis, characterized by the presence of an abscess or perforation, involves acute inflammation of the peritoneum secondary to an infection of the appendix, presenting additional challenges for management. traditionally, the standard treatment for complicated appendicitis has been surgical intervention. however, conservative management, involving antibiotics and drainage, has emerged as a viable alternative for selected patients. recent studies emphasize the importance of selecting appropriate antibiotics based on local resistance patterns and the patient's clinical condition. broad-spectrum antibiotics, including those targeting anaerobic bacteria, are often preferred. in addition, advances in imaging technology, such as ultrasound-guided drainage, have improved the precision and success rates of percutaneous abscess drainage. this minimally invasive approach helps manage localized infections and can prevent the need for immediate surgery. one factor that has gained significant attention in determining the success of conservative treatment for acute complicated appendicitis is the presence of appendicoliths-calcified deposits within the appendix. this study aims to investigate the clinical significance of appendicoliths in the conservative management of acute complicated appendicitis with abscesses.


Eligibility criteria:
inclusion criteria: * patients who aged ≥18 years, who diagnosed as acute appendicitis clinically, who had peri-appendiceal abscess larger than 2 cm in diameter on ct scan, who agreed conservative treatment first, who refused immediate emergency surgery exclusion criteria: * patients younger than 18 years, those with malignancies, those with incomplete clinical or pathological records were excluded from the study
blood sample collection study for pharmacogenomic characterization of participants that previously received namilumab in m1-1188-002-em (priora, [nct01317797]) study

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to obtain blood samples from up to 14 participants who previously received namilumab in the previous study m1-1188-002-em (priora, \[nct01317797\]) to correlate genetic markers with clinical outcomes.

participants who received treatment with namilumab in the previous study m1-1188-002-em (priora \[nct01317797\]) will have two whole blood samples (3 ml each) collected to correlate genetic markers with namilumab treatment responses as determined in the previous study. the study will enroll approximately 14 participants who received namilumab in the previous study. • no intervention is administered in this study. this trial will be conducted in bulgaria, spain and the netherlands. the overall time to participate in this study is 1 day.

Eligibility criteria:
inclusion criteria: 1. the participant (or, when applicable, the participant's legally acceptable representative) voluntarily signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. did not receive namilumab during the priora study (a phase ib double-blind, placebo controlled, randomized, dose-escalating study). 2. participants without any response time point recorded 4-week after the last dose of namilumab and beyond this time point 3. participants who were excluded from post-hoc analysis due to protocol violations during the previous priora study.

Keywords: drug therapy