Kornimate/medical-research-clean huggingface dataset:
arginine therapy for sickle cell disease pain

Conditions: Sickle Cell Disease; Vaso-occlusive Pain Episode

Summary: the aim of this study is to determine whether giving extra arginine, a simple amino acid, to patients with sickle cell disease seeking treatment for a pain crisis (vaso-occlusive painful events (voe) will decrease pain scores, decrease the need for pain medications or decrease length of hospital stay or emergency department visit. funding source - fda oopd.

the purpose of this study is to determine the effects of iv l-arginine hydrochloride therapy in children with sickle cell disease (scd) and vaso-occlusive pain events (voe). specifically, the impact on total opioid use (mg/kg) over the duration of their emergency department (ed) visit and hospital stay will be evaluated.

Eligibility criteria:
inclusion criteria: * established diagnosis of sickle cell disease (scd); all genotypes * pain requiring medical care in an acute care setting (such as the emergency department or ed, hospital ward, day hospital, clinic) not attributable to non-sickle cell causes, that is moderate-to-severe requiring parenteral opioids exclusion criteria: * decision to discharge home from the acute care setting * hemoglobin less than 5 gm/dl or immediate need for red cell transfusion anticipated within next 12 hours * hepatic dysfunction of sgpt greater than 3 times the upper value * renal dysfunction of creatinine greater than 1.0 * mental status or neurological changes * acute stroke or clinical concern for stroke * pregnancy * allergy to arginine * two (2) or more ed visits for voe within the last 7 days prior to current ed visit * hospitalization within 14 days * previous randomization in this arginine rct (patient consented and screen failed before receiving study drug or placebo remains eligible for future participation). * use of inhaled nitric oxide, sildenafil or arginine within the last month * picu admission from the emergency department * hypotension requiring treatment with clinical intervention * acidosis with co2≤ 16 * newly started on hu for \<3 months * not an appropriate candidate in the investigator's judgment * patient refusal

Keywords: arginine therapy
effects of preoperative relaxation and intensified surgery education in patients undergoing herniotomy

Conditions: Hernia, Inguinal; Anxiety; Postoperative Pain

Summary: this study aims to test the effects of a preoperative relaxation intervention and an intensified surgery patient education on pre- and postoperative wellbeing and health in patients undergoing herniotomy.

see above

Eligibility criteria:
inclusion criteria: * referral for herniotomy * preoperative anxiety at least 4/10 points on a numeric rating scale * physical and mental capability to participant * written informed consent exclusion criteria: * emergency surgery * malignoma * recurrence of inaugural hernia * severe comorbidity * severy psychological disorders * immunosuppression * coagulation disorders
effects of a combination of polyphenol-rich extracts on the protection of retinal cells against blue light in the prevention of ocular diseases

Conditions: Eye Abnormalities

Summary: the aim of the study is to confirm that daily supplementation with a product containing a standardized combination of polyphenol-rich extracts has a protective effect against potential blue-light-induced damage to retinal cells.

randomized, double-blind, parallel study conducted under medical supervision on a group of 54 volunteers exposed to blue-light for 6-8h a day. patients receive one of the investigational products or placebo for 6 weeks. study parameters: oct (optical coherence tomography), amsler test, computerized perimetry, schirmer test. in addition, subjective symptoms will be assessed using the visual analog scale (vas) method and a dry eye-related quality-of-life questionnaire. the studied parameters will be measured before and after supplementation.

Eligibility criteria:
inclusion criteria: * women and men, 25-45 years old. * signed informed consent. * volunteers who do not use glasses or contact lenses. * volunteers exposed to blue light for at least 6 - 8 hours a day. exclusion criteria: * intake of supplements containing plant extracts, polyphenols or anthocyanins. * participation in another clinical trial. * oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, aids, rheumatoid arthritis, organ transplant and other gastrointestinal diseases that may affect the results of the study. * women who are pregnant, planning to become pregnant during the study, or breastfeeding. * use of drugs that cause impaired vision or impaired tear secretion (including digoxin, fluoroquinolones, metronidazole, hydrochlorothiazide, retinoids). * current use of eye drops in the treatment of ocular diseases. * ocular diseases.

Keywords: retinal cells ocular diseases blue-light
transatrial pericardial separation to enhance safety of subxiphoid pericardial access for left atrial appendage ligation

Conditions: Atrial Fibrillation; Left Atrial Appendage Ligation; Pericardium; Epicardial Mapping; Heart Atria; Cardiac Surgical Procedures; Cardiac Catheterization; Pneumopericardium; Left Atrial Appendage Occlusion

Summary: we use a tiny catheter through the heart to separate the pericardium with gas. we expect this to improve the safety of the lariat procedure.

the lariat suture device enables non-surgical exclusion of the left atrial appendage possibly to prevent thromboembolism and stroke in patients with atrial fibrillation. subxiphoid needle access to the pericardium (a standard approach to enter the pericardial space surrounding the heart using a needle underneath the breastbone) during lariat risks injury to the heart surface that requires surgical repair. in this protocol the investigators propose test a new method to increase the safety of needle access to the pericardium. before needle access, the investigators introduce a separate tiny catheter into the pericardium from inside the heart through a tiny hole. the investigators then inject gas to push the heart away from the pericardial needle. this reduces the risk of injuring the heart during the standard lariat procedure.

Eligibility criteria:
inclusion criteria: * undergoing subxiphoid access to the "empty" pericardial space as part of a lariat left atrial appendage exclusion procedure * age ≥ 21 years exclusion criteria: • does not consent to participate
a comparison of minimal approach with conventional approach for distal radial fractures

Conditions: Closed Frykman Type II Fracture of Right Radial Head

Summary: the objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.

the objective of this study is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures. from january 2011 to september 2012, 157 patients with distal radial fractures were allocated into group a (n=83) and b (n=74). patients in group a were treated through a 1.5 to 2-cm long incision, and patients in group b were treated through the conventional flexor carpi radialis approach. all fractures were fixed with volar plates. patients were assessed range of motion of the wrist, grip strength of the hand, and pronation strength of the wrist. results were analyzed with the statistical package for social sciences 13.0. a p \< 0.05 was statistically significant.

Eligibility criteria:
inclusion criteria: * fernandez type ii-iv radial fractures. exclusion criteria: * fernandez type i radial fracture. * fernandez type v radial fracture. * open radial fractures. * surgery using k-wires or screws alone. * the use of external fixators. * multiple fractures, pathological fracture.

Keywords: distal radial fracture pronator quadratus mini-approach volar plating open reduction and internal fixation
laparoscopic versus open repair of peptic ulcer perforation

Conditions: Surgery; Emergencies; Peptic Ulcer Perforation

Summary: although laparoscopic repair (lr) of perforated peptic ulcers (ppus) has long been accepted, clinical evidence comparing lr versus open repair (or) remains lacking. the aim of this study is to evaluate the feasibility, safety and outcome of laparoscopic gastric repair and compare it with the outcome open repair by relying on a propensity score matching statistical technique

despite the evolution of medical management of gastroduodenal peptic ulcer (gpu), complications like bleeding and perforation are still not uncommon in clinical practice. according to the literature in average, 2-14% of peptic ulcers result in perforation, most 215 commonly occurring in females over the age of 60 and chronic nsaid, alcohol or tobacco users. management of perforated peptic ulcer entails resuscitation, pharmacotherapy and surgery. traditionally, suture with or without omental patch has been considered the 'gold standard' and still is. it is associated with shorter length of stay, lower transfusion needs and has lower morbidity as compared to gastrectomy. in 1992, it has been proposed that laparoscopy should be routinely considered in the management of perforated duodenal ulcer. nowadays due to the advances in laparoscopic technique, many publications suggest that laparoscopic repair of perforated peptic ulcers could be a superior choice to open repair. these is linked with the advantages of laparoscopic surgery over open surgery such as reduced postoperative pain, lower wound infection rate, decreased length of hospital stay, and earlier functional recovery

Eligibility criteria:
inclusion criteria: * patients surgically treated for benign peptic ulcer perforation exclusion criteria: * age \< 18 years * pregnant and breastfeeding women * malignant ulcer perforation * gastric resection * diagnostic laparoscopy/laparotomy with no further surgical procedures performed

Keywords: peptic ulcer perforation laparoscopy
low-dose dasatinib as first-line treatment for chronic myeloid leukemia

Conditions: Chronic Myelogenous Leukemia

Summary: our goal is to demonstrate that 50mg of dasatinib is as effective as the full dose to induce molecular response as first line therapy in cml.

we will give 50mg of dasatinib daily since the diagnosis for up to 6 months, for the first 2-4 weeks we will evaluate hematic biometry to registry hematic response, at months 3 and 6 a bcr/abl pcr will be taken to evaluate molecular response.

Eligibility criteria:
inclusion criteria: * diagnosis of bcr-abl positive cml in early chronic phase cml. except for hydroxyurea, patients must have received no or minimal prior therapy, defined as \<2 weeks (14 days) of prior fda approved tki. * ecog performance of 0-2 * adequate end organ function, defined as the following: total bilirubin \<1.5x uln, sgpt \<2.5x uln, creatinine \<1.5x uln. * patients must sign an informed consent indicating they are aware of the investigational nature of this study. exclusion criteria: * nyha cardiac class 3-4 heart disease or previous pleural effusion. * pregnancy and lactation * patients with active, uncontrolled psychiatric disorders

Keywords: dasatinib
intranasal fentanyl in preterm infants undergoing peripherally inserted central catheter placement

Conditions: Procedural Pain

Summary: the purpose of this feasibility clinical trial is to explore the role of intranasal fentanyl for pain associated with picc placement in preterm infants. the primary goals are identifying whether enough infants join the study and complete the study procedures.

infants admitted to the neonatal intensive care unit (nicu) are subjected to multiple painful procedures as part of clinical care. it is established that early and repeated exposure to pain is associated with negative consequences. however, pain management strategies continue to be underutilized in nicus worldwide. placement of a picc is a clinically essential painful procedure in infants requiring prolonged intravenous access. the procedure can cause moderate to severe pain. to date, the optimal medication for procedural analgesia during picc placement is not known. intranasal fentanyl has emerged as an option for pain management in infants admitted to the nicu. in preparation for a future definitive clinical trial, this is a feasibility clinical trial exploring the role of intranasal fentanyl for procedural analgesia in preterm infants undergoing picc placement.

Eligibility criteria:
inclusion criteria: * infants with a gestational age at birth \< 32 weeks or birth weight \< 1.5 kg * infants considered medically appropriate for the study by the most responsible physician exclusion criteria: * infants with choanal atresia, nasal mucosal erosion, or epistaxis * infants with facial anomalies * infants diagnosed with genetic conditions known to affect neurological development or severe (grade ≥ iii) intraventricular hemorrhage * infants receiving continuous intravenous infusions or scheduled enteral doses of opioids or sedatives within 12 hours of picc placement * infants with cardiopulmonary instability managed with inotropes, vasopressors, phosphodiesterase enzyme inhibitors, or neuromuscular blocking agents at the time of picc placement * infants prescribed strong cyp3a4 inhibitors (clarithromycin, itraconazole, ketoconazole, posaconazole, ritonavir, voriconazole) at the time of picc placement * infants diagnosed with bronchopulmonary dysplasia (need for supplemental oxygen or need for ventilatory support at 36 weeks corrected gestational age) * infants with a previous documented adverse reaction to any formulation of fentanyl each eligible infant will be enrolled for one picc placement only during the study period

Keywords: fentanyl intranasal drug administration preterm infants neonatal intensive care unit peripherally inserted central catheter line insertion
safety and efficacy of mem 3454 versus placebo in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine in an 8-week treatment study if mem 3454 is a safe and effective treatment for patients with mild to moderate alzheimer's disease.

alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. it is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. the neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death. a consistent and marked change in the brains of patients with ad is degeneration of the cholinergic innervation in the hippocampus and cerebral cortex areas. the activity of choline acetyl transferase (chat) is significantly reduced in these brain regions, and a linear correlation is seen between the reduction in cortical chat activity and the progress of dementia, indicating a progressive loss of cholinergic function. receptor selective nicotinic alpha-7 receptor agonists can modulate acetylcholine in selective brain regions and contribute to symptomatic treatment of ad. mem 3454 is a novel nicotinic alpha-7 receptor selective partial agonist having serotonin type 3 (5-ht3) receptor antagonist properties.

Eligibility criteria:
inclusion criteria: * diagnosis of probable or possible alzheimer's disease * mmse score between 16 and 26 points * modified hachinski ischemia score of less than or equal to 4 * capable of performing cognitive tests and other procedures specified in protocol exclusion criteria: * head trauma associated with cognitive impairment * evidence of significant neurological disease other than ad, such as parkinson's disease, multi-infarct dementia, huntington's disease, normal pressure hydrocephalus, cns tumor, progressive supranuclear palsy, seizure disorder, etc. * received ache inhibitor therapy (e.g., rivastigmine, tacrine or galantamine) or ndma-receptor antagonist, memantine, within 30 days or donepezil within 40 days of randomization * received any investigational drug within 2 months of randomization or treatment with other nicotinic receptor agonists within 3 months of screening

Keywords: alzheimer's disease cognition cognitive impairment
resection+highly purified ctl versus resection alone for hcc

Conditions: Hepatocellular Carcinoma

Summary: there is little evidence showed that adjuvant therapy had been shown to extend the survival of patients with hepatocellular carcinoma (hcc) receiving surgical resection. we investigated whether injections of highly-purified cytotoxic t lymphocytes prolongs recurrence-free survival of patients after resection for hcc.

hepatocellular carcinoma (hcc) is the fifth most common and the third leading cause of cancer-related death worldwide. resection is considered as the main curative treatment for hcc, but recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%, which results in poor prognosis of hcc, and the high recurrence rate has led efforts to develop adjuvant therapies to reduce recurrence. however, the benefit of any form of adjuvant therapy remains unclear. current guidelines didn't recommend any adjuvant therapy after resection. a previous clinical trial from japan reported that cytokine-induced killer(cik) cell immunotherapy increased recurrence-free survival (rfs) after surgical resection of hcc. immunotherapy has become an optional treatment for hcc. cytotoxic t lymphocytes(ctl), a kind of effective t cells that specific recognizing and killing antigen targeted cells through cloning amplification after receiving antigen information from antigen presented cell and playing key role to clear cancerous cells. there is little evidence for adjuvant ctl treatment for hcc receiving resection. so our hypothesis is that adjuvant highly-purified ctl is superior to resection alone for hcc. the aim of this prospective study is to compare the outcome of resection combined with highly-purified ctl with resection for hcc.

Eligibility criteria:
inclusion criteria: * 1. age 18-75 years; 2. first diagnosed hcc, no other treatment received; 3.child-pugh a-b 4. no severe coagulation disorders (prothrombin activity\<40% or a platelet count\<40,000/mm3); 5. eastern co-operative oncology group performance(ecog) status 0-1. exclusion criteria: * 1. pregnant women, breastfeeding women or plan pregnancy for the future 2 years; 2. the presence of vascular invasion or extrahepatic spread on imaging; 3. usage of strong immunosuppressive agents such as corticosteroids, cyclosporine a within six months or longer; 4. hiv antibody or hepatitis c virus antibody positive; 5. immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, buerger's disease, multiple sclerosis and type 1 diabetes); 6. suffering with cancers (except skin cancer, prostate cancer or cervical carcinoma in situ) at the enrolling time or 5 years before; 7. suffering with other organ failure; 8. suffering with severe mental illness; 9. drug addiction (including alcohol) for 1 year before the enrolling time; 10. participate in other clinical trials within three months prior to 3 months before the enrolling time; 11. other researchers believe that the patient is not fit for inclusion.

Keywords: highly-purified ctl
moderate intensity intermittent walking in postmenopausal women

Conditions: Liver Enzymes; Inflammatory Markers

Summary: the goal of this clinical trial is to investigate the impact of a walking training intervention program on liver enzymes and selected inflammatory markers in postmenopausal women with obesity. the main question it aims to answer is: does walking training reduce the risk of liver disease by modulating hepatic-enzymes and selected inflammatory markers? researchers will compare walking training intervention (designed to the experimental group) to non-training intervention (designed to the control group) to see if the training program works to improve liver health in obese postmenopausal women. participants in the experimental (training) group will: underwent a moderate intensity intermittent walking training (miwt) at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session. participants in control group will : not perform any physical training and maintain their usual daily activities.

postmenopausal obesity is an important public health problem accompanied by increased systemic inflammation that escalates the risk of liver disease. exercise improved inflammatory and hepatic function. moderate-intensity intermittent-walking-training (miwt) is the most feasible for obese-postmenopausal-women. this study aimed to investigate whether miwt could reduce the risk by modulating hepatic-enzymes and selected inflammatory markers. thirty-six sedentary obese postmenopausal women (mean age 55.7±3.5) were randomly divided into two groups: training group (tg, n=18) and control group (cg, n=18). the tg underwent a miwt at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session. body composition, hepatic (alanine-transaminase (alt), aspartate-transaminase (ast), alkaline-phosphatase, gamma-glutamyl-transferase (ggt) and serum-bilirubin\] and inflammatory markers \[c-reactive-protein (crp), and erythrocyte-sedimentation-rate (esr)) were evaluated at baseline and after 10-week of protocol.

Eligibility criteria:
inclusion criteria: women included are: * postmenopausal (≥1 year of amenorrhea). * obese (body mass index (bmi) ≥30 kg/m2). * sedentary (\<120 min/week of low to moderate intensity physical activity at during the past 6 months). * aged 50 to 60 years. exclusion criteria: * suffering from any cardiovascular/renal/pulmonary/metabolic disease. * being under menopausal hormone therapy. * presenting any orthopedic limitations interfering the ability to perform the study intervention.

Keywords: alanine transaminase alkaline phosphatase postmenopausal obesity c-reactive protein walking training erythrocyte sedimentation rate
a clinical investigation of the comprehensive®, biomodular®, and bi-angular® shoulder systems

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Humeral Fractures

Summary: the purpose of this prospective clinical data collection is to document the performance and clinical outcomes of biomet humeral stems


Eligibility criteria:
inclusion criteria: * non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis * rheumatoid arthritis * correction of functional deformity exclusion criteria: absolute contraindications: - infection, sepsis, and osteomyelitis relative contraindications: * uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions * osteoporosis * metabolic disorders which may impair bone function * osteomalacia * distant foci of infections which may spread to the implant site * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram

Keywords: total shoulder arthroplasty total shoulder replacement shoulder arthritis