Kornimate/medical-research-clean huggingface dataset:
comprehensive police fatigue management program

Conditions: Sleep Disorders; Sleep Apnea, Obstructive; Restless Legs Syndrome; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders

Summary: police officers work some of the most demanding schedules known, which increases their risk of sleep deprivation and sleep disorders. the need to work frequent overnight shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. the public expects officers to perform flawlessly, but sleep deprivation and unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and performance. in addition, both acute and chronic sleep deprivation adversely affect personal health, increasing the risk of gastrointestinal and heart disease, impairing glucose metabolism, and substantially increasing the risk of injury due to motor vehicle crashes. we propose to conduct a randomized, prospective study of the effect on the safety, health, and performance of a police department of a comprehensive police fatigue management program (cpfmp) consisting of the following interventions: 1. identification and treatment of police with sleep disorders; 2. caffeine re-education; and 3. initiation of a sleep, health and safety educational program. these interventions were chosen because we believe them most likely to lead to measurable improvements on work hours, health, safety, and job performance, and because they are cost effective. the success of the cpfmp will be assessed through an experimental comparison with a standard treatment group that will receive sleep education in the absence of any accompanying interventions. the overall goal of our team will be sleep health detection and treatment program that can be disseminated to practitioners, policymakers and researchers nationwide to reduce police officer fatigue and stress; enhance the ability of officers to cope with shift schedules; improve the health, safety and performance of law enforcement officers; and thereby improve public safety.


Eligibility criteria:
inclusion criteria: * active sworn police officers exclusion criteria: * none

Keywords: police sleep fatigue work hours sleep disorder performance
a study of first-line maintenance erlotinib versus erlotinib at disease progression in participants with advanced non-small cell lung cancer (nsclc) who have not progressed following platinum-based chemotherapy

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Summary: this double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance erlotinib (tarceva) versus erlotinib at the time of disease progression in participants with advanced nsclc who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumor does not harbor an epidermal growth factor receptor (egfr)-activating mutation. participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (po) once daily or placebo. participants who progress on placebo will receive erlotinib 150 mg po once daily as second-line therapy, and those who progress on erlotinib may switch to a non-investigational, second-line chemotherapy. treatments will continue until disease progression, death, or unacceptable toxicity. participants may also be entered into a final survival follow-up (sfu) period upon treatment discontinuation.


Eligibility criteria:
inclusion criteria: * adults greater than or equal to (≥) 18 years of age, or legal age of consent if greater than 18 * advanced or recurrent (stage iiib) or metastatic (stage iv) nsclc * completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle less than or equal to \[≤\] 28 days prior to randomization) * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * prior exposure to agents directed at human epidermal growth factor receptor (her) axis (e.g. erlotinib, gefitinib, cetuximab) * participants whose tumors harbor an egfr-activating mutation * prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening * use of pemetrexed in maintenance setting (pemetrexed allowed during the chemotherapy run-in) * participants who have undergone complete tumor resection after responding to the platinum-based chemotherapy during the screening phase * any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ, or organ-confined prostate cancer * central nervous system (cns) metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated cns metastases or spinal cord compression without stable disease for ≥2 months * human immunodeficiency virus (hiv), hepatitis b, or hepatitis c infection * any inflammatory changes of the surface of the eye
effectiveness and impact on the quality of life of ketogenic diet in pediatric patients

Conditions: Drug Resistant Epilepsy; Autism Spectrum Disorder; Chronic Migraine; Brain Tumor, Pediatric

Summary: the goal of this observational study is to learn about the clinical and nutritional effectiveness of ketogenic diet (kd) in pediatric patients with genetic, neurological or metabolic conditions requiring kd. the main question\[s\] it aims to answer are: * does kd support adequate growth? * does kd improve clinical symptoms? * how does kd impact quality of life? participants will be followed up as per clinical practice

scientific and clinical interest in kd is growing with a progressive increase in its therapeutic indications, ie recent studies show beneficial effects of kd in other diseases like migraine, autism spectrum disorder and brain tumors. however, so far, the majority of results on kd effects have been collected in patients with drug-resistant epilepsy proving its effectiveness on clinical outcome (e.g. reducing epileptic seizures), frequently leaving out the nutritional assessment and the impact on quality of life. nonetheless, these factors are indeed essential to ensure safety and efficacy of kd treatment, especially when dealing with children and in perspective of the progressive expansion of the target population that can benefit from this nutritional therapy. the present multicenter study aims to analyse these poorly explored areas, by evaluating, in a cohort of pediatrics patient with indication to kd therapy, not only the kd effectiveness on the course of the underlying disease, but also the impact on nutritional parameters (e.g. growth, lipid profile, vitamin intake, bone mineral density, ..) and on quality of life.

Eligibility criteria:
inclusion criteria: * pediatric patients (aged \< 18 years) with drug-resistant epilepsy (fail to achieve (and maintain) seizure freedom with adequate trials of two or more antiseizure medications) or genetic, metabolic, neurological (congenital and acquired) diseases treated with ketogenic diet * pediatric patients (aged \< 18 years) with metabolic, genetic or neurological (congenital and acquired) diseases (not necessarily associated with drug-resistant epilepsy) treated with ketogenic diet; this includes the new kd indications or the administration of kd in the icu for status epilepticus. exclusion criteria: * patients affected by beta-oxidation cycle disorders, systemic primary carnitine deficiency, primary dyslipidemia, pyruvate carboxylase deficiency, porphyria, mitochondrial disease, defects in ketone body metabolism (ketogenesis or ketolysis), defect in gluconeogenesis. * children with type 1 diabetes * parents (or caregivers) unable to guarantee adherence to the
effect of probiotic on constipation

Conditions: Constipation

Summary: constipation is a prevalent intestinal disorder. lactobacillus casei strain shirota (lcs) shows potential effect on alleviating constipation. this study evaluated the impact of fermented milk containing lcs on stool consistency and frequency. the stool short chain fatty acid and gut microbiota were also assessed.


Eligibility criteria:
inclusion criteria: * meet rome ⅲ criteria for functional constipation * normal body mass index between 18.5 and 29.9 exclusion criteria: * had a serious disease; * used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study; * allergic to milk protein; * constipated because of organic or neurological lesions; * participated in any other studies within 2 months prior to this study.
comparison of loop-tip cook medical® wire versus traditional endoscopic technique

Conditions: Complications of Surgical and Medical Care: General Terms

Summary: the purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of pep and biliary tree access, in post-ercp pancreatitis in high-risk patients.

selective cannulation of common bile duct (cbd) by insertion of a guide-wire seems to be associated with fewer complication and post-ercp pancreatitis (pep) rate than the conventional biliary tree access with contrast injection even if results are conflicting. the aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of pep and biliary tree access, in pep high-risk patients. type of study: multicentric, prospective and randomized trial patients: pep high-risk patients underwent ercp for benign biliary pathology number of patients: 320 patients (160 for each group) aim: primary end point: the evaluation of the incidence of pep . secondary end point: the evaluation of cbd percentage cannulation.

Eligibility criteria:
inclusion criteria: * high risk patients for post-ercp pancreatitis exclusion criteria: * age \< 18 yrs * allergy to the contrast medium * previous surgery * neoplastic bilio-pancreatic disease * previous ebs

Keywords: loop ercp cannulation biliary wire
efficacy and safety of diamel in patients with nonalcoholic steatohepatitis

Conditions: Nonalcoholic Steatohepatitis; Insulin Resistance

Summary: the purpose of the study is to evaluate whether the addition of diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.


Eligibility criteria:
inclusion criteria: * histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis) * age between 18 and 70 years * ability to provide informed consent * absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g) exclusion criteria: * presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency) * pregnancy or lactation * decompensated cirrhosis * presence of secondary cause of nafl such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery * pharmacological treatment with some potential benefit on nafl including ursodeoxycholic acid, vitamin e, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil * fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter) * contraindication to liver biopsy * refusal to participate in the study * concomitant disease with reduced life expectancy * severe psychiatric conditions * drug dependence

Keywords: nonalcoholic steatohepatitis insulinresistance diet and exercise nutritional supplement nonalcoholic fatty liver disease lifestyle modifications
phase ii study of oral s-1 plus irinotecan (iris) in patients with advanced colorectal cancer

Conditions: Colorectal Cancer

Summary: to assess the usefulness of irinotecan plus s-1 therapy based on the antitumor effect and survival period. by performing a phase ii study of this combination in patients with inoperable or with postoperative colorectal cancer.

a multicenter open-label, single-arm, phase ii clinical trial is conducted on patients with histological stage iv colorectal cancer given irinotecan plus s-1. the usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (dfr), overall survival rate (os), incidence and severity of adverse event.

Eligibility criteria:
inclusion criteria: 1. histological diagnosis of colorectal adenocarcinoma. 2. measurable or assessable lesions. 3. age: 18 \~ 75 years. 4. performance status (ecog): 0 \~ 2. 5. no prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). adjuvant chemotherapy is not defined as previous therapy. 6. no history of treatment with cpt-11 or s-1. 7. no history of radiotherapy to the abdomen. 8. oral intake of s-1 is possible. 9. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3 and 12,000/mm3. hb 10.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5times the upper limit of normal (excluding liver metastasis). t-bil 2.0mg/dl. creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of s-1 can be decreased according to the dose reduction criteria to allow registration in the trial). normal ecg (not considering clinically unimportant arrhythmias and ischemic changes). 10. predicted survival for \>3 months. 11. able to give written informed consent exclusion criteria: 1. severe pleural effusion or ascites. 2. metastasis to the central nervous system (cns). 3. active gastrointestinal bleeding. 4. active infection. 5. diarrhea (watery stools). 6. uncontrolled ischemic heart disease. 7. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. active multiple cancer. 9. severe mental disorder. 10. pregnancy, possible pregnancy, or breast-feeding. 11. flucytosine treatment 12. gilbert's syndrome (4). 13. judged to be ineligible for this protocol by the attending physician.

Keywords: irinotecan, s-1, phase ii, colorectal cancer,
natera ovarian cancer detection assay

Conditions: Adnexal Mass

Summary: the purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. the study will collect blood, tissue, and health information from these individuals.


Eligibility criteria:
inclusion criteria: * presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging * must be planning surgical resection or biopsy * must be treatment naïve * must be 18 years or older * able to understand and sign a written informed consent document * able to provide 40ml of blood (at least 20ml) for each blood draw exclusion criteria: * prior removal of either ovary for any reason * currently pregnant * blood transfusion within 3 months of study enrollment * history of bone marrow or organ transplant * prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer. * a medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia

Keywords: adrexal mass ovarian cancer fallopian tube cancer peritoneal cancer
a study of nipocalimab in reducing the risk of fetal and neonatal alloimmune thrombocytopenia (fnait)

Conditions: Thrombocytopenia, Neonatal Alloimmune

Summary: the purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (fnait).


Eligibility criteria:
inclusion criteria: * pregnant and an estimated gestational age (ga; based on ultrasound dating) from week 13 to 18 at randomization * has a history of greater than or equal to (\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (fnait) (including neonatal platelet count less than (\<) 150×10\^9/liter) with none of them affected by fetal/neonatal intracranial hemorrhage (ich) or severe hemorrhage based on medical records * current pregnancy with presence of maternal anti- human platelet antigen (hpa)-1a alloantibody and positive fetal hpa-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (dna) in maternal blood * health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ecg), and clinical laboratory tests performed at screening * for maternal participant and neonate/infant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit exclusion criteria: * currently pregnant with multiple gestations (twins or more) * history of severe preeclampsia in a previous pregnancy * history of myocardial infarction, unstable ischemic heart disease, or stroke * known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the investigator brochure (ib)) * has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
digital versus conventional impression on discomfort and dental anxiety among preschoolers

Conditions: Dental Anxiety

Summary: background: taking alginate impressions for preschoolers is challenging and might be disturbing for them. therefore, intraoral scanners are suggested as a better alternative to the conventional alginate impression. objectives: the present study aims to evaluate and compare the level of patients' discomfort, dental anxiety, gag reflex, behavior and time required for taking alginate impressions with that of intraoral scanning. materials and methods: the study will be a randomized, controlled clinical trial, parallel design. a total of 666 pediatric dental patients aged from 4-6 years will be selected from the outpatient clinic of the of pediatric dentistry and dental public health department, faculty of dentistry, alexandria university. participants will be allocated into 2 groups. children in the first group will receive digital impressions by an intraoral scanner, while those of the second group will receive conventional alginate impressions. patients' discomfort will be evaluated by a modified vas index supported with emojis. dental anxiety will be evaluated using facial image scale (fis). gag reflex will be assessed by gag severity index (gsi). child's behavior towards the impression technique in the 2 groups will be evaluated using venham's behavior rating scale. time taken to complete the procedures will be recorded using a digital stopwatch.


Eligibility criteria:
inclusion criteria: * children with scores of 3 or 4 during preoperative assessments according to the frankl behavioral rating scale. * no previous dental experience. * patient's parents signed an informed consent before participating in the trial. exclusion criteria: * any physical or mental disability, or psychological problems. * children with temporomandibular joint or periodontal discomfort

Keywords: dental impression digital impression
assessment of movement skills in autism spectrum disorder

Conditions: Movement Disorders

Summary: this study is to explore the degree of impairement in movement skills in children with autistic spectrum disorders

motor impairments in neurodevelopmental disorders specifically autism spectrum disorder (asd) , are prevalent and pervasive . however ,sensori-motor development and self-care activities such as bathing, dressing, eating and toileting, remain little explored in comparison to the other areas of development. some children with asd have difficulty mastering self-care skills, which we will call daily living skills .

Eligibility criteria:
inclusion criteria: * all children with autism from the age of 3 years to 18 years exclusion criteria: * children less than 3 years , children with neurodegenerative disorders or cerebral palsy
impact of group size in weight loss interventions

Conditions: Obesity; Weight Loss

Summary: the present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. it is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.


Eligibility criteria:
inclusion criteria: * adults (at least 21 years-old) * health insurance coverage with capital health plan (chp) * body mass index bmi between 30-45 kg/m2 exclusion criteria: * bmi is less than 30 kg/m2 or greater than 45 kg/m2 * weight loss \> 10 pounds in past 6 months * acute or chronic illnesses for which weight loss is contraindicated * unwilling or unable to give informed consent * unwilling to accept random assignment * unwilling or unable to travel to chp clinic for assessments and groups * likely to relocate out of the area in the next 12 months

Keywords: obesity weight loss group size
dispatcher-activated neighborhood access defibrillation and cardiopulmonary resuscitation

Conditions: Out of Hospital Cardiac Arrest

Summary: the hypothesis of this study is dispatcher-activated neighborhood access defibrillation and cardiopulmonary resuscitation (nad-cpr) would improve survival of out-of-hospital cardiac arrest (ohca).

out-of-hospital cardiac arrest (ohca) is a major health problem, occurring in about 1 in 1,500 adults in the developed countries each year. although layperson cpr and defibrillation are crucial components of chain of survival, layperson cpr rate and it's quality is low and public-access defibrillation (pad) program is not cost-effective.if trained bystanders can know the information of occurrence of ohca and nearest place for automated external defibrillator (aed) at the same time by dispatch center, these neighborhoods could run and give high quality cpr and early defibrillation. if this protocol ,dispatcher-activated neighborhood access defibrillation and cardiopulmonary resuscitation(nad-cpr), is introduced to community, it may improve survival of ohca.

Eligibility criteria:
inclusion criteria: * all ohca with presumed cardiac etiology more than 15 years old * assessed by emergency medical service (ems) providers dispatched by dispatch center * dispatcher detected ohca patients exclusion criteria: * ohca with non-cardiac etiology * prolonged cardiac arrest with a suspected duration more than 30 minutes * cases with rigor mortis or rivor mortis, decapitated or decomposed body * non detected cases by dispatcher

Keywords: out of hospital cardiac arrest cardiopulmonary resuscitation dispatch emergency medicine