Kornimate/medical-research-clean huggingface dataset:
health effects of resistance training on postmenopausal women

Conditions: Hot Flashes; Menopause

Summary: today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. vasomotor symptoms are less prevalent in women who participate in regular physical exercise. it is, however, still uncertain if physical exercise reduces vasomotor symptoms. the purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (rt) on postmenopausal women. end-points include effects from rt in postmenopausal women on 1. clinical outcomes (number and severity of vasomotor symptoms, health-related quality of life (hrqol), body mass index (bmi), abdominal height, muscle strength and mass, browning of fat), 2. diagnostic variables (production of myokines as irisin, immunological markers) and 3. genetic variables (length of telomeres). the control group will be offered resistance training after the intervention period.

the first phase is planned as a pilot-study including 20 women participating for 15 weeks. thereafter an evaluation of the sample size and the study methodology will be made.

Eligibility criteria:
inclusion criteria: * postmenopausal women who had at least 28 moderate to severe hot flashes per week during a screening period of two weeks.(postmenopausal, i.e. had their last menstrual bleeding at least 12 months ago or have increased gonadotrophic hormones showing they are postmenopausal.) * at lest 45 years of age * good physical health and physical ability to take part in organized resistance training or other training at least three times per week. * ability to speak and read swedish * freely informed consent for participation exclusion criteria: * physically active more than 75 minutes of intense exercise per week or more than 150 minutes of low intensity activities * hb \<110 g/l * blood pressure \>160 systolic and/or \>100 mmhg diastolic pressure * ongoing usage or use during the last two months of hormone therapy aimed for hot flashes * treatment with psychopharmacological drugs (e.g ssri or snri) or other treatment with a possible effect on menopausal symptoms * uninvestigated or unstable disease that could affect presence of flushes (e.g thyroid disease) * other medical condition that is judged inappropriate to combine with physical activity or participation in the study.

Keywords: hot flashes menopause hrqol resistance training physical activity adipose tissue
trial of glutamine and antioxidant supplementation in critically ill patients

Conditions: Critical Illness; Sepsis; Multiple Organ Failure

Summary: the purpose of this study is to determine whether providing high dose glutamine and antioxidants to critically ill patients will be associated with improved survival.

background: critically ill patients experience a degree of hyperinflammation, cellular immune dysfunction, and oxidative stress. supplementation with key nutrients, like glutamine and antioxidants, is most likely to have a favourable effect on these physiological parameters leading to an improvement in clinical outcomes. the results of two separate meta-analyses suggested that glutamine and antioxidants may be associated with improved survival. we have recently completed a dosing study to determine the maximal tolerable dose (mtd) of glutamine dipeptides and antioxidants in critically ill patients with evidence of hypoperfusion. the purpose of this protocol is to evaluate the effect of high dose glutamine and antioxidant supplementation on mortality in a large scale randomized trial. study intervention: patients will be randomized to receive glutamine supplementation or antioxidant supplementation (or respective placebo).

Eligibility criteria:
inclusion criteria: * mechanically ventilated patients \> or = 18 years old * 2 or more organ failures related to acute illness exclusion criteria: * \> 24 hours from admission to icu * patients who are moribund * lack of commitment to aggressive care * absolute contraindication to enteral nutrients * severe acquired brain injury * routine elective cardiac surgery * primary admission of burns \> 30% body surface area * weight \ 200 kgms * pregnant or lactating patients * previous randomization in this study * enrollment in a related icu interventional study * child's class c liver disease * metastatic cancer with life expectancy \< 6 months * seizure disorder requiring anticonvulsant medication

Keywords: randomized trial antioxidants glutamine organ failure
pentoxiphylline and vitamin e versus vitamin e in patients with non- alcoholic steatohepatitis

Conditions: Non Alcoholic Steatohepatitis

Summary: 120 patients of biopsy proven nash will be randomized into two groups. cases group will receive combination of pentoxiphylline and vitamin e, and control group will receive only vitamin e.

the investigators plan to randomise 120 patients of biopsy proven nash into cases and control groups. baseline investigations: clinical characteristics * age * gender * anthropometry (bmi, waist circumference, waist- hip ratio, triceps skin fold thickness, mid arm circumference) * alcohol intake should be nil laboratory characteristics * hemogram, inr, kft * lft (especially alt, ggt) , apri (ast to platelet ratio) * fasting lipid profile * other possible etiologies of liver disease (viral markers, ferritin, ana, igg, ceruloplasmin ) * homa-ir (ii) * serum uric acid levels liver stiffness * fibroscan * mr elastography radiological characteristics * usg abdomen variceal status by ugi endoscopy alpha fetoprotein pro- inflammatory markers * tnf-alpha, il-6, adiponectin, leptin and osteopontin liver biopsy and nas score

Eligibility criteria:
inclusion criteria: * age 18 to 70 years * persistently abnormal alt \>1.2 times upper limit of normal * histological evidence of nash/cirrhosis on liver biopsy. ( the minimal criteria for diagnosis of nash included the presence of lobular inflammation and either ballooning of cells or perisinusoidal or pericellular fibrosis in zone 3 of the hepatic acinus) exclusion criteria: * a known case of type 2 diabetes mellitus on treatment * alcohol intake of more than 40gm / week * if they had evidence of cirrhosis with significant portal hypertension * ongoing total parenteral nutrition/ jejunal-ileal bypass * other known liver disease (hepatitis a to e, autoimmune liver disease, wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis) * medication like estrogens, amiodarone, mtx, tamoxifen, att * pregnancy or lactation * hypersensitivity to methylxanthines (e.g., caffeine, theophylline, theobromine ) * recent retinal/cerebral hemorrhage * acute myocardial infarction or severe cardiac arrhythmias * impaired renal function * hypothyroidism
short-term intravenous fluids for prevention of post-ercp pancreatitis

Conditions: Post-ERCP Acute Pancreatitis

Summary: this study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ercp) pancreatitis (pep). pep is the most common serious ercp-related adverse event (ae), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. given the current lack of data on effectiveness of short-term fluid regimens in pep prevention to inform practice, the results of the proposed study have the strong potential to impact ercp practices worldwide, whether positive or negative.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years (due to higher likelihood of undiagnosed cardiac disease or renal insufficiency in patients \>75 years of age) 2. ability to give informed consent 3. native major papillary anatomy 4. ability and willingness to obtain bloodwork the day after ercp exclusion criteria: 1. prior ercp with sphincterotomy and/or sphincteroplasty 2. confirmed or suspected cholangitis or sepsis 3. confirmed pancreatitis, hyperlipasemia, or hyperamylasemia within the preceding 7 days 4. nyha class ii or greater heart failure 5. active pulmonary edema 6. myocardial infarction or ischemia within the preceding 3 months 7. renal insufficiency with crcl \< 40 ml/minute 8. cpt class b or c cirrhosis and/or end-stage liver disease 9. room air oxygen saturation \<90% or requirement of home o2 10. hypernatremia with na+ ≥ 150 meq/l or na+ \<130 meq/l 11. uncontrolled hypertension or hypotension 12. pregnant status
biomarkers in tissue samples from patients with high-risk wilms tumor

Conditions: Clear Cell Sarcoma of the Kidney; Recurrent Wilms Tumor and Other Childhood Kidney Tumors; Rhabdoid Tumor of the Kidney; Stage I Wilms Tumor; Stage II Wilms Tumor; Stage III Wilms Tumor; Stage IV Wilms Tumor; Stage V Wilms Tumor

Summary: this research study is studying biomarkers in tissue samples from patients with high-risk wilms tumor. studying samples of tissue from patients with cancer in the laboratory may help doctors to learn more about changes that occur in dna and identify biomarkers related to cancer.

objectives: i. to assess genomic gains and losses in high risk renal tumors, including up to 80 favorable histology wilms tumors that relapse (rfhwt), 50 anaplastic wilms tumors (uhwt), 15 clear cell sarcomas of the kidney (ccsk), and 40 rhabdoid tumors (rt) using a high density genetic platform to survey for recurrent copy number variations and allelic imbalances. ii. to define transcription patterns within 80 rfhwt, 50 uhwt, 15 ccsk, and 40 rt using a high throughput platform for global gene expression. iii. to define dna methylation patterns within 80 rfhwt, 50 uhwt, 15 ccsk, and 40 rt using a high throughput platform. iv. to identify genetic mutations involved in the pathogenesis of wilms tumor, and in the development of relapse and anaplasia through the study of 80 rfhwt, 50 uhwt, 15 ccsk, and 40 rt using next generation sequencing tools. v. to facilitate the integration of the above databases and allow meaningful access by investigators through the infrastructure provided by target, including its data portal and associated cabig tool. outline: this is a multicenter study. archived tumor tissue samples are analyzed for dna copy number determination, gene expression, dna methylation, and genomic re-sequencing by array-based methods, including pcr analysis, methylation-specific reverse transcriptase-pcr (rt-pcr), and quantitative rt-pcr.

Eligibility criteria:
inclusion criteria: * diagnosis of high-risk wilms tumor meeting ≥ 1 of the following criteria: * relapsed disease * anaplastic disease * clear cell sarcomas of the kidney * rhabdoid tumors * registered on nwts-4, nwts-5 (now cog-q9401), or participation in aren03b2 protocols with clinical follow-up \> 3 years * banked frozen tumor samples and paired normal dna available with clinical data points, including the following: * age, race, and gender * stage and reason for stage * tumor weight * associated precursor lesions (rests) * histologic subtype * site and time of recurrence * days of follow-up * time and reasons for death (e.g., tumor, toxicity, infection, or other)
single-use duodenoscopes performance characteristics and technical outcomes: the suspect italian prospective study

Conditions: Disease of Gastrointestinal Tract

Summary: flexible endoscopes are used globally for the diagnosis and treatment of diseases of the gi tract. duodenoscopes used for endoscopic retrograde cholangiopancreatography (ercp), in order to treat different biliary and pancreatic disorders, have been recently linked to infections transmission following the procedures. given their reusability and their complex design of the tip with a moving metallic component, named the "elevator", these instruments must be reprocessed through high level disinfection (hld) in order to prevent the spread of nosocomial infections. even strict adherence to all hld procedures results in a residual level of potentially infectious microbes. in fact, the united states food and drug administration (fda) postmarket surveillance communication reported duodenoscope culture results demonstrating contamination rates of up to 3.6% for low and moderate-concern organisms and up to 5.4% for high-concern organisms in reprocessed conventional duodenoscopes. as a consequence, at least 20 outbreaks of duodenoscope-transmitted multidrug resistant organism (mdro) infections occurred between 2012 and 2015, despite reported compliance with duodenoscope reprocessing guidelines. the increasing concern that currents practices of reprocessing reusable duodenoscopes is insufficient, has led the fda to released recommendation suggesting to develope a newly designed duodenoscopes. on one hand, a way is to generate duodenoscope with disposable components, such as a one-use end cap, which can be removed and allow access to the components of the elevator and other areas of the duodenoscope for reprocessing. on the other hand, an alternative is to produce a fully disposable single-use duodenoscope. the evident advantage of a single use duodenoscope, over disposable components, is that it completely eliminates the need for reprocessing and more important the risk of transmitting microbial infection from patient to patient.


Eligibility criteria:
inclusion criteria: * 18 years or older * willing and able to comply with the study procedures and provide written informed consent to participate in the study * schedule for a clinically indicated ercp or other duodenoscope-based procedure exclusion criteria: * potentially vulnerable subjects, including, but not limited to pregnant women * subjects for whom endoscopic techniques are contraindicated * subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this is a phase i study of veliparib (abt-888) in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced, unresectable pancreatic cancer. primary objectives: * determine the maximum tolerable dose of veliparib in combination with gemcitabine and intensity modulated radiation therapy in patients with locally advanced pancreatic cancer. * determine the safety and toxicity of the combination of veliparib with gemcitabine and radiation therapy in patients with locally advanced pancreatic cancer

gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on days 1, 8, 15 of the cycle. intensity modulated radiation therapy (imrt) will be given to a total dose of 36 gy in 15 fractions (2.4 gy per fraction, one fraction per day, 5 fractions per week, monday through friday) beginning on day 1. veliparib will be administered per a dose escalation schema. the starting dose of veliparib is 20 mg bid based upon safety/efficacy data available. dose escalation will continue in 20 mg increments until the maximum tolerated dose (mtd) is reached. intra-patient dose escalation will not be allowed.

Eligibility criteria:
inclusion criteria: * patients with histopathological or cytological diagnosis of adenocarcinoma of the pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is deemed locally advanced unresectable or borderline resectable as determined by a pancreatic cancer surgeon and/or following evaluation by a gi oncology tumor board. * age 18 years or older exclusion criteria: * patients who have had prior anti-cancer treatment for their disease * patients who are currently receiving any other investigational agents * metastatic disease * history of allergic reactions attributed to compounds of similar chemical or biologic composition to parp \[poly (adp-ribosome) polymerase\] inhibitors or gemcitabine * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: locally advanced unresectable pancreatic pancreas pancreatic adenocarcinoma
a pancreatic cancer screening study in hereditary high risk individuals

Conditions: Pancreatic Neoplasms

Summary: the main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. magnetic resonance imaging and magnetic cholangiopancreatography (mri/mrcp) will be utilized to screen for early stage pancreatic cancer or precursor lesions. participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for pancreatic cancer.

individuals 50 years of age and older who have a family history of pancreatic cancer will be recruited through the offices of primary care physicians and endocrinologists. those meeting initial criteria will meet with a research aprn and will undergo a secondary screen to determine eligibility. individuals enrolled in the study will undergo a five-minute psychological survey and donation of a blood sample for bio-bank analysis every 6 months for 3 years. mri will be performed annually for 3 years (4 in total). any abnormalities on mri will be reviewed by a multi-disciplinary tumor board and discussed with the participant. the costs of mri will be covered by the study.

Eligibility criteria:
registration-inclusion criteria for familial pancreatic cancer (fpc) and those with a brca1, brca2, lynch syndrome, atm, palb2, cdkn2a, or related gene mutation (one of the following is required for questions 1-3) 1. for fpc: the individual has at least 2 first-degree relatives (fdr) with pc. 2. for fpc: the individual has at least 3 first-, second-, or third-degree relatives with pc with at least 1 pc in a fdr. 3. the individual is a known mutation carrier of brca1, brca2, mlh1, msh2, msh6, or pms2, atm, palb2, cdkn2a, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with pc. 4. the individual is at least 50 years old or 10 years younger than the youngest relative with pc. 5. ecog performance status of 0-1. 6. no known contraindications to mri examination or gadolinium contrast. 7. willing to undergo mri and screening for metal implants or metal injury. 8. estimated gfr \>29 ml/min 9. ability to provide informed consent. 10. willing to return to study site for all study assessments. registration-exclusion criteria: 1. prior history of pancreatic cancer. 2. presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years. 3. received chemotherapy within the past 6 months. (hormonal therapy is allowable if the disease free interval is at least 5 years). 4. hereditary pancreatitis. 5. egfr \< 30 ml/min 6. contraindication to mri examination or gadolinium contrast. 7. pregnant or nursing women. 8. co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Keywords: pancreas cancer mri brca early detection genetics atm palb2 lynch cdkn2a
the prospective cohort study on the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease

Conditions: Intracranial Aneurysm; Natural History; Ischemic Heart Disease; Ischemic Cerebrovascular Disease

Summary: this is a registry study of the natural course of unruptured intracranial aneurysms (uia). in addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. the investigators aim to use research data to create a china national database of uia

this is a registry study of the natural course of unruptured intracranial aneurysms (uia). in addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. the investigators aim to use research data to create a china national database of uia. this study is supported by a research grant from the ministry of science and technology of the people's republic of china. the investigators will collaborate with the other 19 medical centers which locate in the different districts of china. during the study period, all the patients included in this study will observe and treat in the collaborating medical centers. included patients will be followed-up for at least 1year. research data will represent the real natural course of uia in china. for this study, the investigators consulted and hired professional experts about data collection, data and methodology. an intact systematic project steering committee, including data monitoring committee, data management committee, project academic committee, executive group, project manager, project statistician, and technical support center has been built up. scientific regulations have also been made

Eligibility criteria:
inclusion criteria: 1. diagnosis of untreated unruptured intracranial aneurysm (by cta, mra or dsa); 2. patient with premorbid mrs of 3 or less; 3. patient older than 14years; 4. patient consenting to participate to the study; 5. patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention exclusion criteria: subarachnoid hemorrhage with unknown causes; - page 4 of 4 \[draft\] - 2. patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas; 3. patient with malignant tumor; 4. target aneurysm is fusiform, traumatic, mycotic, or dissecting related; 5. inability to obtain informed consent; 6. patients with a life expectancy less than 1 year; 7. participating in the other clinical studies of intracranial aneurysm; 8. refusal of follow-up

Keywords: unruptured intracranial aneurysm benefit-risk ischemic heart disease ischemic cerebrovascular disease antithrombotic anticoagulant people's republic of china multicenter studies
earing protectors influence on newborns preterm sleep pattern

Conditions: Sleep

Summary: preterm newborn sleep deprivation due to medical interventions and environmental characteristics of the neonatal intermediate care unit (nicu) can increase morbidity and developmental deleterious effects. the aim of this study is to test the effect of earmuffs on sleep pattern of preterm neonates. prospective, randomized, controlled, crossover study conducted in nicu of two teaching hospitals from são paulo, brazil. the effect of earmuffs use was analyzed through polysomnography measurement during four "quiet times" periods. it was also analyzed sleep related variables during 24 hours of the day. preterm newborns characteristics and clinical characteristics were also analyzed.


Eligibility criteria:
inclusion criteria: * preterm newborns inside the incubator; * preterm newborns clinically stable; * preterm newborns with no change in hearing screening test; * preterm newborns current weight between 1200 and 2000g. exclusion criteria: * preterm newborns in phototherapy; * preterm newborns in use of invasive mechanical ventilation and noninvasive; * preterm newborns with any type of congenital malformation; * preterm newborns with periventricular hemorrhage grades ii, iii and iv; * preterm newborns that received central nervous system depressant medication and sedative opioid analgesics in the last 24 hours; * preterm newborns using corticoids; * preterm newborn whose mother has a history of illicit drug use during pregnancy

Keywords: sleep; infant, premature; polysomnography; ear protective devices