Kornimate/medical-research-clean huggingface dataset:
a study comparing 4 dose regimens of pla-695, naproxen, and placebo in subjects with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: objectives: primary:to assess the efficacy and safety of pla-695 in subjects with active osteoarthritis (oa) of the knee. secondary:to determine the pharmacokinetics (pk) and pharmacodynamics (pd) of pla-695 among dose levels. to assess health outcome measures. to assess the effect of pla-695 on biomarkers related to clinical responses. to assess pla-695 exposure-response relationship on pd, efficacy, and safety measures. to assess pharmacogenomics (pgx) analysis in oa.

this is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of pla-695 administered qd and 1 dose of pla-695 administered bid for 6 weeks. subjects will be randomized to 1 of 6 treatment groups: pla-695 50 mg, 200 mg, or 400 mg qd, pla-695 200 mg bid, placebo, or naproxen 500 mg bid. subjects will undergo a washout period of 2 to 14 days. the number of days for washout will be determined by the pre-study nsaid of each subject. subjects who washout from previous therapy with an increase in signs and symptoms of oa will be randomly assigned to receive pla-695.

Eligibility criteria:
inclusion criteria: the main inclusion criteria is listed below, additional inclusion criteria is in the protocol. * men or women 50 to 75 years of age. women must be of non-childbearing potential. sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of pla. * diagnosed with idiopathic oa of the knee for at least 3 months duration in accordance with \[1986\] american college of rheumatology (acr) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age \>50 years, crepitus, or morning stiffness \<30 minutes. * radiographic confirmation of oa at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening. * must be currently treated for oa with a stable daily dose of 1 nsaid, including cox-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit. exclusion criteria: these are some of the main exclusion criteria for the the study. additional exclusion are included in the protocol. * history of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis. * grade 4 severity on the kellgren-lawrence scale on the screening target knee radiograph. * any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study. * any clinically significant laboratory abnormality.

Keywords: osteoarthritis arthritis pain
study of tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial acosog-z9001

Conditions: Gastrointestinal Stromal Tumor

Summary: rationale: studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. purpose: this research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial acosog-z9001.

objectives: primary * to examine polymorphisms in selected genes involved in the detoxifying/metabolizing and dna repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (gist) undergoing treatment on clinical trial acosog-z9001. secondary * to examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and dna damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from gist patients for hypothesis generation. (exploratory) * to conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory) * to examine the association between the above polymorphisms and major toxicity (grade 3/4) of adjuvant imatinib mesylate. (exploratory) outline: tumor samples are used for polymorphism and mutation analysis.

Eligibility criteria:
disease characteristics: * tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial acosog-z9001

Keywords: gastrointestinal stromal tumor
factors associated with parental observation of side effects following the child flu vaccine

Conditions: Influenza Vaccine, Influenza

Summary: this study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. we will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as whether there are underlying differences in parents' cognitive biases between those who do and do not re-vaccinate their child.

in 2012, the british joint committee on vaccination and immunisation (jcvi) recommended that the influenza vaccination programme be extended to include children aged 2 to 16. in the three flu seasons in which the child flu immunisation programme has been running (2013-14, 2014-15, 2015-16), uptake rates have been low (approximately 40%). multiple factors are likely to underlie the poor uptake, including thinking the vaccine was unsafe and ineffective and having experienced side-effects related to the vaccine previously. although symptoms are commonly reported following vaccinations, their causes are not always straightforward. although a minority may be directly attributable to the vaccine itself, others may reflect pre-existing or coincidental symptoms that are misattributed to the vaccine. following vaccination, an expectation that the vaccine causes side-effects may also contribute to parents detecting symptoms in their child that might otherwise have gone unnoticed. perception of side-effects may also influence the parent's decision to vaccinate their child again in following years. other possible factors influencing parents' perception of side-effects and their willingness to vaccinate their child again are their personal health beliefs and their interpretations of the information they are given about vaccination and side-effects. these cognitive processes can be measured objectively using experimental tasks, and can reveal characteristic patterns, or 'cognitive biases' which govern behaviour.

Eligibility criteria:
inclusion criteria: * parents of guardians of children aged 2-4 on 31st august 2016 (i.e. born september 1st 2011 to august 31st 2014) who receive the flu vaccine at the gp * parents must be aged 18 or over * parents must be fluent in english exclusion criteria: -

Keywords: children psychological predictors side-effects vaccination
mixed methods feasibility study of an app for childhood obesity prevention and management

Conditions: Child Obesity

Summary: this evaluation evaluated health education england's noobesity digital health app's usability and acceptability to undertake activities improving families' diet, physical activity and weight. the purpose of the study is to evaluate the app's influence on self-efficacy and goal setting and to determine what can be learned to improve its design for future studies, should there be evidence of adoption and sustainability.


Eligibility criteria:
inclusion criteria: * adult users (over 18 years) * fluent in english * willing to use the app * parents or legal guardians of a child or children or health care professionals linked to the parent or guardian * owner of a smartphone to access the app, with 4g data access exclusion criteria: * individuals who are known to the researchers or staff at health education england * deaf or hearing impairment * prior use of the app before study commencement * refusal to give informed consent * children, vulnerable young people, or vulnerable adults.

Keywords: child obesity digital health mobile applications behavior change
firefly ankle sprain study

Conditions: Grade I/II Ankle Sprain

Summary: the device to be tested (fireflytm) stimulates the common peroneal nerve and causes the foot to twitch, and has been shown to increase blood flow. the device is also indicated for the treatment of oedema. in this study the investigators intend to assess the use of the device as an adjunctive therapy for people recovering from grade 1 and 2 ankle sprains.


Eligibility criteria:
inclusion criteria: 1. aged 18 years and over 2. referred to physiotherapy for treatment of ankle sprain 3. clinical diagnosed ankle sprain with evidence of swelling 4. able to understand the subject information sheet and willing to sign the written informed consent form. 5. able and willing to follow the protocol requirements exclusion criteria: 1. has an ankle sprain grade 3 2. evidence of fracture 3. has a pacemaker 4. chronic obesity (bmi index \>40kg/m2). 5. pregnancy. 6. history or signs of previous deep or superficial vein thrombosis/pulmonary embolism. 7. varicosities, ulceration or erosion around the area of the leg where the study device would be fitted 8. not able to fit firefly device
ultrasound-guided serratus anterior plane block for additional pain relief after lung surgery

Conditions: Thoracic Surgery

Summary: the purpose of this study is to see if an anesthesia technique called serratus anterior plane block may provide additional pain relief for the chest wall after lung surgery. the study will evaluate the effect the serratus anterior plane block technique has on the need for opioids after surgery,the level of pain during recovery, and other aspects of recovery, like whether the patient has nausea and their ability to breathe deeply. the effects of the serratus anterior plane block will be compared to the effects of an inactive (sham) block.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years of age who are capable of giving consent. english language proficiency is required. * undergoing elective minimally invasive (vats or rats) anatomic lung resection (segmentectomy or lobectomy) without an epidural. exclusion criteria: * pregnancy (patients must have a negative pregnancy test within 30 days of the operation) * history of documented anaphylaxis or contraindication to local anesthetics * history of ipsilateral thoracic surgery. ipsilateral thoracic surgery indicates any previous thoracoscopic or open (i.e. via thoracotomy) pleural biopsy, lung resection, esophageal surgery, chest wall resection, or other thoracic surgery within the chest cavity. this does not include image-guided lung biopsy. note: mediport placement and other procedures performed by a surgeon/proceduralist not within the chest cavity are not excluded. likewise, patients with a history of ipsilateral breast surgery are also not excluded. the purpose is to exclude patients who may have had injury to the intercostal nerves from previous surgery or who have surgically altered anatomy of the hemithorax. * patients undergoing bilateral procedures * weight \< 50 kg * chronic sustained-release opioid use for \> 2 weeks duration (in the 30 days prior to surgery) * significant cognitive impairment or documented psychological impairment * american society of anesthesiologists (asa) physical status \> 3 * patients may also be excluded from the study if the block is deemed not technically feasible (this may be determined intraoperatively).

Keywords: serratus anterior plane block segmentectomy lobectomy 19-470
association of autophagy-related genes ,lncrna and snps with colorectal cancer in egyptian population

Conditions: Colo-rectal Cancer

Summary: 1. determination of expression level of hottip and eif4ebp1(eukaryotic translation initiation factor 4e-binding protein 1) . 2. investigation of the snp hottip rs1859168 and it's association with crc susceptibility. 3. correlation of the expression of these genes with various stages of crc to determine the prognostic value of each of them.

colorectal cancer (crc) is a common digestive tract tumor 1.it is the third leading cause of death in the world. overall 5-year survival rate is less than 40%, and the occurrence is rising 2. however, the prognosis and therapy have not been significantly improved. therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3. autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.in normal conditions, autophagy is essential for cellular homeostasis 5. autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.among these mechanisms , autophagy appears to be critical 9. eif4ebp1 (eukaryotic translation initiation factor 4e-binding protein 1) is encoded by eif4ebp1 gene.it acts as an effector in mtor (mammilian target of rapamycin) pathway which on activation ,eif4ebp1 is phosphorylated promoting cell proliferation 10. studies have suggested that eif4ebp1 promotes carcinogenesis as in hepatocellular carcinoma .however, its role in crc have not been elucidated 10. long non-coding rnas (lncrnas) are group of rna , 200 nucleotides in length 11,. expression of lncrnas has been discovered in multiple tumors, acting as oncogenes. 'hoxa(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (hottip) has received attention lately.it is up-regulated in crc tissue, regulating genes via epigenetic modification. therefore, it might be a candidate for cancerization and therapy of crc 12. expression of lncrnas could be affected by single nucleotide polymorphisms (snps), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on hottip that alters its expression level 14.. also, it was recently reported that hottip enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15.

Eligibility criteria:
inclusion criteria: * no sex predilection. * age (25-65 yr). * colorectal carcinoma confirmed by histopathological examination exclusion criteria: * -patients who received any treatment. * cases with other organ cancers. * history of chemotherapy and radiotherapy. * systemic diseases such as renal failure, diabetes mellitus, and hypertension.

Keywords: colorectal cancer, hottip
the impact of severe vitamin d deficiency and its correction on bone mineral density (bmd) in postmenopausal women

Conditions: Vitamin D Deficiency

Summary: it is well known that postmenopausal women are at risk for osteoporosis. the study hypothesis is that vitamin d deficiency (≤17.5nmol/l) is frequently associated with osteomalacia and will cause low bmd estimation in dxa scan due to insufficient bone mineralization. we assume that among these postmenopausal women, vitamin d treatment will improve bone mineralization and will cause a rapid increase in bmd. according to the results, bisphosphonates therapy may be an unnecessary treatment. the objective of this study is to evaluate the impact of severe vitamin d deficiency and its correction on bone mineral density (bmd) in postmenopausal women.


Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. female age 55-70 3. at least 2 years past menopause 4. 25(oh)d≤ 17.5nmol/l (≤7 ng/ml) exclusion criteria: 1. vitamin d levels \> 30nmol/l in the past 2 years 2. creatinine \> 1.2%mg 3. calcium ≥ 10.2mg/dl 4. current or previous vitamin d treatment over 2 weeks 5. previous vitamin d treatment over 2 months in the past 2 years 6. bmi\>35 or bmi\<20 7. menopause before age 45 8. type 1 diabetes 9. concomitant disease: 1. mal-absorptive diseases (cystic fibrosis, crohn's, gastric bypass surgery, celiac disease) 2. rheumatoid arthritis 3. nephrotic syndrome 4. chronic renal failure 5. primary hyperparathyroidism 6. hyperthyroidism 7. malignancies excluding skin cancers (within the last 5 years) 8. kidney stones or history of renal colic 10. medications: 9. steroids use (past or present) 10. anti rejection drugs in the last 5 years 11. anticonvulsant (carbamezapine, hydantoin, phenobarbital etc) in the last 5 years 12. any anti osteoporotic medication: prolia, bisphosphonates, teriperatide, evista, protelos, (past or present) 13. post menopausal hrt (in the last 10 years) 14. aromatase inhibitors: femara, arimadex (past or present) 15. current use of ppis (lanton, controloc, zoton, omepradex etc) 16. current or past use of anti depressant ssri (favoxil,cipralex etc)
point-of-care chemistry test (poct) effect on the emergency department (ed)

Conditions: Emergency Department; Length of Stay; Turnaround-time

Summary: the hypothesis of this study is that poct will shorten ed turn-around-time (tat) such as blood drawing tat, lab tat, and decision tat.


Eligibility criteria:
inclusion criteria: * patients older than 15 years * clinically required to have chemistry lab tests * agreement exclusion criteria: * no agreement * esi level 1
control of trichomoniasis

Conditions: Trichomoniasis

Summary: this study is designed to try to find the best method of partner notification and treatment for partners of women with trichomonas

to carry out a randomized trial to compare the effectiveness of three methods of partner notification and treatment for sexual partners of women with vaginal trichomoniasis - patient self-referral of partners (the current practice standard), delivery of curative therapy to partners by patients themselves, or public health style disease intervention carried out by a specially trained disease intervention specialists (dis) locating the partners and delivering the medication in the field. reinfection rates with trichomonas at three months of follow-up among the index women will be the measure of effectiveness.

Eligibility criteria:
inclusion criteria: inclusion criteria {for women}: age {\> 15 years} culture or wet prep proven t. vaginalis infection willingness to provide informed consent and take part in study procedures - exclusion criteria: * exclusion criteria: infection with other std pathogens requiring health dept dis intervention (syphilis or hiv) pregnancy or currently breast feeding recent (8 hours) ingestion of alcoholic beverages or intent to do so in the 24 hours following treatment allergy to metronidazole the presence of a sexual partner in the clinic at the time of enrollment a history of referral by a partner already treated for trichomoniasis report of more than four sexual partners in the preceding 30 days

Keywords: trichomoniasis partner notification
novel approaches in linkage analysis for complex traits

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to develop new statistical methods to explore genetic mechanisms that contribute to the development of hypertension.

background: hypertension affects 50 million americans and is the single greatest risk factor contributing to diseases of the brain, heart, and kidneys. there is a strong evidence that hypertension has a genetic basis. the study will develop novel approaches to better understand the genetic mechanisms contributing to measures of blood pressure (bp) level, diagnostic category (hypertension versus normotension) and correlated traits. design narrative: this genetic epidemiology study will develop novel approaches to better understand the genetic mechanisms contributing to measures of blood pressure (bp) level, diagnostic category (hypertension versus normotension) and correlated traits. the first aim is to localize genes influencing measures of blood pressure levels, diagnostic category and their correlates. this will be done by applying genome-wide multivariate linkage analyses based on the variance components approach and utilizing clusters of traits correlated with measures of blood pressure and/or diagnostics category. the second aim is to develop exploratory diagnostic tools for linkage analysis of complex traits to further enhance our ability to localize genes influencing measures of blood pressure, diagnostic category and their correlates. this will be done by extending the diagnostic tools used in regression analysis to the variance components approach used for linkage analysis of quantitative traits. in this study for example, it can be used to identify outlier families since previous studies have shown that families with outlier values yield false-positive results. tree-structure models will also be extended to pedigree data. tree-based modeling is an exploratory technique for uncovering structure in the data. the use of tree-structure models is advantageous because no assumptions are necessary to explore the data structure or to derive parsimonious model. these models are accurate classifiers (binary outcome) and predictors (quantitative outcomes). all these tools will be incorporated in the s-plus software as a function. s-plus was selected due to its capability and flexibility for analyzing large data sets.

Eligibility criteria:
no eligibility criteria