Kornimate/medical-research-clean huggingface dataset:
the effect of early enteral nutrition feeding process assisted by gastrointestinal ultrasonography

Conditions: Critical Illness; Acute Gastrointestinal Injury

Summary: in critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（en）. acute gastrointestinal injury(agi) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. in our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis agi. thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.

patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. during the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators

Eligibility criteria:
inclusion criteria: * the age is not less than 18 years * within 24 hours after entering icu * acute physiology and chronic health evaluation ii (apache ii) score \> 8 * the estimated length of stay in icu is more than 3 days * informed consent exclusion criteria: * the normal anatomy of stomach, small intestine or the right colon was significantly changed (gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.) * uncontrolled gastrointestinal bleeding * uncontrolled intestinal obstruction * uncontrolled mesenteric vascular disease * pregnancy * breastfeeding * received enteral nutrition or parenteral nutrition within 24 hours prior to icu admission * predict death within 48 hours after icu admission * enrolled in this study before.
nac followed by rh for the treatment of lacc

Conditions: Neoadjuvant Chemotherapy; Locally Advanced Cervical Cancer; Radical Hysterectomy; Objective Response; Laparoscopy; Laparotomy; Concurrent Chemoradiotherapy; Adjuvant Therapy; Systematic Chemotherapy

Summary: this cohort study is to evaluate the role of neoadjuvant chemotherapy (nac) in the treatment of locally advanced cervical cancer (lacc). sixty patients with lacc (figo 2009 stage ib2 to iib) will be enrolled. after informed consents, they would accept the imaging evaluation of pelvic magnetic resonance imaging (mri) and positron emission tomography (pet). after excluding cases of distant metastasis, they will accept two cycles of nac (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks). then a second mri is performed to evaluate the imaging response. for patients achieving objective response, radical hysterectomy (rh, via laparoscopy or laparotomy) and an evaluation of pathologic response are performed. for patients without objective imaging response, the choice of concurrent chemoradiotherapy or radical hysterectomy will be discussed. after rh, adjuvant therapy will be given according to the rh pathologic results. the primary objectives consist of (1) the objective imaging response after nac; (2) the objective pathologic response after rh. the secondary objectives consist of (1) disease-free survival and overall survival after various therapy modalities; (2) severe adverse effects of nac; (3) the effects of nac on the surgical outcomes.


Eligibility criteria:
inclusion criteria: * confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * figo stage ib2 to iib * type ii or iii radical hysterectomy or trachelectomy * performance status of eastern cooperative oncology group (ecog) 0-1 * aged 18 years to 45 years * well cardiopulmonary, liver and kidney functions for neoadjuvant chemotherapy * signed an approved informed consents exclusion criteria: * not satisfying any of the inclusion criteria
pregabalin is an effective treatment for acute postoperative pain following spinal surgery without major side effects

Conditions: Postoperative Pain; Pregabalin; Spine Surgery; Adverse Reaction to Pregabalin

Summary: the objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.

patients experience considerable postoperative pain after spine surgery. because the spine is located at the center of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications such as pulmonary deterioration or pressure sores. it is important to effectively control postoperative pain to prevent such complications. gabanoids are widely used as preemptive multimodal analgesia while their effects and side effects are known to be dose dependent. the objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.

Eligibility criteria:
inclusion criteria: * adult patient undergoing spine surgery at out institution for degenerative lumbar disorder. exclusion criteria: * asa classification over 2 * patients with dizziness or frequent headache * active alcohol or drug usage * intake of any analgesics daily or 48 hours before surgery * impaired renal and/or hepatic function * diagnosed and being treated for anxiety or depression disorders * coverage from worker's compensation insurance or car insurance.

Keywords: postoperative pain pregabalin spine surgery adverse reaction to pregabalin
targeting school feeding programs at vulnerable sub-groups

Conditions: Malnutrition; Cognition

Summary: school feeding programs provide students meals conditional on school attendance, which can have impacts on school participation, cognition and learning, and nutritional outcomes. although the literature on impacts of school feeding programs is substantial, high quality studies with evaluation designs that provide causal impact estimates are relatively few. thus program impacts on educational, cognitive and nutritional outcomes are not well-understood, particularly in a field setting. nutritional impacts in particular are questionable, which may be a result program design. most studies provide only small transfers to children and examine average macro-nutrient effects of the transfer on the treated children, thus it is not surprising that detection of nutritional gains has been minimal. this study is a cluster-randomized evaluation of a school feeding program administered by the world food programme in the northern ugandan districts of lira and pader. the program provides substantially larger food rations than most programs (representing 1/3 of children's daily caloric needs and 99% of iron intake requirements). the key research objectives are: 1. impact on the treated: assess the effectiveness of the program at improving nutritional status, education and cognitive and learning outcomes for school-age children, with particular attention to the anemia status of older school-age girls . 2. impact on untreated but nutritionally vulnerable sub-groups: assess the effectiveness of the program at reducing anemia prevalence in mothers and younger siblings. 3. optimal program design: assess the differential impacts of a program in which children are fed at school compared with one in which they are given dry rations to bring home.


Eligibility criteria:
inclusion criteria: * school age children exclusion criteria: -

Keywords: malnutrition school feeding infant nutrition mother's nutrition fortified food anemia cluster randomized controlled trials effectiveness impact evaluation studies uganda
investigating the equivalence of the eortc qlq-c30 and the qlq-f17

Conditions: Cancer; Quality of Life

Summary: the eortc qlq-c30, a patient-reported outcome measure (prom) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. the qlq-c30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items. researchers and regulatory bodies came up with the idea to construct a shortened eortc questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation. this shortened form termed qlq-f17 includes the physical functioning (pf), role functioning (rf), emotional functioning (ef), cognitive functioning (cf), and social functioning (sf) scales as well as the global health status/quality of life (ql) scale in their original wording. this functioning questionnaire can be amended with symptom-specific items taken from the eortc item library. this method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia. it is an open question, however, whether the qlq-f17 is equivalent to the qlq-c30 in terms of measurement properties. based on empirical research on response biases and order effects, one might argue that elimination of the symptoms between rf and cf-dyspnea (dy), pain (pa), fatigue (fa), insomnia (sl), appetite (ap), nausea/vomiting (nv), constipation (co), and diarrhea (di)-and of the financial difficulties (fi) item between sf and ql may alter the manner in which subsequent items are completed. thus, from a methodological point of view, it is essential to confirm the psychometric properties of the qlq-f17 and to present evidence that scale values derived from the qlq-f17 are equivalent to those of the qlq-c30. only in the case of equivalence may studies using either of the two basic questionnaires be compared directly. the present project is designed to address this research question. this is an international multicenter survey study that will include respondents with cancer from australia, finland, france, germany, italy, poland, romania, spain, sweden, and united kingdom. a randomized cross-over design will be applied, enabling between-patients as well as within-patients comparisons of the qlq-c30 and the qlq-f17. one group of respondents will first fill in the qlq-c30 followed by the qlq-f17, the other group will start with the qlq-f17 followed by the qlq-c30. a sample size of 1.500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement. thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group. reliability and psychometric properties can also be precisely estimated with a sample of this size. the present study is based on the hypothesis that the qlq-f17 and the qlq-c30 questionnaires are equivalent.


Eligibility criteria:
inclusion criteria: patients suffering from cancer or in remission exclusion criteria: none
validation of the genetic signature 354849 as a prognostic method

Conditions: Cervix Cancer

Summary: this prospective study is focused on the validation of the genetic signature of 27 genes as a predictor of the response to concomitant chemotherapy treatment followed by brachytherapy in patients with locally advanced cervical cancer. the genes included are: znf238; sap30; c10orf137; uhrf1; suz12; hmgn4; rbbp4; ppp1cb; slfn11; flj39378; endogl1; recql; trpc1; trio; dnah6; gnl3l; slc36a2; srp9; rpe; ldoc1l; pus7l; ccdc89; loc644921; plekhg1; fam111b; rprd2 y etaa16.

there are several studies of genes or genetic signatures associated with the response to treatment in cervical cancer, but so far it has not been possible to standardize the use of any biomarker or biomarker signature as a predictor of the response to treatment with reproducible results. therefore, there is still a need to develop an effective method to predict the response to chemo-radiotherapy in locally advanced cervical cancer. this prospective study included 189 patients with cervical cancer clinical stages ib2-iva, without previous treatment. tumor samples will be obtained at the confirmatory diagnostic biopsy. all samples will be processed by the pathology laboratory as usual. the rna will be extracted from the paraffin blocks with the rneasy ffpe kit (qiagen) according to the manufacturer's recommendations. the rna will be stored at -20°c until use. quantitative pcr (qpcr) will be performed with the kit high-capacity cdna reverse transcription kit (thermo fisher scientific). primers for the 27 genes will be developed. the relative expression will be calculated using the 2- δδct method, using the expression of β-actin as a normalizing gene. in order to obtain the prognostic score, the score assigned by the classifier for the sample will be calculated from the 2-δδct values obtained for each gene. this will be done by a computer-readable medium containing the type expression profiles related to a good and a bad response to the standard treatment.

Eligibility criteria:
inclusion criteria: * women over 18 years old * cervical cancer at ib2-iva figo´s clinical stages * histology: squamous, adenosquamous or adenocarcinoma * no previous treatment * no distance metastases, discard by pet/ct * functional state ecog (eastern cooperative oncology group) 0-2 * candidates to receive standard chemoradiotherapy treatment followed by brachytherapy exclusion criteria: * previous chemotherapeutic, surgical and/or radiotherapy treatment for female reproductive tract pathologies * previous invasive neoplasia (except non-melanoma skin cancer) unless there is complete remission of the disease of 3 years minimum. * previous systemic chemotherapy for the current cervical cancer.

Keywords: genetic signature treatment response
spectroscopy for diagnostic assessment of oral mucosal lesions

Conditions: Oral Cancer

Summary: the goal of this clinical research study is to test a new way to look for cancer and pre-cancerous tissue changes inside the mouth.

abnormal-looking areas (lesions) inside the mouth may be a sign of cancer or changes that may lead to cancer. these lesions may need to be removed. researchers are looking for a practical way to tell early on whether these lesions are cancer or may become cancer. this study will test a technique called fluorescence spectroscopy, which is under research in this study. each patient may have 1 to 5 lesions and several normal-looking areas inside the mouth exposed to a beam of light. the exposed tissues may emit very small amounts of light called fluorescence. this light is not seen by the eye but is detected by a computer. the small areas exposed to the light beam may then be removed. the patients who need surgery may have the small tested areas removed when the lesions are surgically removed. a small sample from a normal-looking area may also be removed during surgery. patients who do not need surgery may simply have small samples taken from the lesions and a normal-looking area in the clinic rather than in the operating room. the tissues will be looked at under a microscope to see whether they are cancerous. these results will be compared with the spectroscopy results. if you are scheduled to participate in another md anderson study, protocol 2008-0137 entitled, "phase ib study of erlotinib prior to surgery in patients with head and neck cancer" (study chair: dr. william william), some of your collected tissue samples may be shared with dr. william for use on 2008-0137. this is an investigational study. about 395 patients will be consented and screened for this study, with about 381 to take full part in this study. all will be treated at md anderson.

Eligibility criteria:
inclusion criteria: 1. any person 18 years of age or older with a lesion of the oral mucosa. persons with changes in existing lesions or those who develop new lesions can be re-evaluated, but it is not required. exclusion criteria: na

Keywords: oral mucosa lesions oral cancer neoplasia and dysplasia in oral cavity mucosa fluorescence spectroscopy reflectance spectroscopy pre-cancerous lesions cancerous lesions mouth
does tourniquet use in total knee replacement improve fixation

Conditions: Osteoarthritis, Knee

Summary: although a tourniquet may reduce bleeding during total knee replacement (tka), and thereby improve fixation, it might also cause complications. migration as measured by radiostereometric analysis (rsa) can predict future loosening. we will investigate if the use of a tourniquet influences fixation measured with rsa.

the use of a tourniquet during total knee replacement (tka) is a generally accepted routine at many departments. it is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration. we investigate in a rct 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not. primary outcome is mtpm, a meassure of migration(loosening) of the kneeprosthesis. secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (koos) total follow up time 2 years

Eligibility criteria:
inclusion criteria: * primary or secondary osteoarthritis without other severe disease (asa 1-2). exclusion criteria: * were inability to give informed consent, * rheumatic arthritis, * malignancy, * coagulation disorder or medical treatment influencing the coagulation, * liver disease, * severe heart disease or bilateral operation.

Keywords: total knee tourniquet blood loss pain range of motion
effects of walking apnea at high lung volume on hypoalgesia, cardiovascular function and respiratory function

Conditions: Pain; Hypoxia; Hypercapnia; Apnea

Summary: the aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria:
inclusion criteria: - asymptomatic subjects aged between 18 and 64 years. exclusion criteria: * cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies. * history of epilepsy. * pregnant * pharmacological treatment. * participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
the hypotensive effect of metformin in hypertensive patients.

Conditions: Hypertension

Summary: the proposed study is to evaluate the possible effect of metformin on arterial pressure by 24h-ambulatory blood pressure monitory (24h-abpm).

the primary outcome was the difference in mean 24-hour blood pressure variation between the two groups after the intervention. the difference in mean of blood pressure during daytime and nighttime in 24h ambulatory blood pressure monitory, as well as the office bp and laboratory differences were considered secondary outcomes. this randomized, double-blind parallel study was conducted in the hypertension clinic of the department of cardiology, hospital de clínicas de porto alegre (porto alegre, brazil). we selected hypertensive individuals (controlled or not) without diabetes aged 18-70 years. exclusion criteria: metformin intolerance, creatinine \> 1,5 mg/dl risks: adverse effects related to metformin use, mainly diarrhea and nausea benefits: possible lower effect on arterial pressure statistical analysis: sample size was calculated on the basis of a standard deviation of 8 mm hg and effect size of 5 mm hg in 24-h systolic abpm and a two-sided significance level of 5%. a sample size of 42 patients per group was estimated to provide a power of 80% to reject the null hypothesis. considering possible 10% of losses, the final calculated sample was 92 patients. the baseline comparison between groups was performed using the student t test for continuous variables and x2 for categorical variables. in each group, the change in bp by abpm -24 h, daytime and nighttime, and laboratory tests was calculated by subtracting baseline values measured after the intervention period. the difference between groups was calculated by subtracting the variation observed between them (δ-values). the differences in bp variation and laboratory tests were analyzed by analysis of variance for repeated measures (manova). for differences in pressure variation adjustment was considered for the baseline bp values (analysis of covariance). all tests were two-tailed and significance level was 5%. data were analyzed using statistical package for the social sciences (spss) version 13.0.

Eligibility criteria:
inclusion criteria: * hypertensive patients, * aged 18-75 years exclusion criteria: * diabetes * metformin intolerance * creatinine level above 1.5 mg/dl

Keywords: hypertension metformin ambulatory blood pressure monitor
effects of legumes consumption on weight reduction

Conditions: Obese

Summary: this is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.


Eligibility criteria:
inclusion criteria: 1. male and female volunteers between the ages of 20 to 70 years 2. body mass index (bmi) of 25 kg/m2 or higher (based on asia-pacific guideline) 3. volunteers who have agreed to participate in the study and provided a written content by him/herself exclusion criteria: 1. those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease 2. those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).

Keywords: legumes obesity body weight adiponectin 8-epi-pgf2α insulin resistance
bioequivalence study of two treatments for the treatment of plaque psoriasis

Conditions: Plaque Psoriasis

Summary: to compare the safety and efficacy of padagis' product to an fda approved product for the treatment of plaque psoriasis


Eligibility criteria:
inclusion criteria: 1. signed irb approved written informed consent/assent 2. 12 to 75 years of age, inclusive. 3. subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis. 4. baseline investigator's global assessment score of 3 (moderate). 5. subjects must have a body surface area (bsa) between 2% to 20% 6. females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at visit 1/day1(baseline), must be willing to use an acceptable form of birth control during the study. exclusion criteria: 1. pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. 2. current diagnosis of unstable forms of psoriasis in the treatment area. 3. history of unresponsiveness to topical treatment for psoriasis 4. presence of any other skin condition that, in the investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations 5. any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments 6. use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study 7. subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. 8. subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study