Kornimate/medical-research-clean huggingface dataset:
diverting ileostomy and anal functional outcomes after anus preservation surgery

Conditions: Diverting Ileostomy; Middle and Low Rectal Cancer; Functional Outcome; Stoma Complications

Summary: analyze the occurrence of complications, rectal function and quality of life after anus-preserving surgery for middle and low rectal cancer, so as to evaluate the role of protective ileostomy.


Eligibility criteria:
inclusion criteria: necessary conditions: meet one of the following conditions 1. difficult pelvis: narrow pelvis (diameter of ischial tuberosity \<10 cm, diameter of ischial spine \<12 cm) 13 or bmi≥30kg/m2 or tumor diameter≥5cm2. 2. to receive treatment before surgery: preoperative neoadjuvant radiotherapy or concurrent chemoradiation or esd 3. the anastomosis is below the level of the levator ani muscle: such as isr, tatme surgery, etc. other conditions: 1. age: 18 to 75 years old, male or female; 2. preoperative biopsy pathological diagnosis of rectal adenocarcinoma; 3. received mri evaluation before surgery, and the distance between the lower edge of the tumor and the anal edge is no more than 10cm; 4. the clinical stage is t1-3n0-2m0; 5. undertake elective laparoscopic tme for colon-rectal or colon-anal anastomosis 6. ecog score 0-2; 7. heart, lung, liver, and kidney functions can tolerate surgery; 8. patients and their families can understand and are willing to participate in this clinical study, and sign informed consent. exclusion criteria: 1. past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors; 2. patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; 3. neighboring organs need to be combined with organ removal 4. asa grade ≥ grade iv and/or ecog physical status score\> 2 points; 5. those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery; 6. have a history of severe mental illness; 7. pregnant or lactating women; 8. those with a history of taking hormone drugs; 9. patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.
mechanisms regulating wound vascularization

Conditions: Wounds and Injuries

Summary: this pilot study is designed to assess the impact of ischemia/ diminished wound vascularization and stress on wound healing by comparing patterns of gene expression in specific cell types critical to wound healing biology, e.g. macrophages or endothelial cells.

chronic wounds affect approximately 2% of the u.s. population at any given time. animal models can not simulate the complex set of pre-existing conditions in each individual that results in failed wound healing. therefore, human subjects must be used to obtain valid data. adequate wound vascularization that permits blood vessels to deliver oxygen to the wound is a requirement for wound healing to occur. this protocol will attempt to gain greater understanding of the mechanisms of chronic wounds through 3 specific aims: 1) identify the angiogenic mechanisms in wound site macrophages, which are required for healing, 2) determine the impact of stress and glucocorticoid resistance on endothelial cell and macrophage biology and ultimately wound healing outcomes, 3) identify patterns of gene expression in wound endothelial cells that are found in healing versus non-healing wounds. this data will be correlated with the wound oxygenation status to determine the impact of wound vascularization on the observed biological responses.

Eligibility criteria:
inclusion criteria: * age 18-69 years * ischemic wound group * non-ischemic wound group * diabetes with good glycemic control * lower extremity wound exclusion criteria: * age greater ≥ 70 years * end stage renal disease * unable to provide informed consent * pregnant women * therapeutically anticoagulated * prisoners * periwound tcom \< 25mmhg * spinal cord injury * taking immunosuppressive medications * individuals with current diagnosis of a major psychiatric illness (e.g.schizophrenia,psychosis) * severe protein malnutrition- pre-albumin \< 10 mg/dl or albumin \< 2 g/dl * diabetes with poor glucose control-defined as hgb a1c \> 8.4%

Keywords: impact of ischemia impact of stress and identify patterns of gene expression
a db randomized study of r1 and r2 waterjel / aloevera jell in prevention of radiation dermatitis in breast cancer

Conditions: Breast Cancer; Radiation Dermatitis; Erythema

Summary: the purpose of this study is to evaluate the effects of topical r1 and r2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.

all women will be given two types of jell. one should be applied immediately after radiation and the second one, 3 times every day. all women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.all women will be evaluated two weeks after end of radiation period.

Eligibility criteria:
inclusion criteria: 1. woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 gy/fx to a total dose of 50 gy. 2. women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. three weeks is the minimal interval between chemotherapy and start of radiation therapy. 3. patient able to understand the study designed and cooperate with instructions of use. 4. patient able to sign informed consent exclusion criteria: 1. woman with lactose allergy (lactose intolerance are eligible) 2. woman with known connective tissue disorder 3. woman with uncontrolled diabetes 4. patients receiving radiation protocol with 2.64 gy/fx or 1.8 gy/fx 5. woman who is unable to sign an informed consent

Keywords: breast conserving surgery radiation dermatitis
peer interactions and food are substitutable in youth

Conditions: Activity Choices; Caloric Intake; Social Time

Summary: this study examines the effects of increasing the cost of social interactions and food on overweight and non-overweight youth. using a computerized operant task youth will earn points exchangeable for food and social activity. the investigators predict that both overweight and non-overweight children will substitute food for interactions with an unfamiliar peer when this alternative is made expensive. also, the investigators predict that both overweight and lean participants will defend their choice to spend time with a friend even when this alternative is made expensive.


Eligibility criteria:
inclusion criteria: * boys and girls ages 9-11 * children must have a bmi equal to or greater than 15th percentile for their age * children must report at least a moderate liking of the study foods exclusion criteria: * children should not have any food allergies * children should not have any dietary restraint * children should not a cold or upper respiratory distress * children should not have any psychopathology * children should not have any developmental disabilities * children should not be taking any medications that could influence their sense of smell and taste and activity level

Keywords: food reinforcement social reinforcers overweight children
social emotional development in young children with cancer

Conditions: Solid Tumor, Childhood; Brain Tumor, Pediatric

Summary: many children with cancer are diagnosed in early childhood, and as such, will likely miss key social experiences such as participation in preschool or kindergarten, playing on playgrounds, and other normative experiences. in typically-developing children, it is known that these experiences - and the skills that are learned during them - are critical to later well-being. very little is known about the psychological functioning of young children with cancer, as studies have predominantly focused on those who are older (at least 8 years of age). this study will explicitly assess social functioning in preschool-aged children with cancer and follow the development of their social functioning from the end of treatment into survivorship. the goals of this pilot study are to begin to assess the impact of missed early childhood social experiences, as well as the interaction with developing neurocognitive problems. primary objective: explore the impact of cancer in the central nervous system on social functioning of young children (ages 4-6) after completion of therapy.

participants will be evaluated using the same or similar questionnaires at two time points. the first assessment will take place when they are 6-12 months post the end of treatment. participants and their parents/legal guardian will complete an assessment of social and cognitive functioning by completing questionnaires about social, emotional, behavioral, and executive functioning. if the study participant agrees, they will identify another adult (that is, teacher or daycare employee) who may be contacted to complete questionnaires about the participant's social and behavioral functioning. a follow-up study visit will occur about two years later.

Eligibility criteria:
inclusion criteria: * primary diagnosis of a brain or non-cns solid tumor * between 4 and 6 years of age at enrollment * between 6 and 12 months post-therapy at the time of enrollment * treatment plan included chemotherapy * english speaking * cognitive and language capacity to complete measures exclusion criteria: * diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., autism, neurofibromatosis type 1 (nf1), down syndrome) * solid tumor patients who required cns-directed therapy (e.g., radiation, intrathecal chemotherapy) * inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Keywords: childhood cancer social functioning social development
comparative study of 22 and 25 gauge procore eus-guided biopsy in pancreatic mass

Conditions: Pancreatic Neoplasms

Summary: background: eus-guided fine needle aspiration (fna) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. however fna with small needle has sometimes failed in acquisition of tissue due to small caliber. to overcome this limitation, newly designed procore needle was developed and flexible 22 and 25 gauge procore needles were frequently used. however there was no comparative study of the efficacy and accuracy between 22 and 25 gauge procore needle yet. aim: to compare the efficacy and accuracy of eus-guided fna between 22 and 25 gauge procore needle. (the investigators hypothesized that the accuracy of 25 gauge procore needle is not inferior to 22 gauge procore needle.)

patient and methods: patients who have pancreatic or peripancreatic mass in imaging studies which need pathologic confirm. these patients were randomly assigned to 22 gauge or 25 gauge group. procedure: they underwent eus-guided fna, 3 times with 10 times of to-and pro movement each. the number of patients required: we used confidence intervals (cis) with a prespecified non-inferiority margin of 10% for the non-inferiority analysis. we concluded non-inferiority of pc25 to pc22 if the lower limit of the 95% ci for the difference (pc25-pc22) was not lower than -10%. it was assumed that the diagnostic accuracy of one pass was 75% and that of three cumulative passes was estimated to be 98.4% in pc22. based on these assumptions, the calculated sample size was 216 samples with power of 80% and significance level of 5%.

Eligibility criteria:
inclusion criteria: * patients who agree to participate in research * 18 years of age and older patients * patients who have pancreatic or peripancreatic mass in imaging studies exclusion criteria: * contraindication to endoscopy * patients younger than 18 years old * bleeding tendency * cardiopulmonary dysfunction

Keywords: procore fna biopsy
unified protocol for children: a randomized controlled trial for the portuguese population

Conditions: Anxiety Disorders; Mood Disorders; Emotional Disorder; Emotional; Disorder, Childhood, With Anxiety and Fearfulness; Child Mental Disorder; Parenting

Summary: the unified protocol for transdiagnostic treatment of emotional disorders in children (up-c) is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotion disorders (i.e., anxious and/or mood disorders) and their parents. up-c consists of 15 weekly group sessions and unifies cognitive-behavioral, contextual (e.g., mindfulness) and parental training techniques, for parents and children, aimed at reducing the intensity and frequency of strong and aversive emotional experiences in children and their clinical symptomatology. the present study aims to assess the feasibility, acceptability and efficacy of the up-c in the portuguese population in reducing children's anxiety/depression symptoms. it also aims to investigate which mechanisms explain the therapeutic change. participants will be recruited at child mental health services and schools from central portugal and also through online dissemination of the study. a randomized controlled trial (rct) will be conducted in a sample of children aged 6-13 years old with emotional disorders and their parents in order to answer the critical question of whether the up-c is more efficacious in reducing children's symptomatology than a psychoeducational group intervention (active control group). once the eligibility criteria are met (assessed by the project researchers) parents and children will be randomly assigned to one of two study conditions: 1. experimental group (i.e., children and parents who benefit from the up-c program). 2. control group (i.e., children who benefit from a psychoeducational intervention program, named "abc of emotions"). parents and children from both groups will complete several psychometrically robust and developmentally appropriate measures at baseline (t0), mid-treatment (only at week 7 of the up-c; t1), post treatment (t2) and at 3 months follow-up (t3).


Eligibility criteria:
inclusion criteria: * children aged 6-13 * primary diagnosis of an anxiety and/or depression disorder * speaking, reading and understanding portuguese exclusion criteria: * diagnosis of a psychotic disorder, bipolar disorder or intellectual disability; * severe current suicidal/homicidal ideation; * the child is not on a stable dose of a psychotropic or other type of medication for at least 1 month prior to t0 assessment.

Keywords: emotional disorders anxiety and mood disorders children parenting transdiagnostic unified protocol randomized controlled trial
a pilot study of cognitive behavioral therapy - insomnia (cbt-i) among professional firefighters

Conditions: Insomnia; Shift-Work Related Sleep Disturbance

Summary: the primary aim of this study is to investigate the feasibility, acceptability, and preliminary efficacy of an adapted cognitive behavioral therapy - insomnia (cbt-i) intervention in improving sleep in a firefighter population.

after being informed about the study and potential risks, participants will be randomized to the intervention group (group to receive cbt-i) or the no-intervention control group. all participants in the study will complete three assessment visits; one prior to the start of the intervention, one immediately following the 6-week intervention, and one 3-months post-intervention. the intervention group will engage in 6-weeks of cbt-i training aimed at targeting sleep and sleep-related concerns faced as a result of occupational considerations.

Eligibility criteria:
inclusion criteria: * english-speaking * full-time professional firefighter * at least 18 years of age * a global pittsburgh sleep quality index score ≥ 5 (grandner et al., 2006) * be willing and able to participate in all study activities including pre-, post-, and 3-month follow up assessments and 6-weeks of the cbt-i intervention * agree to random assignment to one of two conditions (treatment or control group) * have access to an email account * be willing to wear the fitbit inspire hr device throughout the duration of the intervention and for two weeks following completion of the 6-week intervention exclusion criteria: * endorsement of prior involvement in formal cbt-i interventions * unwillingness to give written informed consent

Keywords: sleep firefighter cbt-i
influence of physostigmine on patient-controlled analgesia (pca) in postoperative intensive care patients

Conditions: Pain

Summary: the study is to evaluate the influence of physostigmine in the postoperative period in intensive care patients considering pain quality, opioid consumption, hemodynamics and mobilisation.

pain management is of major concern in the postoperative period, mostly based on opioids. in numerous experimental and clinical trials cholinergic mechanisms have been demonstrated to play an important antinociceptive role. physostigmine, a central cholineresterase inhibitor, has been shown to produce analgesia and enhance opiate analgesia after systemic injection. this action is not based on µ-receptor (opioid) activity, but can be mostly explained by stimulation of serotonine (5-ht-3) receptors. the major withdrawal of utilizating physostigmine in postoperative care, is due to its short duration of action. in the present study, we examined the effect of a continuous intavenous physostigmine application during a patient-controlled analgesia with piritramide for 48 hours compared to a placebo infusion with nacl. major concern was set for consumption of analgesics, vas-pain scale, hemodynamics, mobilisation and side effects.

Eligibility criteria:
inclusion criteria: * age 18-80 years * indication for postoperative pain therapy and admission to icu * asa i-iii * weight 50-125 kg * patients that are willing to participate in the present study exclusion criteria: * peridural anesthesia for pain management * severe left ventricular function (ef \<30%) * severe/exacerbated copd; asthma * asa iv-v * chronic renal insufficiency(creatinine \> 1,5 mg/dl) * ulcera ventriculi * known allergy to any of the study agents * hb preoperative \<9,5 g/dl * alcohol,drug and/or tablet abuse (opioids, nsar) * emergency operation * pregnancy * women of childbearing age and without a negative pregnancy test * severe liver disease (got oder gpt \> 45 u/l) * severe neurologica derangements (e.g. m. parkinson, multiple sklerosis) * history of apoplexia \<6 monate or residua * perioperative myocardial infarction * patients that are not able to agree to the present study * patients that refuse to participate in the present study * patients that are part of any other study

Keywords: physostigmine postoperative analgesia pain patient-controlled analgesia opioid consumption pain quality (vas score) hemodynamics mobilisation side effects
study of effects of low level laser therapy in the physical training and the muscle responses in humans.

Conditions: Healthy Young Male Volunteers; Non Athletes; Free of Metabolic Disease; Joint, Bone and Muscles of Lower Limbs Free of Any Disease

Summary: the hypothesis of this study is that a chronic program of physical strength training, associates to effects of low level laser therapy (lllt) can, possibly, provide changes in genic expression of muscle and to promote an enhancement of anaerobic muscle performance in humans.


Eligibility criteria:
inclusion criteria: * healthy young male volunteers; * non-athletic physical activity; * body mass index (bmi) under 26; * no prescription medicine or dietary supplement use (such as muscle mass builders. exclusion criteria: * metabolic disease; * joint, bone and muscles of lower limbs with any disease
sas115359: a 6-month study to assess the safety and benefit of inhaled fluticasone propionate/salmeterol combination compared with inhaled fluticasone propionate in the treatment of adolescents and adults (12 years of age and older) with asthma.

Conditions: Asthma

Summary: the purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone. advair™ and flovent™ are trademarks of the glaxosmithkline group of companies.

progress of enrollment, updated annually: this study has been completed and the final clinical study report was submitted to the fda in january of 2016. this is the final update, as this study is complete.

Eligibility criteria:
inclusion criteria: * provided consent to participate in the study * male or female, 12 years of age and older * clinical diagnosis of asthma for at least 1 year prior to the randomization * clinic pef of greater than or equal to 50% of predicted normal value * subject must be appropriately using one of the treatments for asthma listed in the protocol * subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a diskus inhaler * subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization: * requiring treatment with systemic corticosteroids * an asthma-related hospitalization exclusion criteria: * history of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support * concurrent respiratory disease other than asthma * current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. * exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine * presence of a bacterial or viral respiratory infection that is not resolved at randomization * an asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization * more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization * subject must not meet unstable asthma severity criteria as listed in the protocol * potent cytochrome p450 3a4 (cyp3a4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole) * pregnancy, breast-feeding or planned pregnancy during the study * a child in care (cic) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Keywords: advair asthma safety flovent
study of enzastaurin versus placebo with pemetrexed for participants with advanced or metastatic lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * laboratory confirmed diagnosis of nsclc with locally advanced or metastatic disease which cannot be cured. * participants must have disease which progressed after 1 prior systemic cytotoxic chemotherapy regimen for advanced disease. * at least 1 measurable lesion. * must have stopped all previous systemic therapies for cancer for at least 2 weeks prior to enrollment. * must be able to follow study guidelines and be able to show up for appointments. exclusion criteria: * treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * previous treatment with enzastaurin or pemetrexed. * concurrent administration of any other antitumor therapy. * inability to swallow tablets. * pregnant or breastfeeding.