Kornimate/medical-research-clean huggingface dataset:
neoadjuvant folfox chemotherapy for patients with locally advanced colon cancer

Conditions: Colon Cancer

Summary: the main cause of recurrence after surgical treatment of colon cancer is distant metastasis. neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. this randomized multicenter phase iii trial is assessing whether preoperative chemotherapy improves oncologic outcomes of patients with locally advanced colon cancer.


Eligibility criteria:
inclusion criteria: * pathologically confirmed colon adenocarcinoma (\> 15 cm from the anal verge) * radiologic t3/t4 and high risk features by ct scan * no metastasis on ct or pet(positron emission computed tomography) * age ≥ 18 and ≤ 70 years * ecog (eastern cooperative oncology group) performance status 0-1 * no history of colorectal cancer within 5 years * no history of chemotherapy * patients with childbearing potential should use effective contraception during the study and the following 6 months * adequate bone marrow function : white blood cell count of 2 x 109/l or more with neutrophils of1.5 x 109/l or more, platelet count of 100 x 109/l or more, hemoglobin of 9 g/dl (5,6 mmol/l) or more * adequate hepatobiliary function : total bilirubin of 0.4 mg/dl or less, asat (aspartate aminotransferase) and alat (alanine aminotransferase) of 2.5 x uln (upper limits of normal) or less, alkaline phosphatase of 1.5 x uln or less * adequate renal function : gfr (glomerular filtration rate) \> 50ml/min by wright or cockcroft formula * signed written informed consent obtained prior to any study specific screening procedures exclusion criteria: * age \> 70 years and \< 18 years * rectal cancer : 15 cm or less from the anal verge * complicated colon cancer (complete obstruction, perforation, bleeding) * metastatic colon cancer * known hypersensitivity reaction to any of the components of study treatments * inflammatory bowel disease * hereditary nonpolyposis colorectal cancerhnpcc, familial adenomatous polyposis * clinically relevant coronary artery disease or history of myocardial infarction in the last 6 months, high risk of uncontrolled arrhythmia * galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * pregnancy or breast-feeding period * serious non-healing wound or bone fracture * medical, geographical, sociological, psychological or legal conditions that would not permit the patient to complete the study or sign informed consent * any significant disease which, in the investigator's opinion, would exclude the patient from the study
safety and efficacy of gsk233705 plus salmeterol compared with 2 active comparators and placebo in subjects with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of gsk233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.

a multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the, safety, tolerability, pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of gsk233705 (20 and 50 mcg twice daily), compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily alone, in subjects with chronic obstructive pulmonary disease

Eligibility criteria:
inclusion criteria: * females of non-childbearing potential or postmenopausal; * history of copd as defined by ats/ers criteria; * moderate copd responsive to ipratropium and salbutamol; * current smoker or ex-smoker. exclusion criteria: * no instable copd; max 1000 mcg inhaled steroids per day; no b-blockers

Keywords: copd plethysmography. muscarinic receptor antagonist anticholinergic
difficult piv placement in the pediatric ed

Conditions: Pediatric ALL

Summary: insertion of peripheral intravenous (piv) lines is one of the most common procedures in the pediatric emergency department (ed). faster placement of piv lines can decrease time to intervention, as well overall time patients spend in the ed. using ultrasound (us) guidance has been shown to increase the rate of first attempt success from around 50% to 78-85% compared to traditional methods of placing pivs. the pediatric ed at dcmc has us-trained nurses who assist in placing pivs in patients with difficult access. per ed shift, there is an average of 4-6 patients that are considered difficult access. however, because of nursing shortages and the general increased patient flow in the dcmc ed, there may not be a us-trained nurse available when a difficult access patient needs to have a piv placed during a shift. this can lead to an increase in waiting time for the patient and delayed care. at the dcmc ed, if the first attempt at placing a piv is not successful, an algorithm for a level of escalation (i.e., which hospital personnel should attempt subsequent placements and maximum number of attempts) is followed. attempt at piv placement for most patients in the ed can be made by a patient care technician, rn, beside nurse, or charge nurse. if the piv placement is not successful after two tries or if the patient has known risk factors that will complicate the piv placement, the piv placement is escalated to more experienced personnel, which includes us-trained nurses. for the purposes of this protocol, we will refer to these patients and personnel as level 2 placements. pediatric emergency medicine (pem) is a clinical subspecialty that focuses on caring for complicated and acutely ill pediatric patients in the emergency department. in partnership with ascension seton dell children's medical center, ut austin's dell medical school pem fellowship is a rigorous program where fellows are offered a broad experience in all facets of pediatric emergency medicine¸ including clinical care, teaching, research, and administration. a cohort of 12 fellows are currently part of the program and could be trained to administer piv via us, being available to place pivs in patients with difficult access when a us-trained nurse is not available. we hypothesize that adding pediatric emergency medicine (pem) fellows to the rotation of personnel who can insert ivs for pediatric patients with difficult access will shorten time to successful peripheral intravenous (piv) placement overall in the dell children's medical center (dcmc) emergency department (ed).


Eligibility criteria:
inclusion criteria: 1. age 0-17 2. patient meets difficult/escalated piv criteria 3. english- or spanish-speaking parent/guardian exclusion criteria: 1. critical illness presentation, such as sepsis. 2. emergent medical situation, such as airway compromise, code, status epileptics, etc.
effect of vibration therapy on hip girdle muscles in healthy people

Conditions: Hip Dislocation

Summary: this clinical trial(prospective, pilot study) is to learn about the effect of whole-body vibration on hip girdle muscles in healthy children as a primary study aiming for a new clinical intervention protocol to prevent hip dislocation in patients with severe cerebral palsy.

design: prospective, pilot study setting: hospital rehabilitation department intervention: participants will be asked to walk and jump with a surface electromyography(emg) attached to their hip girdle muscles. after the participants are positioned(standing) on the platform of whole-body vibration device, the study practitioner will record the semg values from the hip girdle muscles during the vibration applied. the mean values of repeating the same process with different vibrations applications and the values before vibration will be compared by using the spss using the paired "t-test" or wilcoxon signed rank test for comparison between before and after vibration in the same group.

Eligibility criteria:
inclusion criteria: * healthy children (5 to 15 years old) exclusion criteria: * children with cerebral palsy, muscle paralysis, developmental or congenital hip joint abnormalities * children who underwent hip joint surgery
the safety of oka varicella in children prior to solid organ transplantation

Conditions: Organ Transplantation; Immunosuppression

Summary: this study sought to determine the safety of the varicella vaccine pre- and post-transplantation when given to pediatric patients listed for solid organ transplantation. the study assessed the antibody response to a two-dose vaccine regimen and determined the durability of that antibody response at several intervals in the post-transplant period. as a secondary objective, the relationship between antibody titers and different variables were explored


Eligibility criteria:
inclusion criteria: * children \> 9 months of age and adolescents \< 18 years of age. * pediatric transplant candidates who are in any of the following categories: 1. listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a canadian transplant centre 2. not yet officially listed, but are regarded by their physicians as transplant candidates by virtue of their underlying diseases * no clinical history for varicella. * seronegative for antibodies to vzv except infants 9 - 12 months of age who may be seropositive due to maternal antibodies. * informed consent obtained exclusion criteria: * previous immunization with varicella vaccine. * any established immune deficiency (underlying disease or drug induced) or any neoplastic disease * children on any oral and / or intravenous steroids within 3 months prior to immunization. children on inhaled corticosteroids in excess of 800 mcg of beclomethasone dipropionate ( or equivalent ) per day. * any exposure to varicella or herpes zoster in the previous 4 weeks involving household, playmate or hospital contacts. * inability to delay the transplantation for up to 6 weeks following the last varicella immunization. * presence of a person at increased risk for varicella infection in direct and unavoidable proximity with the vaccinees ( e.g. an immunocompromised sibling) * past history of varicella or known positive antibody titer for varicella except infants 9 - 12 months of ages who may be seropositive due to maternal antibodies * known hypersensitivity to any of the components of the vaccine, including neomycin and gelatin * patients whose mothers are known to be seronegative and plan to become pregnant in the subsequent three months * administration of vzig or any other blood products in the previous six weeks (packed red blood cells excepted). * any significant infection and/or fever at the time of vaccination * any patient receiving or planning to receive salicylates in the six weeks after immunization * any patient who has received any live vaccine for 6 weeks or killed vaccine for 2 weeks prior to or after the scheduled varivax™ vaccination.

Keywords: organ transplantation immunosuppression vaccine varicella pediatrics
immune function of colorectal cancer lymph nodes

Conditions: Colorectal Cancer; Lymph Node

Summary: lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. the role of regional draining lymph nodes in the development of colorectal cancer is still unknown. in this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.


Eligibility criteria:
inclusion criteria: * stage i-iii colorectal cancer patients undergoing radical surgery * complete imaging, pathology and genetics multi-omics data available * 18-75 years old exclusion criteria: * patients with preoperative neoadjuvant therapy * patients with incomplete clinical information * patients with other malignant tumors * patients with acute infections or untreated chronic infections
development of early diagnostic techniques and setup of local therapeutic guidelines and standards

Conditions: Healthy

Summary: end-stage renal disease (esrd) is a healthy, social and economic threat worldwide. in the past ten years, the incidence and prevalence of esrd patients have tremendously increased, ranking at the top in the world. the reasons for such high incidence and prevalence are multifactor. early diagnosis and closed monitor of the patients with chronic kidney disease (ckd) may be beneficial, but not confirmed yet.the advising mechanisms for non-doing or withdraw long-term dialysis. all these studies will be performed in a multicentered project. three medical centers in which ckd researches have been conducted for many years will provide a large cohort and share the data collected from their own hospitals. we expect that the results will provide an excellent guideline for ckd care, achieve cost-effectiveness of dialysis therapy and better life quality of esrd patients.

purpose: development of early diagnostic techniques and setup of local therapeutic guidelines and standards. design: the group plans to host the co-operation of hospitals, based on the geographical distribution of co-operation of several hospitals to choose the renal physician interviews the doctor and patient received a total of 30 objects was conducted qualitative in-depth interviews. time:2008/9/1\~2011/8/31 inclusion criteria): to withdraw from dialysis treatment of chronic kidney disease, qualitative research, to-depth interviews, field observation, video recording, and public hospitals at the same time the collection of literature.

Eligibility criteria:
inclusion criteria: * chronic kidney disease patients with the end of dialysis to withdrawal.

Keywords: hemodialysis patients kidney physician attitudes family wishes 30 numbers require maximum
blood pressure change and outcome

Conditions: Renal Disease; High Blood Pressure

Summary: hyper- and hypotension are important predictors of survival in non-esrd (end stage renal disease) population. in dialysis patients, however, it has been shown that higher blood pressure levels may actually be beneficial to patient outcomes. dynamics of blood pressure evolution over time has not been previously studied in dialysis population. the investigators aim to understand how both blood pressure levels and blood pressure changes over time predict patient survival.


Eligibility criteria:
inclusion criteria: * hemodialysis
study of an investigational drug, asp3026, in patients with solid tumors

Conditions: Solid Tumor

Summary: a study to evaluate the safety and anti-tumor activity of asp3026 in patients with advanced malignancies (solid tumors).

this study will be conducted using a traditional 3 + 3 dose escalation study design. enrollment of at least 3 subjects is planned for each dosing cohort. the decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (dlts) in cycle 1 that are considered by the investigator to be related (possibly or probably) to asp3026. the safety data review committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. each cycle will include 28 days of continuous dosing with asp3026. treatment with asp3026 may continue until one of the discontinuation criteria is met. the maximum tolerated dose (mtd) is defined as the highest dose of asp3026 on a dosing schedule at which \< 33% of subjects experience a dlt during cycle 1. the mtd or lower dose, as determined by the safety data review committee, will be the recommended phase 2 dose (rp2d). twelve additional patients will be treated at the rp2d to further evaluate safety and tolerability.

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status \< 2. * histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor * patient meets at least 1 of the following criteria: * disease progression despite standard therapies * no standard therapies are available or such therapies are not anticipated to result in a durable response * standard therapies are considered unsuitable or have been refused * life expectancy \> 12 weeks * able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing exclusion criteria: * patient exhibits persistent subjective and objective findings of toxicity ≥ grade 2 (ctcae v4.0-jcog) from the previous cancer treatment with antitumor effect (except of alopecias) * received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing * patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study * use of an investigational drug or device within 21 days prior to the scheduled initial dosing * use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing * a positive test for hepatitis b surface antigen (hbsag) or hepatitis c antibody (anti-hcv) * known history of a positive test for human immunodeficiency virus (hiv) infection * patient has central nervous system (cns) or leptomeningeal involvement with clinical symptoms

Keywords: anti-cancer asp3026 anaplastic lymphoma kinase (alk)
safety and efficacy study of ipg patient with home monitoring

Conditions: Bradyarrhythmia

Summary: the number of patients with implantable pulse generator (ipg) has steadily increased in japan causing increment in number of in office follow-ups and greater burden on many hospitals. the purpose of this multicenter randomized study is to demonstrate that biotronik home monitoring system reduces office follow-up visits without compromising patient safety.

patients will be randomized into hm follow-up only (group 1) or hm \& in-office follow-up (group 2) and will be followed-up for 27 months.

Eligibility criteria:
inclusion criteria: * indicated for ipg implantation under japanese guidelines * implanted within the last 45 days or being considered for implant with a biotronik ipg with home monitoring * able to utilize hm system throughout the study * ability to give informed consent * geographically stable and able to return for follow-ups for 27 months * over 20 years old * patient able to understand and follow the procedure stated in protocol exclusion criteria: * contraindicated for ipg under japanese guidelines * patients who are currently included in another cardiac clinical study * patients with expected life period of less than two years * patients who might undergo heart transplantation in next two years.
compassionate use study of tenalisib (rp6530)

Conditions: Hematological Malignancies

Summary: tenalisib has been evaluated as an investigational new drug in number of early clinical studies in patients with relapsed/refractory hematological malignancies and demonstrated acceptable safety and promising efficacy in these patients. since these advanced relapsed/refractory patients have limited therapeutic options, it is reasonable to continue tenalisib in responding patients post completion of their participation in previous clinical studies.


Eligibility criteria:
inclusion criteria: 1. patients must be currently receiving treatment with tenalisib on a previously approved protocol. 2. patients must have had at least one efficacy evaluation in previous study and should have achieved either sd, pr or cr. 3. patients must have completed at least 6 cycles of tenalisib in previous study 4. ability to swallow and retain oral medication. 5. female patients of child-bearing potential must consent to use two medically acceptable methods of contraception. 6. male patients must be willing to use adequate contraceptive measures 7. willingness and ability to comply with trial and follow-up procedures. 8. willingness to provide new written informed consent. exclusion criteria: 1. patient has been discontinued from their previous tenalisib study 4 weeks prior to entering the compassionate use trial. 2. patient progressed while receiving tenalisib therapy in his/her previous study. 3. pregnant or lactating woman. 4. inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. 5. concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.

Keywords: hematological malignancies tenalisib rp6530 compassionate use
targeting healthy weight loss in the context of food insecurity

Conditions: Obesity; Food Insecurity; Food Security; Body Weight

Summary: this pilot and feasibility study will collect information from food insecure, as well as food secure, women with obesity to detail their desires and needs for healthy weight reduction. up to 60 women with obesity will be enrolled. pennington biomedical research center will coordinate this qualitative study and use focus groups discussion to collect formative data.


Eligibility criteria:
inclusion criteria: * willing to provide written informed consent * female * 18 to 65 years of age * bmi ≥ 30 kg/m2 * ability to read and write using english * willing to participate in focus group discussions * willing to be audio/video recorded exclusion criteria: * male * currently pregnant * bmi \<30 kg/m2

Keywords: food insecurity obesity weight loss