Kornimate/medical-research-clean huggingface dataset:
preoperative radiotherapy/ oxaliplatin/ capecitabine treatment for unresectable locally-advanced rectal cancer

Conditions: Rectal Neoplasms

Summary: the purpose of this phase ii trial is to determine the efficacy and safety of the combination of oxaliplatin, capecitabine and radiotherapy as preoperative therapy in locally advanced cancers of the rectum.


Eligibility criteria:
inclusion criteria: * ecog performance status score 0-1. * chemo-naïve patients. * histologically/cytologically confirmed diagnosis of rectal adenocarcinoma (clinically stage mt3 or mt4), either considered (1)inoperable, or (2)locally advanced, where histologically confirmed curative resection is considered unlikely. * evaluable measurable disease on imaging with mri/ct to allow for response assessment. * adequate haematological, renal and liver functions as follows: * anc \> 3000ml * platelet count \> 100,000 ml * urea \& serum creatinine \< 1.5 x upper limit of normal value * total serum bilirubin \< 1.5 x upper limit of normal value * alt \& ast \< 3 x upper limit of normal value exclusion criteria: * prior chemotherapy. * documented allergy to oxaliplatin or capecitabine. * prior radiotherapy to pelvis. * previous or concurrent malignancies at other sites with the exception of basal or squamous cell carcinoma of the skin. * pregnant or lactating females (with negative pregnancy test documentation in pre-menopausal female patients). * currently participating into another clinical trial with any investigational drug in the previous 30 days. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a pharmacokinetic study of vaginally and intravenously administered oxytocin

Conditions: Vaginal Atrophy

Summary: this study aims to evaluate the uptake of oxytocin following intravaginal administration of vagitocin 400iu over a period of 15 days and also to compare oxytocin bioavailability after vaginal and intravenous administration. 12 healthy postmenopausal female volunteers, 40 to 70 years old with vaginal atrophy will be included and will self-administer vagitocin intravaginally on day 2-14 (day 1 and 15 vagitocin is given in the clinic). on day 22 a single intravenous dose of oxytocin 10 iu syntocinon® will be given. oxytocin plasma levels after intravaginal and intravenous administration will be analysed day 1, 15 and 22 at timepoints: -1.0, -0.5, 0, 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0 and 8.0 hours, relative to dosing. based on the obtained plasma levels for oxytocin, pharmakokinetic variables will be calculated. the % of oxytocin which was absorbed following vaginal administration (bioavailability)will also be calculated.


Eligibility criteria:
inclusion criteria: * post-menopausal women with vaginal atrophy as judged by the investigator * willing to participate in the study as indicated by signing the informed consent * healthy post-menopausal women between the ages of 40 and 70 years, inclusive * body mass index (bmi) less than or equal to 32 kg/m2 but greater than or equal to 19 kg/m2 * judged by the investigator to be healthy on the basis of medical evaluation exclusion criteria: * hospitalized subjects * symptoms of any significant acute illnesses at the screening visit * history of significant allergies (including food, asthma, or drug allergies including allergies to any ingredient of the trial product) * known history of sensitivity to oxytocin or related derivatives * follicle-stimulating hormone level \< 40 pmol/ml * known history of narcotic addiction, drug abuse or alcoholism * simultaneously participate in another clinical study * use of any sex steroids including phytoestrogens, hormonal intrauterine device or herbal medicinal products with known estrogenic effects within 3 months prior to baseline * uncontrolled hypertension and/or hypercholesterolemia
self-determination enhancement group for adults with mild intellectual disability and their caregivers in hong kong

Conditions: Intellectual Disability, Mild

Summary: background self-determination is regarded as an adult outcome for people with intellectual disability (id). students with id in western countries learn self-determination knowledge and skills through the systematic curriculum in schools. however, the curriculum for adults with id is still underdeveloped in the west. in hong kong, the self-determination curriculum is rarely available in any setting. objective the proposed study aims to develop a culturally-tailored self-determination enhancement group intervention for adults with id and to evaluate its effectiveness. method the proposed study will consist of two phases. phase one will develop the protocol for the self-determination enhancement intervention and establish its implementation fidelity through a panel review and pilot study. this phase will last eight months. phase two will adopt a randomised controlled trial with pre-test, post-test and three-month follow-up. a total of 120 participants will be randomly assigned to three conditions: self-determination enhancement group, self-determination enhancement plus group (+ parents' involvement) and leisure activity group as a control condition. five groups will be organised for each of the three conditions over 18 months. there will be 10 sessions per group covering the self-determination core components such as self-understanding, goal-setting and attaining, self-regulating and plan adjusting. components for parents include understanding self-determination and skills in supporting people with id to exercise self-determination through positive interaction. validated instruments in chinese will be filled in by participants. statistical analyses will be conducted to examine if the effectiveness of this group intervention can be found and sustained over a three-month period, and the magnitude of change in self-determination competencies and quality of life. implications the proposed study is the first evidence-based local study aimed at examining a culturally-tailored self-determination enhancement intervention for people with id. if the intervention demonstrated as effective, it will be used or modified for use with chinese-speaking people with id in different parts of the world.


Eligibility criteria:
inclusion criteria: * chinese people who have mild intellectual disability (i.e., assessed in their most recent psychological report) * aged 18 or above * able to master basic comprehension and verbal communication skills * willing to complete the group intervention. exclusion criteria: * those who demonstrate severe challenging behaviours will be excluded

Keywords: self-determination enhancement; intellectual disability; culturally-tailored group; chinese societies; randomised controlled trial
re-treatment of participants with paget's disease using zoledronic acid

Conditions: Paget's Disease of the Bone

Summary: the purpose of this study was to demonstrate that participants with paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies czol446k2304 and czol446k2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.

uncontrolled study

Eligibility criteria:
inclusion criteria: * written informed consent * participants with paget's disease randomized to the zoledronic acid arm from the czol446k2304 and czol446k2305 core studies and who were responders by 6 months * confirmed relapse of paget's disease of bone (i.e., serum alkaline phosphatase (sap) above upper limit of normal (uln), bone scan, worsening clinical symptoms) exclusion criteria: * a participant previously treated with zoledronic acid who relapsed and was retreated with anti-resorptive bisphosphonate or calcitonin therapy within the last 12 months * bisphosphonate hypersensitivity * participants with suspected/proven metastases at re-treatment * calculated creatinine clearance \<35 milliliter/minute (ml/min) at screening * serum calcium level \<2.07 millimole/liter (mmol/l) at screening * active primary hyperparathyroidism, hyperparathyroidism, hypoparathyroidism or hypothyroidism other protocol-defined inclusion/exclusion criteria may apply.

Keywords: paget's disease zoledronic acid reclast®/aclasta® infusion re-treatment re-lapse
autoimmunity in the pathogenesis of af

Conditions: Atrial Fibrillation

Summary: this research study is being done to find out whether autoimmune mechanisms are associated with the development of atrial fibrillation.

the study sets out to identify an explanation for the pathogenesis of af, potentially forming the basis for designing novel targeted therapies to prevent or reverse this prevalent human disease. the overall objectives are to determine whether autoimmune diseases are associated with af development and to identify specific diagnostic and prognostic biomarkers that will improve the ability to accurately predict risk of af development. the study will prospectively enroll patients with and without af and determine their serum cytokine levels and assess the functional responses of t cells on the basis of cytokine production after in vitro t-cell specific stimulation, using luminex bead-based multiplex technology.

Eligibility criteria:
inclusion criteria: * cases: af (persistent, paroxysmal af) * controls 1: (no prior history of af or inflammatory or autoimmune diseases) * controls 2: (biopsy proven psoriasis) exclusion criteria: * clinically apparent acute infections over the past 4 weeks * chronic infections * recent malignancies * recent radiation or chemotherapy * chronic kidney disease (≥ stage 2) * organ transplantation * history of chronic liver disease * major surgery or invasive procedure in the past 6 months * internal prosthesis * receiving immunosuppressive therapy * known rheumatologic diseases (except for the participants with psoriasis) * females who are known to be pregnant

Keywords: autoimmune diseases
safety of orectalip® (oxaliplatin) as adjuvant treatment for high-risk stage-ⅱ colorectal cancer

Conditions: Stage-Ⅱ Colorectal Cancer

Summary: open- label, single arm study. to evaluate the safety profile of orectalip® (oxaliplatin), fluorouracil and leucovorin as adjuvant therapy in the treatment of high-risk stage-ⅱ colorectal cancer. primary end point:to evaluate the incidence of grade 0-3 neurosensory symptoms (paresthesia) in the end of study. other end points:the incidence of grade 3 or 4 neutropenia, thrombocytopenia, anemia, nausea, diarrhea vomiting over the 12 weeks. safety will be evaluated including vital signs are recorded at all visits.

there were 18 out of 20 patients who completed the trial and eligible for statistical analysis, 2 patients withdraw because the wound infection. there were 11 (61%) male patients and 7 (39%) female patients. the patients aged from 30 to 73 years and their mean age was 50.4 years. the grade of each adverse event evaluation mainly allocated in grade 0 and grade 1. the incidence of grade 3 or 4 was only found for the following symptoms: leucopenia, neutropenia, and anemia. one (6%) adverse event of leucopenia occurred at visit 1 and visit 2, respectively. one (6%) adverse event of neutropenia occurs at visit 1, visit 2, and visit 3, respectively; while 2 (13%) events occurred at visit 5. one patients suffered adverse event of anemia at visit 5 and visit 6.

Eligibility criteria:
inclusion criteria 1. subject must have world health organization performance status score less than 1. 2. subject must have wbc more than 4,000 cells, platelet count more than 100,000, absolute neutrophil count more than 1,500 serum bilirubin level less than1.5mg, serum creatinine level less than1.5mg exclusion criteria 1. subject who has received oxaliplatin treatment 2. subject who has history of allergy to platinum derivates agents 3. subject who has decompensated liver function(alt、 ast and alkaline phosphatase more than 2.5 times of upper limit of normal range). 4. subject has serious concomitant illness preceding the entry into the study. 5. female subject who is pregnant or breast feeding. 6. female subject who is going to be pregnant within 6 months during treatment.

Keywords: high-risk stage-ⅱ colorectal cancer,orectalip,oxaliplatin
effects of proportioning meat and plant-based protein-rich foods on cardiovascular disease risk factors (s58)

Conditions: Healthy Diet; Cardiovascular Risk Factor

Summary: this project will assess the effects of consuming different proportions of red meat (rm) and plant-based, protein-rich foods (nuts, seeds, and soy products - nss) incorporated into a u.s. healthy eating pattern (hep) on cardiovascular disease risk factors in adults at high risk of developing a heart-related disease.

using a randomized, cross-over (balanced incomplete block) experimental design, forty-eight middle-aged adults who are overweight and have high blood total cholesterol and ldl-c concentrations will be recruited. participants will consume a hep - all foods provided - during 5-week controlled feeding periods. the three hep interventions will be: high rm, low nss; moderate rm, moderate nss; and low rm, high nss. each participant will complete two of the three controlled feeding periods, separated by four weeks when participants will consume their usual unrestricted diet (washout). the hep consumed during the controlled feeding periods will be the same except for the amounts of rm (1, 5, or 9, 3-oz servings/wk) and nss (high, moderate, and low, with amounts adjusted to isocalorically offset changes in rm energy intakes). poultry, egg, and legume intakes will be the same among the three hep. the investigators will measure clinically important cardiovascular disease risk factors before (usual unrestricted diet) and during the last week of each hep intervention. the cardiovascular disease risk factors will include, but are not limited to, comprehensive lipid and lipoprotein profile (changes in low-density lipoprotein cholesterol, ldl-c; primary outcome), lipoprotein fractionation and particle numbers, and blood pressure. the investigators will compare improvements in heart disease risk factors and consumer satisfaction among the three hep.

Eligibility criteria:
inclusion criteria: * male or female; * age 30-69 y; * bmi: 25.0-37 kg/m2; * have hypercholesterolemia (total and ldl cholesterol 200-259 and 130-189 mg/dl, respectively), * systolic/diastolic blood pressure \<140/90 mm hg; * triglycerides \<399 mg/dl, fasting glucose \<109 mg/dl * body weight stable for 3 months prior (±3 kg); * stable physical activity regimen 3 months prior; * medication use stable for 6 months prior; * non-smoking; * non-diabetic; * not acutely ill; * females not pregnant or lactating; * participants must be willing and able to consume the prescribed diets and travel to testing facilities. exclusion criteria: * bmi \ 37 * total cholesterol \>259 mg/dl, low-density lipoprotein cholesterol \>189 mg/dl, * triglycerides \>400 mg/dl, fasting glucose \>110 mg/dl * body weight changes in previous 3 months (±3 kg) * changes in physical activity regimen in the previous 3 months * medication changes in the previous 6 months * smoking * diabetic * acute illness * pregnant or lactating

Keywords: healthy eating pattern
a study to evaluate the preliminary efficacy pharmacokinetics and immunogenicity of bms-188667 administered to subjects with relapsing-remitting multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to determine whether bms-188667 will decrease multiple sclerosis disease activity on mri examinations, as well as decrease the rate of clinical ms exacerbations, compared to placebo


Eligibility criteria:
inclusion * relapsing-remitting ms * at least 1 exacerbation in preceding 2 years * at least 1 mri lesion * stable for 2 months prior to dosing exclusion * progressive ms * currently treated with an immunomodulatory therapy * previously treated with an approved ms drug where treatment was discontinued for lack of efficacy * active bacterial or viral infections

Keywords: ms
clinical features of smoker patients with chronic obstructive pulmonary disease

Conditions: Copd; Smoking

Summary: smoking is the most important factor in the etiology of copd. some of the patients with copd continue to smoke despite knowing this situation or they cannot quit even if they want. the aim of this study is; to examine patients with copd who continue to smoke in terms of perception of dyspnea, exercise capacity, psychological symptoms and quality of life.

the study was designed prospectively. patients with copd who apply to the pulmonary rehabilitation outpatient clinic will be included. the data of patients with copd who are eligible for pr and have been pre-evaluated will be scanned. respiratory function test, arterial blood gas analysis, six-minute walking test (6-mwt), mmrc dyspnea scale, st george quality of life questionnaire and hospital anxiety depression scale will be used in the study. patients with copd who smoke will constitute the study group, and those who quit smoking will constitute the control group.

Eligibility criteria:
inclusion criteria: * smoker copd patients who smoker exclusion criteria: * not volunteer to participate the study

Keywords: copd smoking
laparoscopic vs open total gastrectomy for gastric cancer

Conditions: Gastric Cancer

Summary: the aim of the present study is to demonstrated the the safety and feasibility of laparoscopic total gastrectomy comparing with open total gastrectomy.

gastric cancer is most common cause of cancer-related deaths in the world. laparoscopic distal gastrectomy has been demonstrated to be safe and effective compared with open distal gastrectomy. with an increase in incidences of proximal gastric cancer over the last decades, total gastrectomy has been prefered by surgeons, and laparoscopic total gastrectomy has become the alternative option. however, the safety and feasibility of laparoscopic total gastrectomy have yet to be proved completely.

Eligibility criteria:
inclusion criteria: 1. histologically proven gastric adenocarcinoma in the upper or middle third of the stomach (by preoperative gastrofiberscopy) 2. age between 20 and 80 years old 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 4. clinical stage i-iii (t1-4an0-2m0) according to the 8th edition of the americal joint committee on cancer system (clinical stage was determined based on the finding of gastrofiberscopy and abdominal computed tomography) 5. scheduled for total gastrectomy with d2 lymphadenectomy, and possible for r0 surgery by this procedures (lymphadenectomy is performed on the basis of the criteria of the japanese 6. written informed consent 7. without preoperative chemotherapy and radiotherapy exclusion criteria: 1. clinical stage t1-4n3m0 or t4bn0-3m0 according to the 8th edition of the americal joint committee on cancer system 2. history of chemotherapy, radiotherapy, immunotherapy or target therapy 3. perigastric lymphnode≥3cm 4. received gastric surgery (i.e. gastrectomy or gastrojejunostomy) 5. multiple primary tumors 6. suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases. 7. patients need emergency operation with complication of gastric cancer 8. adhesion due to the previous intraabdominal surgery 9. need for combined organ resection due to aggression of gastric cancer of other disease, 10. vulnerable people who cannot communicate or are pregnant (or planning to be pregnant) 11. currently participating or participated in other clinical trials in the last 6 months

Keywords: gastric cancer, laparoscopic total gastrectomy, open total gastrectomy
treadmill with ankle weights on balance in spastic cerebral palsied children

Conditions: Cerebral Palsy

Summary: the purpose of the study is to investigate the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children.

cerebral palsy defined as a non-progressive, non-hereditary lesion of the cerebral cortex resulting in postural and motion disturbances. spastic cerebral palsied children have deficits in the selection of appropriate sensory inputs for postural control. balance is a complex motor skill often referred to as postural control which is the ability to maintain equilibrium in a gravitational field by keeping or returning the center of body mass over the base of support. treadmill gait training supporting the body weight which simulates walking on flat land is prescribed in rehabilitation of spastic cerebral palsy to improve their balance or to reduce their gait disturbance. several studies support the use of ankle weights during treadmill gait training to reinforce muscle strength and, improve the symmetry of gait while, there is no research conducted on balance in spastic cerebral palsied children. hence, there is need to study the effect of treadmill training combined with ankle weights on balance in spastic cerebral palsied children. fourty children with spastic hemiparetic cerebral palsied children (based on power analysis) from both sexes (6-9 years) will be recruited from different private pediatric physical therapy clinics. they will be divided randomly into control group (20 children) and study group (20 children). control group will be participated in designed physical therapy program in addition to gait training on treadmill with full weight bearing without using of ankle weights. study group will be participated in the same designed physical therapy program received by the control group in addition to gait training on treadmill with ankle weights on the affected side ankle.

Eligibility criteria:
inclusion criteria: 1-children ages will be ranged from 6 to 9 years old. 2-confirmed diagnosis of hemiparetic cerebral palsy by a pediatric neurologist. 3-spasticity grades ranged from 1 to +1 according to modified ashworth. 4-balance problems (frequent falling especially when increasing speed or walking on uneven surface) based on the biodex stability system. 5-independent standing and walking. 6-ability to follow simple verbal commands and instructions exclusion criteria: 1. auditory or visual defects or any perceptual defects. 2. fixed deformities on both upper or/ lower limbs. 3. botox injection. 4. cardiovasucular disease. 5. surgery within the previous 24 months.

Keywords: treadmill biodex balance system cerebral palsy