Kornimate/medical-research-clean huggingface dataset:
treatment of head & neck cancer with chemotherapy and radiation

Conditions: Head and Neck Cancer

Summary: two new cancer treatment drugs called targeted therapies will be added to standard treatment for head and neck cancer to see if an improvement can be made in the effectiveness of treatment for this type of cancer. treatment will include chemotherapy, radiation therapy and targeted therapy taken over a period of 4 months.

in this trial, patients will receive induction treatment with combination chemotherapy(paclitaxel/carboplatin/infusional 5fu) plus bevacizumab. after 6 weeks of treatment, patients will be reevaluated and will then receive concurrent radiation therapy, chemotherapy (weekly paclitaxel),bevacizumab, and erlotinib. induction treatment: paclitaxel 200mg/m2 by vein over 1-3 hours on day 1 \& day 22 carboplatin auc 6.0 by vein over 1 hour on days 1 and 22 bevacizumab 15mg/kg by vein over 60-90 minutes on days 1 and 22 5-fu 200mg/m2 as a 24 hour continuous infusion via pump on days 1 through 43. combined modality treatment: radiation therapy is given daily, monday through friday for approximately 7 weeks. erlotinib 150mg by mouth daily during the entire course of radiation (approximately 7 weeks) paclitaxel 50mg/m2 by vein over 1-hour weekly for 6 weeks beginning day 1 of radiation therapy bevacizumab 15mg/kg by vein over 30-90 minutes on days 50 and 71 at the same time of radiation therapy

Eligibility criteria:
inclusion criteria: * clinically confirmed head \& neck cancer * considered low cure rate with local therapy * no prior treatment for this cancer * able to be up \& about and perform self care * adequate renal and liver function * must be 18 years of age or older * all patients will need an indwelling central venous access catheter * must be able to give written informed consent exclusion criteria: * active cancer treatment in the last 5 years * pregnant or lactating women * history of stroke, transient ischemic attacks, or acute myocardial infarction within the past 6 months or any other serious cardiovascular disease * history of neurological disease * recent history of blood in the sputum or vomitus * non-healing wounds, ulcer or long bone fractures * history of bleeding problems or coagulation problems * history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months * history of uncontrolled hypertension * symptomatic peripheral vascular disease please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
assessing combined bevacizumab-mitomycin c use during ahmed valve revision in recurrent pediatric glaucoma

Conditions: Pediatric Glaucoma

Summary: to asess the efficacy and safety of combining subconjunctival bevacizumab with mitomycin c (mmc) during agv revision surgery in pediatric patients with recurrent glaucoma.

recurrent pediatric glaucoma following ahmed glaucoma valve (agv) implantation presents a therapeutic challenge. this study evaluates the efficacy and safety of combining subconjunctival bevacizumab with mitomycin c (mmc) during agv revision surgery in pediatric patients with recurrent glaucoma.

Eligibility criteria:
inclusion criteria: * children under 12 years with previous agv implantation for primary congenital glaucoma exclusion criteria: * age \>12 years, eyes with no light perception, and those with prior cyclodestructive procedures.

Keywords: pediatric glaucoma ahmed valve bevacizumab mitomycin c
study of safety, tolerability, pharmacokinetics and pharmacodynamics of pra-027 administered to healthy japanese females

Conditions: Uterine Leiomyomata (Fibroids)

Summary: the primary purpose of this study is to assess the safety and tolerability of ascending single oral doses of pra-027 in healthy japanese females. the secondary purpose is to provide the initial pharmacokinetic and pharmacodynamic profiles of pra-027 in healthy japanese female subjects.


Eligibility criteria:
inclusion criteria 1. women of nonchildbearing potential aged 20 to 64 years. must have a negative pregnancy test result within 48 hours before administration of test article. women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound scan. 2. body mass index (bmi) in the range of 17.6 to 26.4 kg/m2 and body weight must be at least 45 kg. 3. healthy as determined by the investigator on the basis of screening evaluation. exclusion criteria 1. any significant cardiovascular, hepatic, renal, respiratory, gynecologic gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 2. any history of drug abuse or admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. 3. use of any investigational drug within 90 days before study day 1, use of any prescription drug within 30 days before study day 1, consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages within 48 hours before study day 1, consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1, use of any over-the-counter drugs, including herbal supplements (except for the occasional use of vitamins ≤100% of the recommended daily allowance), within 14 days before study day 1, or the donation of blood within 90 days before study day 1.
nutritional intervention and glycemic improvement in patients with pre-diabetic cystic fibrosis.

Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Summary: cystic fibrosis (cf) is a genetic disease with an autosomal recessive, chronic and progressive character about 10 to 25% of patients develop cf-related diabetes (drfc). until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and cf patients. the objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis.

cystic fibrosis (cf) is a genetic disease with an autosomal recessive, chronic and progressive character. about 10 to 25% of patients develop cf-related diabetes (drfc), whose pathogenesis is associated with pancreatic fibrosis and destruction. until now, there is no evidence to support the use of low glycemic index diet to improve glycemic response in pre-diabetic and cf patients. the objective of this study is to evaluate the glycemic improvement after nutritional orientation in patients with cystic fibrosis in the pre-diabetic phase. methods: randomized clinical trial in patients with cf aged over 10 years without hospitalization in the last 4 weeks. anthropometric measurements, blood pressure, 24 hour recall and food frequency questionnaire will be evaluated. oral glucose tolerance and glycated hemoglobin test will be dosed at baseline and during 12 weeks of follow-up. the intervention group will receive a nutritional guidance at the beginning of the research.

Eligibility criteria:
inclusion criteria: * tolerance glucose test values between 100 and 125mg / dl and or glucose 2h after 75g of glucose between 140 and 199 mg / dl * stable pulmonary disease in the last four weeks exclusion criteria: * without hospitalization in the last 3 months

Keywords: cystic fibrosis related diabetes
peers® for italy, a study on social skills intervention for adolescents with autism spectrum disorder (asd).

Conditions: Autism Spectrum Disorder

Summary: tthe research aims to verify the italian adaptation of a parent-mediated group training focused on social skills for adolescents with autism spectrum disorder (asd). the program for the education and enrichment of relational skills peers® is an evidence-based program with substantial literature (over 40 studies) applied in several countries. for the present study, about 40 adolescents, both boys, and girls with asd, are enrolled and randomized into two groups. groups (experimental group and waiting list) took part in the italian telehealth adaptation of peers® at different times and were evaluated at several time points (baseline, pre-treatment, post-treatment, and follow-up). the objective of the comparison was to explore the primary outcomes, such as the impact of training on social knowledge and performance, and secondary outcomes, like psychiatric comorbidities and neuropsychological profile. the hypothesis is that social skills (knowledge and performance) improve after training in the experimental group and affect the secondary outcomes, and the achievements are maintained at 3-months follow-up.


Eligibility criteria:
inclusion criteria: * a previous and current diagnosis of asd, by a clinical team, according to dsm-5, clinical observation and structured assessment with standardized tests (autism diagnostic observation schedule- second edition; ados-2; lord et al., 2012) * verbal comprehension index scores at least 80 on the italian version of the wisc-iv scale (orsini et al.,2012). * chronological age between 12 and 18 years; * social problems as reported both by the parents and adolescents; * italian fluency for the adolescent and parent * abstention from other social skills training (following a manualized protocol). * no history of adolescent major mental illness, such as bipolar disorder, schizophrenia, or psychosis; * no history of hearing, visual, or physical impairmentsexclusion criteria: exclusion criteria: * no diagnosis of asd. * iq total score below 70 or verbal comprehension index scores below 80 on the italian version of the wisc-iv scale (orsini et al.,2012). * lack of motivation (both parents or adolescents). * participation in another social skills training (following a manualized protocol). * auto-aggressive behaviors

Keywords: autism spectrum disorder social skills training
a study to compare the efficacy, safety and tolerability of selomax with its individual components

Conditions: Primary Hypertension

Summary: this is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of metoprolol xl plus amlodipine with individual components of the combination. selomaxtm50/5 will also be compared with selomaxtm 25/2.5 in lowering of bp (sbp and dbp) in indian patients with essential hypertension.male and female patients of essential hypertension aged between 18-80 years will be studied. the patients should not have a history of prior cardiovascular disease.


Eligibility criteria:
inclusion criteria: * patients of hypertension (primary) , as judged by 2 bp measurements before randomisation * those who have given their written consent for the study. exclusion criteria: * patients of other forms of hypertension (other than primary) * those who have consistently bp \> /=180/120mmhg * patients with a prior history of chest pain, heart attacks, conduction defects and strokes. * patients of diabetes requiring insulin,asthma and kidney diseases.

Keywords: primary hypertension metoprolol xl amlodipine
strategy of turning performance in individuals with stroke

Conditions: Stroke

Summary: this is a single-blind randomized controlled trial study. thirty individuals with chronic stroke will be recruited and randomly assigned to the experimental and control groups. subjects in the experimental group will receive exergame-based balance training, while subjects in the control group will receive upper limb and trunk training. both groups will undergo a four-week intervention consisting of three sessions per week, each lasting 60 minutes.


Eligibility criteria:
inclusion criteria: * aged ≥18 years * single incident of stroke * stroke duration of at least 6 months * lower limb brunnstrom motor recovery stage between level three and five * functional ambulation categories scale ≥3 exclusion criteria: * individuals with cognitive impairmen (the mini-mental state examination with a score below 24) * visual or auditory impairments * communication disorders * other neurological diseases affecting motor performance, or any orthopedic conditions that could influence walking ability * contraindications to physical activity, such as angina or uncontrolled hypertension

Keywords: turning performance balance performance exergame balance training stroke
sickness absence versus physical, mental, and job-related factors in patients with chronic pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Asthma

Summary: people with chronic respiratory disease have shortened work life, their disease is associated with greater work disability and they are at greater risk of being unemployed. lower employment rates and higher sickness absence is expensive for the community and leads to financial as well as social consequences for the individual. there is a lack of data on factors that can predict sickness absence and disability in patients with pulmonary disease. we therefore want to study a group of people with copd and asthma referred to our clinic. the study will investigate relationships between sickness absence and exercise capacity, job-related factors, disease severity, self-efficacy, health related quality of life and subjective health complaints.


Eligibility criteria:
inclusion criteria: * chronic pulmonary disease * employed * periods of sickness absence in the year prior to admittance exclusion criteria: * lack of ability to complete the rehabilitation program
identifying strategies to alleviate cardiovascular stress in coronary patients during heatwaves

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the optimal cooling strategies to alleviate cardiovascular strain of coronary artery disease individuals during a simulated north american and australian heatwave.

globally, heatwaves are occurring more frequently, are of greater intensity and longer in duration. the devastating health impacts of extreme heat are increasingly recognized, particularly in vulnerable populations, such as adults with coronary artery disease (cad). while the most effective cooling strategy during a heatwave is the use of air conditioning (ac), economical concerns can limit ac use among vulnerable populations. in addition, widespread ac use places a significant burden on the electrical grid, causing brown-outs and black-outs during periods of extreme heat. electric fans offer a cooling strategy with a 50-fold lower power requirement and cost compared to ac. however, the efficacy of fan use during heat waves remains contentious. the primary objective of this study is to identify the optimal cooling strategy to alleviate cardiovascular strain of cad patients exposed to typical north american heatwave conditions (38°c with 60% relative humidity). the secondary objective is to identify the optimal cooling strategy to alleviate cardiovascular strain of cad patients exposed to typical australian heatwave conditions (46°c with 10% relative humidity).

Eligibility criteria:
inclusion criteria: * history of angiographic coronary disease (≥70% arterial diameter narrowing of at least one major epicardial coronary artery) and/or prior coronary revascularization and/or documented prior acute coronary syndrome and/or stable angina and/or perfusion defect during exercise testing. * no cad-related hospitalisations or changes in cardiac medications or change in pattern of angina for at least 3 months prior to enrolment exclusion criteria: * body mass index ≥35 kg/m2. * currently undertaking estrogen therapy. * evidence of current fluid and electrolyte disorders, anemia, abnormal thyroid function, arrhythmias, diabetes, renal disease, liver disease, cerebrovascular disease, significant pulmonary disease, endocrine abnormalities, significant cognitive impairment, psychiatric disorder, substance abuse, degenerative neurological condition or any other medical condition deemed to pose risk during the proposed experiments. * uncontrolled hypertension (\>180/110 mmhg). * recent (\<3 months) coronary bypass surgery. * ejection fraction \<40% and/or clinical evidence/history of heart failure. * significant valvular heart disease * resting ecg abnormalities interfering with observation of st segment changes during testing.
post market clinical follow-up investigation to evaluate performance and safety on pressure ulcers, pu, when using exufiber as intended

Conditions: Pressure Ulcers

Summary: the primary objective of this post market clinical follow-up (pmcf) investigation is to evaluate performance and safety of exufiber when used as intended in stage ii-iv pressure ulcers (pu).


Eligibility criteria:
inclusion criteria: 1. both gender ≥18 years old. 2. subjects with stage 2, 3 or 4 cavity pressure ulcer (acc to epuap) 3. exuding pressure ulcer 4. signed informed consent. exclusion criteria: 1. known allergy/hypersensitivity to the dressing. 2. infected wounds, (2 signs of infection/local inflammation and a positive swab) 3. stage 1 pu 4. dry wounds 5. subjects who will have problems following the protocol 6. subjects included in other ongoing clinical investigation at present or during the past 30 days
home-based psychoeducation for older adults with frailty: a randomised controlled trial

Conditions: Frailty; Well-Being, Psychological

Summary: this study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty. the main question it aims to answer is - could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community? participants will receive 12 weekly online group-based sessions at their homes. the content for the experimental group and control group is different: * intervention group: psychoeducation * control group: physical health education participants will receive three home visits for data collection. some of participants in experimental group will receive interview for process evaluation.


Eligibility criteria:
inclusion criteria: (1) aged 65 or older; (2) identified as frail by the frail scale (score ≥3); (3) mentally competent as determined by the abbreviated mental test (amt ≥6); (4) able to speak and understand cantonese; (5) living at home; (6) experienced in using a smartphone (e.g., sending messages, watching videos). exclusion criteria: (1) have visual or hearing impairments or language barriers that may impact communication or understanding; (2) unfit for home-based exercise, as indicated by a score of 1 or higher on the 25-item home-fast, a tool for identifying home fall hazards; (3) currently engaging in exercise for at least 150 minutes per week over the past four weeks; (4) undergoing active psychiatric or antidepressant treatment or participating in other physical exercise or rehabilitation programs.

Keywords: subjective well-being frailty psychoeducation
family support intervention in intensive care units (the four supports study)

Conditions: Physician-Family Communication in Intensive Care Units; Surrogate Decision-making for Critically Ill Patients

Summary: the purpose of this study is to test the effectiveness of a multi-faceted communication intervention for family members of critically ill patients to reduce the family members' long-term symptoms of depression and anxiety.

one in four elderly americans die in or shortly after discharge from an intensive care unit. an expanding body of literature documents that physician-family communication and end-of-life care is poor in intensive care units. these deficiencies are associated with high rates of adverse psychological outcomes among surrogates, physician-family conflict, and life support decisions that may be inconsistent with patients' goals and preferences. there is a lack on information on practical, generalizable interventions that effectively improve this important aspect of care for elderly patients and their families. the primary aim of this study is to evaluate the effectiveness of a multifaceted communication intervention to improve psychological outcomes among family members of critically ill patients, using a randomized, controlled trial design.

Eligibility criteria:
inclusion criteria for icu patients: * must be unable to make treatment decisions for him/herself, as determined by the patient's physicians. * must have have either an apache ii score of ≥ 25 or, for patients with a primary neurologic diagnosis (e.g. intracranial hemorrhage, subdural hemorrhage, or subarachnoid hemorrhage), physician estimate that the patient has at least a 50% risk of long term, severe functional impairment * must be 50 years old or greater. exclusion criteria for icu patients: * patients who do not have surrogates or at least one family member who is willing to participate in the study. * patients awaiting organ transplantation.

Keywords: intensive care units surrogates family members physicians critically ill depression anxiety emotional support multi-faceted communication grief prognosis family support counselor
interleukin-2 in treating patients with stage iii or stage iv kidney cancer that has been removed with surgery

Conditions: Kidney Cancer

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. purpose: phase ii trial to study the effectiveness of interleukin-2 in treating patients with stage iii or stage iv kidney cancer that has been removed by surgery.

objectives: i. determine the disease free survival and overall survival of patients with resected stage iii or iv renal cancer treated with interleukin-2. ii. measure the degree of rebound lymphocytosis generated by this regimen in these patients. outline: this is an open label study. patients receive interleukin-2 iv over 15-30 minutes on 3 consecutive days weekly for 6 weeks, followed by 2 weeks of rest. patients receive 2 treatment courses, each 8 weeks in duration. patients are followed every 6 months until death. projected accrual: a total of 20 patients will be accrued within 1 to 2 years.

Eligibility criteria:
disease characteristics: histologically proven stage iii or iv renal cancer that has been completely resected and is at high risk for recurrence, including at least one of the following: tumor invades adrenal gland or perinephric tissues but not beyond gerota's fascia (t3a) or tumor extending into renal vein, vena cava (t3b) or tumor grossly extends into vena cava above diaphragm (t3c) or tumor invades beyond gerota's fascia (t4) or any lymph node involvement totally resected (n1-3) or completely resected metastases of all sites no brain metastases patient characteristics: age: not specified performance status: ecog 0-2 life expectancy: not specified hematopoietic: wbc at least 3,500/mm3 platelet count at least 100,000/mm3 hemoglobin at least 9 g/dl hepatic: bilirubin less than 3 times upper limit of normal (uln) ast or alt less than 3 times uln renal: creatinine no greater than 1.9 mg/dl cardiovascular: no prior myocardial infarction within 6 months no lvef less than 35% no primary cardiac arrhythmias beyond occasional pvcs no angina no uncontrolled congestive heart failure no cerebrovascular accident pulmonary: no dyspnea at rest or requirement for supplemental oxygen oxygen saturation greater than 90% for patients with symptomatic lung disease other: not pregnant or nursing negative pregnancy test fetile patients must use effective contraception temperatures greater than 100.5 degrees f must have occult infection excluded no psychiatric disorders prior concurrent therapy: biologic therapy: not specified chemotherapy: no concurrent cyclosporine or methotrexate endocrine therapy: at least 3 weeks since prior corticosteroids no concurrent corticosteroids radiotherapy: not specified surgery: at least 2 weeks since prior surgery other: at least 3 weeks since prior immunosuppressive medications no concurrent immunosuppressive medications

Keywords: stage iii renal cell cancer stage iv renal cell cancer