Kornimate/medical-research-clean huggingface dataset:
impact of decision aids on breast cancer surgery choice: a randomized controlled trial

Conditions: Breast Cancer

Summary: both simple mastectomy and breast conservation therapy (bct) with radiotherapy yield similar survival rates in breast cancer. these two treatment strategies have diverted cosmetic outcome and convenience. thus, shared decision making (sdm) is necessary to aid patients to choose an appropriate treatment that suits thier needs. we have developed a decision aids (das) and plan to conduct a randomized controlled trial (rct) to evaluate its impact on cancer patients. the measurements include a battery of interview-based questionnaires and evaluations of decision regret and postsurgical depression. we expect the das would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after thier treatment sessions.

background: for women with early-stage breast cancer, both simple mastectomy and breast conservation therapy (bct) with radiotherapy yield similar survival rates, making psychological adjustment and quality-of-life issues pivotal in treatment choice. using decision aids (das) is one way to provide information to patients and to involve them in making decisions about their treatment. we have developed a das to be administered after consultation for taiwanese women deciding on breast surgery, and plan to conduct a randomized controlled trial (rct) to evaluate the benefit of das on breast surgery decision making. patients and methods: decision aids are interventions designed to help patients with early breast cancer to make deliberate choices among treatment options by providing information on those options and any potential outcome relevant to different breast cancer surgeries. women considering breast cancer surgery are randomly assigned to receive a das or the standard oral conversation (control condition) after initial consultation, wherein surgeons disclosed the diagnosis and discussed treatment options with patients. participants complete interview-based questionnaires 1 day before and 4 weeks after surgery. primary outcome measures 1 day before surgery are decisional conflict and decision-making difficulties after consultation. secondary outcomes are decision regret and postsurgical depression 1 month after surgery. hypothesis: the das group are predicted to lower decisional conflict scores before surgery, and lower decision regret scores and depression scores 1 month after surgery compared with women in the control arm. our study hopes to support the efficacy of das in helping breast cancer women to arrive at their breast surgery decision.

Eligibility criteria:
inclusion criteria: * taiwanese women newly diagnosed with stage 0 to 3 breast cancer (including patients with ductal carcinoma in situ), who were suitable for breast surgery * patients who were able to give consent and complete the interview exclusion criteria: * patients were diagnosed with nonmalignant breast disease * patients were offered neoadjuvant chemotherapy * patients had cognitive impairment * patients were physically unfit to be interviewed * patients were non-mandarin or -taiwanese
advance study: a study of pegasys (peginterferon alfa-2a (40kd)) + adefovir dipivoxil in patients with hbe(-) chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this 3 arm study will compare the efficacy and safety of combination therapy with pegasys + adefovir dipivoxil (adv) versus pegasys monotherapy, in hbeag-negative chronic hepatitis b patients.patients will be randomized to receive 1)pegasys 180 micrograms sc weekly + adv 10mg po daily for 48 weeks, followed by adv 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)pegasys 180 micrograms sc weekly + adv 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)pegasys 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. the anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-70 years of age; * chronic hepatitis b; * positive hbsag, positive anti-hbe, negative anti hbsag, negative hbeag for at least the prior 6 months; * either nucleoside analogue naive, or has not received ifn-a in the past 6 months. exclusion criteria: * positive for hepatitis a, c, d or hiv; * history or other evidence of a medical condition associated with chronic liver disease other than hepatitis b; * antiviral, antineoplastic or immunomodulatory treatment \<=6 months prior to first dose of randomized treatment.
biomarkers research in anxiety for validation and efficacy

Conditions: Autism; Autism Spectrum Disorder

Summary: a within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

a within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change). the main questions the study aims to answer are: * to evaluate the stability of each potential biomarker over a 3-4-week retest period. the biomarkers are hypothesized to have adequate stability (icc: \> .5) in the absence of intervention. * to determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (cbt) program for treating anxiety, being brave. * to determine which biomarkers are sensitive to treatment response.

Eligibility criteria:
inclusion criteria: * age between 3;0 and 6;11 years old * a diagnosis of autism spectrum disorder using dsm-5 diagnostic criteria * a diagnosis of anxiety disorder using dsm-5 diagnostic criteria * use of fluent 2-3 word phrases or fluent speech (i.e., module 2 or 3 for ados-2) * cognitive ability (either verbal or non-verbal iq) \> 80 using the das-2 * a parent/guardian who is willing/able to participate and respond to interviews/surveys in english and willing/able to participate in being brave parent training in english and support homework activities. exclusion criteria: * presence of seizures * premature birth (\<36 weeks) or low birth weight (\<2500 gms) * known genetic or medical disorders (e.g., fragile x), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter eeg/rsa/edr signal (e.g., anti-convulsants) * significant sensory or motor impairment (e.g., blindness) * major physical abnormalities * exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation) * previous cbt for anxiety * presence of conduct or oppositional defiant disorder or adhd so severe as to interfere with the child's ability to take part in treatment * presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality) * psychotic symptoms in the child or parents * parent/caregiver who is not fluent in english or english is spoken in the home less than half of the time.
s-icd® system ide clinical study

Conditions: Tachycardia, Ventricular

Summary: this clinical study is designed to evaluate the safety and effectiveness of the subcutaneous implantable defibrillator (s-icd) system.

this clinical study is a prospective, non-randomized, multicenter clinical study without a control group conducted in the united states, europe, and new zealand. patients meeting eligibility criteria for implanting an s-icd system will be enrolled in this clinical study, implanted with an s-icd system, and followed prior to hospital discharge, and post-implant at 30 days, 90 days, and 180 days. after the 180-day post-implant follow-up visit, patients will continue to be followed semi-annually until study closure. eligible patients enrolled in this clinical study may also participate in the chronic conversion sub-study. the safety endpoint will be evaluated through the use of a 180-day s-icd system complication-free rate. the effectiveness endpoint will be evaluated using an induced ventricular fibrillation (vf) conversion efficacy rate. spontaneous episodes and chronic conversion testing data will be evaluated using descriptive statistics to provide additional data supporting the continued chronic performance of the s-icd system.

Eligibility criteria:
inclusion criteria: * for patients without an existing transvenous device • patient meets class i, class iia or class iib indications/recommendations for icd implantation per the current published guidelines at the time of enrollment * for patients with an existing transvenous device • patient requires replacement or revision of an existing implanted transvenous icd system * age is ≥ 18 years * an appropriate pre-operative ecg per template provided exclusion criteria: * any condition which precludes the subject's ability to comply with the study requirements, including completion of the study. * females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study. * participation in any other investigational study without prior written consent from the study sponsor. * patients with a serious medical condition and life expectancy of less than one year. * patients with documented spontaneous and frequently recurring vt that is reliably terminated with anti-tachycardia pacing, unless the patient is not a candidate for a transvenous icd system. * patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant. * patients with unipolar pacemakers or implanted devices that revert to unipolar pacing. * patients with severely impaired kidney function as measured by a cockcroft-gault glomerular filtration rate (gfr) with an estimated gfr ≤ 29.

Keywords: icd, defibrillator
a prospective study: tai-chi and post-covid insomnia

Conditions: Insomnia; COVID - 19

Summary: the goal of this study is to see if tai-chi exercises (a type of chinese martial arts) can help people suffering from insomnia after covid-19 when added with cognitive-behavioral therapy (cbt) and drugs compared to cbt and drugs alone. all participants will receive education on sleep hygiene practices, and the principles of cognitive behavioral therapy (cbt). if these approaches were insufficient, they will be given sleep aids, primarily z-drugs. all study subjects engaged in a simple tai chi training program for two weeks. the tai chi training consisted of a series of gentle physical exercises that incorporated elements of meditation, body awareness, imagery, and abdominal breathing. a professional instructor conducted two training sessions for both patients and controls, ensuring that participants could perform the exercises independently at home during the last hour before sleep. each session lasted twenty minutes, to be done daily. participants were given a checklist documenting their sleep and exercise diary to confirm adherence for at least five days each week. after the two-week period, all participants are reassessed using the insomnia severity index.


Eligibility criteria:
inclusion criteria: * covid-19 infections confirmed by pcr (polymerase chain reaction) * over the age of 18 years exclusion criteria: * below the age of 18 years * severely ill patients * patients with chronic respiratory complications * individuals with pre-existing and ongoing depression or anxiety

Keywords: insomnia covid-19 tai chi exercises insomnia severity index
effect of local infiltration anesthesia in a hip arthroplasty fast track program.

Conditions: Hip Osteoarthritis

Summary: fast-track programs in orthopaedic surgery require early motion that can only be achieved by optimal pain management protocols. multimodal analgesia protocols including local infiltration anesthesia (lia) have obtained excellent results in fast-track programs involving total knee arthroplasty but further research and data is needed in total hip arthoplasty programs.


Eligibility criteria:
inclusion criteria: * hip osteoarthritis requiring total hip replacement exclusion criteria: * mental disorders * contraindications for epidural anesthesia * neurologic disorders that could interfere with pain evaluation * allergy to drugs in multimodal analgesic protocol
a study of al2846 versus zoledronic acid in subjects with advanced non-small cell lung cancer with bone metastasis

Conditions: Bone Metastatic Non-small Cell Lung Cancer

Summary: al2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form. 2.18 years and older; eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months. 3.histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction. 4.has received at least two systematic treatment regimens that failed or were unable to tolerate treatment. 5.egfr, alk gene mutations are negative. 6.adequate laboratory indicators. 7.no pregnant or breastfeeding women, and a negative pregnancy test. exclusion criteria: * 1.small cell lung cancer. 2. diagnosed and/or treated additional malignancy within 5 years with the exception of cured cervical carcinoma in situ and non-melanoma skin cancer. 3. has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment. 4. has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases. 5. has known to be allergic to the study drug or any of its excipients. 6. has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by ct or mri examination before the first dose. 7. has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by oxaliplatin. 8. imaging (ct or mri) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear. 9. has spinal cord compression or mandibular osteonecrosis. 10.has multiple factors that affect oral medications. 11.has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation. 12.uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 13. has severe acute comorbidities before the first dose. 14. has participated in other clinical trials within 4 weeks before the first dose. 15.according to the investigators' judgment.
lifestyle intervention for improving insulin resistance and concern for health

Conditions: Insulin Sensitivity; Apathy

Summary: the primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. the main questions the study aims to answer are: 1. does the diet and exercise program improve insulin resistance and apathy? 2. does the addition of soybean to the diet enhance the effect? participants will be given all meals for 12 weeks and will exercise under supervision. they will undergo a test of insulin sensitivity and complete questionnaires. researchers will compare the groups given: 1. a diet to moderate the blood glucose response that contains soybean; and 2. a diet to moderate the blood glucose response that does not contain soybean.

this randomized trial will examine the blood glucose moderating effect of a diet and exercise program in 40 older adults with obesity, insulin resistance, and apathy. the primary objective of this study is to examine the effect of a diet and exercise program on insulin sensitivity and apathy and determine if the addition of soybean to the diet enhances the effect. the primary outcomes of the study are insulin sensitivity measured using the hyperinsulinemic euglycemic clamp test and apathy evaluated using the apathy evaluation scale.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) greater than or equal to 30kg/m2 * mini-mental state examination (mmse) \> 25 * geriatric depression scale-15 (gds-15) \< 6 * apathy evaluation scale - score \> 30 or gds-15 apathy subscale - score ≥ 2 * homeostatic model assessment of insulin resistance (homa-ir) ≥ 3 * sedentary: \< 90 minutes of moderate to vigorous physical activity/week. exclusion criteria: * subjects with a diagnosis of type 2 diabetes received more than five years ago. * participants who have type 1 diabetes * participants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight. * participants who are on concomitant therapy with glucocorticoids. * participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction. * participants that have had a fluctuation in body weight \>5% in the preceding 2 months. * any other conditions that may impede testing of the study hypothesis.
comparison of the effectiveness of sambiloto herbs (andrographis paniculata) and brisk walking exercise on blood pressure of obese patients

Conditions: MeSH

Summary: problem formulation 1. is there an effect of giving jamu sambiloto (andrographis paniculata) on blood pressure in obese people in jekan raya district? 2. is there an effect of brisk walking exercise on blood pressure in obese people in jekan raya district? 3. is there an effect of brisk walking exercise and combined administration of jamu sambiloto (andrographis paniculata) on blood pressure in obese people in jekan raya district? 4. is there a difference in effectiveness between the administration of jamu sambiloto (andrographis paniculata) and brisk walking exercise and the combination on blood pressure in obese people in jekan raya district? research objectives general objective: this study aims to determine the difference in effectiveness between the administration of jamu sambiloto (andrographis paniculata) and brisk walking exercise on blood pressure in obese people in jekan raya district. specific objectives: this study specifically aims to: 1. knowing the effect on blood pressure of obese people in jekan raya district before and after giving jamu sambiloto (andrographis paniculata). 2. knowing the effect on blood pressure of obese people in jekan raya district before and after doing brisk walking exercise. 3. knowing the effect before and after giving jamu sambiloto (andrographis paniculata) and brisk walking exercise on blood pressure in obese people in jekan raya district.

this type of research uses the quasi experimental method type non-equivalent control group design, with a research design in the form of two group pre test and post test design, in this study there are two groups that will be measured pretest before intervention and post test after intervention and 1 control group without being given intervention. the intervention group is divided into two groups, namely the group given the sambiloto herbal medicine, and the group given the brisk walking exercise treatment. quasi-experimental research design with research design in the form of two group pre test and post test design.

Eligibility criteria:
inclusion criteria in this study are: body mass index (bmi) ≥ 25 kg/m2 (obesity 1) blood pressure does not exceed 139/89 mmhg (high normal) adult age (19-39 years) willing to be a respondent with informed consent have health insurance coverage exclusion criteria exclusion criteria in this study are: not in place or out of town during the study experiencing illness that cannot carry out research interventions and data collection resign during the study routine exercise (exercise every day less than 6000 steps). taking anti-hypertensive drugs regularly pregnant and breastfeeding mothers routinely consume jamu sambiloto history of bone and joint disease that prevents physical activity history of cardiovascular or kidney disease

Keywords: obese
neuronal and behavioral effects of implicit priming in obese individuals

Conditions: Feeding Behavior; Obesity; Overweight

Summary: the overall goals of this project are to determine the impact of an implicit priming intervention, designed to alter food perceptions, on both brain responses to food and on food intake behaviors in overweight/obese individuals. the investigators hypothesized that this bottom-up sensory-level conditioning approach would effectively result in reduced preference for high-calorie foods.

one factor that may contribute to susceptibility to obesity is a high responsivity to high-calorie foods in terms of cognitive factors such as emotional associations, reward value or reinforcing properties of food. many of these processes involve learned associations thought to develop via classical conditioning through repeated pairings with external stimuli, which can influence food preferences and intake. as such, improving our understanding of the neuronal mechanisms underlying these processes and attempting to modify them may be a useful strategy to promote weight loss and maintenance. therefore, the proposed study aims to investigate the effects of altering food perception on neuronal responses and food intake behaviors by using implicit priming, in which positively or negatively valenced images are presented immediately prior to food images, but are not consciously perceived. the project goals are to determine the impact of the implicit priming intervention on both brain responses to food cues and on food intake behaviors in overweight/obese individuals. food image ratings were assessed before and after either (a) an active implicit priming intervention or (b) a control intervention. one group of participants (n = 47; "mri sample") completed the intervention during an fmri scan and completed a visual food cues task both before and after the intervention (during fmri), to assess intervention-related change in neuronal responses to food cues. in this group, food intake measures were also taken following fmri. in a separate group of participants (n = 45; "behavioral-only sample"), the primary outcome measure was the change in food image ratings from pre- to post-intervention; fmri and measures of food intake were not assessed in this group.

Eligibility criteria:
inclusion criteria: * overweight/obese adults * healthy weight adults exclusion criteria: * vegetarian, vegan, or having other wide-ranging food restrictions * currently dieting * mri exclusion criteria, if in mri sample (e.g., claustrophobia, metal in the body)