Kornimate/medical-research-clean huggingface dataset:
isoflavone in prostate-specific antigen recurrent prostate cancer

Conditions: Biochemical Recurrent Prostate Cancer

Summary: primary outcome measures: decrease in rate of serum psa rise secondary outcome measures: adherence to treatment regimens quality of life as assessed by fact-p at baseline and at 12 months of treatment modulation of serum testosterone,isoflavone metabolites, and cholesterol estimated enrollment: 27 study start date: november 2003 estimated primary completion date: february 2007 (final data collection date for primary outcome measure)

* pretreatment evaluation included a complete medical history, physical examination (including digital rectal examination), serum psa, free/total testosterone, lipids, serum isoflavone levels (genistein, daidzein, and equol), and assessment of quality of life (functional assessment of cancer treatment-prostate, fact-p questionnaire). * whole blood will be obtained prior to initiation of the study to assess for dna polymorphism. * follow-up serum psa levels to assess efficacy were obtained at 3, 6, 9, and 12 months after initiation of treatment. * medical history, physical examination, serum testosterone, lipids, isoflavone, and quality of life were assessed at 6 and 12 months after initiation of treatment.

Eligibility criteria:
inclusion criteria: * raising serum psa profile after previous definitive therapy (e.g., radical prostatectomy or external beam radiation therapy). * life expectancy of at least one year and performance status of \<2 of zubrod scale. exclusion criteria: * metastatic or locally recurrent disease demonstrated on bone scan, computed tomography or transrectal ultrasound, or be clinically symptomatic at the time of enrollment * no androgen deprivation therapy (adt) or chemotherapy within 12 months of entry into the study. * known allergic reaction to milk or soy products were excluded.

Keywords: isoflavone, psa, prostate cancer, recurrent, quality of life
balance training in diabetic neuropathy

Conditions: Diabetic Neuropathy With Neurologic Complication

Summary: this study evaluates the efficacy of balance training in diabetic neuropathy. control group will receive general exercises while eperimental/ interventional group will receive balance exercises along with general exercises.


Eligibility criteria:
inclusion criteria: * age group: 30-60 years * diabetes type ii patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years * neuropathy present (on the basis of michigan neuropathy screening instrument * have balance impairment ( evaluation on berg balance scale) exclusion criteria: * neuropathy due to other medical conditions like vitamin deficiency, hypothyroidism, auto-immune/ demyelinating diseases * foot ulcers * lower limb amputee * vestibular diseases * retinopathy * cardiac problems * hemiplegia/ stroke

Keywords: diabetes mellitus type 2 diabetic neuropathy rehabilitation balance exercises berg balance scale
breast cancer implementation science study with educational intervention

Conditions: Breast Cancer

Summary: a study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adverse effects for her2+/her2 low breast cancer patients on or about to start on her2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (ae) management and patient-clinician communications.


Eligibility criteria:
inclusion criteria, patient participant group: * ≥ 18 years of age * confirmed diagnosis of her2+ or her2 low breast cancer who are receiving or are about to receive her2-targeted antibody drug conjugates (adcs) * patient must be able to sign informed consent and be willing to participate in and comply with protocol requirements (3 visits \[can be virtual\], entry of survey information, access training, subset: 2 interviews and focus group) \[all virtual\] * patient must be able to read, speak, and understand english * access to or ability to 1) enter information on computer or ipad into hipaa-compliant intelligent dashboard online database; and 2) access training on computer or ipad inclusion criteria, clinician participant group: * clinician agrees to see their own patients at study visits (baseline, interim time point, and end of study) in order to reduce inter-clinician variability that can affect result findings (observe effect of clinician's education on their patients' learning.) * clinician is a physician, np, physician assistant, nurse, or pharmacist who works with patients with her2-positive or her2-low breast cancer. * clinician must be willing to participate in and comply with protocol requirements and provide informed consent (per irb requirements), including availability for interviews (3), case role plays (3), patient visits (3/patient), and training * clinician agrees to access virtual online training videos: sdm, simulation case role play, management of adverse events for patients receiving her2-targeted adcs for her2-positive or her2-low breast cancer exclusion criteria, patient participant group: * history of noncompliance * inability to make required "office visits" (in-person or virtual) * inability to participate in training * non-ambulatory * limiting comorbidities (eg. psychiatric diagnosis; significant cognitive impairment limiting ability to fulfill protocol requirements) * pregnant patients * no internet and computer access exclusion criteria, clinician participant group: • inability to participate in required virtual visits, training, assessments, and other protocol requirements.
a randomized study of polarity or massage therapy to reduce fatigue in breast cancer patients during radiation therapy

Conditions: Fatigue

Summary: this research study is being conducted to compare the effectiveness of two types of complimentary medicine treatments to see if they will reduce the fatigue experienced by breast cancer patients receiving radiation therapy. the treatments being studied are polarity therapy and massage therapy. the primary study hypothesis is that polarity therapy will be efficacious in relieving fatigue in breast cancer patients receiving radiation treatments. the secondary hypothesis is that polarity therapy will be efficacious in improving health-related quality of life in breast cancer patients receiving radiation treatments.

this is a randomized three-arm clinical trial of an intervention examining the efficacy of polarity therapy for the relief of fatigue associated with radiation treatments in breast cancer patients. patients who meets the eligibility criteria and who have signed the consent form will be randomized to one of three trial arms: 1) polarity treatment 2) massage treatment 3) standard care. three treatments will be administered in the 4th, 5th, and 6th calendar weeks of radiation treatment. there will be weekly blood draws to assess cytokine levels. in addition, 6 saliva samples will be gathered per day for 2 days during each of the 4 study weeks to assess cortisol levels. saliva samples will be completed by the participant at home. an actigraph will be worn for the 28 day study period to assess activity and sleep. patients randomized to the standard care arm will receive a polarity or massage treatment gratis following the completion of the study.

Eligibility criteria:
inclusion criteria: * diagnosis of breast cancer * fatigue of 2 or greater on symptom inventory * received at least 8 radiation treatments * able to read english exclusion criteria: * be receiving concurrent chemotherapy * have bone metastasizes * be taking methylphenidate, modafinil, sedatives, or anxiolytics * have a hemoglobin \<11g/dl.

Keywords: fatigue polarity massage
stereotactic body radiotherapy based treatment for hepatocellular carcinoma with extensive portal vein tumor thrombosis

Conditions: Hepatocellular Carcinoma Non-resectable; Portal Vein Tumor Thrombosis; Stereotactic Body Radiotherapy

Summary: macrovascular invasion (mvi) is common in hcc, portal vein tumor thrombus (pvtt) is the most common form of mvi in hcc, with an incidence ranging from 44 to 62.2%. about 10% to 60% of hcc patients have pvtt at the time of diagnosis. the prognosis for those with pvtt remains poor, as their median survival is only 2-4 months via supportive care. there is currently no widely-accepted consensus for the management of hcc with pvtt. according to some guidelines in europe and america, hcc with pvtt is regarded as stage c per barcelona clinic liver cancer (bclc) staging system, and sorafenib alone is recommended as the treatment of choice. this study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.


Eligibility criteria:
inclusion criteria: 1. tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or tace; 2. an eastern cooperative oncology group (ecog) performance status (ps) of 0-2; 3. no refractory ascites; 4. child-pugh class a and b, or class c with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver exclusion criteria: 1. have received local or systemic treatments in the past, including but not limited to tace, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.; 2. diffuse hcc or accompanied by distant metastasis; 3. severe bleeding tendency or coagulation dysfunction within the previous 6 months; 4. patients with a history of hepatic encephalopathy

Keywords: hepatocellular carcinoma portal vein tumor thrombosis stereotactic body radiotherapy
low molecular weight heparin vs direct oral anticoagulant after bariatric surgery

Conditions: Deep Venous Thrombosis

Summary: extended venous thromboemboism prophylaxis after bariatric surgeries: a comparison of low molecular weight heparin with direct oral anticoagulant

this study aims to compare the effectiveness of rivaroxaban versus low molecular weight heparin in reducing the incidence of pmvt after bariatric surgery.

Eligibility criteria:
inclusion criteria: - bariatric patients exclusion criteria: * bleeding tendency
prevention of hypertension: a randomized trial

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases

Summary: to determine whether improved nutrition to correct overweight and high sodium intake, and regular frequent moderate rhythmic exercise to improve cardio-pulmonary fitness and to slow heart rate could lower blood pressure and prevent development of hypertension in hypertension-prone individuals.

background: diet modification is one of the strategies in the primary prevention of hypertension. studies of the association between various factors and blood pressure in different populations have shown the occurrence of specific dietary factors associated with elevated blood pressures. the factors include overweight, alcohol consumption and high sodium intake. heart rate is also an independent predictor of risk of hypertension. diet and exercise are amenable to intervention to influence blood pressure with the aim of reducing the risk of developing hypertension. design narrative: in the first phase of the trial participants were randomized to a monitored (control) group or to an intervention group receiving individualized intervention to achieve changes in diet and physical activity. the goals of the intervention group were: a reduction of at least 10 pounds or 5 percent of body weight for those above desirable weight; a reduction in daily sodium intake to 1800 mg; a modification of alcohol intake to no more than two drinks per day; and an increase in regular, moderate physical activity. the primary endpoint in the first phase of the trial was the comparison of mean blood pressure in the intervention group versus the monitored group. in the second phase of the trial, all randomized participants were followed for a minimum of five years. the primary endpoints in the second phase were the incidence of high blood pressure and/or hypertension.

Eligibility criteria:
men and women, ages 30 to 44. normal high blood pressure of 80-89 mm hg.
motor training for infants with cerebral palsy

Conditions: Cerebral Palsy

Summary: the intervention in this study, let's move, is a motor intervention for infants at risk for cerebral palsy. we will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.

the aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "let's move" delivered using a combined clinic and home (video telehealth) therapy model.

Eligibility criteria:
inclusion criteria: * age at enrollment: between 3-8 months corrected age * caregivers fluent in english * preterm infants with objectively defined severe diffuse white matter abnormality on mri at term or * high-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural mri or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before neonatal intensive care unit discharge and either: * "absent" fidgety movements based on the prechtl general movement assessment (gma) between 3-4 months corrected age or * a score of 56 or below on the hammersmith infant neuromotor examination (hine) between 3-6 months corrected age (31) exclusion criteria: * medical conditions that restrict active participation such as oxygen dependence * infants with significant visual deficits defined by the inability to track an object horizontally * living in a remote location prohibiting drives to the hospital every other week.

Keywords: motor skills occupational therapy physical therapy
entertainement and training after a hip fracture

Conditions: Hip Fractures; Exercise; Aging

Summary: older persons are at riskt for falls and fractures. after hip surgery they are normally treated with physical or occupational therapy. the additional use of computer based exercise games for training and the acceptance of such a technology are unclear. thus, we plant to assess the above outcome ins an observational pilot study.

falls and fall-associated fractures have a big medical burden on our societies. older persons who suffer from a fall that leads to a trauma and fracture often loose functional capacity. they may have prolonged mobility problems and are at risk for long-term care or nursing home institutionalization. to date, measures to prevent such negative outcomes are early mobilization and functional physical or occupational therapy immediately following orthopedic surgery. in addition, patients usually are asked to train at home after hospital discharge. this can be achieved by a home training program or by ambulatory physical therapy. recent technological development has introduced computerized training and gaming platforms into geriatric rehabilitation settings and home exercise training. games that have been developed for a younger population have now been adapted to the needs of older persons. a recent systematic review has demonstrated that such platforms. for example wii significantly improve balance and therefore have the potential to prevent falls\]. however to date such platforms have not been evaluated in a defined geriatric hospital patient population (e.g. after a hip fracture) as an adjunct to in-hospital physical therapy. thus, such platforms could be offered as an additional training opportunity.

Eligibility criteria:
inclusion criteria: living at home or in a retirement home (independent living situation) time between surgery and the start of the gaming intervention less or equal 10 days patient must be able to ambulate and to have full weight bearing exclusion criteria: the following exclusion criteria will apply * acute delirium (daily delirium observation score \> 3 during the first three consecutive days) lasting for more than 10 days. if the delirium resolves within the 10 day period (see above) patients without cognitive decline are still eligible. * a history of severe dementia prior to admission or poor cognition at admission after exclusion of delirium (moca score \< 15 or mmt \< 15). * patients who were initially admitted from a nursing home

Keywords: exergaming hip fracture training acceptance
cardiovascular medication use before first myocardial infarction

Conditions: Myocardial Infarction

Summary: large randomised trials have shown that cardiovascular medications prescribed to patients at high cardiovascular risk are effective in reducing the incidence of cardiovascular events. their use is recommended in the united kingdom and international guidelines (e.g. the national institute of clinical excellence). however, these medications do not prevent cardiovascular events in all patients and there is now a body of research investigating the effects of cardiovascular medications on outcomes in myocardial infarction (mi), including clinical presentation, infarct size and post-mi mortality. however, the independent effects of cardiovascular drugs on post-mi all cause mortality are unclear, and there are limitations to many of the published studies in terms of their cardiovascular drug exposure data. this project utilizes prospectively collected data on cardiovascular drug use, and links to mi data from hospital and mortality records.


Eligibility criteria:
inclusion criteria: patients in gprd practices which are deemed "up to standard" by gprd criteria will be included if their practice agreed to be linked to the myocardial ischaemic national audit project (minap), hospital episode statistics (hes) and office for national statistics (ons) datasets. patients must have at least one year of gprd "up to standard" registration before the date of first myocardial infarction. age over 18. first myocardial infarction occurring between 1st january 2003 and 31st december 2008, as recorded in the hes data or minap. exclusion criteria: patients will be excluded if they do not fulfil one of the inclusion criteria.

Keywords: myocardial infarction antiplatelets lipid lowering agents ace inhibitors angiotensin receptor blockers beta blockers blood pressure lowering drugs
virulence of staphylococcus lugdunensis in severe infections

Conditions: Staphylococcus Lugdunensis; Bacteremia; Endocarditis; Virulence Factors

Summary: the main objective is to identify new virulence factors produced by staphylococcus lugdunensis that can be associated with clinical sign of severe infections and identified symptoms. the methodological approach is based on the comparison between the production of toxins by a given s. lugdunensis isolate classified in patients groups according to the infection clinically defined. each group will be compared to the presence or not of studied virulence factors. clinical features associated with toxin activity are not known for s. lugdunensis. this comparative approach is based on the hypotheses that drove to the definition of patient groups and their clinical criteria. however, in the absence of the evident correlation between production of toxins and kind of infection, the statistical evaluation will be completed by a multi-varied analysis. this approach has not been choosen first because of the multiple parameters that undergo during infection that may reveal relationships without true correlation. about the number of included patients in each defined group, if one of them does not reach the expected count, we still might extend inclusions to 3-6 months more. the presence of severe infections without usually defined risk is intriguing. for these last patients, we have planned, after their individual consent to achieve an exome sequencing. the obtained data will be compared to available resources for the human genome. by filtering data through usual protocols, we hope to able to focus onto few genes that evoke specific sensitivity to infections, e.g. severe endocarditis due to s. lugdunensis without defined risk.


Eligibility criteria:
inclusion criteria: * age 18 or more * signed informed consent form * proved infection by staphylococcus lugdunensis: bacteremia, urine tract infection, endocarditis, bone and joint infections, skin and soft tissue infection, deep infection. exclusion criteria: * age under 18 * pregnancy or breastfeeding * contamination by staphylococcus lugdunensis
the sympara vibe study for hypertension

Conditions: Hypertension

Summary: the purpose of the vibe study is to evaluate the efficacy and safety of the sympara therapeutic system in the treatment of hypertension


Eligibility criteria:
inclusion criteria: * office systolic blood pressure of ≥150mmhg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit or a mean daytime systolic blood pressure ≥135mm hg on 24-hour ambulatory blood pressure measurement * receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician * minimum six- (6) month history of diagnosis and treatment of hypertension exclusion criteria: * previous renal denervation or carotid barostimulation implant * secondary causes of hypertension or primary pulmonary hypertension * prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery * known or suspected baroreflex failure or significant orthostatic hypotension * one or more hospital admissions for a hypertensive crisis within the past year * history of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (tia) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques * diabetes mellitus (type 1) * chronic renal disease requiring dialysis * kidney or liver transplant