Kornimate/medical-research-clean huggingface dataset:
optimizing treatment focused genetic testing in cancer

Conditions: Breast Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer

Summary: this two-part randomized controlled trial aims to evaluate the impact of pre-test video education as compared to pre-test chatbot education.

in this research study, the investigators are introducing the option of two alternatives to genetic counseling before genetic testing: chatbot and video education. the first part of this research study is a pilot study, which is the first-time investigators are examining the use of a chatbot to deliver pre-genetic test education. the chatbot will converse with you about germline genetic testing by text message. the pilot study will enroll 200 participants with a metastatic breast or ovarian cancer diagnosis and will assess the uptake of genetic testing among the two possible groups of pre-genetic test counseling. the second part of this research study will utilize findings from the pilot study for 1000 participants with a diagnosis of breast, ovarian, pancreatic or prostate cancer. in both parts of this research study, participants will be randomized to either the video education or chatbot. participants may request in-person genetic counseling after their respective education prior to testing. other studies at both dfci and outside institutions have started to investigate alternative methods of educating patients about genetic testing. these studies have suggested that alternatives to standard genetic counseling may increase access to genetic testing with similar satisfaction to standard of care. the investigators are hoping to get a sense of participants' preferences for pre genetic test education, understanding, and reactions to the alternative methods of genetic counseling. the investigators are also hoping to understand preferences for communication of their result and whether any treatment changes have been made after they receive their result.

Eligibility criteria:
inclusion criteria: * adult patients over the age of 18 * with a diagnosis of advanced cancer (defined as stage 3 or 4), or * any stage for pancreatic cancer and * no prior cancer genetic panel testing exclusion criteria: * adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women (if known at the time of participation) * prisoners * non-english speakers

Keywords: other cancer
stress in working life

Conditions: Occupational Stress

Summary: the goal of this realist evaluation of a danish cognitive behavioral therapy (cbt)-based stress management for patients with work-related stress is to understand what works, for whom, in what circumstances.the main objectives are: to assess the effect of the stress management intervention on sustainable return to work. to investigate what contexts and mechanisms are associated with patients' return to work rates and level of perceived stress after having received the stress management intervention. to understand from a patient perspective how mechanisms work in specific contexts to generate effects of the stress management intervention. the evaluation comprises two observational studies and one interview study. the intervention cohort are patients with work-related stress who received the stress management intervention between 2012-2018. the comparison cohort are patients who would have been eligible to receive the intervention in 2011-2012, however they did not receive any intervention because it was not offered at that time. in study one return to work rates are compared between the intervention cohort and the comparison cohort to find out if the intervention can help patients return to work at a faster rate. study two will investigate if there are any explanatory variables (such as work type, civil status or level of depressive symptoms) that may explain why some patients benefit more or less from the intervention. study three will explore what it is about the intervention (mechanisms) the patients find are helping them to cope with stress or the opposite in specific circumstances.


Eligibility criteria:
inclusion criteria: * exposure to stressful conditions at work such as a large workload and/or stressful organisational and managerial conditions. * patients must be employed, and if on sick leave there must be plans for return to work during the intervention period. * patients must exhibit severe signs of work-related stress meaning that there must have been a significant work-related impact, the patient must have had physical, psychological, and behavioural stress symptoms for more than four weeks. exclusion criteria: * patient's work-related stress is primarily caused by cooperation problems, bullying and/or harassment, * long-term sick leave \>26 weeks up to referral * more severe stress load outside of work * severe psychiatric conditions that requires treatment * current abuse of alcohol and/or psychoactive stimulants.

Keywords: occupational stress cognitive behavioural therapy realist evaluation
an innovative smartphone application for adverse event management during breast cancer adjuvant chemotherapy

Conditions: Breast Cancer

Summary: the aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (tac) chemotherapy. the investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (qol) scores and reduce adverse events.


Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of invasive breast cancer 2. breast surgery within the past 2-8 weeks 3. adult female 4. must be able to use mobile phones 5. speak and write chinese fluently to sign the informed consent exclusion criteria: 1. severe comorbidity that interferes with outcome evaluation 2. insufficient chinese language skills 3. inability to use mobile phones 4. cognitive disability to give informed consent

Keywords: application adverse event quality of life chemotherapy
a new 3d virtual reality-based upper limb training to improve dexterity in parkinson's disease

Conditions: Parkinson Disease

Summary: we investigate the impact of a 4-week virtual reality-based upper limb training in parkinson's disease. the benefits on dexterity of this training program will be evaluated. for these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.

patients with parkinson's disease (pd) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (adl), such as dressing, grooming as well as higher adl, such as cooking, shopping and regular medication intake. these difficulties further add to the burden of the disease, leading to reduced quality of life (qol). a relatively new, but rapidly growing aspect of training in pd neurorehabilitation offers virtual reality (vr). we explore the effects of a vr-based upper limb hand training compared to a vr control training, which is less specific for dexterity. moreover, we examine the effetcs of the trainings on upper limb related adl, and therefore the impact on qol in patients with pd.

Eligibility criteria:
inclusion criteria: * patients with confirmed pd, according to uk brain bank criteria * hoehn \& yahr stadium i to iv * age 40 to 99 years * written and signed informed consent * self-reported dexterous difficulties exclusion criteria: * moca \<21/30 * psychiatric disease * participation on other interventional trials * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * severe visual impairment

Keywords: parkinson disease virtual reality training dexterity parkinsonian disorders basal ganglia diseases brain diseases central nervous system diseases nervous system diseases movement disorders neurodegenerative diseases
coadministration of ezetimibe with fenofibrate versus pravastatin monotherapy for the treatment of hyperlipidaemia in hiv-infected patients

Conditions: HIV; Hyperlipidemia; HIV Infections

Summary: * the aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in hiv-infected patients treated with protease inhibitors. * single-centre, open, randomized, controlled, prospective pilot study. * 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. the patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.the visit will be every month.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * documented positive hiv antibodies test * on stable therapy with pis for at least 12 months * ldl-cholesterol \>130 mg/dl or triglycerides 200 - 500 mg/dl with non-hdl cholesterol \>160 mg/dl * unresponsive to dietary measures and regular physical exercise of at exclusion criteria: * history of dyslipidemia before antiretroviral therapy * cardiovascular and cerebrovascular diseases * cushing's syndrome * concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers * hypothyroidism * type 1 diabetes mellitus * renal failure

Keywords: treatment experienced
study to assess the efficacy and safety of sk3530 on erectile dysfunction in patients with diabetes mellitus

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to evaluate the efficacy and safety of sk3530 on erectile dysfunction in patients with diabetes mellitus.

sk3530 is a potent and selective phosphdiesterase type 5(pde 5) inhibitor developed for the treatment of erectile dysfunction(ed). since ed is common in men with diabetes mellitus, it is important to determine the efficacy and safety of sk3530 on erectile dysfunction in patients with diabetes mellitus.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 1 or type 2 diabetes. * score below 25 from iief ef domain during 4 weeks of treatment run-in period. * failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period. exclusion criteria: * lab abnormality. * uncontrolled diabetic mellitus(hba1c \> 12%). * high or low blood pressure, orthostatic hypotension. * hyper- or hypo-thyroidism.

Keywords: erectile dysfunction diabetes mellitus sk3530
urinary infection in pregnant women with urinary infection

Conditions: Threatened Preterm Labour

Summary: urine analysis and culture in patients with threatened preterm labour

uti is an infection of the kidneys, bladder, or urethra. infectious cystitis is the most common type of uti, which is caused by a bacterial infection of the bladder. lifetime incidence of utis is 50% to 60% in adult women.utis are among the most common conditions encountered in primary care, hospitals, and extended care facilities . total direct costs of uti treatment (without cultures) have been estimated at us $25.5 billion annually.despite an exceptionally high prevalence of bacteriuria in the population, these infections rarely cause significant renal damage.sexual intercourse is the strongest risk factor. any lifetime sexual activity and any sexual activity during the past year are strongly associated with recurrent uti. even the relatively small amounts of spermicide coating condoms increases the risk of uti. post-menopausal absence of oestrogen is a risk factor for utis. topical oestrogen reduces utis in post-menopausal women; oestrogenisation of the vaginal mucosa promotes lactobacilli colonisation, which reduces the presence of uropathogens and thus the risk of utis and is not recommended over the use of topical oestrogen therapy. urinary incontinence and oestrogen supplementation have also been associated with uti in older women, although the reasons for this are incompletely understood. positive family history of utis is associated with a two- to fourfold increase in risk of recurrent uti . bacteriuria occurs in the presence of indwelling or intermittent catheters, and asymptomatic bacteriuria does not require treatment. gestational and pregestational diabetes are considered a more predominant risk factor in older women.

Eligibility criteria:
inclusion criteria: * pregnant women with preterm labor exclusion criteria: * renal disease intrauterine fetal death

Keywords: uti preterm labour
impact of virtual reality before oocytes retrieval on anxiety and pregnancy rate

Conditions: Anxiety; in Vitro Fertilization; Virtual Reality

Summary: the primary objective of this study is to evaluate the impact of a session of virtual reality (vr) with the objective of lowering the anxiety level on the clinical pregnancy rate following an in-vitro fertilisation (ivf) procedure. indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. this level of stress influences the effect of the infertility treatment. reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.


Eligibility criteria:
inclusion criteria: * adult patients benefiting from an oocytes retrieval as part of their ivf at cliniques universitaires saint-luc. * simple ivf / ivf intracytoplasmic sperm injection (icsi) exclusion criteria: * patients with long-term psychotherapeutic treatment * patients taking psychotropic drugs * patient blind and deaf
microvascular coronary resistance and absolute coronary flow in patients with percutaneous intervention of a chronic total occlusion

Conditions: Chronic Total Occlusion of Coronary Artery; Microvascular Coronary Artery Disease; Coronary; Ischemic; Coronary Microvascular Dysfunction

Summary: it is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure. the aim of the study is to check the variation in the values of the index of microcirculatory resistance (imr) and invasive absolute coronary flow (af). the working hypothesis is that, in the follow-up of these patients, af will increase significantly with respect to its baseline and, conversely, imr will be reduced during the follow-up.


Eligibility criteria:
inclusion criteria: * those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. as a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure. exclusion criteria: * no specific exclusion criteria.
a study of trastuzumab-mcc-dm1 in patients with her2- positive locally advanced or metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: this is a multicenter, open-label, single-arm, expanded access study designed to provide t-dm1 to patients with her2-positive locally advanced or metastatic breast cancer and to evaluate the safety and efficacy of t-dm1 administered by intravenous (iv) infusion.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented breast cancer * locally advanced or metastatic breast cancer * her2-positive breast cancer documented as fish-positive, ihc 3 + or cish-positive by local laboratory assessment * histologically or cytologically confirmed invasive breast cancer: incurable, unresectable, locally advanced breast cancer previously treated with multimodality therapy or metastatic breast cancer * prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting must include both: a taxane, alone or in combination with another agent, and trastuzumab, alone or in combination with another agent in the adjuvant, unresectable, locally advanced, or metastatic setting * documented progression of incurable unresectable, locally advanced, or metastatic breast cancer during their most recent treatment regimen * progression must occur during or after most recent treatment for locally advanced/metastatic breast cancer or within 6 months after completing adjuvant therapy * adequate hematologic and end organ function * agreement to use an effective form of birth control throughout the study * life expectancy ≥ 90 days as assessed by the investigator exclusion criteria: * less than 14 days from the first study treatment since the last anti-cancer therapy, including chemotherapy, biologic, experimental, immune, hormonal or endocrine therapy * prior t-dm1 therapy * history of exposure to cumulative doses of select anthracyclines * history of intolerance or hypersensitivity to trastuzumab, murine proteins, or any of the excipients, that resulted in trastuzumab being permanently discontinued * brain metastases that are untreated or progressive or currently require any type of therapy, including radiation, surgery, and/or steroids to control symptoms from brain metastases within 30 days before the first study treatment * peripheral neuropathy of grade ≥ 3 per national cancer institute common terminology criteria for adverse events (nci ctcae), version 4.0, at the time of the first study treatment * history of clinically significant cardiac dysfunction * current known active infection with hiv, hepatitis b virus, or hepatitis c virus * current severe, uncontrolled systemic disease * major surgical procedure or significant traumatic injury within 28 days prior to first study treatment * pregnancy or lactation note: the site selection process has been completed. patients can enroll at participating sites.

Keywords: tdm-1 eap t-dm1 eap tdm1 eap trastuzumab-mcc-dm1 eap trastuzumab emtansine eap t-pas
a single-dose crossover study of mk0893 in patients with type 2 diabetes (0893-019 am4)(completed)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess the effect of combined treatment with mk0893 plus propranolol versus placebo plus propranolol on hypoglycemia.


Eligibility criteria:
inclusion criteria: * participant has type 2 diabetes (t2dm) * participant is either: not on an oral antihyperglycemic medication for at least 6 weeks; on a single oral antihyperglycemic medication that is not a peroxisome proliferator-activated gamma (ppar-gamma) agonist (e.g. avandia); or on a combination of no more than two antihyperglycemic medications that are not ppar-gamma) agonists * participant has not received insulin for at least 6 months * participant has not been treated with a ppar-gamma agonist for at least 12 weeks * participant has been a nonsmoker for at least 6 months * female participants who are non-pregnant and highly unlikely to conceive due to surgical sterilization, post-menopausal status, not heterosexually active, or willing to use 2 birth control methods exclusion criteria: * participant has a history of stroke, seizures, or neurological disorders * participant cannot tolerate insulin or propranolol * participant has a history of asthma, emphysema or chronic bronchitis * participant is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication within 8 weeks of screening * participant is on or may require treatment with drugs that affect the immune system or with corticosteroids * participant has a history of heart failure or coronary artery disease * participant has a history of uncontrolled high blood pressure * participant is human immunodeficiency (hiv), hepatitis b or hepatitis c positive * participant has a history of type 1 diabetes * participant has a history of hypoglycemia unawareness documented by a blood glucose concentration \< 55 mg/dl (3.1 mol/l) without symptoms of hypoglycemia.
study of repetitive transcranial magnetic stimulation (rtms) as add-on treatment for early alzheimer's disease

Conditions: Alzheimer's Disease; Cognition Disorders

Summary: the aim is to examine the effect of repetitive transcranial magnetic stimulation (rtms) applied at the anodic left cortex dorsolateral prefrontal (cdlpf) of patients with early alzheimer's disease (ad). this study included 15 patients treated with rtms and whose medication reference is stabilized for 3 months by iache. patients with early ad or related disease will be selected in the mcrr of besançon and the psychiatric department of the university hospital of besançon. after giving informed consent, patients will be evaluated by a psychiatrist using the mattis clinical demantia rate (cdr), the hamilton depression rating scale (hdrs), state-trait anxiety inventory (stai), beck depression inventory (bdi) and hamilton anxiety scale (hama). the complete assessment takes 40 minutes. a second evaluation will be realized by a neuropsychologist takes around 120 minutes using mattis cdr, grober free and cued selective reminding test, trail making test (tmt), crossing of test (cot), isaacs set test (sti) , clock-drawing test (cot), signoret's battery of cognitive efficacy (bec96), rey-complex figure test-copy and picture naming 80 items test (do80). each rtms session runs 20 minutes during which pulse trains of 5 seconds of 10 hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session) will be delivered. a psychometric assessment will be conducted again at the end of treatment week and one month after stopping treatment. a neuropsychometric assessment will be conducted one month after stopping the treatment. scales of comfort and acceptability will also be proposed to the patient to determine whether any gene is caused by this treatment. moreover a questionnaire will be proposed to the caregivers (at baseline, at the end of the treatment and 1, 2, 3 and 4 weeks after stopping the sessions) using resource utilisation dementia (rud), apathy inventory (ai), activities of daily living (adl) scale, instrumental activities of daily living (iadl) scale, quality of life in alzheimer's disease (qol-ad) scale, questionnaire of recent change of the personality (cp6). the population of this study will be comprised of patients between 60 to 85 years-old with early alzheimer's characterized according to nincds-adrada criteria. these patients will be recruited on a voluntary basis, after notification and consent in the research center. this study was conducted over a period of 15 months.


Eligibility criteria:
inclusion criteria: * subject diagnosed with early alzheimer's disease or related diseases according to nincds-acdrada criteria. * subject under treatment by iache for at least 3 months. * cdr score ≤ 2 * psychotropic treatments are tolerated if they were administered and unchanged for at least 3 months exclusion criteria: * cdr \> 2 * subjects diagnosed with psychiatric disorder (depression according to dsm-iv criteria, bipolar disorder, schizophrenia, addiction)

Keywords: alzheimer's disease rtms cognition