Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of polyethylene glycolated il-2 (peg il-2) plus zidovudine or dideoxyinosine in hiv positive, asymptomatic and symptomatic individuals

Conditions: HIV Infections

Summary: to investigate the safety of polyethylene glycolated interleukin-2 (peg il-2) given subcutaneously in conjunction with antiviral treatment and to explore the effects of treatment on surrogate markers of efficacy and incidence of opportunistic infection and other clinical markers of hiv disease.

four escalating doses of peg il-2 are studied. patients are stratified by cd4 level. cd4 levels in group a are 200 to 500 cells/mm3; in group b - 1 to less than 200 cells/mm3. further stratification is by p24 positive or negative, antiviral therapy for more or less than a year, and zidovudine (azt) versus didanosine (ddi). the duration of peg il-2 treatment is a maximum of 28 weeks. this is an outpatient study; patients will be observed for four hours after the first dose of peg il-2 and for one hour after subsequent doses.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity by commercially available elisa. * meet disease status criteria. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * concurrent neoplasms other than basal cell carcinoma of the skin, in-situ carcinoma of the cervix or limited cutaneous kaposi's sarcoma. * recently treated hiv-related lymphoma. * major organ allograft. * presence of space occupying central nervous system (cns) lesions or other conditions which would be anticipated to cause cerebral edema. * renal compromise or use of drug therapy anticipated to lead to renal compromise. * active opportunistic infection requiring hospitalization or exclude medication. * requiring continual acyclovir for suppression of herpes infection. concurrent medication: excluded: * acyclovir. * drug therapy anticipated to lead to renal compromise. patients with the following are excluded: * intolerance to zidovudine (azt) at 300 mg/day divided q8h or didanosine (ddi) at 7 mg/kg/day given twice a day. * history of hiv-related lymphoma. * history of asthma requiring frequent therapy, chronic pulmonary disease, hypertension requiring therapy, or congestive heart failure. * any of the symptoms or conditions listed in exclusion - co-existing conditions. prior medication: excluded: - any prior therapy with interleukin-2 (il-2) or peg il-2. excluded 30 days prior to study entry: - treatment with other anti-hiv medication or known immunomodulators or other chemotherapy or radiation therapy. active substance abuse so patients would be anticipated to be poorly compliant with protocol requirements.

Keywords: recombinant proteins polyethylene glycols interleukin-2 didanosine zidovudine
efficacy of music therapy protocols for burn debridement

Conditions: Pain Management

Summary: the purpose of this prospective, crossover randomized study is to explore the efficacy of two music therapy protocols on pain, anxiety, and muscle tension levels throughout the debridement process in individuals hospitalized with moderate to severe burns.

the study is a prospective, randomized crossover clinical trial conducted on a 14-bed inpatient comprehensive burn care center. the purpose of this study is to investigate the efficacy of music-based imagery (mbi) and music alternate engagement (mae) for pain and anxiety management for burn patients throughout the debridement process.

Eligibility criteria:
inclusion criteria: * patient is admitted for at least three days (excluding day of admission) * patient is at least seven years old * patient is able to communicate, i.e. awake and alert * patient is oriented exclusion criteria: * patient admitted for/less than three days * patient under seven years of age * patient not able to communicate, i.e. sedated and/or intubated * patient is not oriented, i.e. active psychosis, hallucinations, delusions, late-stage alzheimer's or dementia diagnoses

Keywords: music therapy pain anxiety muscle tension
pain after stroke, part 2: clinical characteristics and classification of pain in patients after stroke

Conditions: Pain

Summary: the purpose of this study is to investigate the prevalence of characteristics of pain in a cohort of patients with prior stroke suspected of having central post stroke pain, identified through a postal questionnaire.

medical history, pain history, pain drawing, dn4, sensory examination.

Eligibility criteria:
inclusion criteria: * possible neuropathic pain following stroke exclusion criteria: * severe dementia * severe language barriers * patients who cannot cooperate

Keywords: central neuropathic pain central post-stroke pain stroke pain
wbv and acute lateral ankle sprain

Conditions: Postural Control; Subjective Instablity

Summary: the aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus wbv in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months

background: ankle sprains often result in ankle instability, which is most likely caused by damage to passive and neurological structures. whole body vibration (wbv) is a neuromuscular training method improving those neurologic parameters impaired. the aim of this study is to compare the current gold standard functional treatment to functional treatment plus wbv in patients with acute unilateral unstable inversion ankle sprains. methods/design: 60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. patients will be randomized by envelope drawing. all patients will be allowed early mobilization and pain-depending weight bearing, limited functional immobilization by orthesis, price, nsards as well as home and supervised physiotherapy. supervised physical therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a standardized intervention protocol. during supervised physical therapy, the intervention group will perform similar exercises on a side-alternating sinusoidal vibration platform as the control group. two time dependent primary outcome parameters will be assessed. short-term outcome after six weeks will be postural control quantified by the sway index. mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. secondary outcome parameters include return to pre-injury level of activities, residual pain, recurrence, objective instability, energy / coordination, foot and ankle disability index and eq 5d.

Eligibility criteria:
inclusion criteria: * acute, unilateral, unstable, inversion ankle sprain (grade ii, iii) exclusion criteria: * pregnancy * conditions affecting the neuromuscular- or musculoskeletal system * previous surgical interventions to the foot, ankle, knee or hip; known fai, cai * conditions possibly affecting balance * cardiovascular disease including thrombosis * respiratory diseases * abdominal diseases (including gallstones) * urological diseases (including kidney- and bladder stones) * gynaecological diseases and + intrauterine devices * neurological diseases including epilepsia within the last 2 years * acute injuries to the head * patient is not available for follow up visits * patient unable to give informed consent * patient suspected to be non-compliant
effect of hormonal replacement therapy on nocturia in postmenopausal women

Conditions: Nocturia

Summary: aim of this study was to observe the study was adjusted in two parts: part 1 is a crossectional study in which the prevalance, risk factors and etiology of nocturia among postmenopausal women is assessed. part 2 is a cohort study observing the impact of 10 different hormonal substitution therapies on nocturia.


Eligibility criteria:
inclusion criteria: * women with postmenopausal symptoms (hot flushes, atrophy, ..) * all women were 'early' postmenopausal stages +1a,+1b or +1c as defined by the 'stages of reproductive aging workshop' (straw) criteria exclusion criteria: * intake of hrt on the moment of inclusion * women with thyroid dysfunction * women using antihypertensive agents * women with a history of psychiatric or neurological disorders * women with a history of alcohol or drug addiction.
bed rest and muscle strength in icu: interest in the early association of nems with cyclo-ergometer mobilization

Conditions: Weakness, Muscle

Summary: muscles atrophy and weakness are common in intensive care units, their origin is multifactorial. passive then active mobilization with cyclo-ergometer have shown to improve functional abilities and limit muscle weakness among intensive care unit patients. electrical muscle stimulation should limit the atrophy and muscle weakness in intensive care unit associated with early mobilization. this study aims to compare the association early cyclo-ergometer mobilization with electrical muscle stimulation versus cyclo-ergometer mobilization only to prevent muscle atrophy and weakness in intensive care unit.


Eligibility criteria:
inclusion criteria: * patient affiliated to a social security scheme * patient hospitalized in intensive care unit for medical or surgical reasons, under assisted ventilation (invasive, non-invasive ventilation or oxygen-therapy at high speed via the optiflow(r) system delivering a flow between 30 and 60 l.min and a fio2 between 30 and 100%) * state of the patient deemed stable buy the doctor responsible for the care and allowing the action of the physiotherapist (acts on medical prescription) * age more than 18 years old (major patient) and less than 75 years old * duration of mechanical ventilation (invasive or not) less than or equal to 72 hours at the beginning of the inclusion * predicable duration of stay greater than or equal to 3 days exclusion criteria: * impossibility to know the consent of the patient, his legal representative or the person of trust * patient under safeguard of justice, tutorship or curatorship * legionnaire not rectified * cardiac stimulator or defibrillator * cardiorespiratory state clinically not compatible withe early mobilization * neurological problems: intracranial pressure \> 20 mmhg, presence of icu acquired neuropathy, pre-existing diagnosis of neuromuscular disease (ms, als...), acute stroke, epilepsy * orthopedic problems: even partial amputation of a lower limb, unstable fracture, suspicion of fracture, non-fixed spinal cord injury, use of a technique that does not allow to comply with postoperative surgical instructions (range of motion, discharge...), untreated deep vein thrombosis, traumatic sequelae to the origin of disabling manifest muscle weakness of a lower limb at admission * dermatological problems: severe lesions or complex dressing in the lower limbs * morphological criteria : size \ 35 * confirmed psychiatric illness or severe agitation * abdominal surgery without protection by compression belt (medical prescription), or too fragile (medical opinion) * pregnant or lactating women (postpartum is not an exclusion criterion) * patients over 75 years old * hemiplegia / sequential hemiparesis * impossibility to practice electrostimulation on at least one lower limb (manifest muscle weakness of a lower limb at admission (e. g. related to a traumatic sequelae)

Keywords: intensive care units critical illness rehabilitation muscle atrophy muscle weakness cyclo-ergometer electrical muscle stimulation
haal: healthy ageing eco-system for people with dementia

Conditions: Dementia; Devices; Artificial Intelligence; Older People; Caregiver Burden

Summary: haal project aims to test several technological devices in order to improve the quality of life of older people with dementia and their informal and formal caregiver.

the haal study is a feasibility study. the general objectives of the haal project is to be assessed the stress relief at work for formal and informal caregivers, the improvement in the perceived quality of life for informal caregivers and person with dementia, the reduction in case load for the formal caregivers and the increased cost-effectiveness of the haal solution in comparison to the available services. the experimentation will be carried out in 3 sites: italy, the netherlands and taiwan. the study consists in a alpha phase (5 older adults with dementia, 5 formal caregivers and 5 formal caregivers) and in a beta phase (10 older adults with dementia, 10 formal caregivers and 10 formal caregivers).

Eligibility criteria:
inclusion criteria: * being the caregiver of a person with cognitive impairment or dementia; * availability of time to participate; * visit the assisted person at least two times at week or live with him/her. exclusion criteria: * lack of written informed consent

Keywords: dementia caregiver older people technological devices quality of life
clinical study of yq1 plus cisplatin-based chemotherapy in advanced nsclc egfr wild type

Conditions: Epithelial Growth Factor Receptor Negative Non-small Cell Lung Cancer

Summary: this randomized pilot phase ii trial studies the effect of yq1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with egfr/alk wild type non-small cell lung cancer, stage iiib-iv.

this randomized pilot phase ii trial studies the effect of yq1, a herbal medicine, with cisplatin-based chemotherapy on gut microbiota and immune response in patients with egfr/alk wild type non-small cell lung cancer, stage iiib-iv. chinese herbal medicine was known to be beneficial adjuvant or alternative medicine for cancer treatment. however, the mechanism was unknown. this study wants to investigate the effect and mechanism of yq1, which was proved to improve the antitumor immunity, to inhibit cancer progression, and to prolong overall survival of lung adenocarcinoma in a series of preclinical studies.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) that is advanced/metastatic (stage iiib/iv), egfr/alk wild type. * subjects who plan to receive cisplatin-based chemotherapy. * ability to understand and the willingness to sign an institutional review board (irb)-approved informed consent document exclusion criteria: * ecog performance status \>= 3 * wbc =\< 4,000 cells/μl, anc =\< 1,500/mcl, platelets =\< 100,000/mcl , hemoglobin =\< 9 g/dl, * total bilirubin \>= 1.5 x upper limit of normal (uln), ast \>= 1.5x uln, alt \>= 2.5 x uln, creatinine \>= 1.5x uln * current uncontrolled cardiac disease such as angina or myocardial infarction, congestive heart failure. * chronic or current inflammatory bowel disease, post-surgery of intestine, lynch syndrome, fap, peutz-jegher. * history of allergic reactions cisplatin * pregnant women are excluded; breastfeeding should be discontinued prior to study entry. * received any other clinical trail at the same time. * current dementia or other cognitive disorders.

Keywords: chemotherapy herbal medicine lung cancer
phase ib study of ldk378 and auy922 in alk-rearranged non-small cell lung cancer

Conditions: Anaplastic Lymphoma Kinase (ALK); Non-small Cell Lung Cancer

Summary: the primary purpose of the study is to estimate the maximum tolerated dose of the combination of ldk378 and auy922. this study will assess the safety, tolerability, pharmacokinetics and preliminary evidence of anti-tumor activity of the combination of ldk378 and auy922 in alk-rearranged non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic nsclc that has progressed during or following therapy with an alk inhibitor * tumor must carry an alk rearrangement in 15% or more of tumor cells as measured by fish * disease that can be evaluated by recist v1.1 and measurable disease exclusion criteria: * central nervous system (cns) metastases that are symptomatic or require increasing steroids or cns-directed therapy to control cns disease * history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis * clinically significant cardiac dysfunction * inadequate end organ function as defined by specified laboratory values * use of medications known to be strong inhibitors or inducters of cyp3a4/5 that cannot be discontinued at least 1 week prior to start of treatment * use of medications that are mainly metabolized by cyp3a4/5 or cyp2c9 that cannot be discontinued at least 1 week prior to start of treatment * clinically significant, uncontrolled impaired gastrointestinal function or gi disease * prior treatment with a hsp90 inhibitor * radiotherapy to lung within 4 weeks prior to the first dose of study treatment or patients who have not recovered from radiotherapy-related toxicities * pregnant or nursing women * history of pancreatitis or history of increased amylase or lipase that was due to pancreatic disease.

Keywords: anaplastic lymphoma kinase, alk-rearranged lung cancer, non-small cell lung cancer
pharmaceutical literacy and quality of life in spanish population.

Conditions: Health Related Quality of Life; Literacy

Summary: the goal of this study is to learn about the knowledge and abilities that patients have regarding their own medication and to see if that's related to their quality of life. the main questions it aims to answer are: * are patients abilities and knowledge about their medications sufficient to ensure a safe and efective use? * are those knowledge and abilities related to the patient's quality of life? how? patients already taking at least one medication will answer questions about their abilities and knowledge towards medication and their quality of life related to their health state.

a cross-sectional study is carried out, consisting of an interview between the patients and community pharmacists included in the study. the participants selected are adults usually taking medication that answer questions related to their pharmaceutical literacy (ralph interview). this type of literacy refers to three domains regarding functional, comunicative and critical abilities about their own medication. after that, every participant answers a simple survey regarding their health-related quality of life including topics such as mobility, self-care, everyday activities, pain and mental health (eq-5d-5l survey). the recruitment and interviewing take place at the same time, and it requires less than 30 minutes per patient. no follow-up is needed afterward. there are no risks associated with this procedure, and the participation of the patients will always be voluntary and anonymous. previously to the patients' enrollment in the study, proper information will be given to the potential participants and an informed consent will be signed.

Eligibility criteria:
inclusion criteria: * adults currently taking at least one medication prescribed by a physician and living in spain. exclusion criteria: * having physical or cognitive limitations that make it impossible to answer the study questions.

Keywords: pharmaceutical literacy health related quality of life spain community pharmacist
hanyang university medical center (hyumc) registry

Conditions: Coronary Artery Stenosis; Coronary Artery Disease; Blood Pressure

Summary: the hyumc registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. from january 2012, pci-treated patients from hanyang university seoul hospitals and hanyang university guri hospitals were enrolled in this registry. the aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.

in the hyumc registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. the primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.

Eligibility criteria:
inclusion criteria: consecutive patients with cad who underwent pci one or more drug eluting stent (des) with from 2012 at the division of cardiology of hanyang university seoul hospital and hanyang university guri hospital, korea. exclusion criteria: * second or subsequent hospitalization records of patients with multiple admissions * patients who died during index hospitalization * patients who treated with first-generation drug eluting stent * patients with an outpatient follow-up record of less than 6 months * patients with insufficient medical records.
mechanisms of increased ambulatory blood pressure in patients with intradialytic hypertension

Conditions: Intradialytic Hypertension

Summary: the purpose of this study is 1) to determine what physiologic factors (extracellular fluid overload or vasoconstriction) contribute more to increased blood pressure levels between dialysis treatments in hemodialysis patients whose blood pressure increases and decreases during hemodialysis and 2) to determine whether carvedilol provides better control of blood pressure between dialysis treatments than prazosin in patients whose blood pressure increases during dialysis.


Eligibility criteria:
inclusion criteria (for aims 1 and 2): * age more than 18 years * hypertension defined as systolic blood pressure more than 140 mmhg before dialysis or more than 130 mmhg after dialysis * for case subjects with intradialytic hypertension: systolic blood pressure increase more than 10 mmhg from pre to post dialysis in at least 4 out of 6 screening treatments * for control subjects: systolic blood pressure decrease more than 10 mmhg from pre to post dialysis in at least 4 out of 6 screening treatments inclusion criteria for aim 3 includes the case subjects described above. exclusion criteria: for aims 1 and 2: * hemodialysis vintage less than 1 month * amputated arm or leg * presence of cardiac defibrillator or pacemaker * presence of large metal prosthesis * failure to achieve dry weight for case subjects participating in aim 3: * patients with a specific indication for beta blocker therapy including systolic heart failure, history of myocardial infarction, history of tachyarrhythmia or angina being managed with beta blocker therapy. * patients with contraindications to beta blockade including bradycardia (heart rate less than 60 beats per minute) while not on a pulse lowering drug, severe reactive airway disease, prior intolerance to beta blocker therapy * prior intolerance to alpha blocker therapy

Keywords: intradialytic hypertension hemodialysis hypertension extracellular volume endothelial cell dysfunction endothelin 1 carvedilol