Kornimate/medical-research-clean huggingface dataset:
sorafenib for imatinib/sunitinib-failed gist

Conditions: Gastrointestinal Stromal Tumors

Summary: with discovery of kit (cd117) mutations and the advent of kit tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (gist). recently, sunitinib showed activity as second-line therapy in gist patients after failure with imatinib. however, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. in preclinical models, sorafenib inhibits kit activity and cell growth of imatinib-resistant tumors. the objective of this multi-center, non-randomized phase ii study is to evaluate the safety and activity of sorafenib given as third-line therapy for gist.

this is a non-randomized, open-label, multi-center, phase ii study recruiting patients with advanced gist who are pretreated with both imatinib and sunitinib. the current study will provide an estimate of the activity and safety of sorafenib in gist. the primary study endpoint is the disease control rate (dcr), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. secondary endpoints include pfs, os and safety. patients with advanced (unresectable and/or metastatic) gist who failed after previous therapy involving both imatinib and sunitinib will be eligible. failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. there is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other tkis, or chemotherapy in addition to imatinib or sunitinib).

Eligibility criteria:
inclusion criteria: * age over 18 years * advanced gist * failed (progressed and/or intolerable) after prior treatments for gist * ecog performance status of 0\~2 * resolution of all toxic effects of prior treatments * no prior radiotherapy within 1 month before registration * measurable lesion as defined by recist * adequate marrow, hepatic, renal and cardiac functions * provision of a signed written informed consent exclusion criteria: * severe co-morbid illness and/or active infections * pregnant or lactating women * history of other malignancies * active cns disease not controllable with radiotherapy or corticosteroids * active and uncontrollable bleeding from gastrointestinal tract * prior history of sorafenib use * gastrointestinal obstruction or malabsorption syndrome

Keywords: sorafenib gist refractory advanced gist failed after both imatinib and sunitinib
clinical comparison of silicone hydrogel and hema-based daily disposable contact lenses

Conditions: Myopia

Summary: the purpose of this trial was to compare the performance of an investigational daily disposable contact lens to a commercially available daily disposable contact lens.


Eligibility criteria:
inclusion criteria: * normal eyes with no use of ocular medications. * be of legal age of consent and sign informed consent document. if under legal age of consent, legally authorized representative must sign informed consent document and subject must sign assent document. * willing and able to wear spherical contact lenses for protocol-specified timeframe within the available range of powers (-1.00 d to -6.00d in 0.25d steps). * visual acuity with study lenses 20/25 or better. * cylinder less than or equal to 0.75 d. * currently wearing daily disposable lenses. * other protocol-defined inclusion criteria may apply. exclusion criteria: * anterior segment infection, inflammation, or abnormality. * any active anterior segment ocular disease that would contraindicate contact lens wear. * any use of systemic medications for which contact lens wear could be contraindicated as determined by the investigator. * history of refractive surgery or irregular cornea. * eye injury within twelve weeks immediately prior to enrollment for this trial. * currently enrolled in any clinical trial. * other protocol-defined exclusion criteria may apply.
analgesic efficacy of morphine alone or combined with paracetamol and/or ibuprofen for long-bones fractures in children

Conditions: Pain; Long-bone Fractures

Summary: the main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen.

long-bone fractures are a very common complain for visits in paediatric emergency departments. since these fractures are often very painful, morphine is considered the cornerstone treatment in case of severe pain. very few data are available concerning the assessment of analgesic treatment in this condition. in our previous study, less than 50% of patients with a limb fracture had a visual analog scale (vas) ≤ 30 mm after morphine administration. thus, one study make the hypothesis that the use of a combination of morphine and/or paracetamol and/or nsaid could be an effective and safe option for the treatment of pain due to long bone fractures. we undertake to compare different combinations of paracetamol and ibuprofen with morphine to determine the efficacy and safety of these strategies in emergency department paediatric patients with acute traumatic limb pain. the main objective of this study is to evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture and also to study the potential synergic effect of the association paracetamol and ibuprofen. second objectives are * to compare the long term analgesic efficacy of 4 analgesic regimens a)ibuprofen/morphine, b)paracetamol/morphine, c)ibuprofen/paracetamol/morphine and d)morphine for long bone fracture management in the paediatric emergency department. * to assess the tolerance of these 4 regimens. the study is considered as a success if children 2-6 years (6 years included) have a pain score evendol \< 5 and children 7-17 years (17 years included) have a pain score assessed by visual analog scale (vas) ≤ 30 without additional analgesic treatment 30 minutes after drug administration.

Eligibility criteria:
inclusion criteria: * children aged 2 through 17 years (17 years included) * suspected fracture of a long bone requiring morphine analgesia (vas ≥ 60/100 or evendol ≥ 7/15 at the arrival at emergency department) * within the first 12 hours after the injury * at least one signed parental informed consent * affiliated to health insurance exclusion criteria: * analgesic treatment within the 6 hours before inclusion * contraindication to one of the experimental drug: paracetamol or ibuprofen * contraindication to morphine * cognitive impairment * multiple injuries * resuscitation manœuvres * suspected femur fracture * open fracture * pregnant women in the third trimester

Keywords: paediatric emergency pain long-bones fractures morphine ibuprofen paracetamol children
the effect of sensorimotor insoles on gait parameters in adults with flexible flatfoot

Conditions: Flexible Flatfoot

Summary: the flatfoot is one of the most common diagnosis in foot. the main goals of its orthotic intervention in adult population are the control of the rearfoot and midfoot movement, the affection of the forefoot position and the minimalization of painful deformities. however, only low-level evidence exists proving the positive effect of orthotic insoles in these patients. the concept of sensorimotor insoles describes besides the simple mechanical correction also the targeted modulation of activity of muscles participated on the correct foot function. the aim of the project is to assess the influence of customized sensorimotor insoles on the lower limbs' kinematics and the activity of lower limbs' muscles in people with diagnosed flexible flatfoot. the study is designed as a crossover interventional study with experimental and control group (allocation ratio 1:1). participants' lower limbs' kinematics and muscles activity will be assessed on the baseline measurement, immediately after and 3 months after the intervention with sensorimotor insoles in the experimental group. also, the subjective perceived effect of intervention will be assessed through the research. after a washout period, experimental and control group will swap their roles and another period of 3 months will follow. same parameters will be assessed both at the beginning and in the end of each period.


Eligibility criteria:
inclusion criteria: * ability to stand and walk without aid or support * flat foot deformity confirmed by the foot posture index (fpi-6) score \>5 and/or the normalised navicular height truncated \<0.21 exclusion criteria: * congenital and/or acquired neuromuscular or orthopaedic impairments that severely limit mobility and/or balance * any acute pain while standing and/or walking
developing a new, dynamic, therapeutic pacemaker algorithm for stabilising periodic breathing in chronic heart failure.

Conditions: Periodic Breathing

Summary: to evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.

many patients with heart failure exhibit a distinctive abnormal cyclical breathing pattern, 'periodic breathing'. this means that patients have a worse prognosis and they have debilitating symptoms including breathlessness, fatigue and disrupted sleep. many of these patients also have cardiac pacemakers fitted, to improve their heart function. we have discovered a new physiological mechanism linking the heart and lungs, and have shown that by changing the programmed settings of a cardiac pacemakers, we can change a patient's breathing. if we increase the programmed pacing heart rate, we increase the rate of delivery of carbon dioxide to the lungs temporarily, which increases ventilation. when we reduce the programmed pacing heart rate, the converse happens. we aim to demonstrate this phenomenon scientifically, and to use this information to stabilise periodic breathing in heart failure patients using pacemakers. we then plan to continue to investigate whether we can show that sleep quality is improved in heart failure patients with periodic breathing, by our pacing protocol.

Eligibility criteria:
inclusion criteria: * patients with cardiac pacemakers implanted on standard clinical grounds, and either normal left ventricular systolic function (as assessed by echocardiogram) or impaired left ventricular systolic function and stable breathing patterns (as assessed by screening in outpatients' clinic). exclusion criteria: * patients with atrial fibrillation with a ventricular rate of \>70 bpm will be excluded. * patients with implantable cardiac defibrillators with anti-tachycardia therapy set at an unusually low rate (\<120 bpm), because it would limit the ability to vary the heart rate during the experiment. * patients with significant respiratory disease (fev1 \<50% predicted) will be excluded, as will patients with any condition that who have any condition precluding them from lying comfortably on a bed for 90 minutes. * patients who have had a recent deterioration in condition i.e. admission in previous six weeks, those in a brittle condition and those who have end-stage renal failure requiring haemodialysis.

Keywords: respiration sleep apnea pacemaker
an open-label, uncontrolled study of ono-4578 and ono-4538 in combination with standard-of-care modified folfirinox (mffx) or gemcitabine plus nab-paclitaxel (gnp) therapy as first-line treatment in patients with metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ono-4578, ono-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * 1. pancreatic invasive ducatal adenocarcinoma * 2. life expectancy of at least 3 months * 3. patients with ecog performance status 0 or 1 exclusion criteria: * 1. patients with severe complication * 2. patients with multiple primary cancers
clinical study to evaluate the correction of facial wrinkles and folds and safety of yvoire volume versus perlane in nasolabial fold injection

Conditions: Temporary Correction of Wrinkles

Summary: this study was purposed to evaluate the non-inferiority of yvoire volume, a hyaluronic acid product, in terms of correction of wrinkles and safety in nasolabial fold deep-dermal injection, compared to perlane, the control preparation.


Eligibility criteria:
inclusion criteria: 1. age: women in 30\~55 years. 2. those whose wrinkle scores in the treatment site (nasolabial fold) at the screening visit were stage 3 or 4 in the 5-stage wrinkle severity rating scale (wsrs) symmetrically 3. those who were informed on this study in detail, understood it completely, decided to participate in the study own their own and signed on the informed consent form. exclusion criteria: 1. those with a skin disease in the face (skin infection, eczema, psoriasis, rosacea, herpes etc.) 2. those with a history of severe allergy 3. those with hypertrophic scar or a history of kelloid 4. patients with an autoimmune disease 5. those with hepatic dysfunction or abnormality in coagulation, or those administering an anticoagulant (aspirin, warfarin etc.) concomitantly 6. those who had used a local topical preparation (steroid, retinoid) within 4 weeks prior to the study 7. those who had underwent a chemical peeling, laser procedure (including ipl) or insertion of other bioadaptive materials (however, those who had been treated with ha filler could participate in the study if the date of treatment was known and the investigator judged that the filler effect had disappeared). 8. patients with a malignant tumor 9. women in pregnancy or lactation 10. hepatitis carriers or vdrl/hiv positive patients 11. those with a hypersensitivity to the investigational medical device of this study 12. other persons including those considered as difficult to perform this study by the principal investigator
fatigue management in hiv

Conditions: Fatigue

Summary: this randomized clinical trial (rct) pilot study as two main objectives: * determine the overall feasibility of a behavioral intervention for managing fatigue among older adults with hiv infection. * to estimate effect sizes for group differences at 1, 2, and 3 months on five dimensions of fatigue. the investigators hypothesize that adherence, satisfaction, and attrition will be similar for the active intervention group and the attention control group. the investigators also hypothesize that all five dimensions will improve in the intervention group compared to controls over time, and that cohen's d (standard deviation units) will be greater than 0.5 sd units for all five fatigue dimensions at all three post-intervention time points.


Eligibility criteria:
inclusion criteria: * have a diagnosis of hiv infection * be at least 50 years of age * have a fatigue severity score13 \> 4.0 * be retired or on disability * be willing to wear a fitbit one tracker and keep a 7-day diary at 4 time points (electronic, paper, or other convenient format) * be able to speak, understand, and read english * have a telephone, cell phone, computer access, or other means of communication exclusion criteria: * current temporary, part-time, or full-time employment * planning to travel or be away from home during the 3-month study time frame * being pre- or peri-menopausal because of fluctuations in vasomotor symptoms over time * taking hormones to treat symptoms of menopause * brief interview for mental status score \< 13 * aids dementia diagnosis * diagnosed sleep disorder that would not be responsive to behavioral interventions (sleep apnea, restless legs, etc.).

Keywords: fatigue hiv behavioral intervention sleep
improving mental health in school-age children through the kids' empowerment program (kep)

Conditions: Child Mental Disorder

Summary: depression and anxiety are major challenges to american children's optimal mental health, with already high rates exacerbated by the covid-19 pandemic. yet help is beyond reach for many children who do not have access to care for reasons including a severely depleted cadre of professionally trained service providers, fear of stigma that goes along with a diagnosis, low access to clinics, and lack of insurance. without help their problems will likely accelerate and become more deleterious to their development as adolescents and young adults. the current study aims to address the lack of care by providing a program in school classrooms that will reduce children's symptoms of depression and anxiety, as well as enhance their emotion regulation and coping skills. the mental health and adjustment of two groups of children are compared and evaluated at twelve week intervals in this clinical trial - those who first participate in the kids' empowerment program (kep) and a comparison group that participates in the program after the second evaluation. once proven to be successful, the ultimate goal of the project is to disseminate the program throughout the state of michigan and beyond, thereby providing children with tools that will empower them to be successful in managing emotional challenges throughout their life.

the aim of this clinical trial is to conduct an evaluation of whether children who participate in the kids' empowerment program (kep) have fewer symptoms of depression and anxiety after 12 weeks relative to those in the comparison group. further, the investigator seeks to identify for whom the program is most helpful and elements of the program that contribute to success. the experimental condition consists of both those who experience the kep in-person in their classroom (n = 60) and 60 in the comparison condition. standardized measures assess children's mental health, coping, resilience, and emotion regulation before and after 12 weeks. those in the comparison group receive the kep program in their classroom after the second interview. children are interviewed at school and parents complete an online survey.

Eligibility criteria:
inclusion criteria: * child age 6 to 12 years * parent consents to participate interviews and the program * parent agrees to two assessments exclusion criteria: * child age younger than 6 and older than 12 * child with significant developmental or cognitive delays prohibiting program participation

Keywords: mental health intervention
electronic notification of teratogenic risks

Conditions: Teratogens; Abnormalities, Drug-Induced; Contraception

Summary: this study will use a factorial design randomized controlled trial to (1)compare multi-faceted decision support (intervention) to streamlined clinical alerts (control) and (2) evaluate whether collecting information about women's risk of pregnancy using a networked tablet computer (intervention) is superior to the way clinicians usually collect this information (control). over the course of 1 year, we will abstract data from the electronic medical record when study clinicians prescribe teratogenic medications, conduct phone interviews with women prescribed medications by participating clinicians, and survey participating clinicians about their satisfaction with the decision support they receive. we will use this data to confirm our hypotheses that clinicians in the intervention groups will (1) prescribe fewer teratogenic medications, (2) be more likely to prescribe contraception when a teratogenic medication is prescribed, (3) have more patients report satisfaction with the counseling they received, and (4) report more satisfaction with the decision support they received.


Eligibility criteria:
inclusion criteria: * women aged 18-45 seen at a participating primary care clinic exclusion criteria: * non-english speakers

Keywords: teratogens abnormalities, drug-induced contraception
a study of ly3209590 in participants with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the reason for this study is to see if the study drug ly3209590 is safe and effective in participants with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year * participants must have been using multiple daily injections without interruption for at least 3 months * participants must have hba1c values of 5.6% to 9.5%, inclusive * participants must have a body mass index (bmi) of ≤35 kilograms per meter squared (kg/m²) exclusion criteria: * have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening * have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening * have any of the following cardiovascular (cv) conditions: acute myocardial infarction, new york heart association class iii or iv heart failure, or cerebrovascular accident (stroke) * have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease * have an estimated glomerular filtration rate (egfr) \<30 milliliters/minute/1.73 m² * have active or untreated cancer * are receiving chronic (\>14 days) systemic glucocorticoid therapy
the biodistribution of 1-[2 deoxy-2, -18 fluroarabinfuranosyl]cytosine [18fac] in healthy subjects and patients with cancer, autoimmune/inflammatory diseases

Conditions: Cancer; Inflammation

Summary: the purpose of the study is to determine whether positron emission tomography using the new imaging agent 18f-fac can be used for imaging cancer and/or inflammation.


Eligibility criteria:
inclusion criteria: * \> 18 years of age * women of childbearing potential will undergo a pregnancy test free of charge * patients with cancer or autoimmune diseases or healthy subjects

Keywords: 18f-fac imaging cancer inflammation pet