Kornimate/medical-research-clean huggingface dataset:
starting healthy staying healthy pilot trial

Conditions: Obesity

Summary: the purpose of this study is to determine whether a reduction in toddlers' and preschoolers' exposure to television advertising leads to a change in their diet.

tv viewing is among the most significant features of childhood. in the past generation or two, new technologies have made media viewing more ubiquitous and frequent: 30% of children eat regularly in front of tv, one-third under 6 have tvs in their bedrooms, and 30% make tv part of bedtime routines. by the age of 2 years, 90% of children watch tv or videos regularly. among those who watch, average viewing is 1.5 hours daily by age 2. yet the effects of this early viewing are poorly understood. in this study, we focus on children's diet, because children's food preferences have been shown to be easily influenced by advertising, and children's non-educational programming is heavy with advertising for poor nutritional-quality foods. we will recruit 70 families with children ages 24-30 months and randomize them to either a television-minimization intervention (the intervention arm) or a toddler safety and injury prevention arm (the control arm). a case manager will actively work with the intervention arm participants to strategize ways of minimizing their media exposure. in addition, families in the intervention arm will get access both to a study website and to a monthly newsletter. the website and newsletter will inform participants of the potential hazards of early media exposure, and will offer tips for alternative activities and strategies for keeping children occupied while the parent gets a much-needed break. the control arm will have no case manager, but will have access to a website and newsletter that will emphasize toddler safety and injury-prevention themes. at the conclusion of the 4-month trial, we will assess (a) whether the study participants regularly accessed their respective websites; (b) whether the intervention-arm participants have different beliefs and attitudes about television for toddlers; and (c) whether fewer intervention-arm children watch tv compared to control-arm infants. the comparison group will receive a similar intervention, except that it will not mention television viewing, and will instead focus on toddler and preschooler safety and injury-prevention topics, such as the appropriate use of car seats, smoke detectors, hot water heater temperature, safe gun storage, and other similar topics.

Eligibility criteria:
inclusion criteria: * must watch at least 1.5 hours of television a day on average * must speak english at home * residence in or near seattle exclusion criteria: * developmental delay

Keywords: diet, reducing television child behavior
predictive clinical and biological parameters in gynecological cancer

Conditions: Ovarian Cancer; Endometrium Cancer; Cervix Cancer

Summary: research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation


Eligibility criteria:
inclusion criteria: * gynecological cancer suspicion * age \> 18 * signed informed consent exclusion criteria: - emergency exclusion criteria after histological exam any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).

Keywords: ovarian, endometrium, cervix cancer
a clinical study of the safety and efficacy of mebo® wound ointment in subjects with diabetic foot ulcers (pilot)

Conditions: Diabetic Foot Ulcers

Summary: the objective of this study is to evaluate the safety and efficacy of mebo in the treatment of subjects with diabetic foot ulcers (dfus).

this is a phase ii, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of mebo in the treatment of subjects with dfus. subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either mebo or soc.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age * able and willing to provide informed consent * able and willing to comply with protocol visits and procedures * target ulcer duration of ≥4 weeks exclusion criteria: * ulcer of a non-diabetic pathophysiology * known or suspected allergies to any of the components of mebo * malignancy on target ulcer foot * non-compliance in the screening or run-in period

Keywords: diabetic foot ulcers (dfus)
optic nerve sheath diameter in pre-eclamptic parturient receiving magnesium sulfate combined with dexmedetomidine

Conditions: Preeclampsia Severe; Optic Nerve Sheath Diameter

Summary: dexmedetomidine was reported to effectively reduce cerebral metabolism and icp by decreasing cerebrospinal fluid pressure in patients with cerebral tumors or head injuries that require craniotomy. however, it was also reported to exhibit no effect on icp. the effect of mgso4 associated with dexmedetomidine on onsd in severely pre-eclamptic parturient has been understudied . though this study aims to evaluate the effect of dexmedetomidine infusion on raised icp in severely pre-eclamptic parturients using ocular ultrasonography to determine onsd as a measure of icp.

dexmedetomidine, a highly selective α-2-receptor agonist, is a first-line sedative medication in icu and has been increasingly used for obstetric anesthesia. dexmedetomidine, which provides light sedation, possesses analgesic, sympatholytic, anxiolytic properties and attenuates the stress response without significant respiratory depression. in addition, dexmedetomidine-induced stimulation of postsynaptic alpha-2 adrenergic receptor on the cerebral blood vessels can cause cerebral vasoconstriction and decrease cerebral blood flow. however, the effects of dexmedetomidine on icp are controversial. clinical signs of raised icp are not specific and often difficult to interpret, especially during pregnancy and pre-eclampsia. though the use of invasive devices is considered a gold standard in the measurement of icp, ocular sonography is a promising bedside tool, which serves as a noninvasive, readily available, and cost-effective means for indirectly measuring icp. bedside ultrasound can be used as a point-of-care tool for rapidly measuring the optic nerve sheath diameter (onsd), which is a validated indirect means for measuring icp. an increase in icp reflects as a raised onsd since the optic nerve is surrounded by dural sheath and cerebrospinal fluid (csf) containing subarachnoid space, which is distensible in the retrobulbar segment, particularly when csf pressures rise.

Eligibility criteria:
inclusion criteria: * aged18 to 40 years with * at least 36 weeks gestation * admitted with diagnosis of severe pre-eclampsia and scheduled to receive magnesium sulphate therapy before delivery exclusion criteria: * presence of ocular wound or prior ocular surgery * emergency cases, and evidence of fetal compromise * hellp syndrome (hemolysis, elevated liver enzymes, and low platelet levels) * chronic hypertension * hyperthyroidism, and diabetes mellitus * presence of pre-existing chronic lung and/or cardiac diseases * presence of pre-existing chronic renal and/or hepatic diseases * presence of any chronic diseases of central nervous system. * known allergies to the tested drug.
internet-guided cognitive behavioural therapy to improve depression patients with cardiovascular disease

Conditions: Cardiovascular Disease; Depression

Summary: purpose and aims tailored internet-based cognitive behavioural therapy (i-cbt) is a new innovative and person-centred method that is promising that may be used to decrease depression in patients with cardiovascular disease (cvd). in patients with cvd, depressive symptoms is a common co-morbidity leading to decreased wellbeing, and increased morbidity and mortality. depressive symptoms are both underdiagnosed and undertreated in cvd patients. earlier studies have demonstrated the efficiency of cognitive behavioural therapy (cbt) for many psychiatric conditions, but few studies have evaluated cbt in patients with cvd. the overall purpose of this study is to evaluate the effects of the tailored i-cbt program on reducing depressive symptoms and other patient reported outcomes in patients with cardiovascular disease (cvd) and to explore factors related to implementation of the i-cbt program in clinical cardiac care. the primary aim: -to evaluate the effects of the tailored i-cbt depression program on depressive symptoms. secondary aims: * to evaluate effects on quality of life´, sleep and anxiety * to evaluate factors that can influence the i-cbt programs effect on depressive symptoms. * to gain knowledge about the i-cbt program, as perceived by patients and health care professionals. * to explore facilitators and barriers to the implementation of the i-cbt program in clinical practice from the perspectives of patients, health care professionals and policymakers.

power calculation: effect size=0.5, alpha=0.05 (z=1.96), power 0.80 (z -0.84) = 122 participants. due to drop-outs or deaths the size of the study population for the rct study was decided to n=140.

Eligibility criteria:
inclusion criteria: * treatment for cvd according to european society of cardiology guidelines. * stable cvd (nyha class i-iii) and not having been hospitalised for cvd in in the last four weeks. * depressive symptoms (patient health questionnaire-9 17 (phq-9) \> 5 points) exclusion criteria: * severe cvd (nyha iv) or another severe chronic life-threatening disease * severe depression assessed as requiring acute treatment * not being able to dedicate 3-4 hours to participate in the program

Keywords: internet cognitive behavioural therapy
intraoperative sonographically guided resection of non-enhancing gliomas

Conditions: Non-enhancing Cerebral Gliomas

Summary: the purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography

gliomas, not enhancing contrast agent in magnetic resonance imaging (mri), are usually low-grade gliomas. they rarely show intraoperative fluorescence using 5-aminolevulinic acid or fluorescein. intraoperative high-field mri, sonography and navigation are the only ways to assess extent of their resection during surgery. mri is the gold standard, but interrupts surgical workflow and only few hospitals are equipped with device like that. navigation eventually looses it's precision due to brainshift. ultrasound allows assess tumor remnants in real time but has worse imaging quality. currently no randomized trials published their results about efficiency of intraoperative sonography in removing low-grade gliomas. objective of the study is to determine whether intraoperative ultrasound guided resection of non-enhancing gliomas can achieve higher extent of resection than surgery without intraoperative sonography. participants of the study will be randomly operated with and without intraoperative ultrasound. extent of resection will be assessed in postoperative mri by blinded radiologists.

Eligibility criteria:
inclusion criteria: * single supratentorial gliomas without contrast enhancement in preoperative magnetic resonance imaging (presumed low-grade gliomas) * newly diagnosed * previously untreated * karnofsky performance status 60-100% * age 18-79 years * performed magnetic resonance imaging with contrast enhancement exclusion criteria: * glioma spreading to brainstem * previously performed radiotherapy, chemotherapy or immunotherapy * planned supratotal tumor resection until neurophysiologically revealed eloquent areas
fl-reach: pilot trial of a brief dementia caregiver intervention

Conditions: Alzheimer Disease; Dementia

Summary: the primary aim of this study is to test feasibility of a modified reach ii intervention in an outpatient clinic.

primary aim the primary aim of this study is to test feasibility of a modified reach ii intervention in an outpatient clinic. hypothesis: 1. the fl reach intervention can be implemented reliably in this setting, with fidelity to the model and minimal burden on existing clinic structure. secondary aims aim 2: examine the effectiveness of a reach ii translation in an outpatient setting. hypotheses: 2. cg disease knowledge will increase from pre-assessment to post-assessment. 3. caregiver preparedness for caregiving will increase from pre-assessment to post-assessment. 4. perceived risk by cg (cr access to dangerous objects + smoking + supervision + wandering + driving + screaming + desire to hit) will be reduced from pre-assessment to post-assessment. 5. caregivers will demonstrate mastery of skill acquisition related to behavior change strategies. 6. caregiver burden will decrease from pre-assessment to post-assessment. 7. caregiver self-rated health will improve from pre-assessment to post-assessment. 8. caregivers will have initiated the process of advanced care planning by the end of the intervention. 9. all measures will maintain gain in the anticipated direction from baseline measures at 6 months post-assessment. aim 3: identify possible moderators of outcome, such as race/ethnicity, language, dosage or relationship. this aim is exploratory. based in previous evidence, we estimate similar outcomes for all participants regardless of demographic factors, but previous trials have never been attempted in this novel setting. we will examine the data for differential outcomes related to such factors.

Eligibility criteria:
inclusion criteria: * 1. age 18-89 2. identified caregiver or care partner of an individual who has been diagnosed with alzheimer's disease or another dementia by the memory disorders clinic, and/or who has sought ongoing treatment through the memory disorders clinic 3. able to provide informed consent 4. able to engage in the intervention weekly by attending sessions in person at the clinic 5. able to participate in the intervention in english or in spanish 6. no previous experience with a caregiver training program in the past (this applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with) exclusion criteria: * 1. under age of 18 or over the age of 89 2. unable to provide informed consent or subject to a conflict of interest for this study 3. unable to return regularly to the clinic for sessions 4. engaged in another caregiver training program concurrently or have completed a multi-week caregiver training program in the past (this exclusion applies to theory based, structured interventions delivered by professionals, and does not include peer-led support groups that the family may have engaged with)

Keywords: caregiving adrd memory disorders
treatment of non-small cell lung cancer with pd-1 monoclonal antibody combined with donafenib toluene sulfonate

Conditions: Non-small Cell Lung Cancer

Summary: to assess the safety and efficacy of third-line and above therapy of patients with local advanced or metastatic non-small cell lung cancer (nsclc) with combined treatment with launched recombinant humanized anti-pd-1 monoclonal antibody and donafenib tosilate

donafenib has a multi-target and dual anti-tumor effect, similar to sorafenib toluene sulfonate, and its effect is similar to that of sorafenib toluene sulfonate. donafenib has the potential to be effective in the treatment of cancer, including advanced non-small cell lung cancer. pd-1 inhibitor has become a new therapy for advanced non-small cell lung cancer because of its strong specificity, definite efficacy, small side effects and long time of tumor control. this is a single-center, open, single-arm, exploratory phase ib trial. there were two dosages of donafenib (100mg qd and 100mg bid, respectively). three to six subjects were enrolled in the dosages of 100mg qd. the investigators determined that the dosages of 100mg bid were well tolerated

Eligibility criteria:
inclusion criteria: 1、18 years age or older ,male or female 2、histologically or cytologically confirmed diagnosis of local advanced or metastatic nsclc 3、previously received with two or more systemic antitumor treatments (chemotherapy or targeted therapy). chemotherapy treatments must include a two-drug regimen containing platinum, patients with egfr tki drug resistance and unknow t790m mutation, after azd9291 treatment patients with t790m mutation could be enrolled 4、at least one measurable lesion as defined by recist 1.1. a previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation 5、asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater 6、patients must have recovered from all toxicities related to prior anticancer therapies to ≤ 2 (ctcae v5.0). ae of neurology must be ≤ 1 7、life expectancy ≥ 12 weeks 8、ecog performance status 0-1 exclusion criteria: 1. small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer) 2. patients at risk of bleeding treated with antiangiogenic drugs 3. subjects who are using immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose \>10mg/ dprednisone or other therapeutic hormones) and who continue to use it for 2 weeks prior to enrollment 4. patients with active, known or suspected autoimmune diseases, including tuberculosis, hiv infection, active hepatitis, etc. 5. patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc 6. women who are pregnant or lactating, or who are unwilling to use contraception during the trial

Keywords: non-small cell lung cancer
study of systemic amyloidosis presentation and prognosis

Conditions: Amyloidosis

Summary: objectives: i. analyze prospectively the course of amyloid deposition in patients with primary, secondary, myeloma-associated, and hereditary amyloidosis. ii. determine abnormalities of humoral and delayed-type hypersensitivity in these patients. iii. identify prognostic factors in hereditary amyloidosis and develop tests for genetic defects associated with systemic amyloidosis. iv. diagnose familial amyloidotic polyneuropathy (fap) prior to symptom onset. v. validate the correlation of low serum prealbumin and retinol binding protein levels with amyloidosis in patients with fap.

protocol outline: patients receive a comprehensive evaluation with an emphasis on identifying prognostic and diagnostic factors. assessments include gastrointestinal, renal, hematologic, dermatologic, cardiac, and serologic studies. immunologic studies include antinuclear antibody, latex fixation, and serum and urine electrophoresis. genetic trees are constructed using detailed family history data; blood and urine samples are routinely collected from relatives. family members of patients with familial amyloidotic polyneuropathy type ii (indiana type) undergo a flexor retinaculum biopsy of the wrist.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- systemic amyloidosis, i.e.: primary, myeloma associated secondary, e.g., associated with the following conditions: rheumatoid arthritis inflammatory bowel disease

Keywords: amyloidosis arthritis & connective tissue diseases genetic diseases and dysmorphic syndromes rare disease
control of myopia using novel spectacle lens designs

Conditions: Juvenile Myopia

Summary: randomized, controlled, multisite, subject-and observer-masked, 3-arm parallel group clinical trial of 36-month duration to evaluate the safety and efficacy of a novel spectacle lens design in reducing the progression of juvenile myopia.


Eligibility criteria:
inclusion criteria: * children 6-10 years of age (day prior to 10th birthday) at time of informed consent/assent * ser error between -0.75 and -4.50 d * ser power between the two eyes must be less than or equal to 1.50 d * willingness to participate in the trial for 3 years without content lens wear exclusion criteria: * previous or current use of contact lenses * previous or current use of bifocals, progressive addition spectacles lenses * previous or current use of myopia control treatment * astigmatism worse then -1.25 dc in either eye

Keywords: myopia
operational assessment of point-of-care diagnostics in primary healthcare clinics

Conditions: HIV

Summary: diagnostic point-of-care (poc) tests are being rapidly developed and implemented in resource-limited settings. there has been a rapid rise of hiv and tb poc tests in south africa during the last 10-15 years. the investigators sought to determine the existing availability, current usage and future need of poc tests among rural primary healthcare (phc) clinics in south africa's kwazulu-natal province.

several new diagnostics generation devices are specifically designed to assist clinical staff replacing the equivalent laboratory tests and allowing a wide range of disease diagnoses to be performed immediately at the poc. the clinical impact of poc diagnostics has been shown in a variety of diseases conditions, particularly hiv/aids and tb. the world health organisation (who) called for new clinical diagnostics methods that are designed to function in setting with limited access to laboratory services. thus, leading to an increase in marketing, manufacturing and development of poc diagnostics instruments and reagents for use in clinical poc. the advent of poc tests in south africa has led to an improved control of infectious diseases such as hiv and mycobacterium tuberculosis (tb), in this era of drug-resistance. increased availability of poc test in rural and resource-limited settings is encouraged. to maximize the impact of novel diagnostics on patient outcomes in resource-limited settings, the implementation of new diagnostics must be performed within a given context and culture. however, the population-level of diagnostic utility in south africa is not known. the investigators aim to estimate the level of poc diagnostic availability, usage and need in rural south africa, using a cross sectional survey of rural primary healthcare (phc) clinics in kwazulu natal (kzn). the survey focused on the conditions for which the respondent considered a poc test might help improve their clinical decision making during patient care. determining the current accessibility, availability, usage and need for poc diagnostics in rural and resource limited settings can help inform developers and implementers of poc diagnostic services on context-specific deployment and implementation of poc diagnostics to address the unmet needs of patients in these settings.

Eligibility criteria:
inclusion criteria: * primary healthcare clinics located in rural and semi-rural settings exclusion criteria: * primary healthcare clinics located in urban settings

Keywords: point-of-care diagnostics rural primary health care access need usage maternal health