Kornimate/medical-research-clean huggingface dataset:
decoding the cognitive trajectory of hong kong superagers: a longitudinal follow-up study

Conditions: Age-related Cognitive Decline; Cognitive Deterioration; Dementia, Mild

Summary: this is a prospective follow-up study conducted at the department of psychiatry, the chinese university of hong kong. the participants, including high-performing elderly (superagers), normal ageing elderly and neurocognitive disorder (ncd) patients will be re-invited from our previous cohort (2013-2014) (n=488).

objectives: this study aims to investigate the cognitive changes in older adults with different cognitive statuses.

Eligibility criteria:
inclusion criteria: * superagers are determined by the scores of global cognitive function. this ensured that the participants are divided by a measure relevant to the current study without directly biasing the results toward the domain of interest; * normal aging: the cases with the scores of cognitive performance within 1.5 standard deviation (sd) of age and education matched normative values derived from our cohort study, of which presented with hk moca score greater than 26 and cdr score equal to 0; * ncd patients are deﬁned as: evidence of modest decline in one or more cognitive domains, which is set as ≥ 1.5 sd below the age- and education-adjusted normative scores; no interference with independence in everyday activities; and no comorbid major psychiatric disorders. exclusion criteria: * history of bipolar disorders or psychosis; * history of major neurological deﬁcits including stroke, transient ischemic attack or traumatic brain injury; * comorbidities with depressive symptoms.

Keywords: cognitive maintenance cognitive ageing superagers cognition quality of life brain health
mri and magnetometer-guided sentinel lymph node detection in vulvar cancer

Conditions: Vulvar Cancer; Lymph Node Metastasis

Summary: the aim of the feasibility study is to evaluate whether spio-mri and a magnetometer could be a potential substitute to the routine dual technique in pre-and intraoperative sln localization. secondary, to explore if spio-mri could predict lymph node status in comparison to histopathological analysis.

sentinel lymph node (sln) biopsy is the routine procedure for nodal staging in early vulvar squamous cell carcinoma (vscc) in the absence of clinical signs of lymph node metastasis. the gold standard technique for identifying sln utilizes technetium (tc99m) lymphoscintigraphy and blue dye. an alternative method has emerged using superparamagnetic iron-oxide (spio) and magnetic resonance imaging (mri). this study aims to enroll 20 vscc patients scheduled for the sln procedure. determination of the minimal dosage of spio required to avoid excessive mri artifacts while still identifying the sln. intraoperative sln detection with a magnetometer will be compared with the gold standard gamma probe. as secondary objective, in addition to determining the snl, mri analysis of the nodal status will be evaluated for potential metastasis and compared to histopathological results.

Eligibility criteria:
inclusion criteria: histologically confirmed primary vscc \<4 cm, candidates for surgery with slnb age above 18 signed and dated written consent before the start of specific protocol procedures. ecog performance status 0-2 exclusion criteria: contraindications for mri such as electronic implants or severe claustrophobia hip replacement iron overload disease 4. known hypersensitivity to iron or dextran compounds inability to understand given information and give informed consent or undergo study procedure
study of vorasidenib (ag-881) in participants with residual or recurrent grade 2 glioma with an idh1 or idh2 mutation (indigo)

Conditions: Grade 2 Glioma; Residual Glioma; Recurrent Glioma

Summary: study ag881-c-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent grade 2 glioma with an idh1 or idh2 mutation who have undergone surgery as their only treatment. participants will be required to have central confirmation of idh mutation status prior to randomization. approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg qd or placebo.


Eligibility criteria:
key inclusion criteria: * be at least 12 years of age and weigh at least 40 kg. * have grade 2 oligodendroglioma or astrocytoma per who 2016 criteria. * have had at least 1 prior surgery for glioma (biopsy, sub-total resection, gross-total resection), with the most recent surgery having occurred at least 1 year (-1 month) and not more than 5 years (+3 months) before the date of randomization, and no other prior anticancer therapy, including chemotherapy and radiotherapy and not be in need of immediate chemotherapy or radiotherapy in the opinion of the investigator. * have confirmed idh1 (idh1 r132h/c/g/s/l mutation variants tested) or idh2 (idh2 r172k/m/w/s/g mutation variants tested) gene mutation status disease by central laboratory testing during the prescreening period and available 1p19q status by local testing (eg, fluorescence in situ hybridization \[fish\], comparative genomic hybridization \[cgh\] array, sequencing) using an accredited laboratory. * have mri-evaluable, measurable, non-enhancing disease, as confirmed by the birc. * have a karnofsky performance scale (kps) score (for participants ≥16 years of age) or lansky play performance scale (lpps) score (for participants \<16 years of age) of ≥80%. key exclusion criteria: * have had any prior anticancer therapy other than surgery (biopsy, sub-total resection, gross-total resection) for treatment of glioma including systemic chemotherapy, radiotherapy, vaccines, small-molecules, idh inhibitors, investigational agents, laser ablation, etc. * have features assessed as high-risk by the investigator, including brainstem involvement either as primary location or by tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor in the opinion of the investigator (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with activities of daily life and failed 3 lines of antiepileptic drug regimens including at least 1 combination regimen).

Keywords: ag-881
study to evaluate the pharmacokinetic properties of syp-1018 (voriconazole-loaded pnp) and voriconazole (vfend)

Conditions: Systemic Mycotic Infection

Summary: the purpose of this study is to evaluate the pharmacokinetic properties and safety of syp-1018 (voriconazole-loaded pnp) and voriconazole (vfend).


Eligibility criteria:
inclusion criteria: * healthy adults 20-45 years of age * weight of ≥ 60kg ≤ 90kg with bmi of ≥ 19 and \< 27 (bmi(kg/m2)= weight(kg)/{height(m)}2 * voluntary written informed consent exclusion criteria: * history or presence of significant renal, neurologic, pulmonary, endocrine, hematology, oncology, urologic, cardiovascular, musculoskeletal or psychiatric disease * drug allergies to voriconazole * recent history or evidence of drug abuse * recent participation(within 2 months) in other clinical studies * recent donation of blood(within 2months), plasma(within 1month) or transfusion(within 1month)
germline mutations associated with hereditary pancreatic cancer in unselected patients with pancreatic cancer in mexico

Conditions: Pancreatic Cancer; Pancreatic Adenocarcinoma

Summary: pancreatic cancer is a highly lethal disease. the cause of pancreatic cancer is multifactorial. however, around 10% of cases are associated with hereditary predisposition. germline mutations in brca1 and brca2, cdkn2a, stk11, dna mismatch repair (mmr) genes (mlh1, msh2, msh6, or pms2), palb2, fancc, fancg, and atm have been associated with an increased risk for pancreatic cancer. the prevalence of these germline mutations varies across populations. for instance, the prevalence of brca1/2 germline mutations in high-risk populations can be up to 20%. on the other hand, in unselected patient population, the prevalence of brca1/2 germline mutations is 5-7%. in mexican population, data on the prevalence of brca1/2 germline mutations in patients with pancreatic cancer are lacking. identification of brca germline mutations in patients with pancreatic cancer has implications for treatment. also, it allows genetic testing and counselling for family members. this study will determine the prevalence of germline mutations associated with hereditary pancreatic cancer using a comprehensive gene panel in an unselected cohort of patients with pancreatic adenocarcinoma in mexico.

this is an observational study to estimate the prevalence of germline mutations in patients with pancreatic cancer. eighty four genes will be analyzed, all of which have been associated with hereditary cancer. the genes are included on invitae multi-cancer panel ®, performing full-gene sequencing and deletion/duplication analysis using next-generation sequencing technology. the 84 genes include: aip, alk, apc, atm, axin2, bap1, bard1, blm, bmpr1a, brca1, brca2, brip1, casr, cdc73, cdh1, cdk4, cdkn1b, cdkn1c, cdkn2a, cebpa, chek2, ctnna1, dicer1, dis3l2, egfr, epcam, fh, flcn, gata2, gpc3, grem1, hoxb13, hras, kit, max, men1, met, mitf, mlh1, msh2, msh3, msh6, mutyh, nbn, nf1, nf2, nthl1, palb2, pdgfra, phox2b, pms2, pold1, pole, pot1, prkar1a, ptch1, pten, rad50, rad51c, rad51d, rb1, recql4, ret, runx1, sdha, sdhaf2, sdhb, sdhc, sdhd, smad4, smarca4, smarcb1, smarce1, stk11, sufu, terc, tert, tmem127, tp53, tsc1, tsc2, vhl, wrn, wt1.

Eligibility criteria:
inclusion criteria: * female and male participants ≥ 18 years of age. * diagnosed within the previous 6 months with histologically confirmed pancreatic adenocarcinoma stage i to iv. * participant provides written informed consent for the study. * participant must agree to sample collection and genetic testing using the invitae multi-cancer panel ®. exclusion criteria: * diagnosed with pancreatic adenocarcinoma more than 6 months before presenting to the clinical site. * diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors.

Keywords: brca 1/2 germline mutations
comparing engage to pst for late life depression

Conditions: Major Depression

Summary: this is a non-inferiority trial of engage, a new intervention for late-life depression, and problem solving therapy (pst). patient participants will be randomized to either engage or pst and receive 9 weeks of either intervention. interview assessments will be collected at baseline and weeks 2, 4, 6, 8, 9, 26, and 36. clinician participants, social workers from mental health agencies, will be randomized to receive training and certification in either engage or pst.

policy reports document that evidence-based psychotherapies are rarely employed and sustained in the community. several causes of this science to service gap have been identified. one cause, specific to behavioral interventions, is the complexity of interventions and the competencies community clinicians must acquire and sustain over time in order to deliver them. a realistic solution is to streamline behavioral interventions and tailor them to the settings and therapist skill level available in the community. in response to this need, we have developed engage, which: 1) is streamlined on the basis of concepts and findings on the neurobiology of depression; 2) consists of psychotherapeutic and ecosystem management components of known efficacy; 3) has distilled and simplified these components so as they can be accessible to most depressed older patients and taught to larger numbers of clinicians than available therapies, e.g., problem solving therapy (pst); and 4) is personalized through a structured stepped approach focusing on "reward exposure". problem solving therapy is an evidenced-based intervention shown to be effective in treating late-life depression. three hundred (150 per site) patient participants will be randomly assigned to receive 9 sessions of either engage or pst. forty-two clinician participants will be randomly assigned to receive training and certification in either engage or pst. once certified, clinicians will be assigned a patient participant and administer their assigned intervention.

Eligibility criteria:
inclusion criteria (patient participants): * age ≥ 60 years * unipolar, non-psychotic major depression (by scid, dsm-iv) * madrs ≥ 20 * mmse ≥ 24 * off antidepressants or have been on a stable dose of an antidepressant for 12 weeks and do not intend to change the dose in the next 10 weeks * english speaking * capacity to provide written consent exclusion criteria (patient participants): * presence of psychiatric diagnoses other than unipolar, non-psychotic major depression or generalized anxiety disorder * newly started use of psychotropic drugs (\<12wks) or cholinesterase inhibitors other than mild doses of benzodiazepines * current active suicidal intent/plan * current substance abuse

Keywords: major depression depression depressive disorder mental health mental disorder
calming touch for people with agitation or other behavioural symptoms of dementia - a randomized feasibility trial

Conditions: Dementia; Agitation,Psychomotor

Summary: dementia is an increasing health challenge among elderly citizens in denmark. an estimated 87,000 danes live with dementia, and this number is expected to increase to 130,000 in 2030. psychiatric symptoms and behavioral changes decrease quality of life for patients and their spouses and is a challenge for caretakers. behavior changes include agitation which can be divided in four sub-groups: 1) physical aggression, 2) physical non-aggression, 3) verbal aggression, and 4) verbal non-aggression. pharmaceutical management of behavioral changes is common and may be associated with negative side-effects including drowsiness and falls. though non-pharmaceutical interventions such as music, massage and social activities have been recommended the underlying evidence is limited. in this randomized feasibility trial, we will investigate the feasibility and acceptability of therapeutic touch aiming to reduce agitated behavior in people living with dementia in a nursing home that specializes in the care of people living with severe dementia. the success criteria of this randomized feasibility trial are as follows: 1. nursing home residents can be recruited and accept the treatment 'calming touch for people with agitation or other behavioral symptoms of dementia' (cadem) and complete the feasibility project's test protocol. 2. the treatment concept, which involves the nursing staff in charge of the follow-up treatment, can be implemented in practice. 3. the treatment (cadem) shows a tendency towards less restless and aggressive behavior for demented citizens evaluated based on a validated measuring tool.


Eligibility criteria:
inclusion criteria: * citizens who are residents of the care center due to dementia * citizens living at a care center in naestved municipality * demented citizens who exhibit agitated / aggressive behavior (nursing staff observe whether the citizen exhibits agitated behavior within at least one of the subgroups exclusion criteria: * citizens in palliative care * citizens who have received bbaum treatment within the last month
influence of telemonitoring on the management of lvad-patients

Conditions: Heart Failure; Ventricular Assist Device; Telemedicine

Summary: the current study aims to investigate whether telemedical monitoring in patients with terminal heart failure and an implanted left ventricular assist device (lvad) has an influence on lvad-associated complications, hospitalization rates and quality of life. this is a prospective observational study. patients with terminal heart failure and an implanted lvad, where the indication for telemonitoring has already been stated by the attending physician are included in the study. written informed consent is obtained from all patients. the telemedical monitoring is carried out by the west german center for applied telemedicine (wzat) and includes a standardized telephone interview every 3 days. in addition, all patients are equipped with an inr measuring device, a body scale and a clinical thermometer by wzat. the data is documented in an electronic case file (medpower®). in the event of abnormalities, the west german heart and vascular center (whgz) is contacted, and all necessary measures are initiated.


Eligibility criteria:
inclusion criteria: * age\> 18 years * indication for telemedicine * permanently implanted left ventricular assist device (vad) exclusion criteria: * no possibility of telephone contact * patient does not speak german * incompliance * rejection or inability to give consent
comparative study of mmasi before and after hyperthyroid therapy in hyperthyroid subjects with melasma

Conditions: Melasma; Hyperthyroidism

Summary: study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using modified melasma area and severity index (mmasi) score. a quasi experimental (pre-post intervention) study was conducted in jakarta in august 2019-february 2020.

melasma is an acquired and chronic disorder of hyperpigmentation characterized by symmetrical hypermelanoses of the face. the exact pathogenesis of melasma is still unknown. several hormones are thought to play a role, including thyroid hormone. although melasma is not life-threatening, it affects greatly on the quality of life of patients. study's objectives are to determine proportion of melasma cases in hyperthyroid patients and to compare severity of melasma before and after medications of three months hyperthyroid therapy using mmasi score. an experimental (before and after) study was conducted in jakarta in august 2019-february 2020. twenty three newly-diagnosed hyperthyroid patients or had taken hyperthyroid medications of maximum 3 months with melasma were recruited. the severity of melasma were scored with mmasi and dermoscopy of the lesions were collected. the same procedures were done after 3 months of hyperthyroid therapy. the data collected was statistically analyzed using stata version 15.0

Eligibility criteria:
inclusion criteria: * female with age range of 18 to 60 years old * newly diagnosed with hyperthyroid on a laboratory basis * diagnosed with melasma by dermatologist exclusion criteria: * pregnant or breastfeeding * using hormonal contraception or history of using hormonal contraception within 1 year * on anti-seizure therapy or hormone replacement therapy * history of drug use that can affect the thyroid * history of using topical hydroquinone in the last 3 months and / or using a topical steroid and / or an vitamin a analog and / or received chemical peeling in the last 1 month * history of laser therapy and / or mechanical abrasion therapy in the past 9 months

Keywords: melasma modified melasma area and severity index thyroid stimulating hormone free thyroxine
tlc399 (prodex) in subjects with macular edema due to retinal vein occlusion (rvo)

Conditions: Retinal Vein Occlusion; Macula Edema

Summary: randomized, double-masked trial designed to investigate the use of tlc399 (prodex) in subjects with macular edema due to crvo or brvo.

part 1 is a randomized, double-maskedtrial trial designed to investigate the use of tlc399 in subjects with macular edema due to crvo or brvo. three different dose strengths will be evaluated. part 2 is a randomized, double-masked study designed to evaluate 2 doses of tlc399 in subjects with macular edema due to crvo or brvo. subjects will be randomized 1:1 to receive two different dose strenghs of investigational product.

Eligibility criteria:
inclusion criteria: 1. male or female, at least 18 years of age 2. macular edema due to crvo or brvo 3. best-corrected visual acuity (bcva) score of 20/40 to 20/400 4. mean central subfield thickness (cst) ≥350 um 5. willing and able to comply with the study procedure and sign a written informed consent 6. agree to use a medically acceptable form of birth control exclusion criteria: 1. poorly controlled diabetes 2. history of significant intraocular pressure (iop) elevation to steroid treatment 3. history of ocular hypertension and glaucoma 4. cataract surgery in the study eye within 3 months, or intraocular surgery within 6 months prior to screening 5. use of hemodilution for the treatment of rvo 6. use of ivt ranibizumab or bevacizumab in the study eye within 6 weeks prior to screening; or ivt aflibercept within 8 weeks prior to screening 7. ivt ozurdex to the study eye within 6 months prior to screening 8. prior use of retisert or iluvien 9. use of systemic steroids or heparin within 1 month prior to screening
motivational parameters associated with physical activity and sedentary behaviors among persons with chronic diseases

Conditions: Health Behavior

Summary: the principal aim of these researches is to explored the role of motivational parameters, including: automatic and controlled psychological processes and self-regulatory capacities, in physical activity and sedentary behaviors adoption and maintenance. precisely investigators are interested in change in motivational and self-regulatory processes during rehabilitation programs and their prospective influences on self-reported and objective behaviors among persons with chronic diseases.

automatic processes refered to implicit attitudes measured through the implicit association test (iat) and single category (sc-iat). controlled processes refered to the variables of the theory of planned behavior measured by questionnaire. self regulatory capacities refered to the concept of impulsivity measured by questionnaire and executive functions measured through the stroop task and wisconsin card sorting task. physical activity and sedentary behaviors are measured by questionnaire and accelerometry.

Eligibility criteria:
inclusion criteria: * over 18 years old * under health care coverage exclusion criteria: * medical contra-indication to exercise * concerned by acute health procedure * enable to completed computerised tests and questionnaires * under psychiatric treatment

Keywords: physical activity sedentary behavior implicit attitudes self regulation intention chronic diseases
a comparison of two daily disposable contact lenses

Conditions: Refractive Error; Myopia

Summary: this study seeks to evaluate the clinical performance of a new ce marked daily disposable contact lens that contains a wetting agent to a recently improved daily disposable contact lens.


Eligibility criteria:
inclusion criteria: 1. they are of legal age (18 years) and capacity to volunteer. 2. they understand their rights as a research subject and are willing to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they would be expected to attain at least 6/9 (20/30) in each eye with the study lenses. 5. they are able to wear contact lenses with a back vertex power of -1.00 to -6.00ds. 6. they have a maximum of 1.00d of refractive astigmatism (i.e. ≤ 1.00 dc). 7. they have successfully worn contact lenses within six months of starting the study. exclusion criteria: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus. 7. they are pregnant or lactating. 8. they have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. 9. they have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. hiv). 10. they have diabetes. 11. they have taken part in any other clinical trial or research, within two weeks prior to starting this study.