Kornimate/medical-research-clean huggingface dataset:
vismodegib for orbital and periocular basal cell carcinoma

Conditions: Carcinoma, Basal Cell

Summary: basal cell carcinoma (bcca) is the most common human cancer, and frequently affects facial structures. while rarely fatal, facial bcca can be disfiguring and expensive to treat. vismodegib is a small molecule inhibitor of smo developed for the treatment of tumors in which the hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. vismodegib was recently approved by the food and drug administration (fda) for treatment of metastatic and locally advanced bcca. recent reports have suggested that vismodegib treatment for orbital bcca may facilitate eye preservation even if surgery is eventually required in order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular bcca, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular bcca who are being treated with vismodegib as standard of care. patients with tumors that do not respond to treatment with vismodegib, and those who have a good response but poor tolerance of vismodegib, will be offered surgical excision of the tumor. patients with a good response and good tolerance of vismodegib may continue the treatment as long as clinically indicated.


Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (bcca), or a medial canthal bcca that threatens the lacrimal drainage system. * clinical assessment score obtained at baseline. * medical oncology screening performed at baseline. * adequate bcca size and location. * adequate hematopoietic capacity, hepatic and renal function. * male patients must agree to use condoms during treatment and for 3 months after last dose. * male patients must agree to not donate sperm during treatment and for 3 months after last dose. * participant must agree not to donate blood during the study and for 7 months after last dose. * informed consent signed. * if the patient consents to enroll, then blood will be drawn and stored for biomarker analysis. exclusion criteria: * inability or unwillingness to swallow capsules. * inability or unwillingness to comply with study procedures. * pregnant, lactating, or breast feeding women. * women of childbearing potential. * uncontrolled medical illness. * dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. * age under 18 years.
comparison of plasma concentration changes between two types of tablets of fk949e administration to patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this study is to compare the pharmacokinetics of fk949e low dose tablets and fk949e high dose tablets in non-elderly patients with major depressive disorder. the safety of fk949e in the population was also evaluated.

the objective of the study is to compare the pharmacokinetics of fk949e low dose tablets and fk949e high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. the safety of fk949e in the population is also evaluated.

Eligibility criteria:
inclusion criteria: * patients considered to be able to understand and follow subject requirements, as judged by the investigator/sub-investigator. * patients diagnosed with major depressive disorder according to the dsm-iv-tr by means of m.i.n.i. * bmi: 17.6 (inclusive) to 26.4 (exclusive). exclusion criteria: * current or past history of dsm-iv-tr axis i disorder, except major depressive disorder, within the past 6 months before informed consent. * concurrent dsm-iv-tr axis ii disorder that is considered to greatly affect patient's current mental status. * current or past history of dependence of substances (other than caffeine and nicotine) or history of abuse or dependence of alcohol. * unable to suspend treatment with inducers or inhibitors of the drug-metabolizing enzyme, cytochrome p450 3a4 (cyp3a4), for 14 days before the screening assessment and throughout the study. * patients who could not use an appropriate contraception (condoms) during the study. patients who were pregnant or lactating. * patients (carriers) with documented or suspected renal failure, hepatic failure, serious cardiac disease, hepatitis b, hepatitis c, or acquired immunodeficiency syndrome (aids). * patients receiving treatment for hypertension, or patients with concurrent hypertension or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator/sub-investigator. * patients with concurrent hypotension (criterion for hypotension: a systolic blood pressure of less than 100 mmhg), or orthostatic hypotension * patients with a mean qtcf interval of ≥450 ms on a 12-lead ecg at the screening assessment * patients with the risk of torsades de pointe (e.g., those with a history of qt prolongation, those with familial long qt syndrome). * concurrent malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug. * concurrent malignancy or history of cured malignancy within 5 years * current or past history of cerebrovascular disease or transient ischemic attack (tia). * received electroconvulsive therapy within 90 days before the screening assessment

Keywords: fk949e pharmacokinetics major depressive disorder
effect of face yoga on mimic muscles

Conditions: Facial Yoga; Facial Exercises

Summary: this study aimed to investigate the effect of facial yoga on tonus, stiffness and elasticity of facial muscles.

this study was conducted on healthy volunteers aged 25-50 between june 2024 and january 2025. in the participants who agree to participate in the study, a descriptive data form and myotone evaluations of facial muscles will be performed. measurements will be carried out immediately after the participants are recruited and at the end of the 8-week facial yoga programme.

Eligibility criteria:
inclusion criteria: * individuals between 25-50 years of age whose voluntary consent was obtained exclusion criteria: * botox application to the facial area in the last 6 months, * regular use of analgesics and anti-inflammatories, * the presence of infection or tumoural structures within the structures in the facial region, * with tmj disc displacement and joint degeneration, * cervical or tmj fracture, systemic disease, musculoskeletal problem with evidence of specific pathological condition, * any surgical operation related to cervical or tmj problem, * less than 6 months of cervical or tmj-related physiotherapy and rehabilitation services, * the one with facial paralysis, * participants with diagnosed psychiatric illness will not be included in the study.

Keywords: facial yoga myoton tonus stiffness elasticity
covid-19 in baselland: investigation and validation of serological diagnostic assays and epidemiological study of sars-cov-2 specific antibody responses

Conditions: COVID-19 Infection

Summary: the study is to investigate the antibody response in the blood and saliva of people with a known covid-19 infection in the canton of baselland.

this study is to analyse the antibody response in the blood and saliva of people with a known covid-19 infection in the canton of baselland. the study aims to validate strategies to measure antibody levels with minimal intervention and to explore the antibody response and technical capacity for said measurement. the study will collect the minimally necessary samples to deduce a strategy for serum or saliva surveillance of the population of the canton baselland. to achieve this, the study is designed to address the following points: * determine specificity, sensitivity and general utility of point of care (poc) and elisa tests to deduce a strategy for serum surveillance of the population of the canton baselland * especially validate different poc kits in regard of their use for continuous surveillance * gain an understanding of seroconversion and antibody levels of patients and survivors * gain an understanding of the individual antibody and t-cell repertoire of patients and survivors * study whether patterns of convergent antibody evolution is generated in the surviving population or whether the diseases survivors generated an antibody pool recognizing a specific epitope * develop the technology to correlate blood antibody levels with levels detected in the saliva * develop high throughput technologies for the precise detection of immune cell repertoire and binding epitopes

Eligibility criteria:
inclusion criteria: * tested positive for covid-19 in baselland * tested negative for covid-19 in baselland. specifically, needed to show symptoms to be able to deduce cross reactivities. exclusion criteria: * continuous steroid therapy / chemotherapy / immunsuppressiva * subject is treated for cancer * severe autoimmune disease

Keywords: sars-cov-2 infection elisa test lateral flow assay point of care (poc) assay saliva based serology
registeranalysis for the examination of nomi

Conditions: Mesenteric Ischemia

Summary: the registry includes patients undergoing cardiovascular and thoracic surgery at the saarland university medical center, homburg/saar, germany. this study is a monocentric, retrospective study investigating the development of nomi and outcome of patients.

all data were acquired from the hospital electronic health record and the picture archiving computer system (pacs). nomi was suspected if the following clinical signs occured: new onset of oliguria (urine output \ 5.0mmol/l or metabolic acidosis (base excess \<-5mmol/l). in accordance to the definition of cardiogenic shock angiography was performed in patients with a systolic blood pressure \>90 mmhg and a cardiac index \>1.8 l/minute/m².

Eligibility criteria:
inclusion criteria: * the investigators include anonymous data from patients with cardio-thoracic surgery exclusion criteria: * none

Keywords: nomi angiography digital subtraction angiography (dsa)
antineoplaston therapy in treating patients with advanced mesothelioma

Conditions: Malignant Mesothelioma

Summary: current therapies for advanced mesothelioma provide limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced mesothelioma. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on patients with advanced mesothelioma.

advanced mesothelioma patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to 12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with advanced mesothelioma, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with advanced mesothelioma. * to determine objective response, tumor size is measured utilizing physical examination and radiologic studies, performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iv mesothelioma that is unlikely to respond to existing therapy and for which no curative therapy exists * evidence of disease by ct scan or mri patient characteristics: age: * 1 and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/mm\^3 * platelet count at least 50,000/mm\^3 hepatic: * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal * hepatic function adequate renal: * creatinine no greater than 2.5 mg/dl * no renal insufficiency * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no uncontrolled hypertension * no history of congestive heart failure * no cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no serious lung disease (e.g., chronic obstructive pulmonary disease) other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * not at high medical or psychiatric risk * no nonmalignant systemic disease * no active infection prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulatory agents chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy (or less if multiple tumors) and recovered surgery: * recovered from prior surgery other: * prior cytodifferentiating agents allowed * no prior antineoplastons * no other concurrent antineoplastic agents

Keywords: advanced malignant mesothelioma recurrent malignant mesothelioma
executive training and anomia therapy in chronic post-stroke aphasia

Conditions: Anomia; Post-stroke Aphasia

Summary: aphasia is a devastating acquired language impairment mainly caused by stroke, in which anomia is a quintessential clinical feature. if speech-language therapy (slt) has been shown to be effective for persons with aphasia, the relative efficiency of one slt strategy over another remains a matter of debate. the influential relationship between language, executive functions and aphasia rehabilitation outcomes has been addressed in a number of studies, but only few of them have studied the effect of adding an executive training to linguistic therapies.the aim of this study is to measure the efficiency of a protocol combining anomia therapy and executive training on naming skills and discourse in post-stroke aphasic persons at the chronic stage


Eligibility criteria:
inclusion criteria: * 18 \ 80 years * adult person with chronic post-stroke aphasia (\> 6 months postonset) * receiving slt rehabilitation 3 times a week exclusion criteria: * presence of apraxia of speech * major impairment of comprehension * history of other neurological or psychiatric disease exclusion criteria: * presence of apraxia of speech * presence of major impairment of comprehension * presence of history of other neurological or psychiatric disease

Keywords: aphasia speech-language therapy anomia executive functions
aza with or without atra in newly diagnosed unfit aml or intermediate,high or very high risk mds

Conditions: AML; MDS; Old Age; Debility; Hematologic Cancer

Summary: this is a randomized, open-label, multicenter study to compare the efficacy and safety of aza with or without atra in newly diagnosed unfit aml or intermediate,high or very high risk mds

newly diagnosed unfit aml and intermediate,high or very high risk myelodysplastic syndromes (mds) as per ipss-r criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. nowadays, aza are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%\~34%. aza with or without all-trans retinoic acid (atra) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Eligibility criteria:
inclusion criteria: * chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (m3、apl) and myelodysplastic syndromes(2017 edition) * be at least 18 years of age on day of signing informed consent * not suitable for newly diagnosed patients with intensive chemotherapy * not suitable for newly diagnosed patients with receiving hematopoietic stem cell transplantation * the proportion of blast cells was below 50% in bone marrow * total white blood cell (wbc) count ≤10,000/µl；must be able to swallow tablets exclusion criteria: * malignant neoplasms with other progression * serious mental illness uncooperative * refusal to join the study

Keywords: acute myeloid leukemia myelodysplastic syndromes all-trans retinoic acid azacitidine
guilt focused psychological intervention

Conditions: Guilt; Depressive Symptoms; Anxious Symptoms; Stress, Physiological

Summary: participants in the intervention study will be 120 caregivers with guilt feelings linked with care and high levels of emotional distress (anxiety and/or depression), randomly allocated to the intervention conditions: intervention group and cognitive-behavioral comparison group. the intervention will be provided in a group setting and will consist in 8 sessions plus 3 booster sessions. the effect of the intervention on guilt feelings, depressive and anxious symptomatology, and biomarkers of cardiovascular risk will be assessed after the intervention and at follow-ups at 6 months.

1. contact with collaborator centers. centers with previous collaboration with the research team will provide contact data of potential participants. in addition, information of the project will be made available through posters, news, and internet (e.g., social networks). 2. previous to the assessment each participant will be randomly allocated to the intervention conditions (guilt focused intervention (gfi) and cognitive behavioral therapy (cbt)) following the consort recommendations. randomization will be made through random numbers using computerized procedures. 3. once contacted, caregivers will be requested to sign an informed consent and, if the inclusion criteria are met, the interview will take place. interviews will be conducted by trained psychologists blinded to the project aims and hypothesis. 4. the interviews will consist in questions and questionnaires specifically selected for the project. 5. the intervention conditions have been developed following previous studies by the team or recognized researchers, or following previous research studies in the topic of caregiving stress or related topics (e.g. psychotherapeutic strategies for reducing distress). 6. the interventions will take place in group format (maximum 8 participants per group). each intervention will consist in 8 weekly sessions plus 3 booster sessions in a 5 month period. 7. participants will be assessed again after the intervention (2 months) and at the follow-up (6 months).

Eligibility criteria:
inclusion criteria: * identifying themselves as the main caregiver of the relative with dementia * dedicating at least one daily hour to caregiving tasks * having cared for at least three consecutive months * not having participated in a psychotherapeutic intervention in the last year * showing scores equal or higher than 16 on the center for epidemiological studies-depression scale (ces-d; radloff, 1977) and/or 13 on the tension-anxiety subscale from the profile of mood states scale (poms; mcnair et al., 1971) * showing a score of at least 16 in the caregiver guilt questionnaire (losada et al., 2010). exclusion criteria: * those different to the inclusion criteria

Keywords: caregivers dementia depression anxiety stress guilt psychotherapy
budesonide versus mesalazine versus placebo in lymphocytic colitis

Conditions: Lymphocytic Colitis

Summary: the purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.


Eligibility criteria:
inclusion criteria: * signed informed consent * symptoms and signs of indication of lymphocytic colitis exclusion criteria: * infectious diarrhoea, * diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings celiac disease * pregnancy or breast-feeding, * participation in an other clinical trial
inspiratory training in children after fontan

Conditions: Respiratory Muscle Weakness

Summary: this study will assess physical and respiratory capacity, diaphragmatic mobility and quality of life. healthy children and children who have undergone fontan surgery will participate. some children in the late postoperative period of fontan surgery will be randomized to a group of inspiratory muscle training that will last for 2 months. children after fontan surgery will be evaluated twice, once at the beginning and again after two months of follow-up.

this study aims to evaluate physical capacity through cardiopulmonary testing, submaximal physical capacity testing by the 6-minute walk test, respiratory capacity by spirometry, respiratory muscle strength by manovacuometry, diaphragmatic mobility by ultrasound, quality of life by the auqei questionnaire. there are three groups, a healthy control group, a fontan control group and a fontan intervention group. the intervention will be done by respiratory muscle training using the power breath device.

Eligibility criteria:
inclusion criteria: * age 8 to 12 years; * both sexes; * no history of other heart disease; * no history of lung and musculoskeletal diseases; * \&gt;1 year post-operative fontan surgery; * clinically stable; * absence of serious arrhythmias; * medical clearance to participate in the study; the legal guardian has agreed to participate in the research and the child has consented exclusion criteria: * musculoskeletal alterations; * patients with neurological sequelae; * patients with genetic syndromes associated with cognitive or psychiatric disorders; * history of perioperative arrhythmias; * patients with uncontrolled heart failure; * recent angina; * severe arrhythmia; * hemoptysis; * pulmonary hypertension; * diaphragmatic plication; * moderate to severe asthma.

Keywords: congenital heart disease fontan procedure rehabilitation physiotherapy inspiratory muscle training