Kornimate/medical-research-clean huggingface dataset:
a comparison of dox-sl versus adriamycin plus bleomycin plus vincristine in the treatment of severe aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to determine the efficacy of stealth liposomal doxorubicin hydrochloride (dox-sl) in the treatment of severe aids-related kaposi's sarcoma (ks) by comparison with the established therapy abv: adriamycin (doxorubicin)/bleomycin/vincristine. to evaluate the safety and tolerance of dox-sl compared to abv in a population of aids patients with severe ks.

patients are randomized to receive either dox-sl or the abv combination. infusions are given on day 1 and every 2 weeks for a total of six cycles. kaposi's sarcoma lesions are evaluated prior to every cycle, at the end of the last treatment cycle, and 4 weeks following the end of the last treatment. patients must agree to have one or more representative ks lesions biopsied.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * prophylaxis for pcp, cryptococcal, and herpes infections, and antiretroviral therapy (e.g., azt, ddc, ddi) provided these doses have been stable for at least 1 month. * therapy for tuberculosis, fungal, and herpes infections except with potentially myelotoxic chemotherapy. * foscarnet for new episodes of cytomegalovirus infection. * colony-stimulating factors and erythropoietin. patients must have: * biopsy-proven, progressive, aids-related kaposi's sarcoma, with any of the following: * at least 25 mucocutaneous lesions. * ten or more new lesions in the prior month. * documented visceral disease with at least two accessible cutaneous lesions. * two accessible cutaneous lesions with edema. * documented anti-hiv antibody. * no active opportunistic infection with mycobacteria, cytomegalovirus, toxoplasma, pneumocystis carinii, or other microorganisms (if under treatment with myelotoxic drugs). * life expectancy \> 4 months. note: * patients who respond to therapy on this protocol, as well as those who fail the abv combination, are eligible to enter the liposome technology open trial using dox-sl alone. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * clinically significant cardiac, hepatic, or renal disease. * peripheral neuropathy, signs of moderate to severe sensory loss, or moderate to marked motor loss. * inability to comply with the study. concurrent medication: excluded: * other cytotoxic chemotherapy. * ganciclovir. patients with the following prior conditions are excluded: * prior neoplasms treated with extensive chemotherapy that, in the investigator's opinion, has led to irreversibly compromised bone marrow function. * history of idiosyncratic or allergic reaction to bleomycin or vincristine. prior medication: excluded: * prior anthracycline therapy. * cytotoxic chemotherapy or interferon treatment within the past 4 weeks. prior treatment: excluded: * radiation or electron beam therapy within the past 3 weeks.

Keywords: vincristine sarcoma, kaposi liposomes doxorubicin drug therapy, combination acquired immunodeficiency syndrome bleomycin drug carriers
ligilactobacillus salivarius mp101 for elderly in a nursing home

Conditions: Covid19

Summary: the objective of this work was to investigate the effect of ligilactobacillus salivarius mp101 on the functional (barthel index), cognitive (gds/fast) and nutritional (mna) status, and on the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by covid-19.


Eligibility criteria:
inclusion criteria: * living in the nursing home * informed consent obtained exclusion criteria: * absence of informed consent * parenteral nutrition (exclusively) * allergy to cow's milk protein

Keywords: covid-19 elderly nursing home probiotics
quality of life measurement in treatment naïve patients with hepatitis c virus (hcv) genotype 1 (gt1) suffering from fatigue and receiving ombitasvir, paritaprevir, and ritonavir and dasabuvir (viekirax®/exviera®)

Conditions: Chronic Hepatitis C Virus (HCV)

Summary: this is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (viekirax®/exviera®, 3d regimen) on total daytime physical activity and fatigue in participants with hcv gt1.


Eligibility criteria:
inclusion criteria: * treatment-naïve participants * mono-infected participants with chronic hcv gt1 * non-cirrhotic participants * participants with debilitating fatigue (fatigue severity scale \[fss\] greater than or equal to 4) exclusion criteria: * participants with sources of fatigue other than hcv (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue) * participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion * participants who are wheelchair dependent

Keywords: chronic hepatitis c (hcv) genotype 1 paritaprevir ritonavir ombitasvir dasabuvir sustained virological response
neuropsychological sequelae and long covid-19 fatigue

Conditions: Anxiety Depression; Post Traumatic Stress Disorder; Mental Fatigue; COVID-19; Fatigue Syndrome, Chronic

Summary: an association of fatigue with post-viral neuropsychological disturbs has been reported. among patients hospitalized with covid-19 there is an increased incidence of anxiety and depression symptoms. in addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (mazza, m. g. et al 2020). the prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (ptsd) in a study conducted after the outbreak of the covid-19 in iran (silmani et al, 2021), that showed 5.8% of subjects suffering from ptsd after 6 months of sars-cov-2 infection onset. in this study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-covid-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.

this study will address the neuropsychiatric sequelae that remain for at least 6 months after sars-cov-2 acute infection, as depression, anxiety and/or post-traumatic stress disorder. the patiensts will be assessed at the post-covid-19 outpatient clinics of five portuguese hospitals. in the first visit (t1) will be collected the demographic characteristics; the medical history; and the screening of acute disease symptoms and severity. in the second visit (t2), the time frame will be at least 6 months after the positive test and no longer than 9 months, a set of structured questionnaires will be provided, including: the chalder fatigue scale, anxiety and depression hospital scale (hads), the posttraumatic stress symptoms-14 (ptss-14) adapted to covid-19 and the euroqol 5-dimensions (eq-5d).

Eligibility criteria:
inclusion criteria: * ≥18 years; * previous covid-19 at least six months after the diagnosis duly documented in the clinical record; * persistent symptoms after cure criteria defined by who symptomatic patients that attend the post-covid-19 follow-up consultation of the study centres. * sars-cov-2 rna confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab. * sars-cov-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional. exclusion criteria: * patients with ptsd previous diagnosis * severe psychiatric disorders documented in the clinical record * patients not able to respond the questionnaire * patients who had a concomitant severe neurological disorder * clinical and radiological diagnosis of stroke with sequelae * clinical diagnosis of alzheimer's disease * clinical diagnosis of parkinson's disease * patients with persistent fatigue symptoms in the 6 months before sars-cov 2 infection

Keywords: sars-cov-2, fatigue, psychological disorders
a study to evaluate the safety, tolerability, pharmacokinetics (pk) and preliminary clinical activity of ro7673396 in participants with advanced solid tumors harboring rat sarcoma viral oncogene homolog (ras) mutation(s)

Conditions: Neoplasms

Summary: this study aims to evaluate the safety and tolerability of ro7673396 in participants with advanced solid tumors harboring ras mutation(s). this study consists of two stages: stage 1 (dose escalation) and stage 2 (dose expansion). stage 1 will define the recommended dose(s) for expansion (rdes) of ro7673396. stage 2 will evaluate preliminary anti-tumor activity of the rde(s) defined in stage 1 and of other doses of interest for future development in selected solid tumor indications.


Eligibility criteria:
inclusion criteria: * histologically documented, locally advanced, recurrent, or metastatic incurable solid tumors * participants with measurable disease according to recist v1.1 assessed by the investigator * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy ≥12 weeks * adequate hematologic and end-organ function * confirmed presence of the ras mutation(s) exclusion criteria: * current participant or enrollment in another interventional clinical trial * known hypersensitivity or medical contraindication to any component of ro7673396 formulation * refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate study treatment absorption * known and untreated, or active central nervous system (cns) metastases * participants with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal (gi) surgery including gastric resection, a history of inflammatory bowel disease * treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 4 weeks or five half-lives prior to initiation of study treatment * major surgical procedure within 28 days prior to initiation of study treatment, or incomplete recovery from surgery that would interfere with the determination of safety or efficacy of study treatment, or anticipation of need for a major surgical procedure during the study * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * known clinically significant liver disease

Keywords: ras mutated solid tumors
serious games for training in oral rehabilitation

Conditions: Health Knowledge, Attitudes, Practice

Summary: coronavirus disease-19 (covid-19) dramatically changed the learning conditions of dental students, with restricted access to training sessions and clinical practice. the "playdent" project proposed the integration of serious games (sgs) in the third-year curriculum, based on tailor-made scenarios questioning the first dental visit of edentulous patients, and examined whether training with the games would advance students' learning outcomes.

three serious games proposed in addition to conventional lectures and practical exercises in oral rehabilitation of edentulous patients were supposed to improve knowledge and skills of undergraduates. however, in order to assess the influence of sgs on students' learning outcomes and subsequent satisfaction, a single-blind controlled protocol was designed. the null hypothesis was that sgs had no impact on the learning outcomes of undergraduate students.

Eligibility criteria:
inclusion criteria: * adult students (aged at least 18) * enrolled in the third-year at the faculty of dental surgery of the university of paris, * agreeing to participate in the study exclusion criteria: * third-year students who had repeated their courses

Keywords: health education
pressure device in the treatment of ear keloids

Conditions: Keloid Ear

Summary: keloids are benign cutaneous lesions, arising from proliferating fibroblasts. keloids of the ear may occur after helix piercings and are difficult to treat, since they tend to form recurrences. guidelines suggest multimodal therapy, however, recurrence rates remain high and prospective randomized trials are still missing. to unravel the most effective combination of therapeutic options for keloids of the ear, 20 patients will be enrolled in a prospective, randomized trial. patients either undergo surgery using the "fillet technique" and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months, or they are additionally treated with a non-customized pressure device.

the prospective randomized controlled trial will be conducted at the department of otorhinolaryngology, head and neck surgery, university medical center ulm, germany. 20 patients will be enrolled in the study. prior to inclusion, informed written consent is obtained from each patient. patients with immunodeficiency are not included, as well as patients with an infectious disease or patients with a missing capacity for consent. all patients undergo surgery using the fillet technique. to prevent the remaining skin from further damage, the meticulous skin preparation is performed either using the microscope or magnifying glasses. the keloid is "peeled" out of the excessive skin pocket. if necessary skin trimming is performed and non-resorbable monofilament single sutures are placed. the first intracutaneous injection of triamcinolone 10mg/ml is given before wound dressing is placed. a blanching of the lesion marks the endpoint of injection. cutaneous sutures are removed after approximately 7 days. injection of triamcinolone is repeated every 4 to 6 weeks for a total of 6 months. when removing the sutures, patients are randomized using consecutive sampling. patients in group a are treated according to the protocol outlined above, having steroid injections for 6 months after surgical removal of the keloid. group b involves patients who are additionally treated with non-customized pressure devices. the standardized clips (k. egner, dental technique, neu-ulm, germany) used in our study are available in two different sizes for smaller or larger defects. according to the guidelines of the german society of dermatology, patients are advised to wear the clip at least 16 hours per day. medically approved transparent acrylate is used so that change in skin color and therefore amount of pressure can be observed at all times. allergic or toxic skin involvement can be visualized through the transparent surface. adjusting of the clip is done with one or two screws.

Eligibility criteria:
inclusion criteria: * keloids of the helical rim of the ear exclusion criteria: * immunodeficiency * infectious disease * missing capacity for consent

Keywords: pressure device clip triamcinolone fillet technique
hitt device pilot testing for traumatic brain injury

Conditions: Brain Injuries, Traumatic

Summary: the purpose of this research study is to collect data from the eyes of traumatic brain injury (tbi) patients. patients will look at a green target that will measure the fixation of the eye for 30 seconds. in that 30 seconds, the location of the green target will change and the participant is to track, with their eyes, the light as best they can. the device will measure how well fixation was maintained and the speed of the saccadic movements of the eye. data will then be used to determine whether there is correlation between these measures and known tbi.


Eligibility criteria:
inclusion criteria: 1. age ≥18-40 2. documented/ verified mild tbi 3. mild traumatic brain injury will be defined as glasgow coma scale (gcs) of ≥13 at time of study enrollment 4. injury occurred \< 24 hours ago 5. positive acute brain ct for clinical care 6. visual acuity/ hearing adequate for testing 7. fluency in english or spanish 8. ability to provide informed consent 9. enrolled in track-tbi (irb #: 825503) exclusion criteria: 1. catastrophic polytrauma that would interfere with follow-up and outcome assessment 2. prisoners or patients in custody 3. pregnancy in female subjects 4. patients on psychiatric hold (e.g. 5150, 5250) 5. major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment 6. major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment 7. significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g. substance abuse, alcoholism, hiv/aids, major transmittable diseases that may interfere with consent, end-stage cancers, learning disabilities, developmental disorders) 8. low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts) 9. penetrating tbi 10. spinal cord injury with asia (american spinal injury assoc.) score of c or worse 11. any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment. 12. history of poor vision prior to injury (visual acuity worse than 20/40 in either eye) 13. intoxication or chemical impairment at time of examination (upon initial presentation) 14. evidence on hand-light examination of obvious ocular anomaly or misalignment
a study to test the safety and efficacy of mk-8998 in acutely psychotic participants with schizophrenia (mk-8998-004)

Conditions: Schizophrenia

Summary: a study to evaluate the safety and efficacy of treatment with mk-8998 as compared to placebo and olanzapine for acutely psychotic patients with schizophrenia. the primary hypothesis is that in participants undergoing an acute psychotic episode of schizophrenia, mk-8998 6 to 8 mg twice daily is superior to placebo in the treatment of symptoms of schizophrenia as measured by the mean change from baseline in the positive and negative syndrome scale (panss) total score at week 4.


Eligibility criteria:
inclusion criteria: * patient's age is 18 to 55 * patient meets dsm-iv/dsm-iv-tr criteria for a primary diagnosis of schizophrenia * the duration of the patients schizophrenia diagnosis must be greater than 1 year * patient has an acute exacerbation of psychotic symptoms (of at least 3 days but no longer than 6 weeks) and marked deterioration of function exclusion criteria: * patient currently has a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder that would pose a risk to the patient in the opinion of the investigator if they were to participate in the study or that might confound the results of the study * the patient has evidence of acute hepatitis, clinically significant chronic hepatitis, or impaired hepatic function * the patient has a chronic organic disease of the central nervous system (other than schizophrenia) such as, tumors, inflammation, active seizure disorder, vascular disorder, parkinson's disease, alzheimer's disease or other forms of dementia, myasthenia gravis, or other degenerative processes. in addition, patients must not have a history of mental retardation or persistent neurological symptoms attributable to serious head injury * patient has a history of alcohol/drug dependence within 3 months or alcohol/drug abuse within 1 month of screening. exceptions include caffeine and nicotine abuse/dependence * patient has a history of hypersensitivity to olanzapine or poor response to olanzapine in the last 2 years or intolerable side effects due to olanzapine or patients current psychotic relapse occurred while consistently taking a therapeutic dose (10 mg or more) of olanzapine or olanzapine is medically contradicted * patient is refractory to antipsychotic treatment

Keywords: acute exacerbation of schizophrenia
the effect of 3% diquafosol ophthalmic solution on visual display terminal-associated dry eye

Conditions: Dry Eye Syndromes; Computer Vision Syndrome; Asthenopia

Summary: this study aims to evaluate the efficacy and safety of 3% diquafosol ophthalmic solution for visual display terminal (vdt)-associated dry eye and to investigate the mechanism of treatment.

the treatment period is 12 weeks. the day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. the dosing frequency was six times daily for 3% diquafosol ophthalmic solution. the follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of dry eye.

Eligibility criteria:
inclusion criteria: * male or female with a diagnosis dry eye based on chinese dry eye diagnosis standard (2020)； * working in the offices with vdts more than 4h daily； * working in the offices with vdts at least five days per week； * provision of written informed consent. exclusion criteria: * known allergy to any eye drops * ocular therapies other than artificial tears * presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, meibomian gland dysfunction (mgd) over grade 2 (the grade is according to the report of the international workshop on mgd in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results * pregnant and lactating women, or those planning a pregnancy over the course of the study * uncontrolled systemic disease * hypersensitivity or intolerance to diquafosol(dqs) * subjects with a history of anxiety and depression
azacitidine and chimerism in mds or aml patients after allogeneic stem cell transplant

Conditions: Myeloid Malignancy

Summary: previous studies provide a rationale for administration of aza after allo sct for decreasing chimerism. the investigators hypothesize that azacitidine can be well tolerated after sct and help decrease rate of decreasing donor chimerism and hence decrease relapse without increasing gvhd


Eligibility criteria:
inclusion criteria: 1. patients with aml/mds/mpn, cmml post allogeneic sct who experience any drop in total or myeloid chimerism any time after day 30, or their day 30 or day100 myeloid donor chimerism is below 98% without concurrent hematologic relapse (that is, patients with \<5% bone marrow blasts as obtained at that time point) will be offered treatment with azacitidine 2. \>=30 -180 days post sct and patients must have anc\> 1000, plt \> 50,000 3. age 18-75 years old 4. performance score of at least 70% by karnofsky 5. adequate kidney and liver function as demonstrated by: 1. creatinine clearance should be \>60 ml/min 2. total bilirubin \<1.5, alt/ast/alk phos \< 2.5 x normal. no evidence of chronic active hepatitis or cirrhosis. 6. negative beta hcg test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. women of child bearing potential must be willing to use an effective contraceptive measure while on study. 7. patient or patient's legal representative, parent(s) or guardian able to sign informed consent. 8. patients must be off any prior chemotherapy, radiotherapy, or other investigational therapy within 2 weeks prior to start treatment exclusion criteria: 1. positive for hiv, hbsag, hcv or other viral hepatitis or cirrhosis from any cause 2. active or prior cns leukemia, unless in complete remission for at least 2 months. 3. history of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs. 4. uncontrolled infection 5. grade iii, iv graft versus host disease (gvhd